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RESEARCH PRODUCT
Fumaric acid ester treatment in cutaneous lupus erythematosus (CLE): a prospective, open-label, phase II pilot study.
S NozinicCristina SauerlandNikolaos PatsinakidisAysche LandmannGisela BonsmannA M Perusquía OrtizThomas A. LugerAnnegret KuhnAnnegret KuhnAthanasios TsianakasVincent Rulandsubject
AdultMaleFumaric acidmedicine.medical_specialtyColicPilot ProjectsSeverity of Illness IndexDrug Administration Schedule030207 dermatology & venereal diseases03 medical and health scienceschemistry.chemical_compound0302 clinical medicineRheumatologyFumaratesLupus Erythematosus CutaneousMedicineHumansIn patientProspective Studies030203 arthritis & rheumatologybusiness.industryHeadacheMiddle AgedDermatologyAlternative treatmentClinical trialTreatment OutcomeFumaric Acid EsterschemistryCutaneous Lupus ErythematosusFemaleOpen labelbusinessdescription
Objective The aim of the study was to assess the efficacy and safety of fumaric acid esters (FAEs) in patients with cutaneous lupus erythematosus (CLE). Methods In this 24-week, prospective, open-label, phase II pilot study, 11 patients with CLE, refractory to topical corticosteroids, were included. The primary endpoint of the study was the evaluation of the efficacy of FAEs after 24 weeks of treatment as assessed by the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI). Results Compared to baseline, significant improvement in the mean total RCLASI activity score and the mean RCLASI activity score for skin lesions was observed in week 12 ( p = 0.002, p = 0.002, respectively) and in week 24 ( p = 0.009, p = 0.009, respectively). Most common adverse events included abdominal cramps and headache. Conclusions FAEs could be an alternative and safe treatment in patients with therapy-refractory CLE; however, randomized controlled trials are warranted to evaluate the efficacy and safety of FAEs in this disease.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2016-07-11 | Lupus |