Abstract Details

Title Long-term Safety of Ozanimod in Relapsing Multiple Sclerosis and Moderately to Severely Active Ulcerative Colitis

Topic Multiple Sclerosis

Presentation(s) P7 - Poster Session 7 (8:00 AM-9:00 AM)

Poster/Presentation
Number 3-007

Objective Evaluate tolerability/safety of extended ozanimod 0.92 mg/day treatment in adults with relapsing multiple sclerosis (RMS) or moderately to severely active ulcerative colitis (UC).

Background Ozanimod, an oral sphingosine 1-phosphate (S1P) receptor modulator, is approved for treatment of RMS or moderately to severely active UC.

Design/Methods

The RMS population included patients treated with ozanimod 0.92 mg in DAYBREAK (NCT02576717; 10/16/2015 through 2/1/2022), an ongoing open-label extension (OLE) trial of patients from phase 1?3 ozanimod studies. The UC population included pooled patients treated with ozanimod 0.92 mg in phase 2 (NCT01647516), phase 3 (NCT02435992), and respective OLE trials through May 5, 2022. Safety outcomes included treatment-emergent adverse events (TEAEs) and TEAEs of special interest based on association with S1P modulation.

Results

Mean (SD) ozanimod exposure during DAYBREAK among 2494 patients with RMS was 56.4 (15.9) months (11,732.2 patient-years [PY]); exposure in 1158 UC patients was 28.4 (23.3) months (2714.9 PY) (MS/UC combined: 14,447.1 PY). TEAEs occurred in 88.2% of RMS and 74.6% of UC patients. Serious TEAEs were reported in 14.1% and 17.3%, and TEAEs leading to ozanimod discontinuation in 3.6% and 9.3%, respectively. The most common TEAS were nasopharyngitis (20.6%; exposure-adjusted incidence rate [IR] 51.0/1000 PY), headache (16.9%; 40.3/1000 PY), and upper respiratory infection (11.9%; 27.3/1000 PY) in RMS patients, and lymphopenia (12.3%; 53.6/1000 PY), anemia (8.4%; 35.0/1000 PY), lymphocyte count decreased (7.9%; 33.2/1000 PY), and nasopharyngitis (7.9%; 33.2/1000 PY) in UC patients. In MS and UC, respectively, IRs/1000 PY were 229.3 and 194.6 for any infection, 8.4 and 15.2 for serious infection, 13.5 and 11.8 for opportunistic infection, and 3.3 and 6.2 for malignancy. Alanine aminotransferase levels >5× upper limit of normal occurred in 0.8% and 2.3% of RMS and UC patients.

Conclusions Long-term ozanimod 0.92 mg/day was generally well tolerated and safe for most patients with RMS or moderately to severely active UC.

Authors/Disclosures
Jon Riolo, PhD PRESENTER	Dr. Riolo has received personal compensation for serving as an employee of Bristol Myers Squib.
Bruce A. Cree, MD, PhD, MAS, FAAN (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.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
James K. Sheffield, MD (Dianthus Therapeutics)	Dr. Sheffield has received personal compensation for serving as an employee of BMS.
Chun-Yen Cheng	Chun-Yen Cheng has received personal compensation for serving as an employee of Bristol Myers Squibb. Chun-Yen Cheng has stock in Bristol Myers Squibb.
Diego Silva (Bristol-Myers Squibb Company)	Diego Silva has received personal compensation for serving as an employee of BMS. Diego Silva has received stock or an ownership interest from BMS.
Fred D. Lublin, MD, FAAN (Icahn School of Medicine At Mount Sinai)	Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche/Genentech. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurogene. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medimmune/Viela Bio/Horizon. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Receptos/Celgene/BMS. Dr. Lublin 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. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Labcorp. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralight. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Entelexo. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Lublin has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Multiple entities. Dr. Lublin has stock in Avotres. Dr. Lublin has stock in Neuralight. The institution of Dr. Lublin has received research support from Brainstorm. The institution of Dr. Lublin has received research support from biogen. The institution of Dr. Lublin has received research support from NIH.
	No disclosure on file
Jeffrey A. Cohen, MD (Cleveland Clinic)	Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion.

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