DMT01
Treatment-Emergent COVID-19 in Ozanimod Multiple Sclerosis and Ulcerative Colitis Clinical Trials

Thursday, June 2, 2022: 2:30 PM
Woodrow Wilson D (Gaylord National Resort & Convention Center)
Bruce A.C. Cree, MD, PhD , Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA
Ryan C. Ungaro, MD , Icahn School of Medicine at Mount Sinai, New York, NY
Jean-Frederic Colombel, MD , Icahn School of Medicine at Mount Sinai, New York, NY
Corey A. Siegel, MD, MS , Dartmouth-Hitchcock Medical Center, Lebanon, NH
James K. Sheffield, MD , Bristol Myers Squibb, Princeton, NJ
John Vaile, PharmD , Bristol Myers Squibb, Princeton, NJ
Harris A. Ahmad, MD , Bristol Myers Squibb, Princeton, NJ
Ashwini Pai, MD , Bristol Myers Squibb, Princeton, NJ
Shabana Ather, MD , Bristol Myers Squibb, Princeton, NJ
Lorna Charles, MD , Bristol Myers Squibb, Princeton, NJ
AnnKatrin Petersen, MD , Bristol Myers Squibb, Princeton, NJ
Chun-Yen Cheng, PhD , Bristol Myers Squibb, Princeton, NJ
Sonia Afsari, MD , Bristol Myers Squibb, Princeton, NJ
Krzysztof W. Selmaj, MD , Center for Neurology, Łódź, Poland, and Department of Neurology, University of Warmia & Mazury, Olsztyn, Poland



Background: Ozanimod, a sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for the treatment of adults with either relapsing forms of multiple sclerosis (MS) or moderately to severely active ulcerative colitis (UC).

Objectives: We describe COVID-19 outcomes in ozanimod-treated patients with MS or UC in active phase 3 open-label extension studies.

Methods: A database search identified COVID-19 reports in ozanimod-treated patients with MS in the DAYBREAK open-label extension and UC in the True North open-label extension. The analysis period was November 1, 2019 to either May 10, 2021 (MS) or August 31, 2021 (UC). The last COVID-19 event from all patients with ≥1 event was analyzed.

Results: Among 2792 ozanimod-treated patients with MS or UC, 258 developed COVID-19 (confirmed: 215); thus, the incidence in these clinical trial settings was 9.2% during the analysis periods. Most patients with confirmed cases (193/215 [89.8%]) had nonserious infections not requiring hospitalization or meeting other International Conference on Harmonization criteria for a serious event. Of 2181 ozanimod-treated patients with MS, 190 (8.7%) developed COVID-19 (confirmed: 160). Most MS patients with confirmed COVID-19 (148/160 [92.5%]) had nonserious cases; most (158/160 [98.8%]) recovered (5 with sequelae). No MS patients with confirmed cases discontinued ozanimod, 61 temporarily interrupted it (38.1%), and 99 had no change to treatment (61.9%). There were 3 COVID-19‒related deaths in the MS program (case-fatality rate 1.6% in MS, 1.2% overall). Of 611 ozanimod-treated patients with UC, 68 (11.1%) developed COVID-19 (confirmed: 55). A majority of UC patients with confirmed cases (45/55 [81.8%]) had nonserious COVID-19; most (54/55 [98.2%]) recovered (2 with sequelae) and 1 was recovering at data cutoff. One UC patient with confirmed COVID-19 discontinued ozanimod (1.8%), 23 temporarily interrupted it (41.8%), and 31 had no change to treatment (56.4%). No COVID-19‒related deaths were reported in patients with UC. Outcomes in 30 additional MS patients and 13 additional UC patients with suspected COVID-19 were similar to those with confirmed cases.

Conclusions: In the MS and UC open-label extension studies, most patients with confirmed COVID-19 had nonserious infections, recovered, and did not require discontinuation of ozanimod. There were 3 COVID-19‒related deaths in patients with MS.

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