BACKGROUND: Ongoing controversy exists regarding optimal management of disease modifying therapy (DMT) in older people with multiple sclerosis (pwMS). There is concern that the lower relapse rate, combined with a higher risk of DMT-related infections and side effects, may alter the risk-benefit balance in older pwMS. Given the lack of pwMS above age 60 in randomised controlled trials, the comparative efficacy of high-efficacy DMTs such as ocrelizumab has not been shown in older pwMS. We aimed to evaluate the comparative effectiveness of ocrelizumab, a high-efficacy DMT, versus interferon/glatiramer acetate (IFN/GA) in pwMS over the age of 60. METHODS: Using data from MSBase registry, this multicentre cohort study included pwMS above 60 who switched to or started on ocrelizumab or IFN/GA. We analysed relapse and disability outcomes after balancing covariates using an inverse probability treatment weighting (IPTW) method. Propensity scores were obtained based on age, country, disease duration, sex, baseline Expanded Disability Status Scale, prior relapses (all-time, 12 months and 24 months) and prior DMT exposure (overall number and high-efficacy DMTs). After weighting, all covariates were balanced. Primary outcomes were time to first relapse and annualised relapse rate (ARR). Secondary outcomes were 6-month confirmed disability progression (CDP) and confirmed disability improvement (CDI). RESULTS: A total of 248 participants received ocrelizumab, while 427 received IFN/GA. The IPTW-weighted ARR for ocrelizumab was 0.01 and 0.08 for IFN/GA. The IPTW-weighted ARR ratio was 0.15 (95% CI 0.06 to 0.33, p<0.001) for ocrelizumab compared with IFN/GA. On IPTW-weighted Cox regression models, HR for time to first relapse was 0.13 (95% CI 0.05 to 0.26, p<0.001). The hazard of first relapse was significantly reduced in ocrelizumab users after 5 months compared with IFN/GA users. However, the two groups did not differ in CDP or CDI over 3.57 years. CONCLUSION: In older pwMS, ocrelizumab effectively reduced relapses compared with IFN/GA. Overall relapse activity was low. This study adds valuable real-world data for informed DMT decision making with older pwMS. Our study also confirms that there is a treatment benefit in older people with MS, given the existence of a clear differential treatment effect between ocrelizumab and IFN/GA in the over 60 age group.

Alfred Health Melbourne Victoria Australia

CORe Department of Medicine University of Melbourne Melbourne Victoria Australia

Department of Neurological Siences University of Florence Florence Italy

Department of Neurology and Center of Clinical Neuroscience Charles University Prague 1st Faculty of Medicine and General University Hospital Prague Prague Czech Republic

Department of Neurology Tasmanian Health Service Hobart Tasmania Australia

Department of Neurology The Royal Melbourne Hospital Parkville Victoria Australia

Department of Neuroscience Central Clinical School Monash University Melbourne Victoria Australia

Eastern Health Box Hill Victoria Australia

Faculty of Health Sciences University Fernando Pessoa Porto Portugal

Hotel Dieu de Levis Levis Quebec Canada

Hunter New England Health New Lambton New South Wales Australia

Karadeniz Technical University Trabzon Turkey

Medical Point Hospital Izmir Turkey

Melbourne Health Melbourne Victoria Australia

Neurology Centro Hospitalar de São João Porto Portugal

Neurology Jacobs Comprehensive MS Treatment and Research Center Buffalo New York USA

Neuroscience University of Catania Department of Surgical and Medical Sciences and Advanced Technologies 'G F Ingrassia' Catania Italy

The University of Newcastle Newcastle New South Wales Australia

University of Catania Catania Italy

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De-escalating and discontinuing disease-modifying therapies in multiple sclerosis