0936: Immediate and Long-term Effects of the MTX Discontinuation for 1 vs. 2 Weeks on Vaccine Response to Seasonal Influenza Vaccine: A Non-inferiority Randomized Controlled Trial
Seoul National University College of Medicine Jongno-gu, Seoul, South Korea
Disclosure: Disclosure information not submitted.
Jin Kyun Park1, Yun Jong Lee2, Kichul Shin3, Eun Ha Kang2, You-Jung Ha2, Min Jung Kim4, Jun Won Park5, SE RIM CHOI5, Mi Hyeon Kim5, Ji In Jung5, Ju Yeon Kim5, Kevin Winthrop6 and Eun Bong Lee5, 1Seoul National University College of Medicine, Jongno-gu, Seoul, South Korea, 2Seoul National University Bundang Hospital, Seongnam, Republic of Korea, 3Seoul Metropolitan Government- Seoul National University Boramae Medical Center, Seoul, Republic of Korea, 4Seoul Metropolitan Government Boramae Medical center, Dongjak-gu, Seoul, Republic of Korea, 5Seoul National University Hospital, Seoul, Republic of Korea, 6Oregon Health & Science University, Portland, OR
Background/Purpose: Methotrexate (MTX) significantly decreases the vaccine response to pneumococcal and seasonal influenza vaccines and temporarily discontinuing MTX for 2 weeks in patients with rheumatoid arthritis (RA) on a stable dose of MTX significantly increased immunogenicity. This study aimed to determine whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is non-inferior to discontinuing for 2 weeks in RA patients with regards to immediate and long-term vaccine response.
Methods: In this prospective randomized parallel-group multi-center non-inferiority trial study, RA patients on a stable dose of MTX were randomly assigned 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 the proportion of patients with a satisfactory vaccine response, which was defined as ≥4-fold increase in hemagglutination inhibition antibody titers against two or more of the four vaccine strains 4 weeks after vaccination. Secondary outcomes include positive response and antibody titers at 4 and 16 weeks after vaccination. Controls without autoimmune disease were included as a reference.
Results: 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 proportion of satisfactory vaccine responses did not differ between the groups at 4 weeks (68.9% vs. 75.0%, p = 0.364) and at 16 weeks (69.6% vs. 70.3%, p=0.915). The proportion of patients reaching seroprotection and the rise in antibody titer were similar between the groups at 4 and 16 weeks. Vaccine responses in RA patients and controls were similar.
Conclusion: Temporarily discontinuing MTX for 1 week is non-inferior to MTX discontinuation for 2 weeks after vaccination to induce an immediate and long-term satisfactory vaccine response to a seasonal influenza vaccine in patients with RA on a stable dose of MTX. <img src=https://www.abstractscorecard.com/uploads/Tasks/upload/17574/QHOPTGBB-1291523-1-ANY.jpg width=440 height=278.641765704584 border=0 style=border-style: none;>
Figure. Study design and vaccine response at 4 and 16 weeks (A) Study design. (B) The percentage of patients achieving a satisfactory vaccine response, defined as ≥4-fold increase in hemagglutination inhibition (HI) antibody titer 4 weeks and 16 weeks after vaccination against one or more, two or more , three or more, and four vaccine strains. The error bars represent the 95% confidence interval. The 1 week and 2 week MTX hold groups were compared by a chi-square test. The groups did not differ in regard to vaccine response (p >0.05).
Disclosures: J. Park, None; Y. Lee, None; K. Shin, None; E. Kang, None; Y. Ha, None; M. Kim, None; J. Park, None; S. CHOI, None; M. Kim, None; J. Jung, None; J. Kim, None; K. Winthrop, AbbVie, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Pfizer, Roche, Regeneron, Sanofi, UCB, AstraZeneca, Novartis; E. Lee, None.
