Vaccination Safety in Polyarthritis Inflammatory Patients on Leflunomide
The inactivated flu shot is safe and should be administered without delay, but the MMR vaccine is contraindicated while on leflunomide 20 mg daily due to its immunosuppressive effects. 1
Inactivated Influenza Vaccine (Safe - Administer)
The flu shot should be given regardless of leflunomide therapy, as inactivated vaccines are safe in patients on immunosuppressive DMARDs. 1
- Non-live vaccines can be administered to patients with autoimmune inflammatory rheumatic diseases during use of disease-modifying antirheumatic drugs (DMARDs) like leflunomide 1
- Inactivated influenza vaccine should not be withheld because of concerns about exacerbation of chronic immune-mediated or inflammatory illness 1
- Studies demonstrate adequate immune response to influenza vaccine in patients with rheumatic diseases receiving disease-modifying drugs, though immunogenicity may be somewhat reduced 1
- Leflunomide acts as an immunomodulator by inhibiting lymphocyte proliferation, placing patients in a category requiring immunosuppression considerations 2
Practical Considerations for Flu Vaccine
- Use only the inactivated (killed) influenza vaccine, never the live-attenuated nasal spray (LAIV) 1
- The vaccine can be administered without interrupting leflunomide therapy 1
- Vaccination does not increase disease activity in patients with inflammatory arthritis 1
MMR Vaccine (Contraindicated - Do Not Administer)
MMR vaccine should not be administered while on leflunomide 20 mg daily, as live-attenuated vaccines are contraindicated in patients on maintenance immunosuppression. 1
- Live-attenuated vaccines should not be administered to patients with chronic inflammatory diseases on maintenance immunosuppression, including MMR vaccine in patients receiving both low-level and high-level immunosuppression 1
- The American College of Rheumatology conditionally recommends deferring live-attenuated vaccines for patients with rheumatic diseases on immunosuppressive therapy due to risk of uncontrolled viral replication 3
- Leflunomide is classified as an immunosuppressive DMARD that increases risk of immunosuppression according to product labeling 2
Evidence on MMR in Similar Populations
- The available safety data for MMR vaccination in rheumatic disease patients comes primarily from booster (revaccination) studies in pediatric populations on low-dose methotrexate or etanercept, not primary vaccination in adults on leflunomide 1
- One small study showed 11 of 12 rheumatoid arthritis patients (including 10 on leflunomide) who inadvertently received yellow fever vaccine (another live vaccine) seroconverted without clinical infection, but this involved a fractionated dose and vaccination should still be avoided per guidelines 4
If MMR is Absolutely Necessary
- The preferable approach is to administer MMR vaccine 4 weeks before initiating leflunomide therapy 1
- If already on leflunomide, consider holding the medication for an appropriate period before vaccination and waiting 4 weeks after vaccination before restarting, though this requires careful assessment of disease activity risk 3
- Due to leflunomide's long half-life (approximately 2 weeks for the active metabolite), a washout procedure with cholestyramine may be necessary to accelerate drug elimination before live vaccination can be considered 2
Common Pitfalls to Avoid
- Do not confuse inactivated and live vaccines - the flu shot (inactivated) is safe, while MMR (live) is not 1
- Do not defer the flu vaccine while waiting for immunosuppression to decrease - it should be given on schedule 1
- Do not assume all vaccines carry the same risk - inactivated vaccines have an excellent safety profile in immunosuppressed patients, while live vaccines pose theoretical infection risk 1
- Do not use live-attenuated influenza vaccine (nasal spray) in any patient on immunosuppressive therapy 1