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Dharmaraj R, Lemon TP, Elmaoued R, Castillo RO, Alkhouri R. Infusion Reactions to Infliximab in Pediatric Patients with Inflammatory Bowel Disease. CHILDREN (BASEL, SWITZERLAND) 2024; 11:1366. [PMID: 39594941 PMCID: PMC11592503 DOI: 10.3390/children11111366] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Revised: 11/02/2024] [Accepted: 11/07/2024] [Indexed: 11/28/2024]
Abstract
Infliximab (IFX) is a recombinant DNA-derived chimeric IgG monoclonal antibody protein that inhibits tumor necrosis factor alpha (TNF-α). IFX, like other agents derived from foreign proteins, can cause infusion reactions both during and after the infusion. The incidence of infusion reactions ranges between 0% and 15% in pediatric patients. The potential underlying mechanisms for these reactions may include anaphylaxis and anaphylactoid reactions, cytokine release syndrome, serum sickness-like reactions, and the development of antibodies against IFX. Several precautions can help reduce the risk of a new infusion reaction, such as a gradual increase in the infusion rate, scheduled infusions, and administering premedication or immunomodulators alongside IFX. Acute mild to moderate reactions often resolve spontaneously after a temporary cessation of the infusion or reduction in the infusion rate. Strategies like graded dose challenges and premedication can be utilized to prevent recurrence. In cases of severe reactions, desensitization or switching to an alternative biologic may be considered. This article aims to review the most recent guidelines for managing IFX-related infusion reactions in pediatric patients with inflammatory bowel disease (IBD), relying on the best available evidence.
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Affiliation(s)
- Rajmohan Dharmaraj
- Division of Gastroenterology, Department of Pediatrics, University of New Mexico, Albuquerque, NM 87131, USA; (T.P.L.); (R.E.); (R.O.C.); (R.A.)
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2
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Curci D, Lucafò M, Decorti G, Stocco G. Monoclonal antibodies against pediatric ulcerative colitis: a review of clinical progress. Expert Opin Biol Ther 2024; 24:1133-1144. [PMID: 39285823 DOI: 10.1080/14712598.2024.2404076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2024] [Accepted: 09/10/2024] [Indexed: 09/21/2024]
Abstract
INTRODUCTION In children, ulcerative colitis (UC) is often more severe and extensive than in adults and hospitalization for acute exacerbations occurs in around a quarter of subjects. There is a need for effective drugs, which could avoid or reduce the use of corticosteroids which, especially in children, are burdened by a number of severe side effects. The introduction in therapy of monoclonal antibodies has completely changed the therapeutic scenario and the prognosis of the disease. AREAS COVERED In this review, the use of the monoclonal antibodies directed against tumor necrosis factor (TNF)α or other inflammatory targets for the treatment of pediatric UC will be discussed. A search of the literature was done using the keywords 'pediatric,' 'ulcerative colitis,' 'inflammatory bowel disease,' 'monoclonal antibodies;' 'infliximab,' 'adalimumab,' 'golimumab,' vedolizumab," 'ustekinumab' and 'risankizumab.' EXPERT OPINION The use of monoclonal antibodies has greatly increased in recent years in pediatric UC, both in patients who did not respond to conventional therapies, and, more often, as initial therapy. Thanks to therapeutic drug monitoring and to the availability of biologics with different targets, therapy has become more targeted and personalized, with a significant improvement in response, in quality of life, and with a good safety profile.
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Affiliation(s)
- Debora Curci
- Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy
| | - Marianna Lucafò
- Department of Life Sciences, University of Trieste, Trieste, Italy
| | - Giuliana Decorti
- Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy
| | - Gabriele Stocco
- Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy
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Abushamma S, Walker T, Garza K, Chen L, Nix D, Chen CH. Accelerated Infliximab Infusion Safety and Tolerability Is Non-inferior to Standard Infusion Protocol in Inflammatory Bowel Disease Patients: A Randomized Controlled Study. CROHN'S & COLITIS 360 2023; 5:otad022. [PMID: 37288326 PMCID: PMC10243871 DOI: 10.1093/crocol/otad022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/10/2023] [Indexed: 06/09/2023] Open
Abstract
BACKGROUND AND AIM Infliximab is typically given over an infusion time of 2 hours, leading to a significant burden in inflammatory bowel disease (IBD) patients. We aimed to determine the safety and cost-effectiveness of an accelerated infliximab infusion of 1 hour, compared with the standard 2-hour infusion. METHODS Open-label randomized trial where IBD patients receiving maintenance infliximab infusions were randomly assigned to 1- and 2-hour infusion groups, corresponding to study and control groups, respectively. The primary outcome was the rate of infusion reactions. Secondary outcomes were assessment of the effect of premedications and immunomodulators on the rate of infusion reactions, and cost-effectiveness analysis. The cost-effectiveness analysis was based on direct nursing costs for the infusion time, indirect infusion center costs, and cost of productivity loss for patients. This trial is registered with ClinicalTrials.gov, NCT05340764. RESULTS From November 2020 to November 2021, 96 patients were randomly assigned: 51 (53%) to the 1-hour infusion group and 45 (47%) to the 2-hour infusion group. Over a median time of 1 year, 309 infusions were administered in the control group, and 376 in the study group. Fifty-seven (18%) infusions in the control group and 45 (12%) infusions in the study group experienced an infusion reaction. The only infusion reaction was asymptomatic hypotension not requiring infusion discontinuation. No other infusion reactions (mild or moderate/severe) were seen. Diphenhydramine was associated with an increased rate of infusion reactions (OR 2.04 [95% CI 1.18-3.52], P = .01). The average costs were estimated to reduce by 37% in the accelerated infusion group. CONCLUSIONS Accelerated 1-hour infusions are non-inferior in safety and superior in cost-effectiveness compared with standard 2-hour infusions in IBD patients receiving maintenance infliximab infusions. TRIAL IDENTIFICATION NUMBER Registered with ClinicalTrials.gov, NCT05340764.
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Affiliation(s)
- Suha Abushamma
- Division of Gastroenterology, John T. Milliken Department of Medicine, Washington University School of Medicine, Saint Louis, Missouri, USA
| | - Ted Walker
- Division of Gastroenterology, John T. Milliken Department of Medicine, Washington University School of Medicine, Saint Louis, Missouri, USA
| | - Kevin Garza
- Division of General Medicine, John T. Milliken Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA
| | - Ling Chen
- Division of Biostatistics, Washington University School of Medicine, Saint Louis, Missouri, USA
| | - Darren Nix
- Division of Gastroenterology, John T. Milliken Department of Medicine, Washington University School of Medicine, Saint Louis, Missouri, USA
| | - Chien-Huan Chen
- Division of Gastroenterology, John T. Milliken Department of Medicine, Washington University School of Medicine, Saint Louis, Missouri, USA
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Colman RJ, Dykes DMH, Arce-Clachar AC, Saeed SA, Minar P. Infliximab Therapy for Pediatric Crohn Disease and Ulcerative Colitis. PEDIATRIC INFLAMMATORY BOWEL DISEASE 2023:407-422. [DOI: 10.1007/978-3-031-14744-9_31] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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Rusch C, Wood M, Kennedy AG, Tompkins BJ, Frasca JD. Rapid infusion of infliximab biosimilars and the incidence and severity of infusion-related reactions in patients with inflammatory bowel disease. J Clin Pharm Ther 2022; 47:1851-1857. [PMID: 36134561 PMCID: PMC9825869 DOI: 10.1111/jcpt.13779] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2022] [Revised: 08/26/2022] [Accepted: 09/04/2022] [Indexed: 01/11/2023]
Abstract
WHAT IS KNOWN AND OBJECTIVE Infliximab is an anti-tumour necrosis factor agent used in the treatment of inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. While the use of infliximab is well established in the treatment of IBD, there are now four recently FDA-approved infliximab biosimilars that are increasingly used due to their cost-benefit for patients, institutions and payors. In addition, shortening the length of infliximab infusions from 120 min (standard infusion) to 60 min or less (rapid infusion) has been shown to safely provide further cost-benefit while also improving patient convenience. The safety of rapid infusions has been well-established for the infliximab reference product, however, there are limited data available regarding the safety of rapid infusions for infliximab biosimilars. The purpose of this study was to compare the incidence and severity of infusion reactions among patients with IBD receiving rapid infusion of infliximab reference product compared with infliximab biosimilar. METHODS This was a retrospective analysis of electronic health record data of patients with a diagnosis of IBD receiving an infliximab reference product or infliximab biosimilar infusion between December 2020 and December 2021. Patient-level variables included demographics, immunomodulator use, IBD-related hospitalization and infliximab trough concentration and antibody levels. Infusion-related variables of interest included total number of infusions, drug, dose, dosing interval, infusion time and use of pre-medications. Infusion-related reactions were defined as safety concerns documented by the administering nurse (anaphylaxis, shortness of breath, hypotension, swelling, rash, pruritus, hives, flushing, chest pain, muscle pain, joint pain, fevers, chills, headache or hypertension) or administration of emergency medications. Fisher's exact test was used to compare reaction rates. RESULTS AND DISCUSSION A total of 188 patients met inclusion criteria for analysis, and a total of 1124 infusions were administered during the study period. There were no statistically significant differences among any of the pre-specified outcomes. There were no differences in the incidence of infusion reactions among rapid infusion (60 min) infliximab and infliximab biosimilars (p = 0.863). Additionally, there were no differences in the incidence of infusion reactions among standard infusion (120 min) infliximab and infliximab biosimilars (p = 0.993). Finally, there were no differences among the rate of infusion reactions between rapid infusion of infliximab biosimilars and standard infusion of infliximab biosimilars (p = 0.536). Eight patients experienced safety issues, with three patients requiring emergency medications (1.6% of 188 patients). WHAT IS NEW AND CONCLUSIONS Rapid infusions of infliximab biosimilars were not associated with an increase in the incidence of infusion reactions compared with: rapid infusion of infliximab reference product, standard infusion of infliximab biosimilars, or standard infusion of infliximab reference product. This should reassure clinicians that rapid infusions of infliximab biosimilars are safe in clinical practice.
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Affiliation(s)
- Caroline Rusch
- Pharmacy DepartmentUniversity of Vermont Medical CenterBurlingtonVermontUSA
| | - Marci Wood
- Pharmacy DepartmentUniversity of Vermont Medical CenterBurlingtonVermontUSA
| | - Amanda G. Kennedy
- Department of Medicine Quality ProgramThe Larner College of Medicine at The University of VermontBurlingtonVermontUSA
| | - Bradley J. Tompkins
- Department of Medicine Quality ProgramThe Larner College of Medicine at The University of VermontBurlingtonVermontUSA
| | - Joseph D. Frasca
- Division of GastroenterologyUniversity of Vermont Medical CenterBurlingtonVermontUSA
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Ong WC, Lim MS, Chan E, Lim TCT, Lim TG, Chan W. A quality improvement project reduces time spent at an inflammatory bowel disease infusion center with accelerated infliximab infusion protocol. JGH OPEN 2022; 6:470-476. [PMID: 35822121 PMCID: PMC9260204 DOI: 10.1002/jgh3.12776] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/06/2022] [Revised: 04/29/2022] [Accepted: 05/15/2022] [Indexed: 11/11/2022]
Abstract
Background and Aim Methods Results Conclusion
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Affiliation(s)
- Wan Chee Ong
- Department of Pharmacy Singapore General Hospital Singapore
| | - Miao Shan Lim
- Department of Gastroenterology and Hepatology Singapore General Hospital Singapore
| | - Elaine Chan
- Department of Nursing Singapore General Hospital Singapore
| | | | - Teong Guan Lim
- Department of Pharmacy Singapore General Hospital Singapore
| | - Webber Chan
- Department of Gastroenterology and Hepatology Singapore General Hospital Singapore
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O'Connell DM, Nachreiner J, Shu X, Terry E, Imburgia T, Vanderloo J, Lasarev MR, Bogenschutz M. Rapid Infliximab Biosimilar Infusion in Children With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr 2022; 74:605-609. [PMID: 35149648 DOI: 10.1097/mpg.0000000000003402] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
OBJECTIVES Compare prevalence of infusion reaction (IR) between infliximab (IFX) and infliximab biosimilar (IFX-abda) at standard and rapid rates and measure the impact on health care cost in children with inflammatory bowel disease (IBD). METHODS Records of subjects receiving IFX and IFX-abda were reviewed over a 21-month period. Demographics and IRs were recorded. Cost analysis utilized average wholesale pricing, infusion duration, nursing time, and infusion center throughput. RESULTS Fifty-six subjects received 498 infusions. Sixteen subjects received both IFX and IFX-abda. Thirteen IRs occurred for an overall prevalence of 2.6%. One outlier subject accounted for 8 of 13 (62%) of IRs. Data were analyzed with and without the outlier. Standard rate infusion of both IFX and IFX-abda was associated with increased risk of IR compared with rapid rate but only reached significance for IFX when calculated with the outlier removed. Risk of IR was not statistically significant between IFX and IFX-abda for both standard and rapid rates. IFX-abda saved an average of $2,611 per infusion. Rapid infusion saved 70 minutes of infusion time, 20 minutes of estimated nursing time per infusion, and decreased infusion center appointment length by as much as 2 hours per infusion. CONCLUSIONS Rapid IFX-abda appears safe without increased IRs and decreases cost.
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Affiliation(s)
- Daniel M O'Connell
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Wisconsin School of Medicine and Public Health
| | | | - Xin Shu
- Pharmacy Department, University of Wisconsin Hospitals and Clinics
| | - Erica Terry
- University of Wisconsin School of Pharmacy, Madison, WI
| | | | | | - Michael R Lasarev
- Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI
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Vulliemoz M, Brand S, Juillerat P, Mottet C, Ben-Horin S, Michetti P. TNF-Alpha Blockers in Inflammatory Bowel Diseases: Practical Recommendations and a User's Guide: An Update. Digestion 2021; 101 Suppl 1:16-26. [PMID: 32739923 DOI: 10.1159/000506898] [Citation(s) in RCA: 42] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/06/2019] [Accepted: 03/01/2020] [Indexed: 02/04/2023]
Abstract
BACKGROUND Anti-tumour necrosis factor-alpha (anti-TNF) antagonists have been the mainstay in the treatment of inflammatory bowel diseases (IBDs) for over 20 years. SUMMARY This review article aimed to provide an update on recent advances in TNF antagonist therapy for IBDs. Key Messages: Their position in the treatment algorithm has evolved to "rapid step-up therapy" or "top-down therapy" according to disease severity and patients' characteristics. Limitations of anti-TNF antagonists include loss of response in up to 30-50% of patients with or without the development of antibodies. Therapeutic drug monitoring should provide a tailored, personalized approach to this scenario. Recently, biosimilar agents have been approved for IBDs and are considered equivalent in efficacy to the originator.
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Affiliation(s)
- Marianne Vulliemoz
- Crohn's and Colitis Center, Gastroenterologie Beaulieu and Division of Gastroenterology and Hepatology, CHUV, Lausanne, Switzerland,
| | - Stephan Brand
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kantonsspital Sankt Gallen, St. Gallen, Switzerland
| | - Pascal Juillerat
- Department of Visceral Surgery and Medicine, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Christian Mottet
- Crohn's and Colitis Center, Gastroenterologie Beaulieu and Division of Gastroenterology and Hepatology, CHUV, Lausanne, Switzerland.,Centre sédunois de Gastroentérologie, Sion, Switzerland
| | - Shomron Ben-Horin
- Inflammatory Bowel Disease Unit and Gastro-Immunology Laboratory Sheba Medical Center Tel-Aviv University, Tel-Aviv, Israel
| | - Pierre Michetti
- Crohn's and Colitis Center, Gastroenterologie Beaulieu and Division of Gastroenterology and Hepatology, CHUV, Lausanne, Switzerland
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9
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Crane H, Wu N, Chan P, Nguyen P, Williams AJ, Ng W, Connor SJ. Safety, satisfaction, and cost savings of accelerated infusions of standard and intensified-dose infliximab for inflammatory bowel disease. Intern Med J 2021; 52:2143-2149. [PMID: 34405958 DOI: 10.1111/imj.15493] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2021] [Accepted: 07/30/2021] [Indexed: 11/26/2022]
Abstract
INTRODUCTION Infliximab remains a mainstay for treatment of inflammatory bowel disease (IBD), but a long infusion duration and subsequent monitoring can be burdensome to patients and health care providers. We assessed the safety of accelerated infusions for standard and dose-intensified infliximab regimens, and the effect on patient satisfaction and potential cost savings. METHODS Patients with IBD on a stable maintenance dose of infliximab and in clinical remission received one or more accelerated infusions; over 30 min if receiving standard-dose (5 mg/kg), or over 60 min if receiving dose-intensified infliximab (up to 10 mg/kg). Outcomes included incidence of reactions (acute or delayed), patient satisfaction, and potential cost savings. We also explored infliximab trough levels after one and three accelerated infusions. RESULTS 52 patients who received 150 infusions were studied. Incidence of reactions to accelerated infusions was 3.3% (3 out of 89) with standard-dose and 0% (out of 61) with dose-intensified infliximab. Reactions were delayed, mild, and self-limiting. None requiring drug cessation. Patient satisfaction was improved with shortened infusion time as compared to the patients' previous experiences (p = 0.00002). Mean plasma trough level of infliximab reduced from 9.3 mg/L (± 4.9) to 7.9 mg/L (± 4.1) (p = 0.02) with accelerated infusions, but none developed anti-infliximab antibodies. Nursing cost savings were estimated as $123.52 and $247.04 per-patient per-year for standard and dose-intensified infliximab, respectively. CONCLUSION Accelerated infliximab infusions for standard and dose-intensified regimens seems to be safe and improved patient satisfaction. Potential impact on drug trough levels requires further investigations. This article is protected by copyright. All rights reserved.
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Affiliation(s)
- Harry Crane
- Liverpool Hospital, Liverpool, NSW, Australia.,South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia.,Ingham Institute of Applied Medical Research, Liverpool, NSW, Australia
| | - Nan Wu
- Liverpool Hospital, Liverpool, NSW, Australia.,Microbiome Research Centre, St George Hospital, Liverpool, NSW, Australia
| | - Patrick Chan
- Liverpool Hospital, Liverpool, NSW, Australia.,South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia
| | | | - Astrid-Jane Williams
- Liverpool Hospital, Liverpool, NSW, Australia.,South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia
| | - Watson Ng
- Liverpool Hospital, Liverpool, NSW, Australia.,South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia
| | - Susan J Connor
- Liverpool Hospital, Liverpool, NSW, Australia.,South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia.,Ingham Institute of Applied Medical Research, Liverpool, NSW, Australia
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Pusateri A, Hatcher A, Patel N, Lehman J, Hinton A, Afzali A. Impact of rapid infliximab infusions on access at a large academic tertiary medical center. Am J Health Syst Pharm 2021; 78:2046-2052. [PMID: 34050749 DOI: 10.1093/ajhp/zxab225] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
Abstract
PURPOSE Infliximab promotes remission in patients with inflammatory bowel disease (IBD) and rheumatologic disease (RD). Rapid infliximab infusions (RI) reduce infusion time from 2 hours to 1 hour and can enhance access to care, as defined by capacity, safety, and patient characteristics. Our hypothesis for the study described here was that use of RI can enhance access for patients. METHODS Data on all patients receiving infliximab for IBD or RD at our outpatient infusion center from February 2016 to August 2017 were retrospectively analyzed. Demographic and clinical information were collected. RESULTS Of 348 patients who received infliximab, 205 had IBD and 143 had RD. In terms of capacity, 40% of patients received RI, resulting in a 16.1% decrease in average daily infusion time and a 9.8% increase in average daily available scheduled infusion chair time (P = 0.720). In terms of safety, 4 patients switched back to standard infusions after RI, after 3 specifically had reactions to RI. In terms of patient characteristics, more patients with RD versus IBD received RI (P = 0.020). Among the patients with RD, a lower proportion receiving RI were female (P = 0.043). For the patients with IBD, a higher proportion receiving RI were white (P = 0.048). Among both patients with RD and patients with IBD, a higher proportion receiving RI had private insurance (P = 0.016 and P = 0.018, respectively). CONCLUSION RI were safe and increased available chair time. Females with RD, patients of non-White race with IBD, and patients with public insurance were less likely to receive RI. Future directions include patient surveys and evaluation of implicit bias against patient factors that may impact access to RI.
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Affiliation(s)
- Antoinette Pusateri
- Department of Internal Medicine, The Ohio State University, Columbus, OH, USA
| | - Ashley Hatcher
- Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University, Columbus, OH, and The Ohio State University Inflammatory Bowel Disease Center, The Ohio State University, Columbus, OH, USA
| | - Nisha Patel
- The Ohio State University College of Medicine, The Ohio State University, Columbus, OH, USA
| | - Joy Lehman
- Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University, Columbus, OH, USA
| | - Alice Hinton
- Division of Biostatistics, College of Public Health, The Ohio State University, Columbus, OH, USA
| | - Anita Afzali
- Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University, Columbus, OH, and The Ohio State University Inflammatory Bowel Disease Center, The Ohio State University, Columbus, OH, USA
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Munsel EJ, Bryan PJ, Binstadt BA, Bullock D, Correll CK, Downs EM, Hobday PM, Larson-Nath C, Sudel B, Vehe RK. Rapid Infliximab Infusion in the Pediatric Population. J Pediatr Pharmacol Ther 2020; 25:705-708. [DOI: 10.5863/1551-6776-25.8.705] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/12/2020] [Indexed: 11/11/2022]
Abstract
OBJECTIVES
To compare infusion reaction rates between rapid infliximab (REMICADE, Janssen Biotech Inc) infusions and previous standard 2- to 3-hour infusions; additionally, to assess patient satisfaction and reduction in chair time associated with rapid infliximab infusions.
METHODS
Pediatric rheumatology and gastroenterology patients receiving maintenance infliximab therapy using a standard 2- to 3-hour titrated infusion had the opportunity to enroll in the non-titrated rapid 1-hour infusion protocol following tolerance of induction dosing at 0, 2, and 6 weeks. Patients were included from December 1, 2017, to March 31, 2018, via retrospective chart review and patient satisfaction surveys.
RESULTS
Data were collected on 55 patients receiving a total of 160 rapid infliximab infusions. There were 2 infusion reactions during the enrollment and data collection period, resulting in an overall infusion reaction rate of 1.3%. The patient satisfaction survey results showed all patients were at minimum satisfied with the information provided regarding rapid infliximab, decreased time spent in clinic, ease of scheduling, and overall process.
CONCLUSIONS
Our data suggest rapid infliximab infusions are safe in pediatric rheumatology and gastroenterology patients receiving maintenance infliximab infusion therapy. The overall infusion reaction rate of 1.3% in this study is well below the accepted infusion reaction rate of standard-length infliximab infusions of 2% to 3%.
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Affiliation(s)
- Erin J. Munsel
- Department of Pharmacy (EJM, PJB), University of Minnesota Masonic Children's Hospital, Minneapolis, MN
| | - Peter J. Bryan
- Department of Pharmacy (EJM, PJB), University of Minnesota Masonic Children's Hospital, Minneapolis, MN
| | - Bryce A. Binstadt
- Division of Pediatric Rheumatology (BAB, DB, CKC, PMH, RKV), University of Minnesota, Minneapolis, MN
| | - Danielle Bullock
- Division of Pediatric Rheumatology (BAB, DB, CKC, PMH, RKV), University of Minnesota, Minneapolis, MN
| | - Colleen K. Correll
- Division of Pediatric Rheumatology (BAB, DB, CKC, PMH, RKV), University of Minnesota, Minneapolis, MN
| | - Elissa M. Downs
- Division of Pediatric Gastroenterology (EMD, CLN, BS), University of Minnesota, Minneapolis, MN
| | - Patricia M. Hobday
- Division of Pediatric Rheumatology (BAB, DB, CKC, PMH, RKV), University of Minnesota, Minneapolis, MN
| | - Catherine Larson-Nath
- Division of Pediatric Gastroenterology (EMD, CLN, BS), University of Minnesota, Minneapolis, MN
| | - Boris Sudel
- Division of Pediatric Gastroenterology (EMD, CLN, BS), University of Minnesota, Minneapolis, MN
| | - Richard K. Vehe
- Division of Pediatric Rheumatology (BAB, DB, CKC, PMH, RKV), University of Minnesota, Minneapolis, MN
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Bohra A, Rizvi QAA, Keung CYY, Vasudevan A, van Langenberg DR. Transitioning patients with inflammatory bowel disease from hospital-based to rapid home-based infliximab: A stepwise, safety and patient-orientated process towards sustainability. World J Gastroenterol 2020; 26:5437-5449. [PMID: 33024395 PMCID: PMC7520608 DOI: 10.3748/wjg.v26.i36.5437] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/28/2020] [Revised: 08/10/2020] [Accepted: 09/05/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Infliximab and other intravenous biologic infusions are increasingly used for chronic disorders like inflammatory bowel disease (IBD). Rapid infliximab and home-based infusions are attractive solutions to address resource and capacity issues for infusion centres, yet infliximab infusion reactions reportedly occur in up to 25% of patients with IBD, even at the manufacturers' recommended infusion duration of 2 h. AIM To evaluate the safety, cost and patient satisfaction of transitioning from hospital-based, standard 2 h to rapid home-based, 30-min infliximab infusions. METHODS All patients receiving rapid infliximab infusions for IBD between 2014 to 2017 (39 mo) were compared with those who received standard two-hour IFX infusions between 2005-2013 (96 mo) at a single IBD centre. Data (per-infusion and per-individual) including adverse drug reactions (ADR), duration (based on needle-departure time) and other clinical data were extracted from electronic medical records. Multivariable logistical regression analysis assessed factors potentially associated with increased risk of ADRs to rapid infusions. The primary outcome was the safety [as per relative risk (RR) of ADR] of (1) rapid 30 m infusions (both hospital- and home-based) vs standard 2 h infliximab infusions. Also, relative cost per infusion and patient satisfaction and productivity were evaluated in rapid infusion recipients who transitioned to home-based infusions. RESULTS Of 129 patients who received 1461 rapid IFX infusions (2014-2017) were compared with 169 patients who received 2214 standard IFX infusions (2005-2013). Within the rapid cohort, 55 (42.6%) were males, median age 42 years (range 18, 86), 114 (84%) had Crohn's disease (CD) with a median disease duration 5 years (0, 36). Median needle to departure time was higher in the standard than the rapid protocol group, 108 (70, 253) vs 50 (33, 90) min, P < 0.001), with a per infusion cost of $AUD 107.50 vs $49.77, respectively (both P < 0.001). There was no difference in median infusion duration or costs between rapid home vs hospital-based infusions (P = 0.21). 8 patients in the rapid infliximab cohort had an ADR compared with 23 standard infliximab recipients (RR 0.55% vs 1.04% respectively), hence a higher likelihood of ADR with standard compared to rapid infusions [RR 3.0, 95%CI (1.2, 7.7), P = 0.02]. No ADRs were observed in 405 rapid home-based infusions. A lower body mass index (< 22 kg/m2), presence of one or more extra intestinal manifestations, longer disease duration (> 3 years) and previous exposure to another biologic were each independently associated with a higher likelihood of reaction (s) to rapid infusions. All (100%) survey respondents preferred the rapid vs standard infusions, however within rapid infusion recipients, 61.3% found home based infusions more inconvenient than hospital-based infusions despite a median of 0 h per week missed from paid work and no self-reported loss of work productivity. CONCLUSION Transitioning to rapid infliximab infusions appears very safe with significant cost benefit, patient satisfaction and avails the provision of safe, efficient, home-based infliximab infusions by IBD centres worldwide.
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Affiliation(s)
- Anuj Bohra
- Department of Gastroenterology, Eastern Health, Box Hill 3128, Victoria, Australia
- Eastern Health Clinical School, Monash University, Box Hill 3128, Victoria, Australia
| | - Qurat-Al-Ain Rizvi
- Department of Gastroenterology, Eastern Health, Box Hill 3128, Victoria, Australia
| | | | - Abhinav Vasudevan
- Department of Gastroenterology, Eastern Health, Box Hill 3128, Victoria, Australia
- Eastern Health Clinical School, Monash University, Box Hill 3128, Victoria, Australia
| | - Daniel R van Langenberg
- Department of Gastroenterology, Eastern Health, Box Hill 3128, Victoria, Australia
- Eastern Health Clinical School, Monash University, Box Hill 3128, Victoria, Australia
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Hanna KS, Segal EM, Barlow A, Barlow B. Clinical strategies for optimizing infusion center care through a pandemic. J Oncol Pharm Pract 2020; 27:165-179. [PMID: 32972300 DOI: 10.1177/1078155220960211] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
The national pandemic resulting from the novel coronavirus, COVID-19, has made the delivery of care for patients with cancer a challenge. There are competing risks of mortality from cancer versus serious complications and higher risk of death from COVID-19 in immunocompromised hosts. Furthermore, compounding these concerns is the inadequate supply of personal protective equipment, decreased hospital capacity, and paucity of effective treatments or vaccines to date for COVID-19. Guidance measures and recommendations have been published by national organizations aiming to facilitate the delivery of care in a safe and effective manner, many of which, are permanently adoptable interventions. Given the critical importance to continue chemotherapy, there remains additional interventions to further enhance patient safety while conserving healthcare resources such as adjustments in medication administration, reduction in laboratory or drug monitoring, and home delivery of specialty infusions. In this manuscript, we outline how to implement these actionable interventions of chemotherapy and supportive care delivery to further enhance the current precautionary measures while maintaining safe and effective patient care. Coupled with current published standards, these strategies can help alleviate the numerous challenges associated with this pandemic.
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Affiliation(s)
- Kirollos S Hanna
- Mayo Clinic College of Medicine, Rochester, USA
- M Health Fairview, Maple Grove, USA
| | - Eve M Segal
- Seattle Cancer Care Alliance, University of Washington Medical Center, Seattle, USA
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Abstract
OBJECTIVES The aim of the study was to assess whether the incidence of infusion reactions (IR) increases after rapid (≤1 hour) infliximab (IFX) infusions, compared with standard (2-3 hour) infusions in children. METHODS Systematic review including studies describing the number of IR after rapid IFX infusion in children ages 0 to 18 years. RESULTS Four records were included (3 retrospective, n = 498, 347 standard infusions, 3703 rapid infusions). Reported incidences of IR ranged from 0% to 2% of infusions in standard groups (reported 95% confidence intervals [CIs] ranged from 0% to 7%) and from 0% to 2% of infusions in rapid groups (reported 95% CIs ranged from 0% to 12%). None of the studies included reported a significant difference in incidence of IR between the 2 groups. CONCLUSIONS There is insufficient evidence to conclude whether the rate of IR after rapid IFX increases. The consistent finding of no increase in IR in all studies and the low rate of observed IR suggests there is no significant difference in rate of IR.
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Vasudevan A, Gibson PR, Van Langenberg DR. Systematic Review: Cost-effective Strategies of Optimizing Anti-tumor Necrosis and Immunomodulators in Inflammatory Bowel Disease. Inflamm Bowel Dis 2019; 25:1462-1473. [PMID: 30689858 DOI: 10.1093/ibd/izy399] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/25/2018] [Revised: 12/02/2018] [Accepted: 12/20/2018] [Indexed: 12/23/2022]
Abstract
BACKGROUND Medication costs in inflammatory bowel disease (IBD) are now the principal driver of health care costs. Cost-effective strategies to optimize and rationalize treatment are therefore necessary. METHODS A systematic review until April 30, 2018, was performed to identify economic evaluations of strategies to optimize infliximab, adalimumab, and immunomodulators for the treatment of IBD in adults. A qualitative synthesis of the identified studies was performed. RESULTS Seventy articles were identified that met the inclusion criteria. Adalimumab seems cost-effective compared with infliximab as maintenance therapy for moderate to severe Crohn's disease (CD). Infusion costs are a significant additional treatment cost with infliximab. However, other studies found biosimilar infliximab more cost-effective than alternative biologics in fistulizing and moderate-severe luminal CD-although the latter did not reach a willingness-to-pay threshold of <$50,000. In moderate-severe ulcerative colitis, infliximab seems more cost-effective than adalimumab. Multiple tailored approaches to treatment based on objective markers of disease activity or efficacy have been shown to be cost-effective in CD, including following secondary loss of response to anti-TNF therapy for postoperative recurrence and in escalating treatment. For immunomodulator treatment, both thiopurine methyltransferase (TPMT) testing before commencing thiopurines and thiopurine metabolite testing for dose optimization seem cost-effective. CONCLUSION In a win-win for patients and payers, several potential avenues to achieve cost-effectiveness-but also therapeutic optimization of anti-TNF therapies-were elucidated in this review with comparatively sparse data for immunomodulators. Optimizing immunomodulator and anti-tumor necrosis factor alpha therapy to achieve objective disease control seems to be cost-effective at conventional willingness-to-pay thresholds in a number of clinical settings.
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Affiliation(s)
- Abhinav Vasudevan
- Department of Gastroenterology and Hepatology, Eastern Health, Monash University, Eastern Health Clinical School, Box Hill, Victoria, Australia
| | - Peter R Gibson
- Department of Gastroenterology, Alfred Health and Monash University, Victoria, Australia
| | - Daniel R Van Langenberg
- Department of Gastroenterology and Hepatology, Eastern Health, Monash University, Eastern Health Clinical School, Box Hill, Victoria, Australia
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Safety and Tolerability of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease. Am J Gastroenterol 2019; 114:352-354. [PMID: 30333541 DOI: 10.1038/s41395-018-0368-1] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
INTRODUCTION Infliximab for inflammatory bowel disease (IBD) is FDA-approved to be administered 2 h or more. We adopted a new protocol to infuse infliximab over 1 h and in this study, we aimed to determine the safety of a 1-h infusion. METHODS This retrospective cohort included adult IBD patients who received infliximab between June and December 2017 and compared reaction rates of 1-h maintenance infusions to that of 2-h maintenance infusions. RESULTS A total of 551 infusions were administered to 179 patients. The infusion groups demonstrated no significant differences in reaction rates. CONCLUSIONS Infliximab infusion over 1 h is well-tolerated.
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Decreasing Door-to-Door Times for Infliximab Infusions in a Children's Hospital Observation Unit. Pediatr Qual Saf 2019; 4:e131. [PMID: 30937413 PMCID: PMC6426496 DOI: 10.1097/pq9.0000000000000131] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2018] [Accepted: 11/30/2018] [Indexed: 11/26/2022] Open
Abstract
Supplemental Digital Content is available in the text. Introduction: Children with inflammatory bowel disease (IBD) often require infliximab infusions to manage their disease. Infusions administered in the hospital setting require the patient and their families to devote many hours away from home. Changing to a rapid infusion protocol has been shown in the literature to be safe and has the potential to decrease time spent in the hospital receiving infusions. Methods: We describe stepwise changes made over a 4-month period to improve infliximab infusion efficiency and lessen the time spent in the hospital by IBD patients and their families. These changes included the implementation of a standardized order set, defaulting to rapid infusions for eligible patients, eliminating the post-infusion observation window, and improving the pharmacy's efficiency in preparing infusion medications. We utilized several established quality improvement tools, including a smart aim, key driver diagram, plan-do-study-act cycles, and statistical process control charts to measure these interventions. Results: Within three months of starting, the average door-to-door time patients spent in the hospital decreased by 128 minutes (2 hours 8 minutes). This improvement amounts to 768 minutes (12 hours 48 minutes) per year of time returned for normal childhood activities outside of the hospital. There were no infusion reactions during the period monitored. Conclusions: Implementation of a rapid infliximab infusion protocol made an impressive impact on freed family time without sacrificing patient safety. The changes we implemented could be helpful to other centers interested in decreasing in-hospital time for patients with IBD and their families.
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Null K, Kumar V, Lissoos T, Luo M. Infusion administration billing for vedolizumab and infliximab in inflammatory bowel disease. J Med Econ 2018; 21:1102-1109. [PMID: 30101633 DOI: 10.1080/13696998.2018.1511568] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
AIMS Increasing use of biologics has led to interest in treatment components with potential for cost savings. This study was aimed at comparing administration times and associated costs of infliximab and vedolizumab infusions for inflammatory bowel disease (IBD). MATERIALS AND METHODS This study used claims data from the Symphony Health Integrated Dataverse to identify IBD patients using infliximab or vedolizumab between 20 May 2014 and 29 February 2016. Use of Current Procedural Terminology administration codes was evaluated and costs calculated using the 2016 Center for Medicare and Medicaid Services Physician Fee Schedule. Assessments included infusion times, associated costs, productivity loss using average wage estimates from the United States Bureau of Labor Statistics, and home infusion adoption. RESULTS A total of 10,051 infliximab and 3114 vedolizumab patients with first-hour claims were identified; 52.0% were female and 64.5% had Crohn's disease. There were 48,377 infliximab first-hour claims (mean 4.8 infusions per patient); 46,462 (96.0%) had a second-hour claim. In comparison, there were 14,717 vedolizumab claims (mean 4.7 infusions per patient), with only 411 (2.8%) second-hour claims, resulting in vedolizumab cost savings of approximately $1.27 million. The difference in second-hour infusions resulted in 46,051 additional hours of productivity loss with infliximab, and lost wages averaging $1.18 million (range $0.68-$1.77 million). LIMITATIONS Administration costs were inferred as charge costs and not directly assessed. Productivity loss assessed time spent on infusion only, and included a small proportion of patients beyond working age. CONCLUSIONS Second-hour infusion billing was significantly lower with vedolizumab than with infliximab, corresponding to cost savings and reduced productivity loss.
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Affiliation(s)
- Kyle Null
- a Takeda Pharmaceuticals USA Inc. , Deerfield , IL , USA
| | - Varun Kumar
- a Takeda Pharmaceuticals USA Inc. , Deerfield , IL , USA
- b Institute for Clinical and Economic Review , Boston , MA , USA
| | - Trevor Lissoos
- a Takeda Pharmaceuticals USA Inc. , Deerfield , IL , USA
| | - Michelle Luo
- a Takeda Pharmaceuticals USA Inc. , Deerfield , IL , USA
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Rozette NA, Hellauer CM, McKee C, Vazifedan T, Gabriel CA, Dice JE, Yokois NU. Evaluation of Rapid vs Standard Infliximab Infusions in the Pediatric Population. Inflamm Bowel Dis 2018; 24:2007-2014. [PMID: 29788416 DOI: 10.1093/ibd/izy093] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/02/2017] [Indexed: 12/27/2022]
Abstract
BACKGROUND Rapid 1-hour infliximab infusions have been safely implemented in adults, but studies of these rapid infusions in pediatric patients are limited. This study's primary objective was to determine the safety of 1-hour infliximab infusions compared with standard 2- to 3-hour infusions in children with inflammatory bowel disease and other autoimmune disorders. METHODS We conducted an institutional review board-approved prospective study using an unmatched historical control group at a freestanding children's hospital comparing rapid vs standard infusion rates of infliximab and the use of premedications and immunomodulatory agents on the frequency of early and delayed infusion reactions. RESULTS There were 50 subjects with 540 total standard (2- to 3-hour) infusions in the retrospective group and 66 subjects with 545 total rapid (1-hour) infusions assessed in the prospective group. Although the prospective group received a significantly higher infliximab dose, was significantly less likely to receive premedication, and was significantly more likely to receive another immunomodulatory agent, only 2 instances of potential infusion reactions occurred in the 545 rapid infusions (0.36%; 95% confidence interval [CI], 0.22%-11.01%; 3% of patients) administered in the prospective group compared with 1 documented infusion reaction (0.19%; 95% CI, 0.0%-11.47%; 2% of patients) in the retrospective group (odds ratio, 0.65; 95% CI, 0.01-12.93; P = 0.99). CONCLUSIONS This study suggests that rapid infusion of infliximab over 1 hour is not associated with an increased risk of infusion reactions when compared with standard 2- to 3-hour infusions and can be safely used in children with no previous reaction to standard infusions to treat inflammatory bowel disease and other autoimmune diseases.
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Affiliation(s)
- Nicole A Rozette
- Department of Pharmacy, Carilion Clinic Roanoke Memorial Hospital, Roanoke, Virginia
| | - Christina M Hellauer
- Department of Pharmacy, Children's Hospital of The King's Daughters.,Department of Pediatrics, Eastern Virginia Medical School, Norfolk, Virginia
| | - Chephra McKee
- Department of Pharmacy Practice, Texas Tech University Health Sciences Center School of Pharmacy, Abilene, Texas
| | - Turaj Vazifedan
- Department of Pediatrics, Children's Hospital of The King's Daughters
| | - Christos A Gabriel
- Department of Pediatrics, Eastern Virginia Medical School, Norfolk, Virginia.,Division of Pediatric Rheumatology, Children's Hospital of The King's Daughters
| | - James E Dice
- Department of Pharmacy, Children's Hospital of The King's Daughters.,Department of Pediatrics, Eastern Virginia Medical School, Norfolk, Virginia
| | - Nancy U Yokois
- Department of Pediatrics, Eastern Virginia Medical School, Norfolk, Virginia.,Division of Pediatric Gastroenterology, Children's Hospital of The King's Daughters
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de Carvalho JF, Dos Santos MNP, de Oliveira JMV, Lanty Silva ANS, de Araujo RPC, Cardozo JB. Evaluation of the safety and satisfaction of rheumatic patients with accelerated infliximab infusion. Adv Rheumatol 2018; 58:22. [PMID: 30657070 DOI: 10.1186/s42358-018-0016-x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2018] [Accepted: 06/15/2018] [Indexed: 01/02/2023] Open
Abstract
INTRODUCTION Infliximab infusion generally occurs in 2-4 h. Recent studies have suggested the possibility of accelerated infusion (1 h) of this drug. OBJECTIVE To evaluate the safety of accelerated infliximab infusion in patients with rheumatic diseases. In addition, patient satisfaction was also assessed. METHODS A prospective, single-center, non-randomized study with 34 patients with rheumatic diseases was conducted from July to November 2016. Patients with the following were excluded: history of allergic reaction to biologics, asthma or severe atopy. All patients previously received a 2- to 3-h infliximab infusion. The infusion rate was accelerated to 1 h, and premedication was excluded. The infusion was monitored in all patients. RESULTS A total of 34 patients were included in the study [rheumatoid arthritis (n = 16), ankylosing spondylitis (n = 15), psoriatic arthritis (n = 2) and enteropathic arthropathy (n = 1)], with an average age of 48.7 ± 18.6 years; 55.5% of the patients were female, and 29.4% were white. The duration of disease was 9.5 ± 9.2 years, and the duration of infliximab use was 38.9 ± 27.6 months, with a mean dose per infusion of 414.2 ± 158.1 (range, 200-800) mg. The mean infliximab infusion time prior to the study was 2.2 ± 0.4 h. A total of 6 (17.6%) patients received premedication. The premedication was suspended. There were no adverse effects during or after infusion. Ninety-seven percent of the patients and 100% of the health workers were satisfied with the accelerated infusion. CONCLUSION Our data support the safe use of accelerated infliximab infusion in rheumatic patients, with high satisfaction among patients and health workers.
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Affiliation(s)
- Jozélio Freire de Carvalho
- SOS Vida, Rheumatology Unit, Salvador, Bahia, Brazil. .,Institute of Health Sciences, Universidade Federal da Bahia (Federal University of Bahia), Salvador, Bahia, Brazil.
| | | | | | | | - Roberto Paulo Correia de Araujo
- SOS Vida, Rheumatology Unit, Salvador, Bahia, Brazil.,Institute of Health Sciences, Universidade Federal da Bahia (Federal University of Bahia), Salvador, Bahia, Brazil
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El-Matary W, Dykes DMH, Bauman L, Elkadri A, Carroll MW, Izaguirre MR, deBruyn J, Samson CM, Crim AM, Ali S, Grossman A. Rapid Infliximab Infusion in Children with Inflammatory Bowel Disease: A Multicenter North American Experience. Inflamm Bowel Dis 2017; 23:2104-2108. [PMID: 29140940 PMCID: PMC6551232 DOI: 10.1097/mib.0000000000001259] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
BACKGROUND Infliximab (IFX) infusion may lead to development of anti-IFX antibodies, and subsequent infusion reactions (IRs). The safety of rapid IFX infusion administered over 60 minutes has been under-investigated in children with inflammatory bowel disease. In a multicenter study, the frequency and nature of rapid infusion-associated IRs were examined. METHODS The medical records of all consecutive children with inflammatory bowel disease receiving rapid IFX infusions between January 2014 and December 2016 were reviewed. Poisson regression analysis was used to identify possible associated factors with IRs. RESULTS A total of 4120 rapid infusions for 453 children (median age 16 yrs [interquartile range 13.8-17.8], 289 males, 374 with Crohn's disease) were included. One hundred thirty-five participants (29.8%) received rapid IFX infusion for induction and maintenance while the rest received rapid IFX infusion after a median of 5 (interquartile range 4-9) standard infusions. The median dose of IFX using rapid protocol was 8 mg/kg/infusion (interquartile range 6-10). Two hundred sixty-seven (59%) patients received 1 or more premedications and 161 (35.5%) participants received concomitant immunosuppression. Twenty-one participants (4.6%) had IRs with rapid infusions and 2 participants discontinued IFX because of IRs (0.4%). Antihistamine premedications were associated with less frequent IR (adjusted relative risk = 0.30; 95% confidence interval, 0.14-0.64; P = 0.002). CONCLUSIONS In children with inflammatory bowel disease, rapid IFX infusion administered over 60 minutes is safe and well-tolerated. Antihistamine premedications may reduce frequency of IRs (see Video Abstract, Supplemental Digital Content 1, http://links.lww.com/IBD/B632).
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Affiliation(s)
- Wael El-Matary
- Department of Pediatrics, Section of Pediatric Gastroenterology, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada
- Children’s Hospital Research Institute of Manitoba, Winnipeg, MB, Canada
- Department of Pediatrics, University of Alexandria, Alexandria, Egypt
| | - Dana M. H. Dykes
- Department of Pediatrics, Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children’s Medical Center, Cincinnati, Ohio
| | - Laura Bauman
- Department of Pediatrics, Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children’s Medical Center, Cincinnati, Ohio
| | - Abdul Elkadri
- Pediatric Gastroenterology, Children’s Hospital of Wisconsin, Milwaukee, Wisconsin
| | | | - Marisa R. Izaguirre
- Pediatric Gastroenterology, Dell Children’s Medical Center of Central Texas, Austin, Texas
| | - Jennifer deBruyn
- Department of Pediatrics, University of Calgary, Calgary, AB, Canada
| | - Charles M. Samson
- Department of Pediatrics, Gastroenterology, Hepatology, and Nutrition, Washington University School of Medicine, St. Louis, Missouri
| | - Alisa Muniz Crim
- Pediatric Gastroenterology, Nicklaus Children’s Hospital, Miami, Florida
| | - Sabina Ali
- Pediatric Gastroenterology, Stanford Children’s Health, John Muir Hospital, Walnut Creek, California
| | - Andrew Grossman
- Division of GI, Hepatology, and Nutrition, The Children’s Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
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Abstract
Pediatric data on rapid infliximab infusion are scarce. We report our experience with a 1-hour rapid infusion protocol, prescribed in 3 pediatric inflammatory bowel disease units during 18 to 26 months. Children treated with infliximab for inflammatory bowel disease using a standard 2- to 3-hour infusion protocol were switched to a 1-hour protocol if they had received at least 4 standard duration infusions with no infusion reactions, there was no recent dose increase and no more than 10 weeks had elapsed since the previous infusion. A total of 102 children received infliximab infusions during the study period (85 Crohn disease; mean age 14.6 ± 2.6 years) of whom 63 were switched to the rapid infusions. Seven patients on the rapid protocol (11%) and 6 patients on the standard protocol (15%) had infusion reactions (P = 0.55). Consistent with adult data, our study indicates that a 1-hour infliximab protocol in selected patients offers a safe alternative to the traditional 2- to 3-hour infusions.
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Hutsell SQ, Wu M, Park KT. Frequency of Severe Infusion Reactions Associated With Outpatient Infusion of Infliximab Without Premedications. J Pediatr Gastroenterol Nutr 2017; 65:430-431. [PMID: 28937551 PMCID: PMC5533651 DOI: 10.1097/mpg.0000000000001535] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
In this report, we describe incremental changes, during a 2-year period at a single center with the administration of maintenance infliximab infusions. Given practice-driven changes consisting of 1-hour infusions and omission of premedications, we aimed to investigate if these changes contributed to severe infusion reactions. We reviewed approximately 900 infliximab infusions in a pediatric ambulatory infusion center from January 1, 2014, to December 31, 2015, for severe adverse reactions requiring either rescue epinephrine or a code blue or "rapid response" activation. In 2015, these practice changes resulted in a 51% decrease in total infusion hours (1281 to 630 infusion hours), despite a 9% increase in total number of infusions. No increase in severe adverse events associated with either rapid 1-hour infusion or omission of premedications. Our findings highlight a quality-improvement opportunity to standardize infliximab infusions to streamline care in an ambulatory setting.
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Affiliation(s)
- Stephanie Q Hutsell
- *Department of Pharmacy, Lucile Packard Children's Hospital, Stanford †Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA
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Viola A, Costantino G, Privitera AC, Bossa F, Lauria A, Grossi L, Principi MB, Della Valle N, Cappello M. Clinical and economic impact of infliximab one-hour infusion protocol in patients with inflammatory bowel diseases: A multicenter study. World J Gastrointest Pharmacol Ther 2017; 8:131-136. [PMID: 28533923 PMCID: PMC5421112 DOI: 10.4292/wjgpt.v8.i2.131] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2016] [Revised: 12/30/2016] [Accepted: 01/16/2017] [Indexed: 02/06/2023] Open
Abstract
AIM To assess the impact of short infliximab (IFX) infusion on hospital resource utilization and costs. METHODS All inflammatory bowel diseases (IBD) patients who received IFX 1 h infusion from March 2007 to September 2014 in eight centers from Southern Italy were included in the analysis. Demographic, clinical and infusion related data were collected. The potential benefits related to the short infusion protocol were assessed both in terms of time saving and increased infusion unit capacity. In addition, indirect patient-related cost savings were evaluated. RESULTS One hundred and twenty-five patients were recruited (64 with ulcerative colitis and 61 with Crohn's disease). Median duration of disease was of 53 mo and mean age of pts at diagnosis was of 34 years (SD: ± 13). Adverse infusion reactions were reported in less than 4% both before and after short infusion. The total number of infusions across the selected centers was of 2501 (30.5% short infusions). In the analyzed cohort, 1143 h were saved (762 in the infusion and 381 in observation phases) through the rapid IFX infusion protocol. This time saving (-15% compared to the standard protocol in infusion phase) represents, from the hospital perspective, an opportunity to optimize infusion unit capacity by allocating the saved time in alternative cost-effective treatments. This is the case of opportunity cost that represents the value of forgone benefit which could be obtained from a resource in its next-best alternative use. Hence, an extra hour of infusion in the case of standard 2-h IFX represents a loss in opportunity to provide other cost effective services. The analysis showed that the short infusion increased the infusion units capacity up to 50% on days when the IFX infusions were scheduled (infusion phase). Furthermore, the analysis showed that the short IFX infusion protocol leads to time savings also in the post-infusion phase (observation) leading to a time saving of 10% on average among the analyzed centers. Finally, the short infusion protocol has been demonstrated to lead to indirect cost savings of €138/patient (average -€17.300 on the whole cohort). CONCLUSION A short IFX infusion protocol can be considered time and cost saving in comparison to the standard infusion protocol both from the hospital's perspective, as it contributes to increase infusion units capacity, and the patients' perspective, as it reduces indirect costs and the impact of treatment on everyday life and work productivity.
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Creatively Improving Care Delivery. J Pediatr Gastroenterol Nutr 2017; 64:657-659. [PMID: 27984349 DOI: 10.1097/mpg.0000000000001497] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
The medical community has been challenged to improve upon deficiencies in the delivery of patient care. Quality improvement methods are therefore increasingly used in everyday clinical practice. As demonstrated in this review, creative and impactful improvement projects within pediatric gastroenterology can be successfully achieved as either multicenter projects or single-center efforts. Through our willingness to accept the challenge to improve, practitioners within the pediatric gastroenterology community have become leaders in using quality improvement to change practice and improve clinical outcomes.
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Biancone L, Annese V, Ardizzone S, Armuzzi A, Calabrese E, Caprioli F, Castiglione F, Comberlato M, Cottone M, Danese S, Daperno M, D'Incà R, Frieri G, Fries W, Gionchetti P, Kohn A, Latella G, Milla M, Orlando A, Papi C, Petruzziello C, Riegler G, Rizzello F, Saibeni S, Scribano ML, Vecchi M, Vernia P, Meucci G. Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Dig Liver Dis 2017; 49:338-358. [PMID: 28161290 DOI: 10.1016/j.dld.2017.01.141] [Citation(s) in RCA: 39] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/09/2016] [Revised: 12/19/2016] [Accepted: 01/07/2017] [Indexed: 02/08/2023]
Abstract
Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group.
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Affiliation(s)
- Livia Biancone
- Gastroenterology Unit, University of Rome "Tor Vergata", Department of Systems Medicine, Rome, Italy.
| | - Vito Annese
- AOU Careggi, Gastroenterology, Florence, Italy
| | - Sandro Ardizzone
- Gastrointestinal Unit, ASST Fatebenefratelli Sacco - University of Milan, Milan, Italy
| | - Alessandro Armuzzi
- IBD Unit, Presidio Columbus, Fondazione Policlinico Gemelli Universita' Cattolica, Rome, Italy
| | - Emma Calabrese
- Gastroenterology Unit, University of Rome "Tor Vergata", Department of Systems Medicine, Rome, Italy
| | - Flavio Caprioli
- Department of Pathophysiology and Transplantation, University of Milan and Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda,Ospedale Policlinico di Milano, Milan, Italy
| | | | - Michele Comberlato
- Department of Gastroenterology and Digestive Endoscopy, Central Hospital, Bolzano, Italy
| | - Mario Cottone
- Division of Internal Medicine 2, IBD Unit, Hospital "Riuniti Villa Sofia-Cervello", Palermo, Italy
| | - Silvio Danese
- Humanitas Research Hospital and Humanitas University, Rozzano (Milan), Italy
| | - Marco Daperno
- Hospital "Ordine Mauriziano di Torino", Turin, Italy
| | - Renata D'Incà
- Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Italy
| | - Giuseppe Frieri
- University of L'Aquila, Gastroenterology Unit, L'Aquila, Italy
| | - Walter Fries
- Department of Clinical and Experimental Medicine, Clinical Unit for Chroric Bowel Disorders, University of Messina, Messina, Italy
| | - Paolo Gionchetti
- IBD Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy
| | - Anna Kohn
- San Camillo-Forlanini Hospital, IBD Unit, Rome, Italy
| | | | | | - Ambrogio Orlando
- Division of Internal Medicine 2, IBD Unit, Hospital "Riuniti Villa Sofia-Cervello", Palermo, Italy
| | - Claudio Papi
- IBD Unit, San Filippo Neri Hospital, Rome, Italy
| | - Carmelina Petruzziello
- Gastroenterology Unit, University of Rome "Tor Vergata", Department of Systems Medicine, Rome, Italy
| | - Gabriele Riegler
- U.O. of Gastroenterology C.S. - University della Campania "Luigi Vanvitelli", Naples, Italy
| | - Fernando Rizzello
- IBD Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy
| | - Simone Saibeni
- Gastroenterology Unit, Rho Hospital, ASST Rhodense, Rho, Italy
| | | | - Maurizio Vecchi
- Gastroenterology and Gastrointestinal Endoscopy Unit, IRCCS Policlinico San Donato and University of Milan, San Donato Milanese, Milan, Italy
| | - Piero Vernia
- Gastroenterology Unit, Sapienza, University of Rome, Rome, Italy
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Mazzuoli S, Tricarico D, Demma F, Furneri G, Guglielmi FW. Accelerated Infliximab Infusion: Safety, Factors Predicting Adverse Events, Patients' Satisfaction and Cost Analysis. A Cohort Study in IBD Patients. PLoS One 2016; 11:e0166443. [PMID: 27851772 PMCID: PMC5112916 DOI: 10.1371/journal.pone.0166443] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2016] [Accepted: 10/28/2016] [Indexed: 12/24/2022] Open
Abstract
BACKGROUND Standard Infliximab infusion consists of a 2-hour intravenous administration. Recently, Infliximab shortened infusion has been included in the Infliximab label as possible maintenance regimen for patients tolerating Infliximab induction therapy. AIM To verify if accelerated 1-hour Infliximab infusions are as safe as standard administrations, in patients with Inflammatory Bowel Disease. METHODS Seventy-four patients treated between September 2008 and November 2014 were evaluated. Patients were eligible for 1-hour infusion if they had no history of infusion reactions during the previous 2-hour infusions. RESULTS Twenty-three patients received 2-hour infusions, 16 patients received 1-hour infusions, 35 patients received 2-hour infusions followed by 1-hour infusions. A total of 1,123 Infliximab infusions were administered. The proportion of patients experiencing infusion reaction was: 4% over the 1-hour infusions and 9% over the 2-hour (P = 0.318). Adverse reaction/infusion rate was 0.55% over the 1-hour infusions and 0.66% over the 2-hour (P = 0.835). In the logistic model, accelerated infusion was the only statistically significant predictor of infusion reaction risk reduction (-90%; P = 0.024). Mean satisfaction was 8/10 (±0.84) with 1-hour regimen and 6/10 (±0.56) with 2-hour infusions (P = 0.000). The mean total cost was reduced by 47% with the 1-hour regimen (133.54€ and 250.86€ for 1-hour and 2-hour infusions, respectively). CONCLUSIONS Accelerated Infliximab infusion does not increase the acute infusion reaction incidence. In patients with inflammatory bowel disease, the 1-hour regimen should be preferred to 2-hour protocol also due to positive effects on indirect costs and patient's satisfaction.
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Affiliation(s)
- S. Mazzuoli
- Gastroenterology & Artificial Nutrition Dept., “San Nicola Pellegrino” Hospital, Trani (BT), Italy
| | - D. Tricarico
- Department of Pharmacology and Pharmaceutical Sciences, University of Bari “Aldo Moro”, Bari, Italy
| | - F. Demma
- Health Economics & Outcome Research Department - EBMA Consulting, Milano, Italy
| | - G. Furneri
- Health Economics & Outcome Research Department - EBMA Consulting, Milano, Italy
| | - F. W. Guglielmi
- Gastroenterology & Artificial Nutrition Dept., “San Nicola Pellegrino” Hospital, Trani (BT), Italy
- * E-mail:
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Collins G. Organising infusions: Application administration and complications. J Gastroenterol Hepatol 2016; 31 Suppl 1:26. [PMID: 27273034 DOI: 10.1111/jgh.13358] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 03/10/2016] [Indexed: 12/09/2022]
Affiliation(s)
- Glen Collins
- Concord Repatriation General Hospital, Sydney, New South Wales, Australia.
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Qazi T, Shah B, El-Dib M, Farraye FA. The Tolerability and Efficacy of Rapid Infliximab Infusions in Patients with Inflammatory Bowel Disease. Dig Dis Sci 2016; 61:589-96. [PMID: 26441281 DOI: 10.1007/s10620-015-3893-4] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/15/2015] [Accepted: 09/18/2015] [Indexed: 02/08/2023]
Abstract
OBJECTIVE Few studies have assessed the loss of efficacy or patient and caregiver satisfaction with rapid infliximab infusions. The aim of this study is to assess the tolerability, loss of efficacy and to describe the impact on resource utilization and patient satisfaction in rapid infliximab infusions. METHODS Subjects with inflammatory bowel disease receiving rapid infliximab infusions were included in the study. Subjects received maintenance infusions from June 2011 to June 2013. Incidence of adverse reactions and the total number of rapid infliximab infusions were recorded. Efficacy was compared to published studies evaluating the long-term efficacy of infliximab infusions. Patient satisfaction was addressed through a survey following the implementation of the rapid infusion protocol. RESULTS Seventy-five subjects with IBD were included in the study. Five hundred and twenty-two rapid infliximab infusions were provided to patients. There were no acute or delayed infusion reactions. Ten subjects (13 %) required either a dose escalation or interval adjustment between infliximab infusions. A majority of patients reported increased satisfaction with 1-h infliximab infusions, and 97 % of surveyed patients opted to continue rapid infusions. The rapid infliximab infusion protocol increased infusion unit efficiency by increasing capacity by 15 %. Cost savings in the elimination of nursing time translated to approximately $108,150 savings at our institution. CONCLUSIONS Rapid infliximab infusions do not appear to increase the risk of loss of response compared to historical studies of long-term infliximab efficiency. A rapid infliximab infusion protocol improved efficiency in our infusion unit and increased patient and nursing satisfaction.
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Affiliation(s)
- Taha Qazi
- Department of Internal Medicine, Boston University School of Medicine, 72 East Concord Street, Evans 124, Boston, MA, 02118, USA.
| | - Bhavesh Shah
- Department of Pharmacy, Boston Medical Center, Boston, MA, USA
| | - Mohammed El-Dib
- Department of Pharmacy, Boston Medical Center, Boston, MA, USA
| | - Francis A Farraye
- Section of Gastroenterology, Boston University School of Medicine, Boston, MA, USA
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Lichtenstein L, Ron Y, Kivity S, Ben-Horin S, Israeli E, Fraser GM, Dotan I, Chowers Y, Confino-Cohen R, Weiss B. Infliximab-Related Infusion Reactions: Systematic Review. J Crohns Colitis 2015; 9:806-15. [PMID: 26092578 PMCID: PMC4558633 DOI: 10.1093/ecco-jcc/jjv096] [Citation(s) in RCA: 171] [Impact Index Per Article: 17.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/22/2014] [Revised: 05/11/2015] [Accepted: 05/17/2015] [Indexed: 12/28/2022]
Abstract
OBJECTIVE Administration of infliximab is associated with a well-recognised risk of infusion reactions. Lack of a mechanism-based rationale for their prevention, and absence of adequate and well-controlled studies, has led to the use of diverse empirical administration protocols. The aim of this study is to perform a systematic review of the evidence behind the strategies for preventing infusion reactions to infliximab, and for controlling the reactions once they occur. METHODS We conducted extensive search of electronic databases of MEDLINE [PubMed] for reports that communicate various aspects of infusion reactions to infliximab in IBD patients. RESULTS We examined full texts of 105 potentially eligible articles. No randomised controlled trials that pre-defined infusion reaction as a primary outcome were found. Three RCTs evaluated infusion reactions as a secondary outcome; another four RCTs included infusion reactions in the safety evaluation analysis; and 62 additional studies focused on various aspects of mechanism/s, risk, primary and secondary preventive measures, and management algorithms. Seven studies were added by a manual search of reference lists of the relevant articles. A total of 76 original studies were included in quantitative analysis of the existing strategies. CONCLUSIONS There is still paucity of systematic and controlled data on the risk, prevention, and management of infusion reactions to infliximab. We present working algorithms based on systematic and extensive review of the available data. More randomised controlled trials are needed in order to investigate the efficacy of the proposed preventive and management algorithms.
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Affiliation(s)
- Lev Lichtenstein
- Rabin Medical Center, Petach Tikva, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
| | - Yulia Ron
- Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
| | - Shmuel Kivity
- Sheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
| | - Shomron Ben-Horin
- Sheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
| | - Eran Israeli
- Hadassah-Hebrew University Medical Center, Jerusalem, Israel
| | - Gerald M Fraser
- Rabin Medical Center, Petach Tikva, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
| | - Iris Dotan
- Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
| | - Yehuda Chowers
- Rambam Health Care Campus, Haifa, Israel; Bruce Rappaport School of Medicine, Technion Israel Institute of Technology, Haifa, Israel
| | - Ronit Confino-Cohen
- Meir Medical Center, Kfar Saba, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
| | - Batia Weiss
- Edmond and Lily Safra Children's Hospital, Tel Hashomer, Israel; Sackler Faculty of Medicine, University of Tel Aviv, Israel
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Factors influencing acute infusion reactions in inflammatory bowel disease patients treated with infliximab in the era of scheduled maintenance therapy. Eur J Gastroenterol Hepatol 2015; 27:705-11. [PMID: 25856689 DOI: 10.1097/meg.0000000000000354] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
BACKGROUND An acute infusion reaction during infliximab infusions could lead to drug withdrawal and limit the therapeutic armamentarium in inflammatory bowel diseases. AIM To determine the risk and protective factors of an acute infusion reaction. MATERIALS AND METHODS Data were retrieved retrospectively from electronic charts of patients from the 'Clermont-Ferrand IBD cohort'. RESULTS Among 80 patients, including 51 (63.8%) patients with Crohn's disease, 23 (28.8%) experienced an acute infusion reaction. In multivariate analysis, the Crohn's disease nonstricturing nonfistulizing phenotype predicted an acute infusion reaction (odds ratio=11.40, 95% confidence interval 1.5-87.6; P=0.019).Among 1107 infusions, we observed 38 acute infusion reactions (3.4%). In multivariate analysis, only resumption of infliximab after drug holiday was a major risk factor (odds ratio=24.87, 95% confidence interval 4.4-140.0; P<0.001). Concomitant premedication or immunosuppressant therapies did not prevent an acute infusion reaction.The patients who experienced an acute infusion reaction had a trend toward a higher rate of infliximab discontinuation (69.6 vs. 50.9%, P=0.14). CONCLUSION An acute infusion reaction is a major event in the history of inflammatory bowel diseases patients treated with infliximab as it could lead to drug discontinuation and thus limits the therapeutic armamentarium considerably. The resumption of infliximab after drug holiday is a major risk factor for an acute infusion reaction. Premedication efficacy remains questionable and should be limited to these high-risk patients.
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Michielan A, Martinato M, Favarin A, Zanotto V, Caccaro R, Caruso A, Sturniolo GC, D'Incà R. A nurse-led accelerated procedure for infliximab infusion is well tolerated and effective in patients with inflammatory bowel disease. Dig Liver Dis 2015; 47:372-7. [PMID: 25708258 DOI: 10.1016/j.dld.2015.01.152] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/20/2014] [Revised: 01/20/2015] [Accepted: 01/22/2015] [Indexed: 12/11/2022]
Abstract
BACKGROUND Shorter infusions of infliximab for inflammatory bowel disease seem to be as tolerated as standard procedures and nurses may be able to manage them safely. AIMS To test tolerability and effectiveness of a fast nurse-led infusion procedure and the related patients' satisfaction. METHODS We retrospectively compared three different regimens adopted in our outpatient infusion unit from 2010 to 2013: Group 1, a standard procedure with two-hour infusions, preceded by hydrocortisone medication (87 patients, 311 infusions); Group 2, a similar regimen without physician supervision (130 patients, 464 infusions); Group 3, a one-hour nurse-led procedure without routine premedication (176 patients, 1356 infusions). Disease characteristics, infusion reactions, infusions per month and patients' satisfaction were recorded. RESULTS There were significantly fewer infusion reactions in Group 3 than Group 1 (2.2% versus 5.8% respectively; p=0.001). The only significant risk factor for side effects was premedication (odds ratio 4.71, 95% confidence interval 2.21-10.02, p<0.001) which was related to the presence of previous side effects. Number of infusions per month increased by 27% (83 versus 61, p<0.001) without increasing nurses' workload and patients were satisfied. CONCLUSIONS Our fast nurse-led procedure was well tolerated, effective and satisfactory for patients.
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Affiliation(s)
- Andrea Michielan
- Department of Surgical, Gastroenterological and Oncological Sciences, Azienda Ospedaliera - Università di Padova, Padua, Italy.
| | - Matteo Martinato
- Clinical Research Unit, Azienda Ospedaliera - Università di Padova, Padua, Italy
| | - Andrea Favarin
- Department of Surgical, Gastroenterological and Oncological Sciences, Azienda Ospedaliera - Università di Padova, Padua, Italy
| | - Viviana Zanotto
- Department of Surgical, Gastroenterological and Oncological Sciences, Azienda Ospedaliera - Università di Padova, Padua, Italy
| | - Roberta Caccaro
- Department of Surgical, Gastroenterological and Oncological Sciences, Azienda Ospedaliera - Università di Padova, Padua, Italy
| | - Antonino Caruso
- Department of Surgical, Gastroenterological and Oncological Sciences, Azienda Ospedaliera - Università di Padova, Padua, Italy
| | - Giacomo Carlo Sturniolo
- Department of Surgical, Gastroenterological and Oncological Sciences, Azienda Ospedaliera - Università di Padova, Padua, Italy
| | - Renata D'Incà
- Department of Surgical, Gastroenterological and Oncological Sciences, Azienda Ospedaliera - Università di Padova, Padua, Italy
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Park KT, Crandall WV, Fridge J, Leibowitz IH, Tsou M, Dykes D, Hoffenberg EJ, Kappelman MD, Colletti RB. Implementable strategies and exploratory considerations to reduce costs associated with anti-TNF therapy in inflammatory bowel disease. Inflamm Bowel Dis 2014; 20:946-51. [PMID: 24451222 PMCID: PMC3997595 DOI: 10.1097/01.mib.0000441349.40193.aa] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
A health care system is needed where care is based on the best available evidence and is delivered reliably, efficiently, and less expensively (best care at lower cost). In gastroenterology, anti-tumor necrosis factor agents represent the most effective medical therapeutic option for patients with moderate-to-severe inflammatory bowel disease (IBD), but are very expensive and account for nearly a quarter of the cost of IBD care, representing a major area of present and future impact in direct health care costs. The ImproveCareNow Network, consisting of over 55 pediatric IBD centers, seeks ways to improve the value of care in IBD, curtailing unnecessary costs and promoting better health outcomes through systematic and incremental quality improvement initiatives. This report summarizes the key evidence to facilitate the cost-effective use of anti-tumor necrosis factor agents for patients with IBD. Our review outlines the scientific rationale for initiating cost-reducing measures in anti-tumor necrosis factor use and focuses on 3 implementable strategies and 4 exploratory considerations through practical clinical guidelines, as supported by existing evidence. Implementable strategies can be readily integrated into today's daily practice, whereas exploratory considerations can guide research to support future implementation.
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Affiliation(s)
- KT Park
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Center for Health Policy/Primary Care Outcomes Research, Stanford University School of Medicine, Palo Alto, CA
| | - Wallace V. Crandall
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH
| | - Jacqueline Fridge
- Northwest Pediatric Gastroenterology LLC, Randall Children’s Hospital, Portland, OR
| | - Ian H. Leibowitz
- Children’s Digestive Disease Program, Inova Fairfax Hospital for Children, Fairfax, VA
| | - Marc Tsou
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Eastern Virginia Medical School, Norfolk, VA
| | - Dana Dykes
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH
| | - Edward J. Hoffenberg
- Section of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Colorado Denver School of Medicine, Denver, CO
| | - Michael D. Kappelman
- Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC
| | - Richard B. Colletti
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Vermont College of Medicine, Burlington, VT
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Nantes Ó, Rodríguez C, Basterra M, Gómez M, Cambra K, Ibáñez B, Fernandez-Urien I, Arín A. Letter: The feasibility and safety of accelerated infliximab infusions in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2014; 39:444-5. [PMID: 24447320 DOI: 10.1111/apt.12607] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2013] [Accepted: 12/16/2013] [Indexed: 12/08/2022]
Affiliation(s)
- Ó Nantes
- Gastroenterology Department, Complejo Hospitalario de Navarra, Pamplona, Spain.
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Babouri A, Roblin X, Filippi J, Hébuterne X, Bigard MA, Peyrin-Biroulet L. Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases: a prospective multicenter cohort study. J Crohns Colitis 2014; 8:161-5. [PMID: 23994253 DOI: 10.1016/j.crohns.2013.08.004] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/21/2013] [Revised: 08/10/2013] [Accepted: 08/11/2013] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIM In patients with inflammatory bowel disease (IBD) tolerating 2-h infusions of 5mg/kg infliximab scheduled maintenance therapy, the infusion time can be shortened to 1-h with good tolerability. A retrospective study with small sample size demonstrated the feasibility of 1-hour infusion time for 10mg/kg infliximab in IBD patients. METHODS Between November 2011 and July 2012, 63 patients received 1-hour 10mg/kg infliximab infusions under standard operating procedures and were enrolled in a prospective observational study. Intravenous steroid premedication was given to all patients. RESULTS Sixty-three IBD patients on infliximab maintenance therapy (43 Crohn's disease, 34 males) received 1-hour 10mg/kg infusions during the study period. A total of 182 infliximab infusions were administered. Seventeen (26%) patients were receiving concomitant immunomodulators. Two patients experienced (2/182, 1%) severe acute infusion reactions consisting on a cutaneous lupus and one severe anaphylactic reaction. We also observed one (1/182, 0.5%) severe delayed reaction after the first 1-hour infliximab infusion consisting on acne generalis. All 3 reactions led to infliximab discontinuation. No mild acute reactions and 6 mild delayed reactions (6/182, 3%) occurred. CONCLUSIONS In patients with IBD receiving infliximab scheduled maintenance therapy, 1-hour infusion time for 10mg/kg infliximab seems to be well tolerated. This option might be considered in clinical practice in order to decrease the extra-burden of infliximab infusions in this patient population.
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Affiliation(s)
- Abdenour Babouri
- Inserm U954, Department of Hepato-Gastroenterology, University Hospital of Nancy, Université Henri Poincaré 1, Vandoeuvre-lès-Nancy, France
| | - Xavier Roblin
- Departemental of Hepato-Gastroenterology, University Hospital of Saint Etienne, France
| | - Jérôme Filippi
- Departemental of Hepato-Gastroenterology, University Hospital of Nice, France
| | - Xavier Hébuterne
- Departemental of Hepato-Gastroenterology, University Hospital of Nice, France
| | - Marc-André Bigard
- Inserm U954, Department of Hepato-Gastroenterology, University Hospital of Nancy, Université Henri Poincaré 1, Vandoeuvre-lès-Nancy, France
| | - Laurent Peyrin-Biroulet
- Inserm U954, Department of Hepato-Gastroenterology, University Hospital of Nancy, Université Henri Poincaré 1, Vandoeuvre-lès-Nancy, France.
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Onishi H. Pharmacokinetic Evaluation of Chitosan-Succinyl-Prednisolone Conjugate Microparticles as a Colonic Delivery System: Comparison with Enteric-Coated Conjugate Microparticles. Health (London) 2014. [DOI: 10.4236/health.2014.611157] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
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Neef H, Adler J. Letter: rapid infliximab infusion is not always safe--authors' reply. Aliment Pharmacol Ther 2013; 38:844-5. [PMID: 24001100 DOI: 10.1111/apt.12455] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/26/2013] [Accepted: 07/28/2013] [Indexed: 12/08/2022]
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Lankarani KB. Letter: rapid infliximab infusion is not always safe. Aliment Pharmacol Ther 2013; 38:844. [PMID: 24001101 DOI: 10.1111/apt.12447] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2013] [Accepted: 07/19/2013] [Indexed: 02/05/2023]
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