Experience with Serious Cutaneous Events in the DECIDE Study (P2.083)

Objective: Describe the experience with serious cutaneous adverse events (AEs) in DECIDE. Background: Cutaneous AEs were reported in 344 (37[percnt]) and 176 (19[percnt]), and serious cutaneous AEs in 14 (2[percnt]) and 1 (<1[percnt]) patients in the daclizumab HYP (n=919) and intramuscular interferon beta-1a (n=922) groups, respectively. Methods: Investigators assessed AE severity and whether each met the criteria for a serious AE. Information on treatment was obtained from clinical trial and global safety databases. Results: Most cutaneous AEs were mild or moderate in severity (daclizumab HYP, 94[percnt] [n=323/344]; intramuscular interferon beta-1a, 98[percnt] [n=173/176]) and did not require a corticosteroid or were treated with topical corticosteroids (daclizumab HYP, 73[percnt] [250/344]; intramuscular interferon beta-1a, 81[percnt] [143/176]). In the daclizumab HYP group, onset of serious cutaneous AEs ranged from 99-680 days after starting treatment; duration ranged from 1-249 days. Dermatitis and angioedema occurred in 3 and 2 patients, respectively; all other serious cutaneous AEs occurred in one patient each. Three events were considered unrelated to daclizumab HYP. No Stevens-Johnson Syndrome or toxic epidermal necrolysis cases were reported. Three patients continued treatment without sequelae, 8 discontinued treatment/discontinued the study due to the event, and 3 discontinued treatment for another reason. Most daclizumab HYP-treated patients received corticosteroids for their serious cutaneous AE (topical:n=1; systemic:n=3; topical and systemic:n=7; none:n=3). Treatments also included antihistamines (n=9) and other therapies (n=4). One investigator administered a single course of plasma exchange (range: 1-5 exchanges/course) each to 3 daclizumab HYP patients, leading to improvement. All reported serious cutaneous events resolved. Conclusions: Most cutaneous AEs were mild or moderate in severity. Serious cutaneous AEs occurred in 2[percnt] of daclizumab HYP-treated patients; all resolved following topical and/or systemic steroids, antihistamines, other therapies, or treatment discontinuation and none were considered exfoliative life-threatening dermatologic conditions. Study Supported by: Biogen and AbbVie Biotherapeutics Inc. Disclosure: Dr. Ford has received research support from Adamas, Biogen, Genentech, MedImmune, Merck Serono, Novartis, Ono, Roche, Sanofi, Teva. Dr. Khatri has received personal compensation for activities with Novartis, Teva, Mallinckrodt Pharmaceuticals, Genzyme, Biogen, Acorda, Serono, Pfizer, Bayer, and Avanir. Dr. Olsson has received research support from Biogen, Novartis, Genzyme and AstraZeneca. Dr. Ziemssen has received personal compensation for activities with Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceutical, and Almirall. Dr. You holds stock and/or stock options in Biogen Idec. Dr. Wanda Castro has received personal compensation from Biogen as an employee. Dr. McCroskery has received personal compensation for activities with Biogen as an employee. Dr. McCroskery holds stock and/or stock options in Biogen, which supported research in which Dr. McCroskery was involved as an investigator.