Seoul, Republic of Korea—Determining when to administer influenza and other vaccines for patients taking methotrexate (MTX) can be difficult. Patients often are advised to discontinue their medication for conditions such as RA for 2 weeks after getting a shot.

The reason is that MTX significantly decreases the response to pneumococcal and seasonal influenza vaccines. A recent study presented at annual American College of Rheumatology’s (ACR) Convergence 2022 noted that temporarily discontinuing MTX for 2 weeks in patients with RA on a stable dose of MTX significantly increased immunogenicity.

The South Korean study from Seoul National University Hospital sought to determine whether discontinuing MTX for 1 week after seasonal influenza vaccination is noninferior to discontinuing the medication for 2 weeks in RA patients in terms of short- and long-term vaccine response.

For the prospective, randomized parallel-group, multicenter noninferiority trial, researchers randomly assigned RA patients on a stable dose of MTX at a ratio of 1:1 to hold MTX for 1 week or 2 weeks after receiving the quadrivalent 2021-2022 seasonal influenza vaccine containing H1N1, H3N2, B-Yamagata, and B-Victoria strains.

The primary outcome was defined as the proportion of patients with a satisfactory vaccine response—more than a fourfold increase in hemagglutination inhibition antibody titers against two or more of the four vaccine strains 4 weeks after vaccination. Secondary outcomes involved positive response and antibody titers at 4 and 16 weeks after vaccination. Controls without autoimmune disease were included as a reference.

The modified intention-to-treat population included 90 patients in the 1-week MTX hold group and 88 patients in the 2-week MTX hold group. The results indicated that the proportion of satisfactory vaccine responses did not differ between the groups at 4 weeks (68.9% vs. 75.0%, P = .364) and 16 weeks (69.6% vs. 70.3%, P = .915).

Furthermore, the authors advised that both the proportion of patients reaching seroprotection and the rise in antibody titers were similar between the groups at 4 and 16 weeks. The study also found that vaccine responses in RA patients and controls were similar.

“Patients and physicians alike do not often know what to do with methotrexate when a vaccination, including the annual flu vaccine or novel COVID-19 vaccines, is required. It was relieving to find out that skipping methotrexate for one week is as effective as skipping it for two weeks to improve vaccine response with no increase in disease flare risk,” explained lead author Jin Kyun Park, MD, chief of rheumatology at Seoul National University Hospital and associate professor at Seoul National University College of Medicine. “But it is not clear yet whether skipping methotrexate for one week improves response to other vaccines.”

Dr. Park stated that the next step is determining if this approach can be applied to other disease-modifying antirheumatic drugs and vaccines.

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