F. Hoffmann-La Roche Ltd

Author Of 2 Presentations

COVID-19 Late Breaking Abstracts

LB1254 - A real-world data study of Coronavirus-2019 disease severity in patients with multiple sclerosis treated with ocrelizumab (ID 2150)

Speakers
Presentation Number
LB1254
Presentation Topic
COVID-19

Abstract

Background

Ocrelizumab (OCR) is a B-cell depleting monoclonal antibody approved for the treatment of multiple sclerosis (MS), including relapsing and primary progressive forms of MS. The Coronavirus-2019 disease (COVID-19) pandemic raises concerns about clinical course and outcomes of COVID-19 in MS patients undergoing immunosuppressive treatment.

Objectives

To describe the clinical course and outcomes of COVID-19 in multiple sclerosis (MS) patients treated with ocrelizumab (OCR).

Methods

A retrospective cohort study of OCR treated MS patients with COVID-19 diagnosis who received treatment for COVID-19 in the Optum® de-identified COVID-19 Electronic Health Record (EHR) dataset. Inclusion criteria: confirmed COVID-19 diagnosis (ICD10 diagnosis, or positive diagnostic lab test since Feb 20th 2020), and OCR treatment ≤6 months prior to COVID-19 diagnosis. Patients with less than 28 days of follow-up were excluded. COVID-19 severity was categorized according to a 4 level ordinal scale based on worst status experienced during COVID-19 clinical course: 1) not hospitalized, 2) hospitalized, 3) hospitalized requiring invasive mechanical ventilation, 4) death. Secondary outcomes included the proportion of hospitalized patients diagnosed with respiratory failure, bacterial pneumonia, and sepsis on admission.

Results

As of 13 July 2020, there were EHRs for almost 128,000 patients with laboratory or clinically confirmed diagnosis of COVID-19. Forty-seven OCR treated patients were identified (32% male, median age 47 years, median Charlson comorbidity index 1.0, mean BMI 29.4 kg/m2, mean time since OCR initiation 1.3 years). Per COVID-19 severity scale, 75% (n=35) were not admitted to hospital, 21% (n=10) were hospitalized, 2% (n=1) required invasive ventilation and 2% (n=1) died. Compared to OCR cohort, Hospitalized patients (n=12) were older (median age 57.0 years) and consisted of proportionally more males (50%). On hospital admission, of patients not requiring ventilation, 40% (n=4) had respiratory failure, 10% (n=1) bacterial pneumonia and 0% sepsis, while both patients requiring ventilation, one of whom subsequently died, had respiratory failure and sepsis on admission.

Conclusions

In this large US cohort of confirmed/clinically COVID-19, a few treated with OCR were identified with majority experiencing mild disease not requiring hospitalization, and two patients suffering critical illness. This study provides initial real-world insights on the impact of COVID-19 in MS patients treated with OCR.

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Patient-Reported Outcomes and Quality of Life Poster Presentation

P1063 - Treatment persistence and adherence to Ocrelizumab in the real-world setting- an ad-hoc analysis of the CONFIDENCE study (ID 1731)

Speakers
Presentation Number
P1063
Presentation Topic
Patient-Reported Outcomes and Quality of Life

Abstract

Background

Ocrelizumab (OCR) is a humanised anti-CD20+ monoclonal antibody approved for the treatment of relapsing and primary progressive forms of multiple sclerosis (RMS and PPMS). Real-world evidence on adherence and persistence with OCR is limited.

Objectives

To examine the persistence and adherence to OCR in a real-world setting.

Methods

CONFIDENCE (ML39632, EUPAS22951) is an ongoing non-interventional, post-authorization safety study, aiming to enroll 3,000 patients newly treated with OCR and 1,500 patients newly treated with other DMTs at ~250 centers in Germany. Follow up regardless of discontinuation of treatment will be for up to 10 years. In this ad-hoc analysis of CONFIDENCE, persistence and adherence were measured exclusively for patients treated with OCR with at least one post-initiation (i.e., first two 300mg doses IVs') assessment visit. Persistence was examined as a survival function of event-free time from discontinuation. Patients were considered at-risk until the last assessment visit recorded prior to data cut-off (31 March 2020) or censored at time of OCR discontinuation, whichever occurred first. Adherence was assessed using median time intervals between infusions.

Results

Overall, 1614 patients treated with OCR were included in this analysis; 1296 patients with RMS and 318 with PPMS. Median [IQR] age at OCR initiation was 42 [44, 57] years and 52 [33, 51] years in patients with RMS and PPMS, respectively. Most RMS patients were females (66.7%) while gender distribution in PPMS patients was approximately equal (51.6% females). Median [IQR] disease duration from diagnosis up to OCR initiation was longer in RMS (7.9 [3.0, 14.7] years) than in PPMS patients (3.4 [0.8, 9.7] years). Median [IQR] EDSS at OCR start was 3.0 [2.0, 4.5] and 4.5 [3.5, 6.0] in the RMS and PPMS population, respectively. At data cut-off, the median [IQR] OCR exposure duration was 7.85 [5.5, 13.1] months for RMS and 6.87 [0.5, 12.5] months for PPMS patients. Overall, the median time between infusions ranged from 5.9 and 6.0 months and did not differ between RMS and PPMS cohorts. Treatment persistence at 18 months was 96.6% (95% CI: 95.3-97.8%) and very consistent between RMS and PPMS patients.

Conclusions

Adherence to disease-modifying therapy (DMT) is critical for achieving therapeutic goals in MS. This analysis shows high treatment persistence for OCR patients at 18 months and strong adherence to recommendations to administer OCR infusions every 24 weeks.

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