- As of 27 November, 2020, 193 suspected or confirmed cases of COVID-19 were identified in 3,974 patients in 10 ongoing ocrelizumab clinical trials (5% of the trial population). Overall, 81.3% (157/193 cases) were subsequently classified as confirmed COVID-19 infections. The median (range) time since the first ocrelizumab dose was 3.6 years (0.5–11.6) in ocrelizumab-treated patients with COVID-19 infection compared to 3.0 years (0–12.4) in the overall population
- No association between symptomatic COVID-19 infection and time since first ocrelizumab dose was observed (OR=1.03, 95% CI: 0.88–1.22, p=0.68)
- There is an association between increasing number of comorbidities and greater risk of developing symptomatic COVID: one comorbidity (OR=1.68, 95% CI: 1.15–2.47, p<0.01) or ≥2 comorbidities (OR: 2.25, 95% CI:1.09–4.66, p=0.03)
Table 1: Severity and outcomes of COVID-19 in ocrelizumab-treated patients1,2
*Severity categories were assigned as follows: asymptomatic, if it was explicitly stated that no symptoms were present; mild, if
non-hospitalised symptom such as low-grade fever or cough were described; moderate, if shortness of breath was reported; severe, if pneumonia was present; critical, if requiring intensive care and/or mechanical ventilation. †In patients hospitalised due to COVID-19 in the general population, published mortality rates range from 9.7% to 27.0%4,10,16–18.
Data presented as of 30 November, 2020.
Figure 1: Severity of COVID-19 according to age in ocrelizumab-treated patients1
Of the cases with a fatal outcome in the post-marketing setting, 78.1% (25/32) occurred in patients over 50 years of age or with one or more risk factors associated with severe COVID-19 outcomes in the general population (e.g. age >50 years, hypertension, chronic pulmonary disease, chronic kidney disease, diabetes, coronary heart disease, obesity and cancer)
Table 2: Number of cases and deaths in the general population19
*Louapre C, et al. JAMA Neurol 2020;77:1079–88; †Sormani MP, et al. Ann Neurol 2021;89:780–9;
‡Hughes R, et al. Mult Scler Relat Disord 2021;49:102725; §Salter A, et al. JAMA Neurol 2021;78:699–708;
‖Simpson-Yap, et al. medRxiv 2021;doi:10.1101/2021.02.08.21251316v1; ¶The US CoViMS registry data were included in the Data Sharing Initiative study contributing up to 50% of all cases and fatalities included in the analyses.