Temporarily discontinuing methotrexate (MTX) improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA), according to a clinical trial reported in Annals of Rheumatic Diseases.
According to Eun Bong Lee, MD, PhD, of Seoul National University College of Medicine in Korea and colleagues, methotrexate, which is recommended in almost all patients with RA, decreases their response to pneumococcal and seasonal influenza vaccination. Because they typically receive MTX prior to the need for vaccination, the researchers set out to explore a means of improving the vaccine response in patients with RA.
In order to determine whether discontinuing MTX for 4 weeks before, during, or after a seasonal influenza vaccination could improve the efficacy of the vaccine in patients with RA, the researchers conducted a single-center randomized single-blind parallel group intervention study between September 2015 and July 2016.
They divided 199 patients into 4 groups: patients who continued to take MTX; patients who suspended MTX for 4 weeks prior to vaccination; patients who suspended MTX for 2 weeks before and 2 weeks after vaccination; and patients who suspended MTX for 4 weeks following immunization.
Patients who stopped MTX for 2 weeks before and 2 weeks after vaccination achieved a satisfactory vaccine response (51%) compared with patients who never suspended MTX (31.5%, P =.044). Patients who suspended MTX for 4 weeks prior to vaccination did not demonstrate more significant results than patients who never suspended MTX, while patients who suspended MTX for 4 weeks showed a better response than patients who had not suspended treatment.
The researchers reported no severe adverse events related to the vaccine at follow-up. Of the patients, 58 (29.1%) experienced an RA disease flare — the groups with MTX discontinuation 4 weeks prior to vaccination (n=15; 34.1%) and 2 weeks before and after vaccination (n=19; 38.8%) experienced flares more commonly.
“This study is the first to demonstrate a novel strategy that increases the vaccine immunogenicity in such patients with RA,” the researchers wrote. “The fact that discontinuing MTX improves immune responses to vaccines also supports the clinical practice that MTX be discontinued during acute (life-threatening) infections.”
“Further studies are needed to determine whether MTX discontinuation decreases the influenza incidence or alters the course of the disease,” the researchers added.
Park JK, Lee MA, Lee EY, Song YW, et al. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial [published online May 3, 2017]. Annals of Rheumatic Diseases. doi:10.1136/annrheumdis-2017-211128