Objective: To evaluate the efficacy and safety of golimumab in patients with active ankylosing spondylitis (AS). Methods: This was a randomized, double-blind, placebo-controlled trial. The subjects were randomized to receive either golimumab 50mg subcutaneously or placebo every 4 weeks. Patients in both groups received golimumab 50mg from week 24 to week 48. The primary endpoint was the proportion of at least 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) at week 14. The secondary endpoints included at least 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40), ASAS partial-remission, Bath AS functional index, Bath AS disease activity index, Bath AS metrology index, enthesitis index and Jenkins sleep evaluation questionnaire. Results:A total of 25 subjects were included in this study, 13 with golimumab and 12 withplacebo. At Week 14, 6(46.2%) subjects achieved ASAS20 in golimumab group and 2(16.7%) in placebo group. Significant improvements of other efficacy endpoints were also found in golimumab group. Golimumab was safe and well to lerated. Most of the adverse events were slightly impaired liver function, where as elevated aspartate aminotransferase and/or alanine aminotransferase returned to normal without drug with drawal. Conclusion:Golimumab improves AS activity, clinical symptoms and sleep disturbance in patients with active AS with goodsafety and tolerability.
RCT Entities:
Objective: To evaluate the efficacy and safety of golimumab in patients with active ankylosing spondylitis (AS). Methods: This was a randomized, double-blind, placebo-controlled trial. The subjects were randomized to receive either golimumab 50mg subcutaneously or placebo every 4 weeks. Patients in both groups received golimumab 50mg from week 24 to week 48. The primary endpoint was the proportion of at least 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) at week 14. The secondary endpoints included at least 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40), ASAS partial-remission, Bath AS functional index, Bath AS disease activity index, Bath AS metrology index, enthesitis index and Jenkins sleep evaluation questionnaire. Results: A total of 25 subjects were included in this study, 13 with golimumab and 12 with placebo. At Week 14, 6(46.2%) subjects achieved ASAS20 in golimumab group and 2(16.7%) in placebo group. Significant improvements of other efficacy endpoints were also found in golimumab group. Golimumab was safe and well to lerated. Most of the adverse events were slightly impaired liver function, where as elevated aspartate aminotransferase and/or alanine aminotransferase returned to normal without drug with drawal. Conclusion:Golimumab improves AS activity, clinical symptoms and sleep disturbance in patients with active AS with good safety and tolerability.