Experience with low-dose thalidomide therapy in chronic discoid lupus erythematosus

Background Low-dose thalidomide therapy (median dose 100 mg/day, 50-200 mg/ day) in chronic discoid lupus erythematosus was studied with regard to effi cacy, tolerance, and toxicity in 22 patients. Intense contraceptive precaut ions were taken in women patients of childbearing age. Methods An open uncontrolled trial was conducted. Age, the total drug intak e, disease duration, extent/severity, and adverse reactions were studied wi th regard to the final clinical outcome. The follow-up duration was 1.8 yea rs (range 1 month to 3 years). Results With the exception of age (inverse correlation, P < 0.01), the para meters studied did not influence the final clinical amelioration: complete responders numbered 54.5%, partial responders 22.7%, and 13.6% were withdra wn from the trial with complaints of intolerance. The initial (first month) clinical response correlated significantly with the final one (P < 0.01). Drowsiness (40.9%) and somnolence (18.2%) were the most common side-effects , without affecting seriously the daily life of the participants. No case o f real neurotoxicity was confirmed. Relapses occurred within 39.4 +/- 21.4 days after drug withdrawal, presenting a milder clinical picture. Conclusions In the context of a predictable final outcome, low-dose thalido mide therapy is effective as an alternative choice in cases resistant to th e usual treatment.