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Thalidomide for Severe Refractory Ankylosing Spondylitis: A 6-Month Open-Label Trial JAMES CHENG-CHUNG WEI, TSAI WEN CHAN, HUEY-SHYAN LIN, FENG HUANG, and CHAN-TE CHOU
ABSTRACT. Methods. 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. Results. Three patients withdrew due to rash. Two patients were lost to followup due to lack of efficacy. Eight patients completed the trial. Four patients attained > 50% improvement (2 juvenile AS, 1 peripheral AS, and 1 psoriatic arthritis). Four patients attained > 20% improvement (2 axial and 2 peripheral AS). Total response rate accordingly was 80% (8/10). Mean BASDAI improved significantly from baseline to Week 24 (4.97 vs 3.1; p = 0.0156). Mean BASFI improved from baseline to Week 24 (5.24 vs 3.06; p = 0.0078), and BAS-G from 6.02 to 3.21 (p = 0.0078). Significant laboratory improvements were found in ESR (from 69.5 to 34.2 mm/h; p = 0.0156), but not CRP (from 6.08 to 3.01 mg/dl; p = 0.078) or IgA (from 496 to 505 mg/dl; p = 0.375). Dry mouth, constipation, and dizziness were common, but no severe adverse events were found. Conclusion. Thalidomide is a promising treatment for patients with active AS who are resistant to conventional therapies other than biologics. (J Rheumatol 2003;30:2627-31) Key Indexing Terms:
ANKYLOSING SPONDYLITIS
From the Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Chung Shan Medical University, Taichung; Division of Rheumatology, Department of Internal Medicine, Kaohsiung Medical University and the Department of Nursing, Fooyin Institute of Technology, Kaohsiung; Rheumatology Division, Department of Medicine, Veterans General Hospital, Taipei, Taiwan; and Division of Rheumatology, Department of Medicine, Chinese PLA General Hospital, Beijing, China. J.C.C. Wei, MD, Division of Allergy, Rheumatology and Immunology, Department of Internal Medicine, Institute of Medicine, Chung Shan Medical University; T.W. Chan, MD, Division of Rheumatology and Immunology, Department of Internal Medicine, Kaohsiung Medical University; H.S. Lin, Associate Professor, Department of Nursing, Fooyin Institute of Technology; F. Huang, MD, PhD, Division of Rheumatology, Department of Medicine, Chinese PLA General Hospital; C.T. Chou, Division of Allergy, Rheumatology and Immunology, Department of Internal Medicine, Veterans General Hospital. Address reprint requests to Dr. J.C.C. Wei, Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Chung Shan Medical University, 110, Sec. 1, Chien Kuo N. Road, Taichung 402, Taiwan. E-mail: wei3228@ms3.hinet.net Submitted October 23, 2003; revision accepted May 26, 2003. |