PMID- 24729398 OWN - NLM STAT- MEDLINE DCOM- 20141222 LR - 20220419 IS - 1462-0332 (Electronic) IS - 1462-0324 (Linking) VI - 53 IP - 9 DP - 2014 Sep TI - 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. PG - 1654-63 LID - 10.1093/rheumatology/keu132 [doi] AB - 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. CI - (c) The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com. FAU - Bao, Chunde AU - Bao C AD - 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. FAU - Huang, Feng AU - Huang F AD - 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. FAU - Khan, Muhammad Asim AU - Khan MA AD - 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. FAU - Fei, Kaiyin AU - Fei K AD - 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. FAU - Wu, Zhong AU - Wu Z AD - 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. FAU - Han, Chenglong AU - Han C AD - 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. FAU - Hsia, Elizabeth C AU - Hsia EC AD - 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. LA - eng SI - ClinicalTrials.gov/NCT01248793 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20140411 PL - England TA - Rheumatology (Oxford) JT - Rheumatology (Oxford, England) JID - 100883501 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antirheumatic Agents) RN - 91X1KLU43E (golimumab) SB - IM MH - Adult MH - Antibodies, Monoclonal/adverse effects/blood/*therapeutic use MH - Antirheumatic Agents/adverse effects/blood/*therapeutic use MH - Double-Blind Method MH - Female MH - Humans MH - Injections, Subcutaneous MH - Male MH - Quality of Life MH - Severity of Illness Index MH - Spondylitis, Ankylosing/blood/*drug therapy/rehabilitation MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Asia OT - China OT - ankylosing spondylitis OT - biologic OT - spondyloarthritis OT - spondyloarthropathy OT - tumour necrosis factor EDAT- 2014/04/15 06:00 MHDA- 2014/12/23 06:00 CRDT- 2014/04/15 06:00 PHST- 2014/04/15 06:00 [entrez] PHST- 2014/04/15 06:00 [pubmed] PHST- 2014/12/23 06:00 [medline] AID - keu132 [pii] AID - 10.1093/rheumatology/keu132 [doi] PST - ppublish SO - Rheumatology (Oxford). 2014 Sep;53(9):1654-63. doi: 10.1093/rheumatology/keu132. Epub 2014 Apr 11.