2-week dc of MTX and Influenza Vaccination in RA (2 wk MTX)

Seoul National University

Status

Unknown

Conditions

Methotrexate

Influenza

Rheumatoid Arthritis

Treatments

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT02897011

SNUH-IMJ-003

Details and patient eligibility

About

To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves the vaccination response to a seasonal influenza.

Full description

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 antirheumatic 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 of the preventive diseases is crucial and recommended in all patients unless contraindicated.

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 MTX at the time of when vaccinations. To improve the vaccine response, a short term discontinuation of MTX could be considered. In a prior study, we discovered that a temporary discontinuation of MTX for 4 weeks during peri-vaccination period tended to be associated with an improved response to vaccination with trivalent influenza vaccination (Figure 1). It remains to be defined whether MTX discontinuation for shorter period increases the vaccination efficacy while minimizing the RA flare rate.

Enrollment

318 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females ≥ 19 years and < 65 years of age at time of consent
Have a diagnosis of RA per ACR criteria
Must understand and voluntarily sign an informed consent form including writing consent for data protection
Stable doses of methotrexate over the preceding 6 weeks

Exclusion criteria

Pregnant or lactating females
Previous anaphylactic response to vaccine components or to egg.
Acute infection with T >38°C at the time of vaccination
History of Guillain-Barre syndrome or demyelinating syndromes
Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study
Blood transfusion within 6 months
Active rheumatoid arthritis necessitating a recent change in the drug regimen
Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
Any condition including laboratory abnormality which places the subject at unacceptable risk
Subjects who decline to participate