Objective: To investigate the long term efficacy and safety of thalidomide in the treatment of refractory ankylosing spondylitis.
Methods: A total of 232 patients with refractory ankylosing spondylitis were recruited into open study using thalidomide at a dose of 150 mg/d, bath ankylosing spondylitis disease activity index (BASDAI), spinal pain score and thalidomide related side effects were observed regularly.
Results: From the third month, BASDAI and spine pain score decreased significantly when compared with those of the base line (P<0.05). Such improvement became more obvious as time went on. A total of 148 patients (63.8%) got >50% improvement in BASDAI and spine pain score, and 76 cases (32.8%) reported absence of spine pain. The major side effects were drowsiness, constipation, dry mouth, dizziness and dandruff. Thirty two patients (13.8%) withdrew from the study because of adverse events. Most of the adverse effects disappeared as thalidomide was stopped.
Conclusion: Long term thalidomide is effective and safe for treating resistant ankylosing spondylitis and it has cumulative effect as duration prolongs.