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December 10, 2014
Some New Therapies Increase Varicella-Zoster Infection Rates In MS Patients 

Stanford, CA—A new study urges greater vigilance in identifying increasing numbers of varicella-zoster virus (VZV) infections in patients with multiple sclerosis (MS).

Background in the article, which was published recently in JAMA Neurology, suggests the infections are of growing concern, especially with the introduction of more disease-modifying treatments that affect T-cell–mediated immunity in MS patients.

The study, led by researchers from Stanford University, sought to assess the incidence, risk factors, and clinical characteristics of VZV infections in fingolimod-treated patients and provide recommendations for prevention and management.

For the industry-backed research, rates of VZV infections in fingolimod clinical trials were based on pooled data from the completed controlled phase 2 and 3 studies (3,916 participants) and ongoing uncontrolled extension phases (3,553 participants) receiving fingolimod at a dosage of 0.5 or 1.25 mg/d, interferon beta-1a, or placebo.

Eligible to participate in the studies were male and female patients aged 18 through 55 years (18-60 years for the phase 2 studies) who had been diagnosed with relapsing-remitting MS.

In the postmarketing setting, reporting rates since 2010 were evaluated for patients receiving fingolimod, 0.5 mg/d, with total exposure of 54,000 patient-years at the time of analysis.

Results indicate that VZV rates of infection were low overall but higher with fingolimod compared with placebo—11 versus 6 per 1,000 patient-years. Ongoing extension studies showed a similar rate. Rates reported in the postmarketing settings were comparable—7 per 1,000 patient-years—and remained stable over time.

While patients receiving fingolimod were more likely to report herpes zoster infection compared with those on other disease-modifying treatments, the proportion of serious herpes zoster infections was not higher. The report also suggests that corticosteroid treatment for relapses might be a risk factor for VZV reactivation.

“Rates of VZV infections in clinical trials were low with fingolimod, 0.5 mg/d, but higher than in placebo recipients,” study authors conclude. “Rates reported in the postmarketing setting are comparable. We found no sign of risk accumulation with longer exposure. Serious or complicated cases of herpes zoster were uncommon.”

The researchers recommend evaluation of a patient’s VZV immune status before initiating fingolimod therapy and immunization for patients susceptible to primary VZV infection.

While routine antiviral prophylaxis is not needed, according to study authors, using concomitant pulsed corticosteroid therapy beyond 3 to 5 days requires an individual risk-benefit assessment. They also urge vigilance to identify early VZV symptoms to allow more timely antiviral treatment.


U.S. Pharmacist Social Connect