Eriko Kudo-Tanaka1,2, Takashi Shimizu2, Takuro Nii2, Satoru Teshigawara2, Maiko Yoshimura2, Akane Watanabe2, Soichiro Tsuji2, Hideki Tsuboi3, Makoto Hirao3, Akiko Yura2, Yoshinori Harada2, Makoto Sueishi4, Yasuo Suenaga5, Noriyuki Chiba6, Takeharu Tonai7, Koichiro Saisho8, Atsushi Ogata9, Masato Matsushita2, Jun Hashimoto2, Shiro Ohshima1, Shigeto Tohma10, Yukihiko Saeki1. 1. a Department of Clinical Research , NHO Osaka Minami Medical Center , Kawachinagano, Osaka , Japan. 2. b Department of Rheumatology and Allergology , NHO Osaka Minami Medical Center , Kawachinagano, Osaka , Japan. 3. c Department of Orthopedics , NHO Osaka Minami Medical Center , Kawachinagano, Osaka , Japan. 4. d Department of Rheumatology , NHO Shimoshizu National Hospital , Yotsukaido, Chiba , Japan. 5. e Department of Rheumatology , NHO Beppu Medical Center , Beppu, Oita , Japan. 6. f Department of Rheumatology , NHO Morioka National Hospital , Morioka, Miyagi , Japan. 7. g Department of Orthopedics , NHO Zentsuji National Hospital , Zentsuji, Kagawa , Japan. 8. h Department of Rheumatology , NHO Miyakonojo National Hospital , Miyakonojo, Miyazaki , Japan. 9. i Department of Respiratory Medicine , Allergology and Rheumatic Disease, Osaka University Graduate School of Medicine , Osaka , Japan. 10. j Department of Rheumatology , NHO Sagamihara National Hospital , Sagamihara, Kanagawa , Japan.
Abstract
OBJECTIVES: To examine whether or not earlier therapeutic intervention with methotrexate (MTX) prevents the development of rheumatoid arthritis (RA) in patients with recent-onset undifferentiated arthritis (UA) showing high anti-citrullinated peptide antibody (ACPA) titers. METHODS: The patients were divided into two groups, one was treated with MTX (MTX+ group, n = 29), and the other was treated without MTX (MTX- group, n = 19), and other disease-modifying anti-rheumatic drugs were not permitted in the two groups before the primary endpoint was met. The primary endpoint is the occurrence of definite RA, and it was compared in the two groups after 1 year. RESULTS: The percentage of patients who developed definite RA in the MTX+ group (17.2%) was significantly lower than that in the MTX- group (78.9%) (log-rank test, P < 0.001, n = 48); adjusted hazards ratio: 0.028 [95% confidence interval (CI): 0.003-0.250, P = 0.001, n = 39]. Treatment effectiveness was not decreased by major risk factors of RA onset such as smoking habits and human leukocyte antigen-DRB1 shared epitope (SE) (smoking habit, odds ratio [OR]: 0.041 [95% CI: 0.007-0.246] P < 0.001; SE, OR: 0.022 [95% CI: 0.002-0.204] P < 0.001). The safety issues were comparable between the two groups. CONCLUSIONS: This suggests that early therapeutic intervention with MTX could safely prevent the development of RA in patients with recent-onset UA showing high ACPA titers.
OBJECTIVES: To examine whether or not earlier therapeutic intervention with methotrexate (MTX) prevents the development of rheumatoid arthritis (RA) in patients with recent-onset undifferentiated arthritis (UA) showing high anti-citrullinated peptide antibody (ACPA) titers. METHODS: The patients were divided into two groups, one was treated with MTX (MTX+ group, n = 29), and the other was treated without MTX (MTX- group, n = 19), and other disease-modifying anti-rheumatic drugs were not permitted in the two groups before the primary endpoint was met. The primary endpoint is the occurrence of definite RA, and it was compared in the two groups after 1 year. RESULTS: The percentage of patients who developed definite RA in the MTX+ group (17.2%) was significantly lower than that in the MTX- group (78.9%) (log-rank test, P < 0.001, n = 48); adjusted hazards ratio: 0.028 [95% confidence interval (CI): 0.003-0.250, P = 0.001, n = 39]. Treatment effectiveness was not decreased by major risk factors of RA onset such as smoking habits and human leukocyte antigen-DRB1 shared epitope (SE) (smoking habit, odds ratio [OR]: 0.041 [95% CI: 0.007-0.246] P < 0.001; SE, OR: 0.022 [95% CI: 0.002-0.204] P < 0.001). The safety issues were comparable between the two groups. CONCLUSIONS: This suggests that early therapeutic intervention with MTX could safely prevent the development of RA in patients with recent-onset UA showing high ACPA titers.