Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous
involvement at some point during course of their disease. In spite of the esthetic
consequence during the acute phase, the main problem is still related to its disfiguring and
incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the
conventional therapy. Unfortunately, approximately 30% will be refractory to these measures.
For those patients, immunosuppressive therapy can be an alternative with controversial
results. Several series have shown a 90% of clinical efficacy in patients treated with
Thalidomide. Unfortunately, the main drawback has been the serious described side effects
such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide
analogue, more potent, efficient and with better safety profile has been discovered. The main
objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients
with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this
drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare
after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve
patients with refractory cutaneous lupus will be included. Lenalidomide will be started at
5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the
end of follow up.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute