Â鶹´«Ã½Ó³»­

Â鶹´«Ã½Ó³»­

Explore the latest content from across our publications
Join The Â鶹´«Ã½Ó³»­

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Low Rate of Infections With Long-term Use of Ozanimod in Relapsing Multiple Sclerosis Trials
Multiple Sclerosis
P7 - Poster Session 7 (5:30 PM-6:30 PM)
9-005
To evaluate infection rates with long-term exposure to ozanimod HCl 1mg in clinical trial participants with RMS.
By modulating sphingosine 1-phosphate receptor subtype 1, ozanimod reduces circulating lymphocytes, potentially increasing susceptibility to infections.
SUNBEAM (NCT02294058; ≥12 months) and RADIANCE (NCT02047734; 24 months) were multicenter, randomized, double-blind, phase 3 trials comparing oral ozanimod HCl 1 and 0.5mg/d with intramuscular interferon β-1a 30µg/week in adults (18?55 years) with RMS. Participants who completed any ozanimod RMS clinical trial were eligible to enroll in an open-label RMS extension trial (DAYBREAK; NCT02576717) of ozanimod HCl 1mg/d. Infection rates with ozanimod HCl 1mg are compared descriptively in controlled phase 3 trials (SUNBEAM and RADIANCE) and in participants who received ozanimod HCl 1mg in any RMS trial.
In pooled controlled phase 3 studies, 882 participants received ozanimod HCl 1mg (mean [SD] exposure, 18.1 [6.0] months; 1345.4 person years [PY] on study). The incidence of infections was 35.1% and serious infections was 1.0%. The overall infection rate was 300.5/1000 PY; herpes zoster rate (including varicella zoster virus [VZV] infection) was 3.7/1000 PY. The most common infections were nasopharyngitis (11.1%) and upper respiratory tract infection (5.9%). Opportunistic infections, predominately herpes related, occurred in 1.8%. With longer term exposure to ozanimod HCl 1mg in any trial (n=2631; data cutoff 1/31/2019; mean [SD] exposure 32.0 [12.8] months; 7058.5 PY on study), overall infection incidence was 48.6% and serious infections was 1.7%. The overall infection rate was 270.1/1000 PY. Herpes zoster rate (including VZV infection) was 5.3/1000 PY. No serious opportunistic infections occurred.
In RMS participants with longer ozanimod HCl 1mg exposure, overall infection rates were similar to those with ≤24 months’ exposure in controlled phase 3 trials. Non-serious herpes zoster infections were infrequent, but increased over time. No serious opportunistic infections have been reported with ozanimod.
Authors/Disclosures
Hans-Peter Hartung, MD, FÂ鶹´«Ã½Ó³»­ (Heinrich Heine University Medical Faculty)
PRESENTER 		Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS Celgene. Dr. Hartung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Geneuro. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Neurology.
Bruce A. Cree, MD, PhD, MAS, FÂ鶹´«Ã½Ó³»­ (UCSF, Multiple Sclerosis Center) The institution of Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuron23. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal/Sandoz. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. The institution of Dr. Cree has received research support from Genentech. The institution of Dr. Cree has received research support from Kyverna. Dr. Cree has received publishing royalties from a publication relating to health care.
Krzysztof W. Selmaj (University of Warmia and Mazury) Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK) Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
No disclosure on file
James K. Sheffield, MD (Dianthus Therapeutics) Dr. Sheffield has received personal compensation for serving as an employee of BMS.
Neil Minton Neil Minton has received personal compensation for serving as an employee of Bristol Myers Squibb. Neil Minton has received stock or an ownership interest from Bristol Myers Squibb.
Anne Janjua Anne Janjua has received personal compensation for serving as an employee of Bristol-Myers Squibb Company.
No disclosure on file
Amit Bar-Or, MD, FRCPC (University of Pennsylvania) Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. The institution of Dr. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.