Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study)

Toshifumi Hibi, Yuya Imai, Asako Senoo, Kentaro Ohta, Yoshifumi Ukyo, Toshifumi Hibi, Yuya Imai, Asako Senoo, Kentaro Ohta, Yoshifumi Ukyo

Abstract

Background: The global phase 3 studies of golimumab [PURSUIT-SC and PURSUIT-maintenance (M)], an anti-tumor necrosis factor-α (anti-TNFα) antibody, have demonstrated clinical efficacy and safety as induction and maintenance therapies in patients with moderate to severely active ulcerative colitis (UC). This study aimed to evaluate the efficacy and safety of golimumab as maintenance therapy in the Japanese population.

Methods: In this phase 3, double-blind (DB), placebo-controlled, parallel group, randomized withdrawal study, 144 Japanese patients with moderately to severely active UC received golimumab doses of 200 mg (at week 0) and 100 mg (at week 2) subcutaneously during the 6-week open-label induction phase. Patients who responded to golimumab induction therapy entered the DB maintenance (M) phase and were randomized (1:1) to receive 100 mg of golimumab subcutaneous injection (SC) or placebo every 4 weeks for 52 weeks. The primary endpoint was clinical response through M-week 54; secondary endpoints included clinical remission and mucosal healing at M-week 30 and 54.

Results: Among induction responders, more patients on golimumab treatment (56.3%) maintained clinical response through M-week 54 versus the placebo group (19.4%). At both M-week 30 and 54, 50% golimumab-treated patients achieved clinical remission versus the placebo group (6.5%) and a higher proportion of patients on golimumab (59.4%) experienced mucosal healing than the placebo group (16.1%). Incidence of treatment-emergent adverse events was 96.9% in the golimumab group and 71% in the placebo group. Overall, the efficacy and safety results in this study were comparable with those observed in global studies.

Conclusions: Golimumab SC treatment maintained clinical efficacy through week 54 among induction responders, and no new safety signals were observed in the patients with moderate to severely active UC.

Clinical trial registration: The study is registered at ClinicalTrials.gov NCT01863771.

Keywords: Anti-TNFα antibody; Golimumab; Japanese patients; Maintenance therapy; PURSUIT; Ulcerative colitis.

Conflict of interest statement

Yuya Imai, Asako Senoo, Kentaro Ohta and Yoshifumi Ukyo are employees of Janssen Pharmaceutical K.K., Japan. Dr. Toshifumi Hibi is a consultant for Janssen Pharmaceutical K.K., Japan.

Figures

Fig. 1
Fig. 1
Study design and patient disposition. E Primary efficacy evaluation, DB double-blind, I-week induction week, M-week maintenance week, OL open-label, SC subcutaneous; a every 4 weeks through M-week 52; b patients who responded to golimumab 100 mg at M-week 8 continued to receive golimumab 100 mg every 4 weeks through M-Week 52 at the same dose
Fig. 2
Fig. 2
Proportion of patients with clinical response through M-week 54, Full analysis set-DB. CI confidence interval, DB double-blind, M-week maintenance week
Fig. 3
Fig. 3
a Proportion of patients with clinical remission at both M-week 30 and M-week 54; full analysis set for the DB-maintenance phase. b Proportion of patients with mucosal healing at both M-week 30 and M-week 54; full analysis set for the DB-maintenance phase. c Change of partial Mayo score overtime; full analysis set for the DB-maintenance phase. CI confidence interval, DB double-blind, I-week induction week, M-week maintenance week

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Source: PubMed

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