A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous Golimumab Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis: PURSUIT-Maintenance

Abstract

Purpose: To evaluate the safety and efficacy of SC golimumab (GLM) maintenance therapy in patients with moderately to severely active UC who responded to GLM induction. Methods: 1228 patients were enrolled from the PURSUIT-IV and PURSUIT-SC induction studies. The primary analysis population consisted of patients (n=464) who responded to GLM induction and were randomized to receive placebo (PBO), GLM 50 mg, or GLM 100 mg at baseline (wk0) and q4 wks through wk52. Primary endpoint was clinical response through wk54. Major secondary endpoints at both wks 30 and 54 were clinical remission, mucosal healing, and clinical remission among patients in clinical remission at wk0 of this study, and clinical remission with corticosteroid discontinuation at wk54 among patients receiving corticosteroids at wk0 of this study. Safety data is summarized for randomized patients; selected events of interest are summarized for all treated patients (including 464 randomized patients, 129 PBO induction responders who continued on PBO and 635 PBO or GLM induction non-responders who received GLM100 mg q4wks). Results: Among the 464 patients in clinical response to GLM induction who were randomized, 28% discontinued drug prior to the last dosing visit at wk52. Greater proportions of patients receiving GLM 50 mg (47%) or GLM 100 mg (51%) were in clinical response through wk54 vs PBO (31%; p=0.01 and p<0.001, respectively). Clinical remission at both wk 30 and wk 54 for PBO, GLM 50 mg, and GLM 100 mg was 15%, 24% (p=0.091), and 29% (p=0.003), mucosal healing at both wk 30 and wk 54 was 27%, 42%, and 44% (p=0.001). Numerically, more patients in both GLM groups (who were in remission at wk0) maintained clinical remission through wk54 vs PBO (24%, 37%, and 40% for PBO, GLM 50 mg, and GLM 100 mg). Corticosteroid free remission at wk54 was 18%, 28%, and 23% for PBO, GLM 50 mg, and GLM 100 mg; not statistically significant. Through wk54, the proportions of randomized patients with ≥1AE were 66%, 73%, and 73%, serious AEs were 8%, 8%, and 14%, for the PBO, GLM 50 mg, and GLM 100 mg groups (average wks of follow-up 33, 44 and 46); a similar profile was observed with all treated patients. Among all treated patients, there were 4 cases of active TB on GLM, and 3 deaths on GLM 100 mg due to: malnutrition and sepsis, disseminated TB, and cardiac failure. Malignancy rates were 0.4%, 0.0% and 0.3% (PBO, GLM 50 mg and GLM 100 mg). Conclusion: Among GLM induction responders, GLM 50 mg and GLM 100mg q4wks maintained clinical response through wk54; GLM 100 mg q4wks achieved long-term clinical remission and mucosal healing at both wk 30 and 54. The safety of GLM UC was similar to GLM experience in other labeled rheumatologic indications and with other anti-TNFs. Disclosure: William J Sandborn, Brian G. Feagan, Jean-Frederic Colombel, Walter Reinisch, Peter Gibson, Judith Collins, Gunnar Jarnerot, and Paul Rutgeerts - all investigators for Janssen R&D, LLC. Colleen Marano, Richard Strauss, Jewel Johanns, Hongyan Zhang, and Cynthia Guzzo - all employees of Janssen R&D.