Ofatumumab in multiple sclerosis: 2-year immune profiling and clinical correlates

Vollständiger Abstract

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Abstract Introduction Anti-CD20 monoclonal antibodies, such as ofatumumab, have significantly improved the management of multiple sclerosis (MS). Still, their long-term immunological effects, particularly on non-B-cell populations, remain poorly explored. We characterized longitudinal changes in circulating lymphocyte subsets and explored their clinical correlates in people with MS treated with ofatumumab. Methods We conducted an observational cohort study including adults with MS who initiated ofatumumab and had paired baseline and on‑treatment assessments after at least 2 years ( n =34). Immunophenotyping quantified total lymphocytes and subsets (CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD20+, CD56+, CD27+, CD27+CD3+, CD27+CD19+, CD3+CD20 +). Longitudinal change was modeled with linear mixed‑effects regression (fixed effects: age, sex, follow‑up duration, comorbidities, BMI, previous DMT; random intercept for subject). Annualized percentage change of each laboratory measure was related to relapses, MRI activity, EDSS progression, NEDA‑3, and EDSS improvement using multivariable logistic regression with the same covariates. Results Over approximately 2 years of treatment, we observed increased total lymphocytes (Coeff 251.47; 95% CI 29.29–473.64; p =0.027), CD3+ (368.79; 183.66–553.91; p