PMID- 27251051
OWN - NLM
STAT- MEDLINE
DCOM- 20170912
LR  - 20220409
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 33
IP  - 7
DP  - 2016 Jul
TI  - 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.
PG  - 1231-45
LID - 10.1007/s12325-016-0353-2 [doi]
AB  - INTRODUCTION: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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. FUNDING: Biogen and AbbVie 
      Biotherapeutics Inc. TRIAL REGISTRATION: ClinicalTrials.gov identifier, 
      NCT01064401.
FAU - Krueger, James G
AU  - Krueger JG
AD  - Laboratory for Investigative Dermatology, The Rockefeller University, 120 York 
      Ave., New York, NY, 10065, USA. kruegej@mail.rockefeller.edu.
FAU - Kircik, Leon
AU  - Kircik L
AD  - Department of Dermatology, Mount Sinai Hospital, One Gustave L. Levy Place, New 
      York, NY, 10029, USA.
FAU - Hougeir, Firas
AU  - Hougeir F
AD  - Douglas Dermatology and Skin Cancer Specialists, LLC, 4645 Timber Ridge Drive, 
      Douglasville, GA, 30135, USA.
FAU - Friedman, Adam
AU  - Friedman A
AD  - Department of Dermatology, George Washington University School of Medicine and 
      Health Sciences, 22nd & I Street NW, Washington, DC, 20037, USA.
FAU - You, Xiaojun
AU  - You X
AD  - Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
AD  - Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA, 02210, USA.
FAU - Lucas, Nisha
AU  - Lucas N
AD  - Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
FAU - Greenberg, Steven J
AU  - Greenberg SJ
AD  - AbbVie, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
FAU - Sweetser, Marianne
AU  - Sweetser M
AD  - Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
AD  - Alnylam Pharmaceuticals, Inc., 300 Third Street, Cambridge, MA, 02142, USA.
FAU - Castro-Borrero, Wanda
AU  - Castro-Borrero W
AD  - Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
FAU - McCroskery, Peter
AU  - McCroskery P
AD  - Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
FAU - Elkins, Jacob
AU  - Elkins J
AD  - Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01064401
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160601
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunoglobulin G)
RN  - 0 (daclizumab HYP)
RN  - CUJ2MVI71Y (Daclizumab)
RN  - XRO4566Q4R (Interferon beta-1a)
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*adverse effects/therapeutic use
MH  - Daclizumab
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/administration & dosage
MH  - Incidence
MH  - Interferon beta-1a/*adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy
MH  - Severity of Illness Index
MH  - Skin Diseases/*chemically induced
MH  - Treatment Outcome
PMC - PMC4939160
OTO - NOTNLM
OT  - Cutaneous events
OT  - Daclizumab high-yield process
OT  - Dermatology
OT  - Interferon beta
OT  - Neurology
OT  - Relapsing-remitting multiple sclerosis
OT  - Safety
EDAT- 2016/06/03 06:00
MHDA- 2017/09/13 06:00
PMCR- 2016/06/01
CRDT- 2016/06/03 06:00
PHST- 2016/03/30 00:00 [received]
PHST- 2016/06/03 06:00 [entrez]
PHST- 2016/06/03 06:00 [pubmed]
PHST- 2017/09/13 06:00 [medline]
PHST- 2016/06/01 00:00 [pmc-release]
AID - 10.1007/s12325-016-0353-2 [pii]
AID - 353 [pii]
AID - 10.1007/s12325-016-0353-2 [doi]
PST - ppublish
SO  - Adv Ther. 2016 Jul;33(7):1231-45. doi: 10.1007/s12325-016-0353-2. Epub 2016 Jun 
      1.