title: Cutaneous Adverse Events in the Randomized, Double-Blind, Active-Comparator DECIDE Study of Daclizumab High-Yield Process Versus Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis.
abstract: Cutaneous adverse events (AEs) have been observed in clinical studies of daclizumab high-yield process (HYP) in relapsing-remitting multiple sclerosis (RRMS). Here, we report cutaneous AEs observed in the randomized, double-blind, active-comparator DECIDE study (ClinicalTrials.gov identifier, NCT01064401).
  
  
  
  DECIDE was a randomized, double-blind, active-controlled phase 3 study of daclizumab HYP 150 mg subcutaneous every 4 weeks versus interferon (IFN) beta-1a 30 mcg intramuscular (IM) once weekly in RRMS. Treatment-emergent AEs were classified and recorded by investigators. Investigators also assessed the severity of each AE, and whether it met the criteria for a serious AE. Cutaneous AEs were defined as AEs coded to the Medical Dictionary for Regulatory Activities System Organ Class of skin and subcutaneous tissue disorders. The incidence, severity, onset, resolution, and management of AEs were analyzed by treatment group.
  
  
  
  Cutaneous AEs were reported in 37% of daclizumab HYP-treated patients and 19% of IFN beta-1a-treated patients. The most common investigator-reported cutaneous AEs with daclizumab HYP were rash (7%) and eczema (4%). Most patients with cutaneous AEs remained on treatment (daclizumab HYP, 81%; IM IFN beta-1a, 90%) and had events that were mild or moderate (94% and 98%) and subsequently resolved (78% and 82%). Most patients with cutaneous AEs did not require treatment with corticosteroids or were treated with topical corticosteroids (daclizumab HYP, 73%; IM IFN beta-1a, 81%). Serious cutaneous AEs were reported in 14 (2%) daclizumab HYP patients and one (<1%) IM IFN beta-1a patient.
  
  
  
  There was an increased risk of cutaneous AEs with daclizumab HYP. While physicians should be aware of the potential for serious cutaneous AEs, the typical cutaneous AEs were mild-to-moderate in severity, manageable, and resolved over time.
  
  
  
  Biogen and AbbVie Biotherapeutics Inc.
  
  
  
  ClinicalTrials.gov identifier, NCT01064401.
authors.affiliation: Laboratory for Investigative Dermatology, The Rockefeller University, 120 York Ave., New York, NY, 10065, USA. kruegej@mail.rockefeller.edu.
authors.forename: James G
authors.initials: JG
authors.lastname: Krueger
authors.affiliation: Department of Dermatology, Mount Sinai Hospital, One Gustave L. Levy Place, New York, NY, 10029, USA.
authors.forename: Leon
authors.initials: L
authors.lastname: Kircik
authors.affiliation: Douglas Dermatology and Skin Cancer Specialists, LLC, 4645 Timber Ridge Drive, Douglasville, GA, 30135, USA.
authors.forename: Firas
authors.initials: F
authors.lastname: Hougeir
authors.affiliation: Department of Dermatology, George Washington University School of Medicine and Health Sciences, 22nd & I Street NW, Washington, DC, 20037, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Friedman
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.|Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA, 02210, USA.
authors.forename: Xiaojun
authors.initials: X
authors.lastname: You
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
authors.forename: Nisha
authors.initials: N
authors.lastname: Lucas
authors.affiliation: AbbVie, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Greenberg
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.|Alnylam Pharmaceuticals, Inc., 300 Third Street, Cambridge, MA, 02142, USA.
authors.forename: Marianne
authors.initials: M
authors.lastname: Sweetser
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
authors.forename: Wanda
authors.initials: W
authors.lastname: Castro-Borrero
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: McCroskery
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
authors.forename: Jacob
authors.initials: J
authors.lastname: Elkins
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use; D000077561:Daclizumab; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage; D015994:Incidence; D000068556:Interferon beta-1a / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D012720:Severity of Illness Index; D012871:Skin Diseases / Q000139:chemically induced*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; C000598527:daclizumab HYP; D000077561:Daclizumab; D000068556:Interferon beta-1a
keywords: Cutaneous events; Daclizumab high-yield process; Dermatology; Interferon beta; Neurology; Relapsing-remitting multiple sclerosis; Safety