title: Fumaric acid ester treatment in cutaneous lupus erythematosus (CLE): a prospective, open-label, phase II pilot study.
abstract: 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.
authors.affiliation: Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany Division of Immunogenetics, Tumor Immunology Program, German Cancer Research Center, Heidelberg, Germany research@izks-unimedizin-mainz.de.
authors.forename: A
authors.initials: A
authors.lastname: Kuhn
authors.affiliation: Division of Immunogenetics, Tumor Immunology Program, German Cancer Research Center, Heidelberg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Landmann
authors.affiliation: Department of Dermatology and Allergology, Klinikum Bremen Mitte, Bremen, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Patsinakidis
authors.affiliation: Institute of Neuropathology, University Hospital Muenster, Muenster, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Ruland
authors.affiliation: Division of Immunogenetics, Tumor Immunology Program, German Cancer Research Center, Heidelberg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Nozinic
authors.affiliation: Department of Dermatology, University Hospital Muenster, Muenster, Germany.
authors.forename: A M
authors.initials: AM
authors.lastname: Perusquía Ortiz
authors.affiliation: Institute of Biostatistics and Clinical Research, University of Muenster, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Sauerland
authors.affiliation: Department of Dermatology, University Hospital Muenster, Muenster, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Luger
authors.affiliation: Department of Dermatology, University Hospital Muenster, Muenster, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Tsianakas
authors.affiliation: Department of Dermatology, University Hospital Muenster, Muenster, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Bonsmann
mesh_terms: D000328:Adult; D003085:Colic / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D005650:Fumarates / Q000008:administration & dosage* / Q000009:adverse effects; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008178:Lupus Erythematosus, Cutaneous / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D005650:Fumarates
keywords: Cutaneous lupus erythematosus; RCLASI; alternative treatment; clinical trial; fumaric acid esters