Abstract
IntroductionCutaneous lupus erythematosus (CLE) is a chronic disease characterized by disfigurement and a relapsing course. Thalidomide has proven its efficacy in refractory cutaneous lupus disease, although it is not exempt from significant side effects and frequent relapses after withdrawal. New thalidomide analogues have been developed but lack clinical experience. The aim of this preliminary phase II study was to evaluate the efficacy and safety of lenalidomide in patients with refractory CLE.MethodsFifteen patients with refractory cutaneous lupus disease were enrolled in this single-center, open-label, non-comparative pilot trial between January 2009 and December 2010. Oral lenalidomide (5 to 10 mg/day) was administered and tapered according to clinical response. Patients were followed up for a mean of 15 months (range: 7 to 30). Primary efficacy endpoint was the proportion of patients achieving complete response, defined by a Cutaneous Lupus Erythematosus Disease Area and Severity index (CLASI) activity score of 0. Other secondary endpoints included development of side effects, evaluation of cutaneous and systemic flares, and impact on the immunological parameters.ResultsOne patient discontinued treatment due to side effects. All remaining patients saw clinical improvement and this was already noticeable after 2 weeks of treatment. Twelve of those patients (86%) achieved complete response but clinical relapse was frequent (75%), usually occurring 2 to 8 weeks after lenalidomide's withdrawal. No influence on systemic disease, immunological parameters or CLASI damage score was observed. Side effects including insomnia, grade 2 neutropenia and gastrointestinal symptoms, were minor (13%). These resolved after withdrawing medication. Neither polyneuropathy nor thrombosis was observed.ConclusionLenalidomide appears to be efficacious and safe in patients with refractory CLE, but clinical relapse is frequent after its withdrawal.Trial registrationClinicalTrials.gov: NCT01408199.
Highlights
Cutaneous lupus erythematosus (CLE) is a chronic disease characterized by disfigurement and a relapsing course
Primary efficacy endpoint was the proportion of patients achieving complete response, defined by a Cutaneous Lupus Erythematosus Disease Area and Severity index (CLASI) activity score of 0
All remaining patients saw clinical improvement and this was already noticeable after 2 weeks of treatment
Summary
Cutaneous lupus erythematosus (CLE) is a chronic disease characterized by disfigurement and a relapsing course. Most patients respond to the standard first-line therapy of topical steroids and antimalarials, approximately 30 to 40% of cases will be refractory to these regimens For this significant minority, there is no consensus algorithm and Thalidomide, a glutamic acid derivative, is an agent with a mechanism of action that includes both tumoricidal and immunomodulatory effects. There has been a renewed interest in its use, and currently is prescribed in various oncologic, dermatologic, and inflammatory conditions, including refractory cutaneous lupus erythematosus (CLE) [8] In the latter, a significant rapid clinical response has been reported in 80 to 90% of the treated patients [8,9,10,11,12,13,14,15,16,17]. Despite its effectiveness, sustained long-term remission after its withdrawal is low, relapse occurs frequently and it is not exempt from severe side effects that are the main limitation on its continued use [17]
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