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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
Author(s) -
Li Zhanguo,
Zhang Fengchun,
Kay Jonathan,
Fei Kaiyin,
Han Chenglong,
Zhuang Yanli,
Wu Zhong,
Hsia Elizabeth C.
Publication year - 2016
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.12723
Subject(s) - golimumab , medicine , rheumatoid arthritis , rheumatology , placebo , methotrexate , adverse effect , clinical endpoint , randomized controlled trial , gastroenterology , physical therapy , adalimumab , alternative medicine , pathology
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 ( ACR 20) criteria at week 14 was the primary endpoint. Other assessments included the 28‐joint count Disease Activity Score using C‐reactive protein ( DAS 28‐ CRP ) and Health Assessment Questionnaire‐Disability Index ( HAQ ‐ DI ) through week 52. Adverse events ( AE s) were monitored through week 56. Results ACR 20 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 DAS 28‐ CRP response at week 14 (65.2% vs . 30.3%, P < 0.001) or ACR 20 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 ACR 20 in Group 1 approached that in Group 2. Through week 16, 23.5% of Group 1 and 26.7% of Group 2 patients reported AE s. 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 .