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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.
Adv Ther. 2016 07; 33(7):1231-45.AT

Abstract

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.

Authors+Show Affiliations

Laboratory for Investigative Dermatology, The Rockefeller University, 120 York Ave., New York, NY, 10065, USA. kruegej@mail.rockefeller.edu.Department of Dermatology, Mount Sinai Hospital, One Gustave L. Levy Place, New York, NY, 10029, USA.Douglas Dermatology and Skin Cancer Specialists, LLC, 4645 Timber Ridge Drive, Douglasville, GA, 30135, USA.Department of Dermatology, George Washington University School of Medicine and Health Sciences, 22nd & I Street NW, Washington, DC, 20037, USA.Biogen, 225 Binney Street, Cambridge, MA, 02142, USA. Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA, 02210, USA.Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.AbbVie, 1 North Waukegan Road, North Chicago, IL, 60064, USA.Biogen, 225 Binney Street, Cambridge, MA, 02142, USA. Alnylam Pharmaceuticals, Inc., 300 Third Street, Cambridge, MA, 02142, USA.Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27251051

Citation

Krueger, James G., et al. "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." Advances in Therapy, vol. 33, no. 7, 2016, pp. 1231-45.
Krueger JG, Kircik L, Hougeir F, et al. 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. Adv Ther. 2016;33(7):1231-45.
Krueger, J. G., Kircik, L., Hougeir, F., Friedman, A., You, X., Lucas, N., Greenberg, S. J., Sweetser, M., Castro-Borrero, W., McCroskery, P., & Elkins, J. (2016). 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. Advances in Therapy, 33(7), 1231-45. https://doi.org/10.1007/s12325-016-0353-2
Krueger JG, et al. 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. Adv Ther. 2016;33(7):1231-45. PubMed PMID: 27251051.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Krueger,James G, AU - Kircik,Leon, AU - Hougeir,Firas, AU - Friedman,Adam, AU - You,Xiaojun, AU - Lucas,Nisha, AU - Greenberg,Steven J, AU - Sweetser,Marianne, AU - Castro-Borrero,Wanda, AU - McCroskery,Peter, AU - Elkins,Jacob, Y1 - 2016/06/01/ PY - 2016/03/30/received PY - 2016/6/3/entrez PY - 2016/6/3/pubmed PY - 2017/9/13/medline KW - Cutaneous events KW - Daclizumab high-yield process KW - Dermatology KW - Interferon beta KW - Neurology KW - Relapsing-remitting multiple sclerosis KW - Safety SP - 1231 EP - 45 JF - Advances in therapy JO - Adv Ther VL - 33 IS - 7 N2 - 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. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/27251051/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_ DB - PRIME DP - Unbound Medicine ER -