Abstract:

Objective To evaluate the efficacy and safety of etanercept in treatment of ankylosing spondylitis. Methods Eighty-six patients were randomized into experiment group and control group (n=43). Patients in experiment group were treated with non-steroidal antiinflammatory drugs (NSAIDs) and etanercept (25 mg, twice/week, subcutaneous injection in the upper arm), and those in control group were managed with NSAIDs and sulfasalazine. Reexaminations were performed after treatment for 3 months, and the prevalence of low back pain, time of morning stiffness, Bath ankylosing spondylitis disease activity index(BASDAI), Bath ankylosing spondylitis functional index(BASFI), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were analysed, and the prevalence of adverse effects was observed. Results Compared with those at administration, the prevalences of low back pain significantly reduced (P<0.05 or P<0.01), the time of morning stiffness significantly decreased (P<0.05), BASDAI and BASFI significantly improved, and ESR and CRP significantly decreased 3 months after treatment in both groups (P<0.05). After treatment for three months, the clinical parameters in experiment group were more favourable than those in control group (P<0.05). There was no significant difference in the prevalence of adverse effects between two groups (P>0.05). Conclusion Etanercept has favourable short-term therapeutic effects on ankylosing spondylitis with minor adverse effects.

Key words: ankylosing spondylitis, etanercept, sulfasalazine