COVID-19 in people with multiple sclerosis treated with ocrelizumab

ABSTRACT

Introduction: As of May 2021, over 215,000 people with multiple sclerosis (pwMS) have been treated with ocrelizumab. Aims: To understand the factors that affect the development of symptomatic COVID-19 and its outcome in ocrelizumab-treated pwMS. Methods: Symptomatic COVID-19 cases in ocrelizumab-treated pwMS were identified from 10 ongoing clinical trials as of 28 May 2021. There was no systematic screening or reporting of asymptomatic cases and non-hospitalised cases were not necessarily captured completely. We assessed severity based on serious event definition of European Medicines Agency, 1995, ICH Harmonised Tripartite Guideline E2A. We calculated mortality, risk factors and treatment duration and time since last dose of ocrelizumab using all doses. Results: As of 28 May 2021, 406 (9.9%) cases of COVID-19 were identified in 4,104 patients;32.5% (n=132/406) were serious, 85.5% (n=347/406) of all cases and 67.4% (n=89/132) of the serious cases recovered/were recovering. In all cases, 28.3% (n=115/406) had at least one comorbidity, 29.8% (n=121/406) were above 50 years old compared with 31.1% (n=1,277/4,104) of those at risk. In serious cases, 34.1% (n=45/132) had at least one comorbidity, 37.9% (n=50/132) were above 50 years old. The incidence rates of symptomatic and serious COVID-19 were stable from month-to-month during the 6-month interval between ocrelizumab infusions. Qualitative analysis of the serious and fatal COVID-19 cases from the pooled clinical trials, and in a more diverse population of ocrelizumab-treated pwMS in the post-marketing dataset (approximately 1,600 COVID-19 cases reported cumulatively as of end of May 2021), will be presented. Conclusions: In the ongoing ocrelizumab clinical trials in patients with relapsing multiple sclerosis and primary progressive multiple sclerosis, the majority (85.5%) of patients with symptomatic COVID-19 recovered or were recovering;comorbidities were associated with symptomatic COVID-19 and known risk factors for severe outcomes from the general or MS populations were also present among the ocrelizumab-treated pwMS with severe outcomes. Furthermore, COVID-19 outcomes appeared to be independent from time-to-last ocrelizumab infusion.