Efficacy and safety results from a Phase 3, randomized, placebo-controlled trial of subcutaneous golimumab in Chinese patients with active rheumatoid arthritis despite methotrexate therapy.
Zhanguo Li, Fengchun Zhang, Jonathan Kay, Kaiyin Fei, Chenglong Han, Yanli Zhuang, Zhong Wu, Elizabeth C Hsia
Author Information
Zhanguo Li: Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.
Fengchun Zhang: Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China.
Jonathan Kay: Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
Kaiyin Fei: Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Chenglong Han: Patient-Reported Outcomes, Janssen Global Services, Malvern, Pennsylvania, USA.
Yanli Zhuang: Biologics Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Zhong Wu: Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Elizabeth C Hsia: Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
AIM: The efficacy and safety of golimumab + methotrexate (MTX) were evaluated in Chinese patients with active rheumatoid arthritis (RA) despite MTX therapy. METHODS: Chinese patients (n = 264) were randomly assigned (1 : 1) to receive subcutaneous injections of placebo + MTX with crossover to golimumab 50 mg + MTX at week 24 (Group 1) or to golimumab 50 mg + MTX (Group 2) every 4 weeks. Group 1 patients with inadequate response entered blinded early escape to golimumab 50 mg + MTX at week 16. At least a 20% improvement in the American College of Rheumatology (ACR20) criteria at week 14 was the primary endpoint. Other assessments included the 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI) through week 52. Adverse events (AEs) were monitored through week 56. RESULTS: ACR20 response at week 14 was significantly higher in Group 2 (40.9% [54/132]) compared with Group 1 (15.9% [21/132]; P < 0.001). Greater proportions of patients in Group 2 compared with Group 1 had a DAS28-CRP response at week 14 (65.2% vs. 30.3%, P < 0.001) or ACR20 response at week 24 (42.4% vs. 15.9%, P < 0.001), and Group 2 had a significantly greater change in HAQ-DI at week 24 (-0.26 vs. 0.15, P < 0.001). After week 24, the proportion of patients achieving ACR20 in Group 1 approached that in Group 2. Through week 16, 23.5% of Group 1 and 26.7% of Group 2 patients reported AEs. Among golimumab + MTX-treated patients, 50.2% and 4.2% had ≥ 1 AE or serious AE, respectively, through week 56. No unexpected safety signals were observed. CONCLUSION: Among MTX-experienced Chinese patients with active RA, a significantly greater proportion of patients receiving golimumab + MTX had improvements in the signs and symptoms of RA compared with MTX monotherapy. Safety findings were consistent with previous studies of golimumab in patients with RA.
