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.

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.

• Authors: Chunde Bao, Feng Huang, Muhammad Asim Khan, Kaiyin Fei, Zhong Wu, Chenglong Han, Elizabeth C Hsia
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 53 Issue 9 Pg. 1654-63 (Sep 2014) ISSN: 1462-0332 [Electronic] England
• PMID: 24729398 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: [email protected].

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• golimumab

Topics

• Adult
• Antibodies, Monoclonal (adverse effects, blood, therapeutic use)
• Antirheumatic Agents (adverse effects, blood, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Injections, Subcutaneous
• Male
• Quality of Life
• Severity of Illness Index
• Spondylitis, Ankylosing (blood, drug therapy, rehabilitation)
• Treatment Outcome
• Young Adult