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Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse

Alexandra Balshi1, Madelyn Esser1, John P Dempsey2

  • 1Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

Multiple Sclerosis and Related Disorders
|March 5, 2026
PubMed
Abstract

Insights

Multiple sclerosis (MS) disease-modifying therapies (DMTs) are linked to increased appendicitis reports. Patients on these treatments should be aware of early warning signs for this common surgical emergency.

Area of Science:

  • Immunology
  • Neurology
  • Pharmacovigilance

Background:

  • Appendicitis is a common surgical emergency with links to immune function.
  • The relationship between multiple sclerosis (MS) disease-modifying therapies (DMTs) and appendicitis risk is not well understood.
  • Investigating potential adverse events associated with MS treatments is crucial for patient safety.

Purpose of the Study:

  • To identify if specific MS DMTs are associated with a higher incidence of appendicitis reporting.
  • To analyze real-world data for potential safety signals between MS DMTs and appendicitis.
  • To quantify the risk of appendicitis associated with MS DMTs.

Main Methods:

  • Utilized data from the FDA Adverse Event Reporting System (FAERS).
  • Conducted a pharmacovigilance analysis comparing appendicitis reports for MS DMTs against other medications.
  • Calculated reporting odds ratios to assess disproportionately high reporting.

Main Results:

  • Identified 965 reports of appendicitis linked to MS DMTs.
  • A pooled analysis revealed a significantly higher reporting of appendicitis for MS DMTs (ROR, 2.83; 95% CI, 2.63-3.06).
  • Specific DMTs including ocrelizumab, ofatumumab, natalizumab, alemtuzumab, fumarates, cladribine, and interferon beta demonstrated disproportionately high appendicitis reporting.

Conclusions:

  • MS patients using DMTs may face an increased risk of appendicitis.
  • Healthcare providers should counsel MS patients on recognizing early appendicitis symptoms.
  • Prompt medical evaluation is recommended for individuals with MS experiencing potential appendicitis warning signs.
Keywords:
AppendicitisDisease-modifying therapyMultiple sclerosisPharmacovigilance

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