Treatment of ankylosing spondylitis with a recombinant human tumor necrosis factor receptor-Fc fusion protein: a multicenter, randomized, double blind, controlled trial / 中华风湿病学杂志

ABSTRACT

Objective To evaluate the efficacy and safety profile of a recombinant human tumor necrosis factor receptor Fc fusion protein in ankylosing spondylitis (AS). Methods This was a multicenter,randomized, double-blind, placebo-controlled trial in the first 6 weeks and then followed by an open-labeled trial in the next 6 weeks. One hundred and forty-three patients of active AS were randomly assigned to receive 25 mg twice-weekly subcutaneous injections of rhTNFRFc or placebo for 6 weeks. The primary endpoint was proportion of ASAS20 responders at week 6. The secondary endpoints were the proportion of subjects achieving a BASDAI 20%, BASDAI 50% and BASDAI 70% improvement at week 6. Other secondary endpoints, related to reducing signs and symptoms of AS and improving range of motion and physical function, were evaluated.Results Treatment with rhTNFRFc resulted in significant improvement. At 6 weeks, 68% of the 71 patients in the rhTNFR Fc group had a treatment response, as compared with 28% of those in the placebo group(P＜0.01). Improvements over base-line values for other measures of disease activity were significantly greater in the rhTNFRFc group, rhTNFRFc was well tolerated, The most frequently treatment related adverse event was injection site reaction. Conclusion rhTNFRFc has demonstrated consistent evidence of efficacy and is well tolerated in the treatment of active AS.