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Herpes Zoster Infections With Multiple Sclerosis Disease-Modifying Therapies: A Real-World Pharmacovigilance Study

Alexandra Balshi1, Grace Leuenberger1, John Dempsey1,2

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

Neurology. Clinical Practice
|March 14, 2025
PubMed
Abstract

Insights

Immunosuppressive multiple sclerosis (MS) therapies increase the risk of herpes zoster (HZ). Data show varying HZ reporting risks across MS disease-modifying therapies (DMTs), highlighting the need for HZ vaccination before treatment.

Area of Science:

  • Neurology
  • Pharmacology
  • Infectious Diseases

Background:

  • Multiple sclerosis (MS) treatments include disease-modifying therapies (DMTs) that can suppress the immune system.
  • Immunosuppression may elevate the risk of opportunistic infections, such as herpes zoster (HZ), also known as shingles.
  • Evaluating HZ risk across different MS DMTs is crucial for patient safety.

Purpose of the Study:

  • To assess the risk of herpes zoster (HZ) associated with various immunosuppressive multiple sclerosis (MS) disease-modifying therapies (DMTs).
  • To compare the relative reporting odds of HZ across a spectrum of MS DMTs using pharmacovigilance data.

Main Methods:

  • Utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) and OpenVigil 2.1 databases.
  • Analyzed reports of HZ in patients receiving specific immunosuppressive MS DMTs, including ocrelizumab, fingolimod, and natalizumab.
  • Calculated reporting odds ratios (RORs) and 95% confidence intervals (CIs) to quantify HZ risk.

Main Results:

  • A total of 4,210 HZ reports were identified across the studied MS DMTs.
  • All analyzed MS DMTs showed disproportionately higher RORs for HZ compared to other medications in FAERS.
  • Alemtuzumab exhibited the highest reporting risk (ROR 11.1), followed by ocrelizumab (9.3) and fingolimod (5.6).

Conclusions:

  • Immunosuppressive MS DMTs are linked to increased HZ reporting in pharmacovigilance databases.
  • The findings underscore the critical importance of HZ vaccination prior to initiating MS DMTs.
  • Proactive vaccination can help prevent avoidable HZ infections in MS patients undergoing treatment.

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