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 efficacy, tolerance, and toxicity in 22 patients. Intense contraceptive precautions were taken in women patients of childbearing age.


METHODS
An open uncontrolled trial was conducted. Age, the total drug intake, disease duration, extent/severity, and adverse reactions were studied with regard to the final clinical outcome. The follow-up duration was 1.8 years (range 1 month to 3 years).


RESULTS
With the exception of age (inverse correlation, P < 0.01), the parameters studied did not influence the final clinical amelioration: complete responders numbered 54.5%, partial responders 22.7%, and 13.6% were withdrawn from the trial with complaints of intolerance.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 of 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 thalidomide therapy is effective as an alternative choice in cases resistant to the usual treatment.
Kyriakis
K P
KP
Department of Dermatology, The West Attica General Hospital and Leprosy Center, Athens, Greece.
Kontochristopoulos
G J
GJ
Panteleos
D N
DN
D000328:Adult; D001066:Appetite / Q000187:drug effects; D003248:Constipation / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008179:Lupus Erythematosus, Discoid / Q000188:drug therapy*; D008297:Male; D008599:Menstruation Disturbances / Q000139:chemically induced; D008875:Middle Aged; D010292:Paresthesia / Q000139:chemically induced; D010352:Patient Dropouts; D012008:Recurrence; D012074:Remission Induction; D012867:Skin / Q000187:drug effects / Q000473:pathology; D012894:Sleep Stages / Q000187:drug effects; D013792:Thalidomide / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D013792:Thalidomide