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

William J. Sandborn, Brian G. Feagan, Colleen Marano, Hongyan Zhang, Richard Strauss, Jewel Johanns, Omoniyi J. Adedokun, Cynthia Guzzo, Jean Frederic Colombel, Walter Reinisch, Peter R. Gibson, Judith (Judy) Collins, Gunnar Järnerot, Paul Rutgeerts

Research output: Contribution to journalArticle

370 Citations (Scopus)

Abstract

Background & Aims Subcutaneous golimumab, a fully human monoclonal antibody to tumor necrosis factor-α (TNFα), was evaluated as maintenance therapy in TNFα 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 (US)
JournalGastroenterology
Volume146
Issue number1
DOIs
StatePublished - Jan 2014

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Ulcerative Colitis
Placebos
Tumor Necrosis Factor-alpha
Investigational Therapies
golimumab
Therapeutics
Monoclonal Antibodies
Injections
Research

Keywords

  • Fully Human Monoclonal Antibody
  • Inflammatory Bowel Disease
  • Randomized Withdrawal Trial

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Sandborn, W. J., Feagan, B. G., Marano, C., Zhang, H., Strauss, R., Johanns, J., ... Rutgeerts, P. (2014). Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology, 146(1). https://doi.org/10.1053/j.gastro.2013.06.010

Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. / Sandborn, William J.; Feagan, Brian G.; Marano, Colleen; Zhang, Hongyan; Strauss, Richard; Johanns, Jewel; Adedokun, Omoniyi J.; Guzzo, Cynthia; Colombel, Jean Frederic; Reinisch, Walter; Gibson, Peter R.; Collins, Judith (Judy); Järnerot, Gunnar; Rutgeerts, Paul.

In: Gastroenterology, Vol. 146, No. 1, 01.2014.

Research output: Contribution to journalArticle

Sandborn, WJ, Feagan, BG, Marano, C, Zhang, H, Strauss, R, Johanns, J, Adedokun, OJ, Guzzo, C, Colombel, JF, Reinisch, W, Gibson, PR, Collins, JJ, Järnerot, G & Rutgeerts, P 2014, 'Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis', Gastroenterology, vol. 146, no. 1. https://doi.org/10.1053/j.gastro.2013.06.010
Sandborn, William J. ; Feagan, Brian G. ; Marano, Colleen ; Zhang, Hongyan ; Strauss, Richard ; Johanns, Jewel ; Adedokun, Omoniyi J. ; Guzzo, Cynthia ; Colombel, Jean Frederic ; Reinisch, Walter ; Gibson, Peter R. ; Collins, Judith (Judy) ; Järnerot, Gunnar ; Rutgeerts, Paul. / Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. In: Gastroenterology. 2014 ; Vol. 146, No. 1.
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