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Rheumatology (Oxford). 2014 Sep;53(9):1654-63. doi: 10.1093/rheumatology/keu132. Epub 2014 Apr 11.

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 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.

Abstract

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.

KEYWORDS:

Asia; China; ankylosing spondylitis; biologic; spondyloarthritis; spondyloarthropathy; tumour necrosis factor

PMID:
24729398
DOI:
10.1093/rheumatology/keu132
[Indexed for MEDLINE]

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