Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis

William J Sandborn, Brian G Feagan, Colleen W Marano, Hongyan Zhang, Richard Strauss, Jewel Johanns, Omoniyi J Adedokun, Cynthia A Guzzo, Jean-Frederic Colombel, Walter Reinisch, Peter Raymond Gibson, Judith F Collins, Gunnar Jarnerot, Paul Rutgeerts

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415 Citations (Scopus)

Abstract

Background Aims Subcutaneous golimumab, a fully human monoclonal antibody to tumor necrosis factor-a (TNFa), was evaluated as maintenance therapy in TNFa antagonist-naive adults with moderate-to-severe active ulcerative colitis, despite conventional therapy, who responded to golimumab induction therapy. Methods We performed a phase 3, double-blind trial of patients who completed golimumab induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment, eg, PURSUIT). Patients who responded to induction therapy with golimumab (n = 464) were assigned randomly to groups given placebo or injections of 50 or 100 mg golimumab every 4 weeks through week 52. Patients who responded to placebo in the induction study continued to receive placebo. Nonresponders in the induction study received 100 mg golimumab. The primary end point was clinical response maintained through week 54; secondary end points included clinical remission and mucosal healing at both weeks 30 and 54. Results Clinical response was maintained through week 54 in 47.0 of patients receiving 50 mg golimumab, 49.7 of patients receiving 100 mg golimumab, and 31.2 of patients receiving placebo (P =.010 and P
Original languageEnglish
Pages (from-to)96 - 109
Number of pages14
JournalGastroenterology
Volume146
Issue number1
DOIs
Publication statusPublished - 2014

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