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

Abstract

Introduction: Real-world evidence for the effectiveness and safety of golimumab (GLM) in patients with ulcerative colitis (UC) is limited. The aim of this study was to investigate the 52-week effectiveness and safety of GLM treatment for UC. Methods: This prospective, multicentre, post-marketing surveillance study is conducted in 393 patients with UC in Japan (UMIN000027542). Clinical remission (partial Mayo score ≤2), adverse drug reactions (ADRs) and their predictors, and treatment persistence were analysed. Results: The safety analysis sets comprised 391 patients. Patients in clinical remission at baseline were excluded, and 336 were used for effectiveness analysis. Clinical remission was 47.9%, 48.5%, 44.6%, and 39.6% at weeks 6, 22, 36, and 52, respectively, in the intent-to-treat analysis. In biologic-naïve patients, clinical remission was slightly higher than that in biologic-experienced patients. At week 52, patients who concomitantly used corticosteroids at baseline showed numerically lower clinical remission rates than non-users of corticosteroids (34.9% vs 44.5%). Multivariate analysis showed that smoking history (P=0.040, odds ratio [OR]=1.911, 95% confidence interval [CI] 1.030–3.546) was an independent factor associated with clinical remission at week 52. ADRs occurred in 71 patients (18.2%) and included 9 cases of rash. Serious ADRs occurred in 40 patients (10.2%), including 8 cases of UC exacerbation. Additionally, the presence of comorbidities was associated with ADR incidence (P=0.010, OR=2.000, 95% CI 1.183–3.380). Conclusion: The real-world effectiveness of GLM treatment was confirmed in biologic-naïve and -experienced populations. The safety profile of GLM treatment was consistent with previous findings.

Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix Study

“…Furthermore, we found that no biologic use before GLM initiation and disease history of >60 months were significantly associated with a higher proportion of patients achieving CR in the induction phase, and no prior biologic use was significantly associated with a higher proportion of patients achieving CR in the maintenance phase. Despite many reports from overseas on the efficacy of GLM [ 4 – 13 , 15 – 19 , 21 ], there have been few studies on the factors that influence the effectiveness of GLM in actual clinical practice in Japan [ 23 ]. The clinical factors we have identified in this study regarding GLM treatment of Japanese UC patients are essential for future treatment strategies.…”

“…Therefore, it is important to know the actual clinical data, which differs from clinical trials [ 33 ]. In Japan, there is one clinical trial on GLM [ 22 ] as well as one post-marketing surveillance report [ 23 ]; however, there are few clinical research reports. Therefore, we examined the effectiveness, factors associated with response, and safety of GLM treatment in patients with UC using data from a cohort study in Hokkaido, Japan (Phoenix cohort) [ 34 ].…”

“…In addition, among induction responders, patients receiving GLM treatment maintained a clinical response of 56.3% and achieved CR based on the Mayo score at 50.0%. Real-life observational studies showed that the proportion of patients achieving CR in the induction phase ranged from 14.3% to 51.5%, while those in the maintenance phase ranged from 17.6% to 49% [ 4 – 10 , 13 , 16 , 17 , 19 – 21 , 23 ], although it should be noted that some studies performed GLM dose escalation and the proportion of patients with prior biologic use varied among studies. Taken together, the proportions of patients achieving CR in the induction and maintenance phases obtained in the present cohort data were comparable with those of previous reports, including clinical trials [ 2 , 3 , 22 ] and real-world data [ 4 – 10 , 13 , 16 , 17 , 19 – 21 , 23 ].…”

“…In addition, GLM persistence rates at 1 and 2 years after initiation were 54.5% and 45.4%, respectively. Other real-world cohort studies of GLM reported that the treatment persistence rates ranged from 44.7% to 63% at 1 year [ 8 , 11 , 15 – 17 , 20 , 23 ] and 22.5–46% at 2 years [ 15 , 16 ]. Thus, the persistence rates of GLM in Japanese patients with UC have a similar tendency to that reported in a previous study.…”

“…In addition, the PURSUIT-J study showed that GLM treatment for 54 weeks maintained clinical efficacy and safety through week 54 among induction responders in biologic-naïve Japanese patients with moderate-to-severe active UC [ 22 ]. However, there have been limited reports on the effectiveness and safety of GLM in Japanese UC patients in real clinical practice [ 23 ]. In addition, the characteristics of patients who respond to GLM treatment, including the impact of prior therapy and concomitant medications, are not fully understood.…”