Clinical outcomes and drug sustainability after non-medical switch from ustekinumab originator to biosimilars in inflammatory bowel disease

Table 1 Demographics and clinical characteristics of inflammatory bowel disease patients who underwent non-medical biosimilar switching, n (%)

Characteristics	IBD (n = 81)
CD/UC	69/12
Male gender	38 (46.9)
Median age at inclusion, years, (IQR)	42.0 (22.0-61.0)
Median duration of disease, years, (IQR)	12.0 (8.0-27.0)
Disease phenotype of CD
A1/A2/A3	31.9%/50.7%/17.4%
L1/L2/L3	17.4%/24.6%/58%
B1/B2/B3	53.6%/28.8%/19.7%
Disease phenotype of UC1
UC: E1/E2/E3	-/16.7/83.3
UC: S1/S2/S32	33.3/16.7/50
Upper GI involvement in CD	9 (14.0)
Perianal/fistulizing disease in CD	15 (21.7)
Extra-intestinal manifestation3	22 (27.2)
Previous intestinal surgery in CD4	35 (50.7)
Earlier medical therapy
Oral 5-ASA	39 (48.1)
Corticosteroid	72 (88.8)
Immunomodulators (AZA, MTX)	34 (42)/20 (24.7)
Ustekinumab originator dose before switch
Q8 week	30 (37)
Q6 week	2 (2.5)
Q4 week	49 (60.5)
Median duration of originators, months (IQR)	58 (31-89)
Biological exposure before ustekinumab originator	67 (82.7)
Multiple biologicals	16 (19.7)
Infliximab	44 (54.3)
Adalimumab	32 (39.5)
Vedolizumab	7 (8.6)

¹Disease location was classified using Montreal classification: E1, proctitis; E2, left-sided colitis; E3, extensive colitis; L1, terminal ileal; L2, colonic; L3 ileocolonic.

²Severe disease activity was defined as a partial Mayo score of 7-9 for ulcerative colitis.

³Extra-intestinal manifestation: Arthritis (15), spondylitis (14), uveitis (1), cutaneous (4), psoriasis (4).

⁴Type of previous surgeries; ileocecal resection (28), small bowel resection (11), colectomy and/or ileal pouch-anal anastomosis (16).

Three patients had certolizumab: And 1 patient golimumab. AZA: Azathioprine; CD: Crohn’s disease; IBD: Inflammatory bowel disease; IQR: Interquartile range; MTX: Methotrexate; UC: Ulcerative colitis; 5-ASA: 5-aminosalicylic acid.