Immunotherapy prevents long-term disability in relapsing multiple sclerosis over 15 years
Eva Kubala Havrdova,
Anneke van der Walt,
Vincent Van Pesch,
Maria Laura Saladino,
Jose Luis Sanchez-Menoyo,
on behalf of the MSBase Study group
Posted 23 Aug 2019
bioRxiv DOI: 10.1101/735662
Posted 23 Aug 2019
Objective: Whether immunotherapy improves long-term disability in multiple sclerosis has not been satisfactorily demonstrated. This study examined the effect of immunotherapy on long-term disability outcomes in relapsing-remitting multiple sclerosis. Methods: We studied patients from MSBase followed for 1 year, with 3 visits, 1 visit per year and exposed to a multiple sclerosis therapy, and a subset of patients with 15-year follow-up. Marginal structural models were used to compare the hazard of 12-month confirmed increase and decrease in disability, EDSS step 6 and the incidence of relapses between treated and untreated periods. Marginal structural models were continuously re-adjusted for patient age, sex, pregnancy, date, disease course, time from first symptom, prior relapse history, disability and MRI activity. Results: 14,717 patients were studied. During the treated periods, patients were less likely to experience relapses (hazard ratio 0.60, 95% confidence interval 0.43- 0.82, p=0.0016), worsening of disability (0.56, 0.38-0.82, p=0.0026) and progress to EDSS step 6 (0.33, 0.19-0.59, p=0.00019). Among 1085 patients with 15-year follow-up, the treated patients were less likely to experience relapses (0.59, 0.50- 0.70, p=10-9) and worsening of disability (0.81, 0.67-0.99, p=0.043). Conclusions: Continued treatment with multiple sclerosis immunotherapies reduces disability accrual (by 19-44%), the risk of need of a walking aid by 67% and the frequency of relapses (by 40-41%) over 15 years. A proof of long-term effect of immunomodulation on disability outcomes is the key to establishing its disease modifying properties.
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