Infliximab versus disease modifying antirheumatic drugs in the treatment of ankylosing spondylitis / 中华风湿病学杂志

ABSTRACT

Objective To evaluate the efficacy and safety of infliximab and traditional disease modifying antirheumatic drugs (DMARDs) in the treatment of ankylosing spondylitis (AS). Methods Sixty patients with definite AS were treated with infliximab 5 mg/kg infusion at 0, 2, 6, 12 weeks and were followed up for 12 weeks. The primary endpoint was proportion of ASAS 20 responders at week 12. The secondary endpoints were the proportion of ASAS 50, the change from baseline in Bath AS functional index (BASFI).The improvement of signs and symptoms of AS and physical function were evaluated. The statistical treatments were used t-test andA2 test. Results The proportion of ASAS 20 responders at 2, 6, 12 week was 70%, 83% and 93% respectively. The proportion of ASAS50 responders at patients at 2, 6, 12 week was 13%, 37% and 57% respectively. Results for other secondary efficacy endpoints showed that infliximab could provide substantial benefits to patients with AS by reducing clinical signs and symptoms and improving range of motion, physical function and quality of life. Ten percent of the subjects reported treatment- related adverse events. The most frequently occurred were upper respiratory tract infection, followed by gastrointestinal adverse events and infusion reaction. Most treatment-related adverse events were mild to moderate in severity and disappeared after drug withdrawal. Conclusion Infliximab has been demonstrated to be effective and is well tolerated in the treatment of AS.