Herpes Zoster Risk Slightly Increased in Patients Taking Biologics

Dr. Norman Putzki, MD PhD Global Program Medical Director Neuroscience Development Franchise Novartis Pharma AG Basel, Switzerland MedicalResearch.com Interview with:
Dr. Norman Putzki, MD PhD
Global Program Medical Director
Neuroscience Development Franchise
Novartis Pharma AG Basel, Switzerland

Medical Research: What is the background for this study? What are the main findings?

Dr. Putzki: Herpes zoster (HZ) infections are increasingly reported in patients taking multiple sclerosis (MS) disease modifying treatments (DMTs). This has been a particular concern ever since more potent MS DMTs have become available.

We have assessed the experience with oral fingolimod, a first in class S1P receptor modulator licensed for multiple sclerosis treatment in 2010, which has today more than 140,000 patient years of exposure in MS clinical trials and the post-marketing setting. Key findings include the fact that Herpes Zoster (HZ) infections occurred at a low rate in clinical trials but were more frequent than with placebo.

In the post-marketing setting, Herpes zoster reporting rates have not increased over time versus clinical trials, and rates have remained stable over time (so there is no risk accumulation).

Our article, which is the result of a consensus meeting with experts in the field of MS and infectious diseases, provides general guidance on risk mitigation; this includes vigilance and appropriate HZ infection management, relevant to physicians when prescribing MS DMTs.

Medical Research: What should clinicians and patients take away from your report?

Dr. Putzki: The assessment of immunity to varicella zoster virus (VZV) prior to treatment initiation with fingolimod is recommended. The Centers for Disease Control and Prevention (CDC) provides general guidance on how to assess immunity, by means of laboratory antibody testing and patient history. Adults who do not have evidence of immunity can be vaccinated to varicella virus to obtain immunity. This will prevent primary varicella infections which are feared to be more serious in adults compared to children. Re-activation of VZV infection – Herpes zoster (HZ) – is more frequent with increasing age. The available VZV antibody tests to measure VZV immunity is not predictive to quantify the risk of HZ infections, and the assessment of VZV T cell immunity in clinical practice is not possible at this point. It is important to be aware that corticosteroids, often used for treatment of MS relapses, can increase the risk of HZ infections. The dose and duration of corticosteroid treatment require the physician’s judgment. Vigilance towards early symptom recognition of Herpes zoster and anti-viral treatment is important.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Putzki: Despite experience exceeding now 140,000 patient years, we will continue our assessment of VZV infections in patients treated with fingolimod in ongoing clinical trials and also in the post-marketing setting. Besides MS, this includes new indications such as pediatric MS and chronic inflammatory demyelinating polyneuropathy (CIDP).

Citation:
Arvin AM, Wolinsky JS, Kappos L, et al. Varicella-Zoster Virus Infections in Patients Treated With Fingolimod: Risk Assessment and Consensus Recommendations for Management. JAMA Neurol. Published online November 24, 2014. doi:10.1001/jamaneurol.2014.3065.

 

 

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