Two‐year effectiveness and safety of golimumab in ulcerative colitis: An IG‐IBD study

Abstract

Background Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response. Objective This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis. Methods Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy. Results A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range 4–142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio (OR) = 3.02, 95% confidence interval (CI) 1.44–6.29, p = 0.003) and being able to discontinue steroids at week 8 (OR = 3.32, 95% CI 1.34–8.30, p = 0.010) and week 14 (OR = 2.94, 95% CI 1.08–8.02, p = 0.036) were associated with longer persistence on therapy. At week 54, 65/124 (52.4%) post-induction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy ( p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients. Conclusions Biological-naïve status and not requiring steroids at weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.

Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan

“…The overall ADR incidence was also comparable to those previously reported [ 19 , 27 ]. In the current study, the most frequent ADRs by SOC were infections and infestations (21 patients, 5.4%), followed by skin and subcutaneous tissue disorders (19 patients, 4.9%), similar to previous findings [ 16 , 17 ]. Comorbidities were identified as a risk factor for an increased ADR incidence by multivariate analysis.…”

“…Regarding safety outcomes, the profile was consistent with previous reports [16,17,27]. The overall ADR incidence was also comparable to those previously reported [19,27].…”

“…Clinical remission by partial Mayo scores was ∼40% 1 year after GLM initiation in UC patients, including the biologic-experienced population. The main reason for GLM therapy withdrawal was a lack of efficacy, and ADRs during the 52-week observation period were similar to previous findings [ 16 , 17 , 19 , 27 ].…”

“…Studies on the safety and effectiveness of GLM in clinical settings remain limited, and its characteristics for UC therapy are not fully understood, including the impact of previous biologic therapy and concomitant medications. Several observational studies on patients treated with GLM have recently been published [ 16 , 17 ]. However, most have included a limited sample size [ 18 , 19 ], mainly biologic-naive population [ 20 , 21 ], or short follow-up period [ 22 , 23 , 24 ].…”

Long-Term Efficacy and Safety of Golimumab for Ulcerative Colitis in a Pediatric Inflammatory Bowel Disease Center in Japan

“…Conversely, patients with PNR to IFX failed to maintain remission with drugs that have similar mechanisms of action. These tendencies were also reported in an adult study [ 24 ]. For pediatric UC, the latest ECCO/ESPGHAN consensus guidelines for pediatric UC stipulated that GLM has no role in patients with PNR to IFX [ 25 ].…”