OCR-treated clinical trial patients
Clinical trial data: OCR-treated pwMS in 10 ongoing Roche/Genentech clinical and post-marketing trials (OPERA I, OPERA II, ORATORIO, Phase II, LIBERTO, CONSONANCE, ENSEMBLE, VELOCE, OCARINA, OBOE; clinical cut-off date 28 May 2021).
Reference population for clinical trial data: Includes pwMS who were receiving ongoing OCR treatment at the beginning of January 2020 and newly enrolled patients thereafter; patients withdrawing from treatment between January 2020 and May 2021 were also included.
*Reported cases were defined as symptomatic, as the vast majority of cases in our database are reported as such and no systematic collection of positive tests in asymptomatic patients has been implemented;
†Based on serious event definition of European Medicines Agency, 1995; ICH Harmonised Tripartite Guideline E2A;
‡For severity, data on 10 (2.5%) cases were missing;
§For outcome, data on 9 (2.2%) cases were missing.
*Reported cases were defined as symptomatic, as the vast majority of cases in our database are reported as such and no systematic collection of positive tests in asymptomatic patients has been implemented.
N=3,925, Cox regression adjusted for study group and country group. Number of comorbidities: Comorbidities were selected from a COVID-19 specific list of adverse event terms within the System Organ Classes ‘metabolism and nutrition disorders', ‘respiratory, thoracic and mediastinal disorders', ‘vascular disorders', 'cardiac disorders’ or ‘nervous system disorders’. The number of comorbidities is the number of System Organ Classes with at least one adverse event term (range 0–5).
OCR-treated post-marketing patients
*Calculated on all cases where age was reported (82.4%, n=1,292);
†Calculated on all serious cases where age was reported (86.3%, n=465);
‡Severity categories were assigned as follows: Asymptomatic, if it was explicitly stated that no symptoms were present; mild, if non-hospitalised symptoms such as low-grade fever or cough were described; moderate, if shortness of breath was reported; severe, if pneumonia was present; and critical, if requiring intensive care and/or mechanical ventilation.
BMI, body mass index; CT, controlled trial; COVID-19, coronavirus disease 2019; COVID, coronavirus disease; CI, confidence interval; EDSS, Expanded Disability Status Scale; HR, hazard ratio; ICH, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; OCR, ocrelizumab; PCR, polymerase chain reaction; PPMS, primary progressive MS; PM, post-marketing; pwMS, people with MS; PV, pharmacovigilance; RMS, relapsing MS; RRMS, relapsing remitting MS; RWD, real-world data; SPMS, secondary progressive MS.
M-XX-00007055 (Date of preparation: October 2021)