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3.
Multiple Sclerosis Journal ; 28(3 Supplement):354-355, 2022.
Article in English | EMBASE | ID: covidwho-2138866

ABSTRACT

Introduction: The long-term benefit-risk profile of ocrelizumab (OCR) in patients (pts) with multiple sclerosis (MS) can be evaluated by regular safety reporting of clinical trial (CT) and post-marketing (PM) data. Safety/efficacy of OCR have been characterised in Phase II (NCT00676715) and Phase III (NCT01247324;NCT01412333;NCT01194570) trials and related open-label extension (OLE) periods, in relapsing-remitting MS, relapsing MS (RMS) and primary progressive MS (PPMS). It is important to understand the long-term safety profile of OCR and consider the impact of COVID-19. Aim(s): To report the continuity in safety by reporting longer-term safety evaluations from OCR CT and OLE periods over a 9-year follow-up period (up to November 2021). Method(s): Safety outcomes, with and without COVID-19, are reported for the OCR all-exposure population from 11 ongoing CTs in MS. Rates per 100 patient years (PY) are presented. Result(s): Over more than 9 years of follow-up, 5,848 pts with MS received OCR treatment in 11 CTs (25,153 PY of exposure;November 2021). Reported rates per 100 PY (95% CI) were: Adverse events (AEs), 232.71 (230.83-234.60), [excluding COVID-19 (EX COV) 230.12 (228.25-232.01)];infections, 69.89 (68.86-70.93), [EX COV 67.37 (66.36-68.39)];serious AEs, 7.61 (7.27-7.96), [EX COV 6.90 (6.58-7.23)];serious infections (SI), 2.74 (2.54-2.96), [EX COV 2.04 (1.87-2.22)];malignancies, 0.41 (0.34-0.50);SI leading to withdrawal, 0.12 (0.08-0.18), [EX COV 0.08 (0.05-0.13)];and AEs leading to discontinuation, 0.97 (0.85-1.10), [EX COV 0.93 (0.81-1.06)]. As of March 2022, over 250,000 pts with MS initiated OCR globally in the PM setting. Data remain generally consistent with those observed in CTs factoring in the impact of the COVID-19 pandemic. Conclusion(s): AE rates in the OCR all-exposure population remain generally consistent with the controlled treatment period in RMS/PPMS populations. Serious infection and malignancy rates remain within the range reported for pts with MS in realworld registries. COVID-19 did not lead to increased treatment withdrawal. Over a 9-year follow-up period, no new or unexpected safety signal was seen in pts treated with OCR in ongoing CTs. OCR continues to exhibit a stable and favourable safety profile. Regular reporting of longer-term safety data will continue.

4.
Multiple Sclerosis Journal ; 28(3 Supplement):106-107, 2022.
Article in English | EMBASE | ID: covidwho-2138831

ABSTRACT

Background: Prospective, deeply phenotyped research cohorts monitoring people with multiple sclerosis (MS) depend on careful participant engagement that was threatened by COVID19- related restrictions to in-clinic visits. Coincidentally, there was forced adoption of televideo-enabled care. Objective(s): To leverage a natural experiment of "going virtual" during the pandemic to evaluate two hypotheses pertaining to remote MS research: that (1) global costs of remote visits are lower, and (2) disability evaluations are non-inferior. Method(s): Between 3/2020 and 12/2021, 207 UCSF EPIC/ ORIGINS MS cohort participants underwent hybrid in-clinic and virtual research visits. Among these, 96 contributed 100 'matched visits', i.e. in-clinic (Neurostatus, NS-EDSS) and remote (televideo-, tele-EDSS;electronic patient-reported, ePR-EDSS) evaluations within 14 days. Clinical and socio/ demographic characteristics were collected. First, visit costs were compared. Then, the quality of data extracted was compared using non-inferiority design with NS-EDSS as primary outcome. Result(s): The 96 participants contributing 100 matched visits had mean age 41.4 years (SD 11.7) and MS duration 1.4 years (SD 3.4);69% were female and 72% White, 8% lived in lowincome zip codes;median driving distance was 70 miles (mean 545). The costs of remote visits to participants (travel, caregiver time), to research (facilities, personnel, parking, participant compensation), and carbon footprint were all lower than in-person visits (p<0.05 for each). Median cohort EDSS was similar, whether evaluated using NS-EDSS (2), tele-EDSS (1.5) or ePREDSS (2), with range 0-6.5. Utilizing a TOST for Non-inferiority, both remote evaluations were non-inferior to NS-EDSS within+/-0.5 EDSS point (p<0.01 for each). Year-to-year, the % of participants with worsening/stable/improved EDSS scores was similar, whether the annual evaluations both used NS-EDSS, or whether the annual evaluation switched from NS-EDSS to tele-EDSS. Discussion(s): "Going virtual" during the pandemic represented a natural experiment in which to test hypotheses about remote research visits. These visits lowered costs for investigators and participants. Further, remote assessments were non-inferior to NS-EDSS and for more precision, could be supplemented with biosensors. Together, these insights support the conduct of research that is more inclusive to participants regardless of geography, race, income, opportunity costs or ability level.

5.
Multiple Sclerosis Journal ; 27(2 SUPPL):762, 2021.
Article in English | EMBASE | ID: covidwho-1496063

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.

6.
Multiple Sclerosis Journal ; 27(2 SUPPL):607-608, 2021.
Article in English | EMBASE | ID: covidwho-1495999

ABSTRACT

Introduction: Ongoing consistent safety reporting is crucial to understand the long-term benefit-risk profile of ocrelizumab (OCR) in patients with multiple sclerosis (MS), in both clinical trials and globally, in the post-marketing (PM) setting. Safety/efficacy of OCR have been characterised in Phase II (NCT00676715) and Phase III (NCT01247324;NCT01412333;NCT01194570) trials and related open-label extension (OLE) periods, in patients with relapsing-remitting MS, relapsing MS (RMS) and primary progressive MS (PPMS). It is important to understand the longterm safety profile of OCR independent of any impact of COVID- 19 infections. Aims: To maintain continuity in the safety update by reporting longer-term safety evaluations from OCR clinical trials and OLE periods up to November 2020 and selected PM data, excluding COVID-19 cases;the latter will be communicated in a separate late-breaking abstract. Methods: Safety outcomes, excluding COVID-19, are reported for the OCR all-exposure population in Phase II/III trials and associated OLEs plus ongoing Phase IIIb trials in MS (VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, LIBERTO and CONSONANCE). To account for different exposure lengths, rates per 100 patient years (PY) are presented. The number of postmarketing OCR-treated patients is based on estimated number of vials sold and US claims data. Results: In clinical trials, 5,688 patients with MS received OCR (21,675 PY of exposure;Nov 2020). Reported rates per 100 PY (95% confidence interval) were: Adverse events (AEs), 238 (236- 240);infections, 71.8 (70.7-73.0);serious AEs, 7.05 (6.71-7.42);serious infections, 2.0 (1.82-2.20);malignancies, 0.42 (0.34- 0.52);and AEs leading to discontinuation, 0.96 (0.83-1.10). As of December 2020, over 200,000 patients with MS initiated OCR globally in the PM setting. Data remain generally consistent with those observed in clinical trials. Conclusions: AE rates in the OCR all-exposure population and PM settings, excluding COVID-19 infections, remain generally consistent with the controlled treatment period in RMS/PPMS populations. Serious infection and malignancy rates remain within the range reported for patients with MS in real-world registries. In patients with RMS and PPMS, OCR demonstrates a consistent and favourable safety profile;these longer-term data are in accordance with the safety outcomes initially observed during the controlled treatment periods. Regular reporting of longer-term safety data will continue.

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