TREATMENT-EMERGENT COVID-19 INFECTIONS IN OZANIMOD ULCERATIVE COLITIS AND MULTIPLE SCLEROSIS CLINICAL TRIALS

ABSTRACT

Introduction: Ozanimod, a sphingosine 1-phosphate (S1P) receptor S1P1 and S1P5 modulator, is approved in the United States for moderately to severely active ulcerative colitis (UC) and in multiple countries for relapsing multiple sclerosis (MS). We describe COVID-19 outcomes in ozanimod-treated UC or MS patients in active phase 3 open-label extension studies. Methods: A database search identified COVID-19 infection reports in ozanimodtreated patients with UC in the True North open-label extension and MS in the DAYBREAK open-label extension. The analysis period was November 1, 2019 to either August 31, 2021 (UC) or May 10, 2021 (MS). The last COVID-19 event from all patients with ³1 event was analyzed. Results: Among 2792 ozanimod-treated patients with UC or MS, 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 Harmonisation criteria for a serious event. Of 611 ozanimod-treated patients with UC, 68 (11.1%) developed COVID-19 (confirmed 55;Figure 1). A majority of UC patients with confirmed cases (45/55 [81.8%]) had nonserious COVID-19;most (54/55 [98.2%]) recovered (2 with sequalae) 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 UC patients. Of 2181 ozanimod-treated pts with MS, 190 (8.7%) developed COVID-19 (confirmed 160;Figure 2). Most MS patients with confirmed COVID-19 (148/160 [92.5%]) had nonserious cases;most (158/160 [98.8%]) recovered (5 with sequelae) (Figure 1). No MS patients with confirmed cases discontinued ozanimod, 61 temporarily interrupted it (38.1%), and 99 had no change to treatment (61.9%). Outcomes in 13 additional UC patients (Figure 1) and 30 additional MS patients (Figure 2) with suspected COVID-19 were similar to those with confirmed cases. There were 3 COVID-19-related deaths in the MS program. Conclusion: In the UC and MS open-label extension studies, most patients with confirmed COVID-19 had nonserious infections, recovered, and did not require ozanimod discontinuation. There were 3 deaths in MS patients (case-fatality rate 1.6% in MS, 1.2% overall). (Figure Presented)(Figure Presented)