Multiple sclerosis and related disorders · 2026
Differential safety profiles of disease-modifying therapies in MS: Age- and sex-based analysis from a real-world cohort.
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Ercan Melike Cakan, Cakan Elif, Gumus Yasemin, Ozen Nazire Pınar Acar, Tuncer Aslı, Karabudak Rana
Аннотация
BACKGROUND/OBJECTIVES: Age and sex may modulate adverse events (AE) under disease-modifying therapies (DMTs) in Multiple Sclerosis (MS), yet comparative real-world data across agents remain limited. We assessed age- and sex-specific adverse event (AE) patterns within individual disease-modifying therapy (DMT) cohorts (dimethyl fumarate, fingolimod, natalizumab, and ocrelizumab) in a real-world setting.
METHODS: Demographics, EDSS, laboratory parameters (CBC, LFTs, immunoglobulins), infections (PCR/culture), and first-dose ECG/HR were extracted for single-centre retrospective cohort (2010-2021). The primary outcome was AE incidence. Predictors of AEs were analysed using Cox proportional hazards regression, while predictors of COVID-19 infection were assessed using Poisson regression.
RESULTS: Among 1137 evaluations (DMF 228; fingolimod 539; natalizumab 70; ocrelizumab 300) in 658 patients, lymphopenia was the most frequent AE. In the fingolimod cohort, female sex and younger age at treatment onset were associated with grade 3-4 lymphopenia (adjusted HR 0.33, 95% CI 0.23-0.48 and HR 0.97, 95% CI 0.96-0.99; BH-adjusted P = 0.005 for both), and male sex with LFT abnormalities (adjusted HR 3.10, 95% CI 1.51-6.32; BH-adjusted P = 0.007). First-dose bradycardia occurred in 13.7%, with comparable heart rate reductions across age groups and sexes. Nominal associations in DMF (older age with lymphopenia) and ocrelizumab (male sex with bacterial infection and neutropenia) did not survive BH correction. Older age was associated with lower COVID-19 incidence in the fingolimod and ocrelizumab cohorts (BH-adjusted P = 0.036 and P < 0.001).
CONCLUSION: In this real-world cohort, fingolimod showed robust sex- and age-specific AE patterns, whereas nominal associations in DMF and ocrelizumab cohorts are interpreted as hypothesis-generating pending validation. These findings support further investigation of therapy-specific, demographically informed monitoring strategies in MS.
METHODS: Demographics, EDSS, laboratory parameters (CBC, LFTs, immunoglobulins), infections (PCR/culture), and first-dose ECG/HR were extracted for single-centre retrospective cohort (2010-2021). The primary outcome was AE incidence. Predictors of AEs were analysed using Cox proportional hazards regression, while predictors of COVID-19 infection were assessed using Poisson regression.
RESULTS: Among 1137 evaluations (DMF 228; fingolimod 539; natalizumab 70; ocrelizumab 300) in 658 patients, lymphopenia was the most frequent AE. In the fingolimod cohort, female sex and younger age at treatment onset were associated with grade 3-4 lymphopenia (adjusted HR 0.33, 95% CI 0.23-0.48 and HR 0.97, 95% CI 0.96-0.99; BH-adjusted P = 0.005 for both), and male sex with LFT abnormalities (adjusted HR 3.10, 95% CI 1.51-6.32; BH-adjusted P = 0.007). First-dose bradycardia occurred in 13.7%, with comparable heart rate reductions across age groups and sexes. Nominal associations in DMF (older age with lymphopenia) and ocrelizumab (male sex with bacterial infection and neutropenia) did not survive BH correction. Older age was associated with lower COVID-19 incidence in the fingolimod and ocrelizumab cohorts (BH-adjusted P = 0.036 and P < 0.001).
CONCLUSION: In this real-world cohort, fingolimod showed robust sex- and age-specific AE patterns, whereas nominal associations in DMF and ocrelizumab cohorts are interpreted as hypothesis-generating pending validation. These findings support further investigation of therapy-specific, demographically informed monitoring strategies in MS.