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Introduction <p>Ofatumumab, an anti-CD20 monoclonal antibody, is a high-efficacy disease-modifying therapy for relapsing multiple sclerosis (RMS). Although pivotal trials demonstrated substantial benefits, real-world data are required to confirm treatment persistence, effectiveness, safety, and biological markers of response in routine clinical settings. This study evaluated the real-world outcomes of ofatumumab in patients treated at a specialised multiple sclerosis (MS) centre in southeastern Spain, including exploratory analyses of B&#xa0;cell kinetics, comorbidity burden using the Charlson Comorbidity Index (CCI), and ethnicity.</p> Methods <p>A retrospective observational study was conducted in adults with MS initiating ofatumumab between December 2022 and December 2025, with ≥ 6&#xa0;months of continuous therapy. Demographic, clinical, radiological, laboratory, and pharmacological data were extracted from electronic medical records. Statistical analyses encompassed Kaplan–Meier estimates.</p> Results <p>Eighty-seven patients were included (mean age 43&#xa0;years; 75.9% female; 88.5% relapsing–remitting phenotype). Over a median 22-month follow-up, treatment persistence was 95.4%. Annualised relapse rate (ARR) declined from 0.48 pre-treatment to 0.03 on treatment. No evidence of disease activity (NEDA-3) was achieved in 93.1%, with no significant differences between treatment-naïve and previously treated patients. Sustained CD19<sup>+</sup> B&#xa0;cell depletion was confirmed in all assessments. Immunoglobulin levels remained mostly stable. Ofatumumab was generally well tolerated: systemic injection-related reactions occurred in 29.9% and infections in 6.9%. Exploratory analyses showed no significant differences in relapse or magnetic resonance imaging outcomes by CCI category or ethnicity.</p> Conclusion <p>In this Spanish real-world single-centre cohort, ofatumumab demonstrated high persistence, substantial suppression of inflammatory activity, and a favourable safety profile in routine clinical practice. Sustained B&#xa0;cell depletion aligned with clinical and radiological stability. These findings support the real-world effectiveness of ofatumumab across diverse patient profiles and complement evidence from pivotal trials. Further prospective studies with broader populations and longer follow-up are warranted to refine understanding of long-term outcomes and determinants of treatment response variability.</p>

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Real-World Effectiveness and Safety of Ofatumumab: Analysis of B Cell Depletion, Comorbidities and Ethnicity in a Spanish Cohort

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月6日

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  • Luis Moreno-Navarro,
  • Lourdes Ruiz-Escribano-Menchen,
  • Josefa Polache-Vengud,
  • Ester Lobato-Martinez,
  • Angel P. Sempere

摘要

Introduction

Ofatumumab, an anti-CD20 monoclonal antibody, is a high-efficacy disease-modifying therapy for relapsing multiple sclerosis (RMS). Although pivotal trials demonstrated substantial benefits, real-world data are required to confirm treatment persistence, effectiveness, safety, and biological markers of response in routine clinical settings. This study evaluated the real-world outcomes of ofatumumab in patients treated at a specialised multiple sclerosis (MS) centre in southeastern Spain, including exploratory analyses of B cell kinetics, comorbidity burden using the Charlson Comorbidity Index (CCI), and ethnicity.

Methods

A retrospective observational study was conducted in adults with MS initiating ofatumumab between December 2022 and December 2025, with ≥ 6 months of continuous therapy. Demographic, clinical, radiological, laboratory, and pharmacological data were extracted from electronic medical records. Statistical analyses encompassed Kaplan–Meier estimates.

Results

Eighty-seven patients were included (mean age 43 years; 75.9% female; 88.5% relapsing–remitting phenotype). Over a median 22-month follow-up, treatment persistence was 95.4%. Annualised relapse rate (ARR) declined from 0.48 pre-treatment to 0.03 on treatment. No evidence of disease activity (NEDA-3) was achieved in 93.1%, with no significant differences between treatment-naïve and previously treated patients. Sustained CD19+ B cell depletion was confirmed in all assessments. Immunoglobulin levels remained mostly stable. Ofatumumab was generally well tolerated: systemic injection-related reactions occurred in 29.9% and infections in 6.9%. Exploratory analyses showed no significant differences in relapse or magnetic resonance imaging outcomes by CCI category or ethnicity.

Conclusion

In this Spanish real-world single-centre cohort, ofatumumab demonstrated high persistence, substantial suppression of inflammatory activity, and a favourable safety profile in routine clinical practice. Sustained B cell depletion aligned with clinical and radiological stability. These findings support the real-world effectiveness of ofatumumab across diverse patient profiles and complement evidence from pivotal trials. Further prospective studies with broader populations and longer follow-up are warranted to refine understanding of long-term outcomes and determinants of treatment response variability.