Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosusReport as inadecuate




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Arthritis Research and Therapy

, 14:R265

First Online: 07 December 2012Received: 23 July 2012Revised: 29 September 2012Accepted: 12 November 2012

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.

AbbreviationsACLEacute cutaneous lupus erythematosus

ACRAmerican College of Rheumatology

AEadverse event

ANAantinuclear antibodies

CLASICutaneous Lupus Erythematosus Disease Area and Severity Index

CLEcutaneous lupus erythematosus

CRcomplete response

DLEdiscoid lupus erythematosus

ENAextractable nuclear antigen

LETlupus erythematosus tumidus

PRpartial response

SAEserious adverse event

SCLEsubacute cutaneous lupus erythematosus

SLEsystemic lupus erythematosus

SLEDAISystemic Lupus Erythematosus Disease Activity Index.

Electronic supplementary materialThe online version of this article doi:10.1186-ar4111 contains supplementary material, which is available to authorized users.

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Author: Josefina Cortés-Hernández - Gabriela Ávila - Miquel Vilardell-Tarrés - Josep Ordi-Ros

Source: https://link.springer.com/







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