Monday, 9 February 2015

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


  1. We rheumatologists tend to vaccinate people before we start them on MTX or biologics. Maybe that trend ( as the "treat-to-target" mantra did) will spread to neuro?)

  2. I am wondering if Gilenya users can be vaccinated for shingles. It looks horrid in all the ads on US tv. But of course, the vaccine makers aim to scare the heck out of everyone over 50.

    1. I think the standard now is to test for antibodies and then vaccinate those MSers who do not have antibodies against before starting them on Gilenya.

  3. I have been travelling to and spending time in exotic locations in the subtropics, where dengue (which has no vaccine), polio, hepatitis and potentially yellow fever are a risk, for 20 years and there often move in not very hygienic places and among people with a poor health status. Due to this I luckily had a number of vaccines against these before ms and fingolimod but some, such as yellow fever, which would be a live vaccine that I cannot take anymore, would be due to come up again. The only vaccine I have been getting is the flu vaccine but as my exotic locations are on the other side of the world from my country I cannot get it for the flu season there. Also, at home, I work among very many people. So far I have not caught anything neither here nor there beyond colds about twice a year and once outside the home flu season a real flu on a plane from a non-exotic location. Recently, my whole family had a real flu and I did not catch it since I was vaccined. Based on your post, I am suprised at how well my immune system seems to react on G - or have I just been lucky so far? Will be steering clear of yellow fever epidemics, though, and agree with the rheumatologist above that vaccinations prior to G would make sense, as I had by coincidence.


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