TY - JOUR
T1 - Long-term benefit of golimumab for patients with moderately to severely active ulcerative colitis
T2 - Results from the PURSUIT-maintenance extension
AU - Reinisch, Walter
AU - Gibson, Peter R.
AU - Sandborn, William J.
AU - Feagan, Brian G.
AU - Strauss, Richard
AU - Johanns, Jewel
AU - Padgett, Lakshmi
AU - Adedokun, Omoniyi J.
AU - Colombel, Jean Frederic
AU - Collins, Judith
AU - Rutgeerts, Paul
AU - Tarabar, Dino
AU - Marano, Colleen
N1 - Funding Information:
This work was supported by Janssen Research & Development, LLC, Spring House, PA, USA.
Funding Information:
WR reports having 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 & Development, LLC, Danone Austria, Elan, Ferring, Genentech, Grünenthal, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, Millennium, 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. PRG reports consulting fees from Ferring Pharmaceuticals, Janssen Research & Development, LLC, Shering-Plough, and AbbVie, speaker fees from Ferring Pharmaceuticals, Janssen Research & Development, LLC, Abbott/AbbVie, Schering-Plough, and Fresenius Kabi, and research support from Ferring Pharmaceuticals, Janssen Research & Development, LLC, Schering-Plough, AbbVie, Fresenius Kabi, and Norgine. WJS reports grants, personal fees and non-financial support from AbbVie, grants and personal fees from Prometheus Laboratories, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Takeda, grants and personal fees from Atlantic Pharmaceuticals, grants and personal fees from Janssen Research & Development, LLC, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Genentech, grants and personal fees from Nutrition Science Partners, personal fees from Kyowa Hakko Kirin, personal fees from Millennium Pharmaceuticals, personal fees from Celgene Cellular Therapeutics, personal fees from Santarus, personal fees from Salix Pharmaceuticals, personal fees from Catabasis Pharmaceuticals, personal fees from Vertex Pharmaceuticals, personal fees from Warner Chilcott, personal fees from Gilead Sciences, personal fees from Cosmo Pharmaceuticals, personal fees from Ferring Pharmaceuticals, personal fees from Sigmoid Biotechnologies, personal fees from Tillotts Pharma, personal fees from Am Pharma BV, personal fees from Dr August Wolff, personal fees from Avaxia Biologics, personal fees from Zyngenia, personal fees from Ironwood Pharmaceuticals, personal fees from Index Pharmaceuticals, personal fees from Nestle, personal fees from Lexicon Pharmaceuticals, personal fees from UCB Pharma, personal fees from Orexigen, personal fees from Luitpold Pharmaceuticals, personal fees from Baxter Healthcare, personal fees from Ferring Research Institute, personal fees from Amgen, personal fees from Novo Nordisk, personal fees from Mesoblast Inc., personal fees from Shire, personal fees from Ardelyx Inc., personal fees from Actavis, personal fees from Seattle Genetics, personal fees from MedImmune [AstraZeneca], personal fees from Actogenix NV, personal fees from Lipid Therapeutics Gmbh, personal fees from Eisai, personal fees from Qu Biologics, personal fees from Toray Industries Inc., personal fees from Teva Pharmaceuticals, personal fees from Eli Lilly, personal fees from Chiasma, personal fees from TiGenix, personal fees from Adherion Therapeutics, personal fees from Immune Pharmaceuticals, personal fees from Celgene, personal fees from Arena Pharmaceuticals, personal fees from Ambrx Inc., personal fees from Akros Pharma, personal fees from Vascular Biogenics, personal fees from Theradiag, personal fees from Forward Pharma, personal fees from Regeneron, personal fees from Galapagos, personal fees from Seres Health, personal fees from Ritter Pharmaceuticals, personal fees from Theravance, personal fees from Palatin, personal fees from Biogen, and personal fees from Western University [owner of Robarts Clinical Trials]. BGF reports consulting fees from Abbott/ AbbVie, Actogenix, Albireo Pharma, Amgen, Astra Zeneca, Avaxia Biologics Inc., Axcan, Baxter Healthcare Corp., Boehringer-Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, GiCare Pharma, Gilead, Given Imaging Inc., GSK, Ironwood Pharma, Janssen Biotech [Centocor], Johnson & Johnson/Janssen Research & Development, LLC, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Merck, Millennium, Nektar, Novo Nordisk, Prometheus Therapeutics and Diagnostics, Pfizer, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, Tillotts, UCB Pharma, Vertex Pharma, Warner-Chilcott, Wyeth, Zealand, and Zyngenia, speaker fees from Abbott/AbbVie, Johnson & Johnson/Janssen Research & Development, LLC, Takeda, Warner-Chilcott, UCB Pharma, having been a scientific advisory board member for Abbott/AbbVie, Amgen, Astra Zeneca, Avaxia Biologics Inc., Bristol-Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Ferring, Johnson & Johnson/Janssen Research & Development, LLC, Merck, Novartis, Novo Nordisk, Pfizer, Prometheus Laboratories, Salix Pharma, Takeda, Teva, Tillotts Pharma AG, and UCB Pharma, and research support from Abbott/ AbbVie, Amgen, Astra Zeneca, Bristol-Myers Squibb, Johnson & Johnson/ Janssen Research & Development, LLC, Roche/Genentech, Millennium, Pfizer, Receptos, Santarus, Sanofi, Tillotts, and UCB Pharma. J-FC reports having served as a consultant, advisory board member, or speaker for Abbott Laboratories, Bristol Meyers Squibb, Ferring, Genentech, Giuliani SPA, Given Imaging, Janssen Research & Development, LLC, Merck & Co, Millennium Pharmaceuticals, Inc, Pfizer, Inc, Prometheus Laboratories, Sanofi, Schering Plough Corporation, Takeda, Teva Pharmaceuticals, and UCB Pharma [previously named Celltech Therapeutics, Ltd]. JC reports research funding from Janssen Research & Development, LLC and UCB Pharma, and has served on the Speakers bureau for Salix. PR reports research funding and/or has served as a speaker, consultant, and/or advisory board member for Abbott Laboratories, Janssen Research & Development, LLC, Merck Research Laboratories, Merck Serono, UCB Pharma, Millenium/Takeda, Genentech/ Hoffman LaRoche, Neovacs, Bristol-Myers Squibb, Robarts, Tillotts, Pfizer, and Falk Pharma. DT reports no conflicts of interest. RS, JJ, LP, OJA and CM are employees of Janssen Research & Development, and LLC, and may own Johnson & Johnson stock and/or options.
Funding Information:
Writing and editorial support was provided by James P. Barrett, BS, an employee of Janssen Scientific Affairs, LLC, and Christine Fernandes, MS, an employee of Synchrogenix.
Publisher Copyright:
© 2018 European Crohn's and Colitis Organisation (ECCO). Published by Oxford University Press.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2018/8/29
Y1 - 2018/8/29
N2 - Background and Aims To evaluate the safety and efficacy of 3 additional years of subcutaneous golimumab maintenance in patients with moderately to severely active ulcerative colitis. Methods The PURSUIT-maintenance long-term extension enrolled patients who had completed placebo or golimumab 50 mg or 100 mg treatment every 4 weeks [q4w] through Week 52 and evaluations at Week 54 [n = 666]; treatment continued through Week 212. Patients receiving placebo were discontinued after study unblinding. Efficacy endpoints, golimumab concentrations, and anti-drug antibodies were summarized as observed for golimumab-induction responders who continued golimumab therapy during the long-term extension. Observations relating to safety were summarized for all treated patients. Results Overall, 63% of patients who were receiving golimumab at the beginning of the extension remained on treatment through the end of the study. Among all treated patients in the extension, rates of adverse events of special interest [e.g. tuberculosis, demyelination, and malignancy] were infrequent. Nine deaths occurred during the extension [1 placebo, 1 golimumab 50 mg, and 7 golimumab 100 mg]. Serum golimumab concentrations were dose-proportional and were maintained over time. During the extension through Week 228, anti-drug antibody rates with golimumab 50 mg and 100 mg were 4.4% and 3.7%, respectively. Among golimumab-induction responders, 99.3% had no disease or mild disease activity as per the Physician's Global Assessment, 92.5% were corticosteroid-free, and 76.1% had an Inflammatory Bowel Disease Questionnaire score of ≥170 at Week 216. Conclusions Subcutaneous golimumab treatment of moderately to severely active ulcerative colitis for up to 3 additional years during the extension maintained clinical benefit with no new safety signals observed. ClinicalTrials.gov number NCT00488631.
AB - Background and Aims To evaluate the safety and efficacy of 3 additional years of subcutaneous golimumab maintenance in patients with moderately to severely active ulcerative colitis. Methods The PURSUIT-maintenance long-term extension enrolled patients who had completed placebo or golimumab 50 mg or 100 mg treatment every 4 weeks [q4w] through Week 52 and evaluations at Week 54 [n = 666]; treatment continued through Week 212. Patients receiving placebo were discontinued after study unblinding. Efficacy endpoints, golimumab concentrations, and anti-drug antibodies were summarized as observed for golimumab-induction responders who continued golimumab therapy during the long-term extension. Observations relating to safety were summarized for all treated patients. Results Overall, 63% of patients who were receiving golimumab at the beginning of the extension remained on treatment through the end of the study. Among all treated patients in the extension, rates of adverse events of special interest [e.g. tuberculosis, demyelination, and malignancy] were infrequent. Nine deaths occurred during the extension [1 placebo, 1 golimumab 50 mg, and 7 golimumab 100 mg]. Serum golimumab concentrations were dose-proportional and were maintained over time. During the extension through Week 228, anti-drug antibody rates with golimumab 50 mg and 100 mg were 4.4% and 3.7%, respectively. Among golimumab-induction responders, 99.3% had no disease or mild disease activity as per the Physician's Global Assessment, 92.5% were corticosteroid-free, and 76.1% had an Inflammatory Bowel Disease Questionnaire score of ≥170 at Week 216. Conclusions Subcutaneous golimumab treatment of moderately to severely active ulcerative colitis for up to 3 additional years during the extension maintained clinical benefit with no new safety signals observed. ClinicalTrials.gov number NCT00488631.
KW - Corticosteroid use
KW - inflammatory bowel disease questionnaire
KW - physician's global assessment
UR - http://www.scopus.com/inward/record.url?scp=85055800273&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85055800273&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjy079
DO - 10.1093/ecco-jcc/jjy079
M3 - Article
AN - SCOPUS:85055800273
VL - 12
SP - 1053
EP - 1066
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
SN - 1873-9946
IS - 9
ER -