Comparative effectiveness of natalizumab and anti-CD20 monoclonal antibodies in relapsing-remitting multiple sclerosis: a real-world propensity-score matched study DOI

Bassem Yamout,

Raed Alroughani,

Saleh A. Mohamed

et al.

Journal of Neurology Neurosurgery & Psychiatry, Journal Year: 2025, Volume and Issue: unknown, P. jnnp - 335704

Published: June 1, 2025

Background Head-to-head randomised trials or real-world studies comparing the safety and efficacy of natalizumab anti-CD20 monoclonal antibodies are limited. This study aimed to compare effectiveness versus ocrelizumab/rituximab in a cohort relapsing-remitting multiple sclerosis (RRMS) patients using data from Middle East North Africa Committee for Treatment Research Multiple Sclerosis (MENACTRIMS) registry. Methods registry-based, retrospective, multicentre was carried out seven Eastern countries by analysing MENACTRIMS All adults RRMS treated with natalizumab, rituximab ocrelizumab maintained on treatment at least 12 months were included. Patients matched propensity scores. Primary outcomes annualised relapse rate (ARR), confirmed disability progression improvement MRI activity. Results A total 1954 met inclusion criteria, 1277 receiving therapy (768 509 ocrelizumab) 677 natalizumab. Natalizumab significantly reduced ARR compared therapies (0.062 vs 0.092, p=0.001). Confirmed rates, no evidence disease activity (NEDA-3) similar between two groups. However, demonstrated higher rates (9.3% 5.5%, p=0.03). Adverse events more frequent group (36.4% 27.5% Conclusion In this large, cohort, associated lower ARR, greater likelihood improvement, lesser adverse events, but persistence therapies. These findings provide valuable insights into comparative these therapies, aiding clinicians personalised decisions.

Language: Английский

A Window into New Insights on Progression Independent of Relapse Activity in Multiple Sclerosis: Role of Therapies and Current Perspective DOI Open Access
Tommaso Guerra, Pietro Iaffaldano

International Journal of Molecular Sciences, Journal Year: 2025, Volume and Issue: 26(3), P. 884 - 884

Published: Jan. 21, 2025

In multiple sclerosis (MS), there is significant evidence indicating that both progression independent of relapse activity (PIRA) and relapse-related worsening events contribute to the accumulation progressive disability from onset disease throughout its course. Understanding compartmentalized pathophysiology MS would enhance comprehension mechanisms, overcoming traditional distinction in phenotypes. Smoldering thought be maintained by a continuous interaction between parenchymal chronic processes neuroinflammation neurodegeneration intrathecal compartment. This review provides comprehensive up-to-date overview neuropathological immunological related mechanisms underlying PIRA phenomena MS, with focus on studies investigating impact currently available therapies these complex mechanisms.

Language: Английский

Citations

0
Comparative effectiveness, safety and persistence of ocrelizumab versus natalizumab in multiple sclerosis: A real-world, multi-center, propensity score-matched study DOI Creative Commons
Elena Barbuti,

Assunta Castiello,

Valeria Pozzilli

et al.

Neurotherapeutics, Journal Year: 2025, Volume and Issue: unknown, P. e00537 - e00537

Published: Jan. 1, 2025

Ocrelizumab (OCR) and Natalizumab (NTZ) are highly effective treatments widely used in Multiple Sclerosis (MS). However, long-term, real-world comparative data on clinical effectiveness, safety treatment persistence limited. This retrospective analysis included relapsing progressive MS patients initiating at two Italian Universities ("La Sapienza" "Federico II"). Propensity-score nearest-neighbor matching with a caliper of 0.1 was conducted to adjust for between-group differences age, sex, previous status, phenotype, disease duration, MRI activity baseline. Differences follow-up duration were adjusted pairwise censoring. Cox proportional hazard regression models Evidence (EDA-3) its components (relapses, activity, confirmed disability progression) as outcomes. Treatment discontinuation rate occurrence adverse events (AEs) tested using logistic regression. We identified 308 (140 OCR, 168 NTZ) mean (SD) 75.7 (30.8) months. Patients treated OCR older less active frequenlty naïve baseline than NTZ-treated patients. The PS-matching procedure retained 140 (70 pairs) 55.9 (14.3) No significant found between NTZ terms relapses, or progression. associated higher incidence mild moderate AEs, comparable persistence. study provides evidence effectiveness over 5-year observation period, being AEs and, possibly,

Language: Английский

Citations

0
Long-Term Evaluation of Effectiveness and Immunological Implications of Ocrelizumab in a Real-World Cohort DOI Creative Commons
Tommaso Guerra, Francesca Caputo,

Antonella Bianco

et al.

Drugs - Real World Outcomes, Journal Year: 2025, Volume and Issue: unknown

Published: March 14, 2025

Extended follow-up data from real-world cohorts of patients with multiple sclerosis treated ocrelizumab (OCR) are becoming widely available. This monocentric retrospective study aimed to evaluate the long-term effectiveness OCR and its impact on immunoglobulin (Ig) levels, lymphocyte subsets, infections in a cohort relapsing remitting, primary progressive, secondary progressive sclerosis. Patients followed at Multiple Sclerosis Center Bari ≥ 2 years treatment were retrospectively recruited 2024. Twelve-month confirmed disability worsening, improvement, annualized relapse rate before after start estimated magnetic resonance imaging scans collected. Changes IgG/IgM/IgA levels baseline for up 6 serum T CD4+, CD8+, natural killer lymphocytes assessed. Infection occurrence, type, outcomes investigated. Multivariable Cox models examined association clinical radiological factors risk worsening relationship clinical-laboratoristic factors. The final retrieved 140 (80 37 23 progressive) median (interquartile range) 4.62 (4.10–5.04) years. In entire cohort, mean decreased 0.61 year 0.02 second year, thereafter all our remained free relapses activity. overall percentage stable increased fourth parallel reduction worsening. A multifocal onset presence least two significant (p < 0.05) During follow-up, IgG level was observed, which further decreased, third year. Immunoglobulin M slightly over time, whereas IgA stable. No changes cell absolute number, slight CD8+ during observed. Ocrelizumab did not determine infection long term no observed Ig severe infections. prevented disease activity effect immune system most patients.

Language: Английский

Citations

0
Development of Early Progression Independent of Relapse Activity significantly impacts on Disability Accumulation in Patients with Multiple Sclerosis DOI

María Agustina Zárate,

Mariano Marrodán, María Agustina Piedrabuena

et al.

Multiple Sclerosis and Related Disorders, Journal Year: 2025, Volume and Issue: 100, P. 106529 - 106529

Published: May 14, 2025

Language: Английский

Citations

0
CONFIDENCE treatment success: long-term real-world effectiveness and safety of ocrelizumab in Germany DOI Creative Commons
Mathias Buttmann, Martin S. Weber, Sven G. Meuth

et al.

Frontiers in Neurology, Journal Year: 2025, Volume and Issue: 16

Published: May 21, 2025

Background Early high-efficacy treatment for people with relapsing multiple sclerosis (pwRMS) may provide better long-term outcomes compared the escalation strategy. In this study, we present an analysis of success and safety from CONFIDENCE study in a real-world cohort pwRMS treated ocrelizumab different lines up to 5.5 years. Methods The ongoing German non-interventional post-authorization (ML39632, EUPAS22951), evaluates effectiveness therapy pwMS newly or other disease-modifying therapies 10 This presents (proportion no clinical disease activity measured by relapse progression discontinuation due adverse event [AE] lack therapeutic effectiveness), confirmed disability (CDP), annualized rates, stratified number previous MS (PMSTs). Results At data cutoff (11 October 2023), full set included 2,261 ≥1 dose ocrelizumab. baseline, mean age (SD) participants was 41.16 (11.39) years (treatment-naïve, 39.19 [12.95] years; ≥3 PMSTs, 42.80 [10.08] years), Expanded Disability Status Scale (EDSS) score 3.08 (1.86) 2.37 [1.54]; 3.57 [1.90]). Overall, 58.4% continuous achieved baseline until year 5 (74.0 50.3% 0 PMSTs). main reasons not achieving were CDP, while AEs played minor role. proportion did increase longer duration tended be higher more PMSTs. spectrum similar across lines, new unexpected observed. Conclusion remained high over treatment, even among RMS Only small discontinued AEs. These results support early intervention optimize pwRMS. Trial registration https://catalogues.ema.europa.eu/node/3142/administrative-details , identifiers ML39632 EUPAS22951.

Language: Английский

Citations

0
Drones en la distribución de insumos médicos para esclerosis múltiple: desafíos y oportunidades en Colombia DOI
Sebastián Rodríguez

Neurología Argentina, Journal Year: 2025, Volume and Issue: unknown

Published: May 1, 2025

Citations

0
Comparative effectiveness of natalizumab and anti-CD20 monoclonal antibodies in relapsing-remitting multiple sclerosis: a real-world propensity-score matched study DOI

Bassem Yamout,

Raed Alroughani,

Saleh A. Mohamed

et al.

Journal of Neurology Neurosurgery & Psychiatry, Journal Year: 2025, Volume and Issue: unknown, P. jnnp - 335704

Published: June 1, 2025

Background Head-to-head randomised trials or real-world studies comparing the safety and efficacy of natalizumab anti-CD20 monoclonal antibodies are limited. This study aimed to compare effectiveness versus ocrelizumab/rituximab in a cohort relapsing-remitting multiple sclerosis (RRMS) patients using data from Middle East North Africa Committee for Treatment Research Multiple Sclerosis (MENACTRIMS) registry. Methods registry-based, retrospective, multicentre was carried out seven Eastern countries by analysing MENACTRIMS All adults RRMS treated with natalizumab, rituximab ocrelizumab maintained on treatment at least 12 months were included. Patients matched propensity scores. Primary outcomes annualised relapse rate (ARR), confirmed disability progression improvement MRI activity. Results A total 1954 met inclusion criteria, 1277 receiving therapy (768 509 ocrelizumab) 677 natalizumab. Natalizumab significantly reduced ARR compared therapies (0.062 vs 0.092, p=0.001). Confirmed rates, no evidence disease activity (NEDA-3) similar between two groups. However, demonstrated higher rates (9.3% 5.5%, p=0.03). Adverse events more frequent group (36.4% 27.5% Conclusion In this large, cohort, associated lower ARR, greater likelihood improvement, lesser adverse events, but persistence therapies. These findings provide valuable insights into comparative these therapies, aiding clinicians personalised decisions.

Language: Английский

Citations

0