Thalidomide for severe refractory ankylosing spondylitis

Recent research published in Rheumatology suggests that thalidomide treatment is useful in patients with severe ankylosing spondylitis (AS) refractory to conventional therapy.Dr. James Cheng-Chung Wei of Chung Shan Medical University (Taiwan) and colleagues note that therapies targeting tumor necrosis factor (TNF) alpha have shown dramatic results in patients with refractory AS. However, these biological modifying agents such as infliximab "are expensive and not available in many countries."As a result the researchers, noting that thalidomide also inhibits TNF alpha, sought to examine its effect in an open label 6-month study of 13 patients. These patients had documented resistance to conventional non-biologic therapies including nonsteroidal antiinflammatory drugs, sulfasalazine, and methotrexate. Three participants had juvenile AS, 9 had adult AS and the remaining patient had AS with psoriasis.After 3 months' observation on a pre-existing regimen, oral thalidomide was added, starting at 100 mg/day for one week, then 200 mg/day for another 23 weeks. Outcomes were measured through the Bath AS Disease Activity Index (BASDAI), Functional Index (BASFI), Global Index (BAS-G), IgA, C-reactive protein (CRP), and eosinophil sedimentation rate (ESR).Of the study population, two patients withdrew from the study because they developed severe rashes, one did so because of dizziness and a further two dropped out because they experienced no treatment effect after 8 weeks. Four of the eight subjects who completed the course of treatment showed a greater than 50% improvement and the other four demonstrated an improvement of more than 20%. In addition, the authors noted significant improvements in measures of function, disease activity and a significant improvement in eosinophil sedimentation rate.Wei et al comment on the minor adverse events such as dizziness and constipation that were seen in "most patients", but report that "there were no serious adverse events". The researchers observe that "specific TNF-alpha antagonists are not available or affordable in most Asian countries" and conclude that thalidomide "is a viable alternative."The researchers conclude that "thalidomide is a promising treatment for patients with active AS who are resistant to conventional therapies other than biologics".Reference...