NeuroTransData GmbH

Author Of 1 Presentation

COVID-19 Late Breaking Abstracts

SS02.04 - First results of the COVID-19 in MS Global Data Sharing Initiative suggest anti-CD20 DMTs are associated with worse COVID-19 outcomes

Abstract

Background

As the COVID-19 pandemic amplifies, efforts to minimise the risk on vulnerable people are essential. People with multiple sclerosis (MS) may be a vulnerable group due to the high proportion taking long-term immunosuppressive disease-modifying therapies (DMTs). Studies from Italy and France suggest older age, higher disability and progressive MS are associated with severe COVID-19, yet there remains uncertainty around the influence of DMTs.

Objectives

Given the many approved MS DMTs and the relatively low frequency of COVID-19 in MS patients per country, international data sharing is desirable to examine the impact of DMTs on COVID-19 severity. Here, we present the first results of the COVID-19 in MS global data sharing initiative of the MS International Federation and MS Data Alliance and many other data partners to inform MS clinical management during the COVID-19 pandemic.

Methods

Clinician-reported data from 21 countries were aggregated into a dataset of 1540 patients. Characteristics of admission to hospital, admission to intensive care unit (ICU), need for artificial ventilation, and death, were assessed in patients with confirmed or suspected COVID-19 infection using log-binomial regression. Adjusted prevalence ratios (aPR) were calculated adjusting for age, sex, MS type, and Expanded Disability Status Scale (EDSS).

Results

Of 1540 patients, 476 (30.9%) with suspected and 776 (50.4%) with confirmed COVID-19 were included in the analysis. Older age, progressive MS and higher EDSS were associated with higher frequencies of severe outcomes. Anti-CD20 DMTs, ocrelizumab and rituximab, were positively associated with hospital admission (aPRs=1.19 & 1.58), ICU admission (aPRs=3.53 & 4.12), and the need for artificial ventilation (aPRs=3.17 & 7.27) compared to dimethyl fumarate. Higher frequencies of all three outcomes were associated with combined anti-CD20 DMT use compared to all other DMTs (hospitalisation aPR=1.49; ICU aPR=2.55; ventilation aPR=3.05) and compared to natalizumab (hospitalisation aPR=1.99; ICU aPR=2.39; ventilation aPR=2.84). Importantly, associations persisted on restriction to confirmed COVID-19 cases and upon exclusion of each contributing data source in turn. No associations were observed between DMTs and death.

Conclusions

This study used the largest federated international cohort of people with MS and COVID19 currently available. We demonstrate a consistent association of anti-CD20 DMTs with hospitalisation, ICU admission and use of artificial ventilation suggesting their use among MS patients at risk for COVID-19 exposure may be a risk factor for more severe COVID-19 disease. To address study limitations, further research incorporating comorbidities, smoking and body mass index is required. Alternative study designs are needed to address questions on COVID-19 susceptibility among people with MS.

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Author Of 2 Presentations

Observational Studies Late Breaking Abstracts

LB1185 - Real-world experience with Ocrelizumab in the German NeuroTransData Registry (ID 1978)

Speakers
Presentation Number
LB1185
Presentation Topic
Observational Studies

Abstract

Background

Ocrelizumab (OCR) is approved for the treatment of relapsing and primary progressive forms of multiple sclerosis (MS).

Objectives

In a real-world setting, to describe 1) baseline characteristics of patients with MS treated with OCR, 2) treatment pathway across lines of therapy up to initiation of OCR, and 3) initial clinical experience.

Methods

This analysis included adult patients with MS from the German NeuroTransData (NTD) Registry, a network of 66 neurology outpatient services across Germany. Patients were treated with OCR between January 2018 and January 2020. Descriptive statistics were used to analyze baseline patient characteristics recorded within 3 months prior to or at time of OCR initiation. Occurrence of relapse was analyzed in relapse-remitting MS (RRMS) patients with ≥3 months follow-up data from OCR initiation.

Results

As of January 2020, the NTD registry included 439 patients treated with OCR, including 352 patients with RRMS, 35 with relapsing secondary progressive MS (rSPMS), and 52 with primary progressive MS (PPMS). Median age at OCR initiation varied from 41.7 years, 54.5 years, to 52.5 years in patients with RRMS, rSPMS, and PPMS, respectively. Most RRMS and rSPMS patients were female (64.8% and 54.3%) compared to PPMS patients (46.2%). Median disease duration from symptom onset up to OCR initiation was longer in rSPMS patients (14.9 years) than in RRMS (10.8 years) and PPMS (5.7 years). Median EDSS at OCR start was 2.5, 6.0, and 4.0 in the RRMS, rSPMS, and PPMS cohorts, respectively. OCR was initiated as first disease modifying therapy (DMT) therapy in 12.2%, 11.4%, and 71.2% of RRMS, rSPMS, and PPMS patients, respectively. 258 RRMS patients directly switched from another DMT, primarily from fingolimod (23.3%) and natalizumab (19.8%). 319 patients with RRMS had ≥3 months follow-up during OCR exposure; of these, 283 remained relapse free (88.7%; 95% CI 84.9, 91.8) within a median follow-up time of 1 year (Q1-Q3, 0.6-1.3 years). Annualized relapse rate was 0.13 (95 % CI 0.09, 0.16).

Conclusions

In this German outpatient real world cohort, RRMS and rSPMS patients treated with OCR, on average had a disease duration ≥10 years and already reached a moderate to severe disability status. Most patients received previous DMT and OCR was initiated most frequently as second line treatment. Although PPMS patients showed a shorter disease duration, the disability status was relatively severe. Only about one third of patients received previous DMT.

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Clinical Outcome Measures Poster Presentation

P0073 - Effectiveness of peginterferon beta-1a versus non-pegylated interferons and glatiramer acetate in a real-world setting using propensity score matching (ID 1659)

Speakers
Presentation Number
P0073
Presentation Topic
Clinical Outcome Measures

Abstract

Background

Peginterferon (pegIFN) beta-1a with a prolonged half-life and increased systemic exposure was developed for the treatment (tx) of relapsing-remitting multiple sclerosis (RRMS) resulting in less frequent dosing intervals without attenuating the biological or pharmacodynamic properties associated with existing IFN treatments. Real-world data with pegIFN beta-1a in clinical practice are limited. NeuroTransData GmbH (NTD) is a Germany-wide network of neurologists and psychiatrists. The NTD MS registry is a database capturing demographic, clinical history, and clinical variables from MS patients in a real-world setting.

Objectives

To compare pegIFN beta-1a populations with populations using the following injectables: SC IFN beta-1a, IM IFN beta-1a, SC IFN beta-1b, glatiramer acetate (GA).

Methods

NTD registry data from adult patients with RRMS who initiated tx no earlier than 2014, had ≥12 months of tx exposure, and ≥1 EDSS measurement or a relapse after index therapy initiation were retrospectively analyzed. Primary endpoints were annualized relapse rate (ARR) and time to first relapse. The secondary endpoint was time to confirmed disability progression (CDP). Patient characteristics between treatment groups were compared using propensity-score matching (PSM).

Results

In total, 175 pegIFN beta-1a patients, 308 from the IFN group (SC IFN beta-1a, IM IFN beta-1a, SC IFN beta-1b), and 287 GA patients were included in the analysis set. Mean tx duration was 2.5, 2.7, and 2.4 years, respectively. After PSM, no difference was found in the ARR and time to relapse between pegIFN beta-1a patients and patients from the IFN group (estimated ARR ratio 1.18; 95% CI 0.72, 1.94; p= 0.5047; relapse hazard ratio [HR] 1.14; 95% CI 0.71, 1.84; p=0.5790) or the GA group (estimated ARR ratio 0.74; 95% CI 0.45, 1.24; p=0.2608; relapse HR 0.76; 95% CI 0.47, 1.25; p=0.2813). For time to CDP, a significantly higher estimated treatment effect in favor of pegIFN beta-1a was found compared to both, the IFN (CDP HR 0.43; 95% CI 0.21, 0.89; p=0.0234) and the GA group (CDP HR 0.46; 95% CI 0.22, 0.97; p=0.0425).

Conclusions

Statistically significant superiority of pegIFN beta-1a was demonstrated for time to CDP. However, the current analysis is limited by small sample sizes and follow-up time. Updated results with larger sample sizes and longer follow-up time will be presented in order to assess if superiority of pegIFN beta-1a in other endpoints can be supported by statistical evidence.

This study was funded by Biogen.

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