Edward C Keystone1, Mark C Genovese2, Stephen Hall2, Sang-Cheol Bae2, Chenglong Han2, Timothy A Gathany2, Stephen Xu2, Yiying Zhou2, Jocelyn H Leu2, Elizabeth C Hsia2. 1. From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine. edkeystone@mtsinai.on.ca. 2. From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
Abstract
OBJECTIVE: To evaluate the safety and efficacy of golimumab (GOL), a human antitumor necrosis factor antibody, in patients with active rheumatoid arthritis (RA) despitemethotrexate (MTX) therapy through 5 years in the GO-FORWARD trial. METHODS:Patients with active RA despite MTX therapy were randomly assigned to receive placebo + MTX (Group 1), GOL 100 mg + placebo (Group 2), GOL 50 mg + MTX (Group 3), or GOL 100 mg + MTX (Group 4). Patients in groups 1, 2, and 3 with inadequate response could enter early escape at Week 16 to GOL 50 mg + MTX or GOL100 mg + MTX, and all remaining Group 1 patients crossed over to GOL 50 mg + MTX at Week 24. The blind was maintained through the 52-week database lock, after which treatment adjustments were permitted. Adverse events (AE) were monitored through Week 268. Efficacy was evaluated using the American College of Rheumatology (ACR) 20/50/70 responses and a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). Response rates at Week 256 were analyzed by an intent-to-treat analysis. RESULTS: A total of 444 patients were randomized, and 313 received GOL through Week 252; 301 patients completed the safety followup through Week 268. Infections were the most common type of AE; 172 patients (39.6%) had ≥ 1 serious AE. No unexpected safety signals were observed. At Week 256, ACR20/50/70 responses were achieved by 63.1%, 40.8%, and 24.1%, respectively, of all randomized patients. About 78% of all patients achieved a good or moderate DAS28-CRP response. CONCLUSION: Improvements in the signs and symptoms of RA were maintained through 5 years. AE through 5 years were consistent with earlier reports of the GO-FORWARD trial; no apparent increased risk was observed over time.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of golimumab (GOL), a human antitumor necrosis factor antibody, in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy through 5 years in the GO-FORWARD trial. METHODS:Patients with active RA despite MTX therapy were randomly assigned to receive placebo + MTX (Group 1), GOL 100 mg + placebo (Group 2), GOL 50 mg + MTX (Group 3), or GOL 100 mg + MTX (Group 4). Patients in groups 1, 2, and 3 with inadequate response could enter early escape at Week 16 to GOL 50 mg + MTX or GOL 100 mg + MTX, and all remaining Group 1 patients crossed over to GOL 50 mg + MTX at Week 24. The blind was maintained through the 52-week database lock, after which treatment adjustments were permitted. Adverse events (AE) were monitored through Week 268. Efficacy was evaluated using the American College of Rheumatology (ACR) 20/50/70 responses and a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). Response rates at Week 256 were analyzed by an intent-to-treat analysis. RESULTS: A total of 444 patients were randomized, and 313 received GOL through Week 252; 301 patients completed the safety followup through Week 268. Infections were the most common type of AE; 172 patients (39.6%) had ≥ 1 serious AE. No unexpected safety signals were observed. At Week 256, ACR20/50/70 responses were achieved by 63.1%, 40.8%, and 24.1%, respectively, of all randomized patients. About 78% of all patients achieved a good or moderate DAS28-CRP response. CONCLUSION: Improvements in the signs and symptoms of RA were maintained through 5 years. AE through 5 years were consistent with earlier reports of the GO-FORWARD trial; no apparent increased risk was observed over time.
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