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To examine the efficacy of thalidomide in the treatment of active ankylosing spondylitis (AS) refractory to conventional therapies. In a 6-month open-label trial, we studied 13 men with different subtypes of active AS: 3 juvenile AS, 9 adult AS, and one AS with psoriasis. All patients were resistant to conventional nonbiologic therapies including nonsteroidal antiinflammatory drugs, sulfasalazine, and methotrexate. After 3 months' observation on a preexisting regimen, oral thalidomide was added, starting at 100 mg/day for 1 week, then 200 mg/day for another 23 weeks. Outcome measures included the Bath AS Disease Activity Index (BASDAI), Functional Index (BASFI), Global Index (BAS-G), IgA, C-reactive protein (CRP), and eosinophil sedimentation rate (ESR). Response to treatment was defined following the Ankylosing Spondylitis Assessment criteria. Three patients withdrew due …