ClinicSpeak: fingolimod affects vaccination

Can I travel to exotic destinations without vaccinations on fingolimod? #ClinicSpeak #MSBlog #MSResearch

"The study below clearly demonstrates that fingolimod reduces your immune response to recall and new antigens in the flu and tetanus vaccines. I am not surprised by this as fingolimod is an immunosuppressive therapy and has been associated with opportunistic infections, albeit it rarely. Importantly, you need to remember that live vaccinations are contraindicated whilst on fingolimod. The most commonly used live vaccines given to adults are varicella-zoster, oral polio and yellow fever. The fact that live vaccines are contra-indicated and there is a reduced response to inactivated vaccines (flu & tetanus) means that you need to be very careful about travelling to exotic destinations with endemic infections you have never seen before; for example, yellow fever, dengue, Japanese B encephalitis, etc. If you are planning to travel to any exotic places please discuss things with your neurologist or MS nurse specialist. You need to be careful when travelling to exotic destinations on fingolimod; it is best to plan your travel to avoid the high seasons associated with highest risk of infections and take precautions to avoid being infected."

Epub: Kappos et al. Randomized trial of vaccination in fingolimod-treated patients with multiple sclerosis. Neurology. 2015 Jan 30. pii: 10.1212/WNL.0000000000001302.

OBJECTIVE: To evaluate immune responses in fingolimod-treated MSers against influenza vaccine (to test for responses against anticipated novel antigens in seronegative patients) and recall (tetanus toxoid [TT] booster dose) antigens.

METHODS: This was a blinded, randomized, multicenter, placebo-controlled study. MSers aged 18 to 55 years with relapsing MS were randomized (2:1) to fingolimod 0.5 mg or placebo for 12 weeks. At week 6, MSers received seasonal influenza vaccine (containing antigens of California, Perth, and Brisbane virus strains) and TT booster dose. Antibody titres against influenza and TT were estimated at baseline (prevaccination) and 3 and 6 weeks postvaccination. The primary efficacy variable was responder rate (proportion of patients showing seroconversion or significant increase [≥4-fold] in antibody titers against at least one influenza virus strain) at 3 weeks post-vaccination and vs placebo.

RESULTS: Of 138 randomized MSers (fingolimod 95, placebo 43), 136 completed the study (2 discontinued in fingolimod group). The responder rates (odds ratio; 95% confidence interval) for influenza vaccine (fingolimod vs placebo) were 54% vs 85% (0.21; 0.08-0.54) at 3 weeks and 43% vs 75% (0.25; 0.11-0.57) at 6 weeks postvaccination. For TT, responder rates were 40% vs 61% (0.43; 0.20-0.92) at 3 weeks and 38% vs 49% (0.62; 0.29-1.33) at 6 weeks postvaccination. Adverse events were reported in 86.3% and 79.1% of MSers receiving fingolimod and placebo, respectively.

CONCLUSION: Most fingolimod-treated MSers were able to mount immune responses against novel and recall antigens and the majority met regulatory criteria indicating seroprotection. However, response rates were reduced compared with placebo-treated MSers. This should be kept in mind when vaccinating MSers on fingolimod.

CoI: multiple

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