TY - JOUR
T1 - Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors
T2 - Findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study
AU - Smolen, Josef S.
AU - Kay, Jonathan
AU - Doyle, Mittie
AU - Landewé, Robert
AU - Matteson, Eric L.
AU - Gaylis, Norman
AU - Wollenhaupt, Jürgen
AU - Murphy, Frederick T.
AU - Xu, Stephen
AU - Zhou, Yiying
AU - Hsia, Elizabeth C.
N1 - Funding Information:
The authors thank Michelle L Perate, MS and Mary H Whitman, PhD of Janssen Scientific Affairs, LLC for their assistance with manuscript preparation and submission. This study was sponsored by Janssen Research & Development, LLC and Merck/Schering-Plough Research Institute. The specific ethical bodies that approved the GO-AFTER protocol are as follows: Australia – Research and Ethics Committee, Daw Park/South Australia; Cabrini Human Research Ethics Committee, Malvern, Victoria; Northside Health Service District – Redcliffe-Caboolture Human Research, Redcliffe, Queensland. Austria – Ethik-Kommission der Medizinischen, Universität Wien und des Allgemeinen Krankenhauses der Stadt Wien, Vienna. Canada – IRB Services, Aurora, ON; Sunnybrook Health Science Center REB, Toronto, ON; Mount Sinai Hospital Research Ethics Board, Toronto, ON; Health Research Ethics Authority, St. John’s, NL; University Health Network Research, Toronto, ON. Finland – HUS, Helsingin ja Uudenmaan sairaanhoitopiiri, Medisiininen eettinen toimikunta, Biomedicum Helsinki, HUS. France – CCPPRB Montpellier, Hôpital St-Eloi, Montpellier Cedex 5. Germany – Geschäftsstelle der Ethik-Kommission, der Medizinischen Fakultät der Universität zu Köln Gebäude 5, Köln. The Netherlands – Clinical Trial Centre Maastricht, Medische Ethische Commissie AZM/UM/6229 HX Maastricht. New Zealand – Multi-region Ethics Committee, c/o-Ministry of Health, Wellington. Spain – Comité Etico de Investigación, Clínica de Cantabria Hospital Universitario Marqués de Valdecilla, Santander; LEC – Comité Ético de investigación Clínica, Hospital Virgen de la Macarena Avda. Sevilla; LEC – Comité Ético de Investigación, Clinica de Andalucía Edificio Arena 1, Dpto. Investigación, Sevilla; Comité Etico de Investigación, Clínica de Cantabria Hospital Universitario Marqués de Valdecilla, Santander; LEC – Comité Ético de Investigación Clínica, Hospital Dr. Peset, C/Gaspar Aguilar, Valencia. United Kingdom – Newcastle and North Tyneside, Research Ethics Committee 1, Jarrow. USA – Quorum Review, Inc., Seattle, WA; Washington University School of Medicine, Washington University Medical Center Office of Washington, University Medical Center IRB (OWUMC IRB), Human Studies Committee (HSC), St. Louis, MO; UCSD Human Research Protection Program, La Jolla, CA; Mayo Foundation Institutional Review Board, Rochester, MN; University of North Texas Health Science Center at Fort Worth Institutional Review Board, Fort Worth, TX; University of Pittsburgh Institutional Review Board, Pittsburgh, PA; Partners Human Research Committee, Boston, MA; Office of Protection for Research Subjects, Los Angeles, CA.
Funding Information:
JSS has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB; and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. JK has received research grant support paid to the University of Massachusetts Medical School from AbbVie Inc., Ardea Biosciences Inc., Eli Lilly and Company, and Roche Laboratories Inc.; and consultation honoraria from AbbVie Inc., Amgen Inc., AstraZeneca, Bristol Myers Squibb Co., Crescendo BioScience Inc., Epirus Biopharmaceuticals Inc., Genentech Inc., Hospira Inc., Janssen Biotech Inc., PanGenetics B.V., Pfizer Inc., Roche Laboratories Inc., and UCB Inc. MD was an employee of Janssen Research and Development at the time this study was conducted, and is now employed by Alexion Pharmaceuticals. RL has received research grant support from Abbott, Pfizer, Roche, and UCB; and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Glaxo, Janssen, MSD, Pfizer, Roche, and UCB. ELM has received consultation honoraria from Janssen, and research grant support from Janssen, Mesoblast, Novartis, Pfizer, Roche, and UCB. NG has received research grant support and consultation and/or speaking honoraria from Janssen and served as Medical Director Rheumatology Division – Cardinal Health during the time the study was conducted. JW has received consultation and/or speaking honoraria from Abbott, Amgen, BMS, Chugai, MSD, Medac, Pfizer, Roche, Sanofi-Aventis, and UCB. FTM has received speaking honoraria from Abbott Immunology and Janssen. SX, YZ and ECH are employees of Janssen Research and Development, LLC. No nonfinancial conflict of interest exists for any author.
Publisher Copyright:
© Smolen et al.; licensee BioMed Central.
PY - 2015/1/22
Y1 - 2015/1/22
N2 - Introduction: The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s). Methods: Patients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) received placebo (Group 1) or golimumab 50 mg (Group 2) or 100 mg (Group 3) injections every 4 weeks. Patients in Groups 1 and 2 with inadequate response at week 16 escaped to golimumab 50 and 100 mg, respectively. At week 24, Group 1 patients crossed-over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status, and Group 3 maintained dosing. During the long-term-extension (LTE), golimumab 50 mg could be increased to 100 mg, and 100 mg could be decreased to 50 mg. Data through 5 years are reported for all patients (safety) and patients using methotrexate (efficacy, intention-to-treat (ITT) analysis with last-observation-carried-forward for missing data and non-responder imputation for unsatisfactory efficacy discontinuations). Results: In total, 459 of 461 randomized patients received the study agent, 304 of whom were methotrexate-treated and included in efficacy analyses. Through week 256, the proportions of methotrexate-treated patients achieving American-College-of-Rheumatology (ACR) responses were 37.6% to 47.0% for ACR20, 21.4% to 35.0% for ACR50, and 7.8% to 17.0% for ACR70 response across randomized groups. Golimumab safety through week 268 was generally consistent with that at week 24 and week 160 and other anti-TNF agents. Conclusions: In some patients with active RA discontinuing previous TNF-antagonist therapy, golimumab safety and efficacy, assessed conservatively with ITT analyses, was confirmed through 5 years.
AB - Introduction: The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s). Methods: Patients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) received placebo (Group 1) or golimumab 50 mg (Group 2) or 100 mg (Group 3) injections every 4 weeks. Patients in Groups 1 and 2 with inadequate response at week 16 escaped to golimumab 50 and 100 mg, respectively. At week 24, Group 1 patients crossed-over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status, and Group 3 maintained dosing. During the long-term-extension (LTE), golimumab 50 mg could be increased to 100 mg, and 100 mg could be decreased to 50 mg. Data through 5 years are reported for all patients (safety) and patients using methotrexate (efficacy, intention-to-treat (ITT) analysis with last-observation-carried-forward for missing data and non-responder imputation for unsatisfactory efficacy discontinuations). Results: In total, 459 of 461 randomized patients received the study agent, 304 of whom were methotrexate-treated and included in efficacy analyses. Through week 256, the proportions of methotrexate-treated patients achieving American-College-of-Rheumatology (ACR) responses were 37.6% to 47.0% for ACR20, 21.4% to 35.0% for ACR50, and 7.8% to 17.0% for ACR70 response across randomized groups. Golimumab safety through week 268 was generally consistent with that at week 24 and week 160 and other anti-TNF agents. Conclusions: In some patients with active RA discontinuing previous TNF-antagonist therapy, golimumab safety and efficacy, assessed conservatively with ITT analyses, was confirmed through 5 years.
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U2 - 10.1186/s13075-015-0516-6
DO - 10.1186/s13075-015-0516-6
M3 - Article
C2 - 25627338
AN - SCOPUS:84925957520
VL - 17
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
SN - 1478-6354
IS - 1
M1 - 14
ER -