Subcutaneous Golimumab Induces Clinical Response and Remission in Patients with Moderate-to-Severe Ulcerative Colitis

摘要

Background & aims: Little is known about the efficacy of golimumab, a fully human monoclonal antibody to tumor necrosis factor (TNF)-alpha, for treatment of ulcerative colitis (UC). We evaluated subcutaneous golimumab induction therapy in TNF-alpha antagonist-naive patients with moderate-to-severe UC despite conventional treatment. Methods: We integrated double-blind phase 2 dose-finding and phase 3 dose-confirmation trials in a study of 1064 adults with UC (Mayo score: 6-12; endoscopic subscore > 2; 774 patients in phase 3). Patients were randomly assigned to groups given golimumab doses of 100 mg and then 50 mg (phase 2 only), 200 mg and then 100 mg, or 400 mg and then 200 mg, 2 weeks apart. The phase 3 primary end point was week-6 clinical response. Secondary end points included week-6 clinical remission, mucosal healing, and Inflammatory Bowel Disease Questionnaire (IBDQ) score change.