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Safety and efficacy of golimumab in Chinese patients with active ankylosing spondylitis: 1-year results of a multicentre, randomized, double-blind, placebo-controlled phase III trial.

Author(s): Bao C(1), Huang F(2), Khan MA(2), Fei K(2), Wu Z(2), Han C(2), Hsia EC(3).

Affiliation(s): Author information: (1)Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793 baochunde_1678@126.com. (2)Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793. (3)Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793.

Publication date & source: 2014, Rheumatology (Oxford). , 53(9):1654-63

OBJECTIVE: The aim of this study was to assess the efficacy and safety of golimumab in Chinese patients with active AS. METHODS: Two hundred and thirteen patients were randomized in a 1:1 ratio to receive either s.c. injections of placebo from weeks 0 to 20 followed by golimumab 50 mg from weeks 24 to 48 (group 1, n = 105) or golimumab 50 mg from weeks 0 to 48 (group 2, n = 108), both every 4 weeks. Placebo crossover occurred at week 24, while early escape was at week 16. The primary endpoint was an improvement of at least 20% in the Assessment of SpondyloArthritis international Society (ASAS20) criteria at week 14. Major secondary endpoints included week 24 ASAS20 response and week 14 change scores for BASFI and BASMI. RESULTS: Golimumab treatment elicited significantly better responses than placebo in week 14 ASAS20 response [49.1% (53/108) vs 24.8% (26/105), respectively, P < 0.001], week 24 ASAS20 response (50.0% vs 22.9%, P < 0.001) and mean improvements in BASFI (-1.26 vs 0.11, P < 0.001) and BASMI (-0.42 vs -0.19, P = 0.021) scores at week 14. Additionally, golimumab treatment led to significant improvements in the mental and physical components of health-related quality of life (HRQoL) and sleep problems at week 24, all of which were further improved through week 52. During the 16-week placebo-controlled study period, 31.4% and 30.6% of patients had adverse events (AEs) in groups 1 and 2, respectively; similar AE reporting rates were observed through week 24 (34.3% and 32.0%) and among the golimumab-treated patients through week 56 (41.2%). CONCLUSION: Golimumab significantly reduced clinical symptoms/signs and improved physical function, range of motion and HRQoL in Chinese patients with active AS without unexpected safety concerns. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01248793.

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