Original ResearchFull Report: Clinical—Alimentary TractSubcutaneous Golimumab Maintains Clinical Response in Patients With Moderate-to-Severe Ulcerative Colitis
Section snippets
Patients
PURSUIT-M (NCT00488631) was a phase 3, multicenter, placebo-controlled, double-blind, randomized-withdrawal study conducted at 251 centers between September 2007 and October 2011. The institutional review board or ethics committee at each site approved the protocol, and patients provided written informed consent. All authors had access to the study data and reviewed and approved the final manuscript.
Participants in PURSUIT-M had completed 1 of 2 golimumab induction studies: PURSUIT-IV or
Patient Disposition, Baseline Characteristics, and Baseline Concomitant Medications
The PURSUIT-M study was conducted at 251 sites in Eastern Europe (477 patients), North America (323 patients), Asia Pacific and South Africa (237 patients), and Western Europe and Israel (191 patients). Overall, 1228 patients were enrolled from the induction studies, including 464 patients who were randomized in the primary analysis population (ie, were in clinical response to golimumab at week 6 of an induction study) and 764 patients who were enrolled but not randomized (ie, nonrandomized
Discussion
PURSUIT-M was a phase 3, placebo-controlled, randomized withdrawal study that evaluated the efficacy and safety of golimumab maintenance therapy. PURSUIT-M was a randomized withdrawal study of an anti-TNFα biologic agent in UC evaluating 2 golimumab maintenance doses. The target population for this study comprised patients with moderate-to-severe UC who were in clinical response to golimumab induction after participation in companion induction studies. The primary end point, maintenance of
Acknowledgments
Editorial and writing support were provided by James P Barrett, BS and Mary Whitman, PhD (Janssen Services, LLC). Members of the PURSUIT-Maintenance Study Group are listed in the Appendix.
This study was designed and conducted by the PURSUIT-Maintenance Steering Committee (WJS, BGF, J-FC, WR, PRG, JC, GJ, PR) and Janssen Research and Development, LLC (CM, HZ, JJ, OA, RS, CG), who jointly analyzed and interpreted the data, and contributed to the manuscript: William Sandborn prepared the first
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Authors names in bold designate shared co-first authorship.
This article has an accompanying continuing medical education activity on page e14. Learning Objective: Upon completion of this CME activity, successful learners will be able to formulate a treatment plan which employs anti-tumor necrosis factor therapy with golimumab in patients with moderate to severe ulcerative colitis.
Conflicts of interest The authors disclose the following: William Sandborn has received consulting fees from Abbott, ActoGeniX NV, AGI Therapeutics, Inc, Alba Therapeutics Corp, Albireo, Alfa Wasserman, Amgen, AM-Pharma BV, Anaphore, Astellas, Athersys, Inc, Atlantic Healthcare, Ltd, Aptalis, BioBalance Corp, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Celek Pharmaceuticals, Cellerix SL, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, EnGene, Inc, Eli Lilly, Enteromedics, Exagen Diagnostics, Inc, Ferring Pharmaceuticals, Flexio Therapeutics, Inc, Funxional Therapeutics, Ltd, Genzyme, Corp, Gilead Sciences, Given Imaging, GlaxoSmithKline, Human Genome Sciences, Ironwood Pharmaceuticals, Janssen Research and Development, LLC, KaloBios Pharmaceuticals, Lexicon Pharmaceuticals, Lycera Corp, Meda Pharmaceuticals, Merck Research Laboratories, Merck Serono, Millenium Pharmaceuticals, Nisshin Kyorin Pharmaceuticals, Novo Nordisk, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, Inc, PDL Biopharma, Pfizer, Procter and Gamble, Prometheus Laboratories, ProtAb, Ltd, Purgenesis Technologies, Inc, Relypsa, Inc, Roche, Salient Pharmaceuticals, Salix Pharmaceuticals, Santarus, Schering Plough, Shire Pharmaceuticals, Sigmoid Pharma, Ltd, Sirtris Pharmaceuticals, SLA Pharma UK, Ltd, Targacept, Teva Pharmaceuticals, Therakos, Tilliotts Pharma AG, TxCell SA, UCB Pharma, Viamet Pharmaceuticals, Vascular Biogenics, Ltd, Warner Chilcott UK, Ltd, and Wyeth; has received research grants from Abbott, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Janssen Research and Development, LLC, Milennium Pharmaceuticals, Novartis, Pfizer, Procter and Gamble, Shire Pharmaceuticals, and UCB Pharma; has received payments for lectures/speakers bureau from Abbott, Bristol-Myers Squibb, and Janssen Research and Development, LLC; and holds stock/stock options in Enteromedics. Brian Feagan has received consulting fees from Millennium, Merck, Janssen Research and Development, LLC, Elan/Biogen, Janssen-Ortho, Teva Pharmaceuticals, Bristol-Myers Squibb, Celgene, UCB Pharma, Abbott, Astra Zeneca, Serono, Genentech, Tillotts, Unity Pharmaceuticals, Albireo Pharma, Given Imaging, Inc, Salix Pharm, Novonordisk, GlaxoSmithKline, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Nektar, Pfizer, Shire, Wyeth, Zealand Pharm, Zyngenia, gICare Pharma, Inc, and Sigmoid Pharma; has received research grants from Merck, Millennium, Tillotts, Abbott, Protein Design Labs, Novartis, Janssen Research and Development, LLC, Elan/Biogen, UCB Pharma, Bristol-Myers Squibb, Genentech, CombinatoRx, ActoGeniX, and Wyeth; has received payments for lectures/speakers bureau from UCB, Abbott, Janssen Research and Development, LLC; and has served as a Scientific Advisory Board member for Astra Zeneca, Elan/Biogen, Merck, Celgene, Novartis, UCB Pharma, Salix Pharmaceuticals, Abbott Laboratories, Pfizer, Tillotts Pharma AG, and Prometheus Laboratories. Jean-Federic Colombel has served as a consultant, advisory board member, or speaker for Abbott Laboratories, Bristol Meyers Squibb, Ferring, Genentech, Giuliani SPA, Given Imaging, Janssen Research and Development, LLC, Merck & Co, Millenium Pharmaceuticals, Inc, Pfizer, Inc, Prometheus Laboratories, Sanofi, Schering Plough Corporation, Takeda, Teva Pharmaceuticals, and UCB Pharma (previously named Celltech Therapeutics, Ltd). Walter Reinisch has served as a speaker, consultant, and/or advisory board member for Abbott Laboratories, Aesca, Amgen, Astellas, Astra Zeneca, Biogen IDEC, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Janssen Research and Development, LLC, Danone Austria, Elan, Ferring, Genentech, Grünenthal, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Robarts Clinical Trial, Schering-Plough, Setpointmedical, Shire, Takeda, Therakos, Tigenix, UCB Pharma, Vifor, Yakult Austria, and 4SC. Peter R Gibson has received consulting fees from Ferring Pharmaceuticals, Abbott, Janssen Research and Development, LLC, Schering-Plough, and Merck; he has received research support from Falk Pharma GmbH, Shire, Orphan Australia, Abbott Fresenius Kabi, and Norgine; and payment for lectures from Abbott, Merck, Janssen Research and Development, LLC, and Fresenius Kabi. Judith Collins has received research funding from Janssen Research and Development, LLC, and UCB Pharma; and has served on the speakers bureau for Salix. Gunnar Järnerot has received research funding from Janssen Research and Development, LLC. Paul Rutgeerts has received research funding and/or served as a speaker, consultant, and/or advisory board member for Abbott Laboratories, Janssen Research and Development, LLC, Merck Research Laboratories, Merck Serono, UCB Pharma, Millenium/Takeda, Genentech/Hoffman LaRoche, Neovacs, Bristol Myers Squibb, Robarts, Tillotts, Pfizer, and Falk Pharma. Colleen Marano, Richard Strauss, Hongyan Zhang, Jewel Johanns, Omoniyi Adedokun, and Cynthia Guzzo are employees of Janssen Research and Development, LLC.
Funding The study was funded by Janssen Research & Development, LLC (Spring House, PA).