Published online Dec 21, 2016. doi: 10.3748/wjg.v22.i47.10432
Peer-review started: August 11, 2016
First decision: September 5, 2016
Revised: September 25, 2016
Accepted: October 31, 2016
Article in press: October 31, 2016
Published online: December 21, 2016
To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response.
We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician’s global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database.
Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted.
This real-life practice study endorses golimumab’s promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.
Core tip: Golimumab is a fully humanized anti-tumor necrosis factor-alpha monoclonal antibody, which has recently been accepted in clinical practice. Pivotal studies have demonstrated the drug’s benefits, but real-life studies are still scarce. This observational, prospective and multi-center study in moderate-severe ulcerative colitis patients, confirmed golimumab’s short-term (14 wk) effectiveness. A high percentage of patients had responded and were off steroids at the end of follow-up. No severe adverse events were observed. Intensification (reducing the drug administration interval or increasing the dosage) may be useful in many slow-to-respond cases.