Abstract Details

Title Herpes Zoster Reports in Multiple Sclerosis Patients Treated With Disease Modifying Drugs – An Analysis of EudraVigilance Database

Topic Multiple Sclerosis

Presentation(s) P10 - Poster Session 10 (8:00 AM-9:00 AM)

Poster/Presentation
Number 18-003

Objective The aim of this study was to assess the number of reports of adverse Herpes Zoster (HZ) infections in multiple sclerosis (MS) patients, treated with different disease modifying therapies (DMTs), using data collected in EudraVigilance database.

Background MS itself as well as many currently available DMTs, with immunosuppressive mechanism of action, used in MS treatment are known to be risk factors for adverse HZ infection development. During HZ infection serious complications e.g. postherpetic neuralgia or herpes zoster ophthalmicus might develop, impacting significantly patients’ quality of life. The available data concerning HZ development in MS patients treated with DMTs is limited, highlighting the need for further investigation.

Design/Methods We reviewed EudraVigilance database to identify reported cases of HZ infection in MS patients receiving different DMTs. Reports from 2003-2024 were analyzed with computer programs such as: RStudio and Microsoft Excel. Reporting odds ratios (RORs) for the drugs were calculated, and Fisher's exact test was used to determine statistical significance (P-value < 0.05).

Results

We identified 2017 reports of HZ infections, concerning MS patients treated with different DMTs. The percentage values of HZ reports varied significantly between different DMTs. Values form 0.2% (glatiramer acetate), to 3.9% (cladribine) of all adverse reports, mark HZ as a relevant complication during MS treatment. The highest ROR values were noted for fingolimod (4,09), cladribine (3,33) and alemtuzumab (2,27), followed by siponimod (1,97). The lowest RORs were calculated for glatiramer acetate (0,17), interferons (≈0,21) and teriflunomide (0,35).

Conclusions

Our study shows that some DMTs used in MS might be linked with significant increase in the risk of HZ infection development. While treating MS patient with DMTs, clinicians should always carefully evaluate the risk of adverse HZ. Moreover, vaccination against HZ should be recommended, to reduce the risk of HZ infection, enabling patients to benefit fully form the available MS treatment.

Authors/Disclosures
Rafal Kulakowski PRESENTER	Mr. Kulakowski has nothing to disclose.
Michal Chrzanowski, Pharm	Mr. Chrzanowski has received personal compensation for serving as an employee of AstraZeneca. Mr. Chrzanowski has a non-compensated relationship as a Board Member with Polish Society of Pharmacovigilance that is relevant to AAN interests or activities.
Maciej Niewada, MD, PhD	Dr. Niewada has received personal compensation for serving as an employee of HealthQuest Sp zoo. Dr. Niewada has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for pharmaceutical and medical devices companies. Dr. Niewada has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for HealthQuest. The institution of Dr. Niewada has received research support from MSD.
Dagmara M. Mirowska-Guzel, MD, PhD	Prof. Mirowska-Guzel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Mirowska-Guzel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Mirowska-Guzel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Glaxo.

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