ABSTRACT
Background and aims: Patient satisfaction and quality of life improvement is important to ensure persistence with treatment. In PRO-MSACTIVE (NCT03589105) phase IV study, evaluating ocrelizumab (OCR), patients with active relapsing multiple sclerosis (RMS) were administered selfreported patient reported outcomes (PROs) questionnaires. We report the interim analysis of PROs data. Methods: In PRO-MSACTIVE, patients receive OCR infusions for a 48-weeks treatment period. Efficacy and safety were assessed and several PROs questionnaires were self-administered prior to the administration of OCR: MS symptom severity scale (SymptoMScreen), Modified Fatigue Impact Scale (MFIS), EuroQol 5-Dimension Questionnaire (EQ-5D-5L with VAS), Work Productivity and Activity Impairment scale (WPAI:SHP), Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Treatment Satisfaction Questionnaire (TSQM-14). Results: PRO-MSACTIVE has enrolled 422 patients in France (female 73.7%;mean (SD) age 39.7 years (10.5);25.1% naïve of previous DMT;mean (SD) baseline EDSS 2.80 (2.04)). This interim analysis included data at W48 from 335 patients who have completed their treatment period before COVID-19 lockdown. Improvement from baseline total mean (SD) scores were observed for SymptoMScreen (-1.3 (8.8)), MFIS (-2.9 (13.47)), EQ-5D-5L with VAS health state score (+4.07 (17.02)), WPAI:SHP activity impairment (-5.31 (23.65)), MusiQoL (+1.52 (11.0)) and TSQM-14 (+8.13 (21.39)). TSQM-14 total mean (SD) score improved from 59.7 (19.69) to 68.55 (20.03). The largest improvements from baseline were observed for MusiQoL on the psychological wellbeing, coping and activities of daily living domains. EDSS score was improved (<-0.5) or stable (-0.5;+0.5) for 85.4% of patients. Conclusion: In PRO-MSACTIVE, patients with active RMS reported improvement in PROs from baseline to W48.
ABSTRACT
Background and aims: PRO-MSACTIVE (NCT03589105) is a phase IV study evaluating the efficacy, safety and impact of ocrelizumab (OCR), an anti-CD20 antibody, on patient reported outcomes in patients with active relapsing multiple sclerosis (RMS). We report the interim analysis findings. Methods: In PRO-MSACTIVE, patients with active RMS, ≥18 years, receive OCR infusions for a 48-weeks treatment period. The primary endpoint of the study was the percentage of patients free of disease activity at week (W) 48 (defined by no relapse since enrolment and no T1 gadolinium (Gd)-enhancing lesion and no new and/or enlarging T2 lesion as detected by brain MRI [without MRI rebaseline]) and was evaluated in this interim analysis using the population of patients who have completed the 48 weeks of treatment phase before France COVID-19 lockdown. Results: In total, 422 patients (375 RRMS, 47 SPMS;female 73.7%;mean (SD) age 39.7 years (10.5);25.1% naïve of previous DMT;mean (SD) baseline EDSS 2.80 (2.04)) were enrolled. This interim analysis included data from 335 patients at W48. Most patients (65.1% [95%CI 59.7%-70.2%]) were free of all protocol-defined disease activity events. Regarding individual activity events, 87.2% of patients were relapse free at W48, 83.6% had no T1 Gd-enhancing lesion and 76.1% had no new/enlarging T2 lesion. The adjusted annualised relapse rate (0.13) was low. There were no deaths and safety results were consistent with prior studies. Conclusion: The efficacy of ocrelizumab in RMS patients was confirmed in a pragmatic setting and was in line with the other OCR study results. No safety signals were observed.
ABSTRACT
Background: 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. Objectives: 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. Methods: 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. Results: 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). Conclusions: 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.