Arthritis, Rheumatoid Clinical Trial
Official title:
Effect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
To investigate whether a short term discontinuation of methotrexate (MTX) will improve the vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease activity in a randomized clinical trial.
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects the joints
as the main target of the inflammation. Patients with RA require chronic treatment with
disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX), which
constitutes the mainstay of treatment.
Underlying immune dysfunction and the additional immune suppression associated with treatment
render patients with RA more susceptible to infection. Thus, vaccination against preventable
diseases including influenza, pneumococcal pneumonia and hepatitis B is recommended for all
RA patients who are subject to treatment with immunesupprssive drugs, unless there is a
contraindication to the use of vaccination. However, low dose of glucocorticoids,
conventional DMARDs and biological DMARDs including tumor necrosis factor inhibitors have
been reported to substantially decrease vaccine response (4); MTX has been reported to be
associated with a decreased response to seasonal influenza vaccination by up to 15%.
To optimize a vaccine response, vaccination should be administrated before the treatment with
immunesuppressive medications is initiated. However, most patients with RA are already on
stable dose of DMARDs at the time of when vaccinations, especially vaccine against seasonal
influenza that needs annual administration, are considered. Alternatively, temporarily
discontinuation of DMARDs might restore normal immune response to and so improve the efficacy
of vaccination.
Although a short term discontinuation of DMARDs during perioperative period has not been
associated with increased disease activity the longer discontinuation of DMARDs might lead to
a significant aggravation of RA disease activity. To optimize the vaccine response, a short
term discontinuation of DMARDs could be considered if this approach proves to be safe and
effective.
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