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Ocular toxicity associated with anti-CD20 monoclonal antibodies: A pharmacovigilance analysis using the FAERS

Yun Kuang1, Yan Guo2, Yaxin Liu1

  • 1Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, China.

Multiple Sclerosis and Related Disorders
|March 27, 2026
PubMed
Abstract

Insights

Anti-CD20 antibody treatments can cause ocular side effects, including infections. Specific risks like blepharospasm with ofatumumab and vision changes with rituximab require careful monitoring in patients, especially those with multiple sclerosis.

Area of Science:

  • Pharmacovigilance and Immunology
  • Ophthalmology
  • Neurology

Background:

  • Anti-CD20 monoclonal antibodies are crucial for treating B-cell malignancies and autoimmune conditions.
  • However, their potential for ocular toxicity is not fully understood, necessitating comprehensive safety evaluations.

Purpose of the Study:

  • To systematically assess ocular adverse events (OAEs) linked to anti-CD20 therapies.
  • To identify potential safety signals and patterns of ocular toxicity across different anti-CD20 agents.

Main Methods:

  • Utilized the U.S. FDA Adverse Event Reporting System (FAERS) database from Q4 2014 to Q3 2024.
  • Employed disproportionality analyses with Bayesian shrinkage estimators and subgroup analyses based on clinical indications.

Main Results:

  • Identified 29,363 OAE reports, primarily associated with rituximab, ofatumumab, and ocrelizumab.
  • All agents showed signals for ocular infections, indicating a potential class effect.
  • Ofatumumab was linked to increased blepharospasm risk in multiple sclerosis (MS) patients; rituximab showed a significant association with dyschromatopsia in MS patients.

Conclusions:

  • Anti-CD20 antibodies necessitate vigilant ocular monitoring, particularly for patients with multiple sclerosis.
  • Observed risks of blepharospasm and dyschromatopsia suggest potential central nervous system and optic pathway effects requiring further investigation for safer MS treatment strategies.
Keywords:
Anti-CD20 monoclonal antibodiesFAERS databaseOcular toxicityPharmacovigilance

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