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SS02.06 - Clinical Characteristics and Outcomes in Patients with Coronavirus Disease 2019 and Multiple Sclerosis
Risk factors associated with the severity of COVID-19 in patients with multiple sclerosis (MS) begin to be identified from several cohort studies. Disease modifying therapies (DMTs) may modify the risk of developing a severe COVID-19 infection, beside identified risk factors such as age and comorbidities.
The objective was to describe the clinical characteristics and outcomes in patients with COVID-19 and to identify the factors associated with COVID-19 severity.
This multicenter, retrospective, observational cohort study (COVISEP registry, NCT04355611) included patients with MS presenting with a confirmed or highly suspected diagnosis of COVID-19 between March 1, 2020 and July 14, 2020. The main outcome was COVID-19 severity assessed on a 7-point ordinal scale (ranging from 1: not hospitalized, no limitations on activities, to 7: death; cutoff at 3: hospitalized, not requiring supplemental oxygen). We collected demographics, neurological history, Expanded Disability Severity Score (EDSS), comorbidities, COVID-19 characteristics and outcome. Univariate and multivariate logistic regression models were used to estimate the influence of collected variables on COVID-19 outcome.
A total of 405 patients (mean age: 44.7 years, female/male: 293/112, mean disease duration: 13.4 years) were analyzed. Seventy-eight patients (19.3%) had a COVID-19 severity score ≥ 3, and 12 patients (3.0%) died from COVID-19. Median EDSS was 2.0 (range: 0-9.5), 326 patients (80.5%) were on DMT. There was a higher proportion of patients with COVID-19 severity score ≥ 3 among patients with no DMT relative to patients on DMTs (39.2% versus 14.4%, p<0.001). Multivariate logistic regression models determined that age (OR for 10 years: 1.8, 95% CI: 1.4-2.4), EDSS (OR for EDSS ≥ 6: 4.5, 95% CI: 2.0-10.0) were independent risk factors for COVID-19 severity score ≥ 3 (hospitalization or higher severity) while immunomodulatory treatment (interferon or glatiramer acetate) was associated with lower risk of COVID-19 severity score ≥ 3 (OR: 0.2, 95% CI: 0.05-0.8). EDSS was associated with the highest variability of COVID-19 severe outcome (R2= 0.18), followed by age (R2= 0.06) and immunomodulatory treatment (R2= 0.02).
EDSS and age were independent risk factors of severe COVID-19, while exposure to immunomodulatory DMTs (interferon and glatiramer acetate) were independently associated with lower COVID-19 severity. We did not find an association between other DMTs exposure (including immunosuppressive therapies) and COVID-19 severity. The identification of these risk factors should provide the rationale for an individual strategy regarding clinical management of MS patients during the COVID-19 pandemic.
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P0195 - Characteristics of Therapeutic Sequences of Patients Enrolled in the PRO-MSACTIVE Study Evaluating Ocrelizumab in Active Relapsing Multiple Sclerosis (ID 727)
At any time in multiple sclerosis (MS) management, a disease-modifying therapy (DMT) stop, restart or change can occur. In PRO-MSACTIVE (NCT03589105), an open-label, single-arm, phase IV study designed to evaluate the efficacy, safety and impact of ocrelizumab on patient reported outcomes in patients with active relapsing MS (RMS), every patient’s treatment history was gathered.
To describe the therapeutic management of French patients with active RMS (relapsing-remitting [RRMS] and secondary progressive [SPMS]), as reported at baseline, prior to the first ocrelizumab infusion (IV OCR).
PRO-MSACTIVE is being conducted in France (46 active centers) in patients with active RMS, ≥18 years old, naïve or pretreated with DMT. Washout periods between the last DMT taken by the patient and baseline IV OCR were pre-specified. For each patient, all previous DMTs were collected during the screening period, ≤4 weeks prior to baseline.
Treatment history was documented for the 422 enrolled patients: 376 RRMS and 46 SPMS. Most (74.9%) had at least one previous DMT prior to the first IV OCR: 73.9% for RRMS and 82.6% for SPMS patients. The longest therapeutic sequence includes 8 DMTs prior to the first IV OCR. The most frequent previous DMTs were β interferons and assimilated products (IFN-AP) (51.4% all patients, 49.2% RRMS, 69.6% SPMS); selective oral immunosuppressants (30.8% all patients, 30.6% RRMS, 32.6% SPMS; mainly fingolimod); and teriflunomide (24.2% all patients, 24.5% RRMS, 21.7% SPMS). IFN-AP ranked first among the older DMTs (46.5% all patients, 45.0% RRMS, 58.7% SPMS). Mean time (standard deviation, SD) from the oldest DMT to the first IV OCR was 6.55 yrs (5.44) for RRMS patients, and 14.20 yrs (8.46) for SPMS patients. The most recent DMTs prior to IV OCR were fingolimod (22.8% all patients, 23.7% RRMS, 15.2% SPMS); dimethyl fumarate (14.7% all patients, 15.7% RRMS, 6.5% SPMS); teriflunomide (14.5% all patients, 14.6% RRMS, 13.0% SPMS); IFN-AP (14.0% all patients, 14.1% RRMS, 13.0% SPMS); and natalizumab (4.3% all patients, 4.5% RRMS, 2.2% SPMS). Mean time (SD) from the most recent DMT to the first IV OCR was 2.65 yrs (2.12) for RRMS patients and 3.01 yrs (2.85) for SPMS patients.
Treatment history with DMTs prior to the first IV OCR is well characterized in the PRO-MSACTIVE study. These data permit a better understanding of the therapeutic strategies in RMS patients in current medical practice.