[The efficacy and safety of long-term thalidomide in the treatment of ankylosing spondylitis].

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.

CONCLUSIONS

Long term thalidomide is effective and safe for treating resistant ankylosing spondylitis and it has cumulative effect as duration prolongs.