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.
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
SN - 1478-6354
VL - 17
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
IS - 1
M1 - 14
ER -