Hisashi Yamanaka1, Shouhei Nagaoka2, Soo-Kon Lee3, Sang-Cheol Bae4, Tsuyoshi Kasama5, Hitomi Kobayashi6, Yuichi Nishioka7, Yukitaka Ueki8, Yohei Seto1, Makoto Nishinarita9, Naoto Tamura10, Noriko Kimura11, Kazuyoshi Saito12, Tetsuya Tomita13, Yasushi Nawata14, Sadahiro Suzuki15, Yoshiaki Ishigatsubo16, Yasuhiko Munakata17, Yuichi Makino18, Eisuke Inoue19, Yoshiya Tanaka12, Tsutomu Takeuchi11. 1. a Institute of Rheumatology, Tokyo Women's Medical University , Japan . 2. b Internal Department of Rheumatology , Yokohama Minami Kyosai Hospital , Japan . 3. c Department of Rheumatology , Yonsei University College of Medicine , Korea . 4. d Hanyang University Hospital for Rheumatic Diseases , Korea . 5. e Department of Rheumatology , Showa University Hospital , Japan . 6. f Department of Internal Medicine , Itabashi Chuo Medical Center , Japan . 7. g Department of Rheumatism , Nishioka Clinic for Rheumatic Diseases and Allergic Diseases , Japan . 8. h Rheumatic Diseases Center , Sasebo Chuo Hospital , Japan . 9. i Department of Internal Medicine and Rheumatology , Nishinarita Clinic , Japan . 10. j Department of Internal Medicine and Rheumatology , Juntendo University Faculty of Medicine , Japan . 11. k Division of Rheumatology , Department of Internal Medicine Keio University School of Medicine , Japan . 12. l The 1st Department of Internal Medicine , School of Medicine University of Occupational & Environmental Health , Japan . 13. m Department of Orthopedic Surgery , Osaka University Hospital , Japan . 14. n Center for Rheumatic Diseases , Chibaken Saiseikai Narashino Hospital , Japan . 15. o Department of Connecting Tissue Disease , Shinonoi General Hospital , Japan . 16. p Rheumatology, Hematology, Infectious Diseases , Yokohama City University Hospital , Japan . 17. q Internal Medicine, Rheumatology , Taihakusakura Hospital , Japan . 18. r The 2nd Department of Internal Medicine , Asahikawa Medical University Hospital , Japan , and. 19. s Division of Biostatistics , National Center for Child Health and Development , Japan.
Abstract
OBJECTIVES: To investigate the efficacy and safety of etanercept (ETN) in patients with rheumatoid arthritis (RA) with moderate disease activity and the possibility to discontinue ETN after achieving remission. METHODS: Multicenter, randomized, and open-label study was conducted in Japan and Korea. RA patients (disease duration <5 years) with moderate disease activity despitemethotrexate (MTX) treatment were allocated to either MTX or ETN + MTX (Period 1) for 12 months. Patients who achieved sustained remission defined as DAS28 < 2.6 at both 6 and 12 months in the ETN + MTX group, were randomized to either continue or discontinue ETN for 12 months (Period 2). RESULTS: A total of 222 patients were enrolled in Period 1 and clinical remission was achieved in 106/157 (67.5%) and 5/28 (17.9%) patients in the ETN + MTX and MTX groups, respectively. In Period 2, sixty-seven patients were randomized and finally 28/32 (87.5%) and 15/28 (53.6%) patients who continued or discontinued ETN maintained clinical remission. Baseline disease activity and the presence of comorbid diseases influenced the maintenance of remission after ETN discontinuation. CONCLUSIONS:ETN + MTX was efficient for RA patients with moderate disease activity into remission. After achieving sustained remission, a half of the patients who discontinued ETN could maintain remission for 1 year.
RCT Entities:
OBJECTIVES: To investigate the efficacy and safety of etanercept (ETN) in patients with rheumatoid arthritis (RA) with moderate disease activity and the possibility to discontinue ETN after achieving remission. METHODS: Multicenter, randomized, and open-label study was conducted in Japan and Korea. RApatients (disease duration <5 years) with moderate disease activity despite methotrexate (MTX) treatment were allocated to either MTX or ETN + MTX (Period 1) for 12 months. Patients who achieved sustained remission defined as DAS28 < 2.6 at both 6 and 12 months in the ETN + MTX group, were randomized to either continue or discontinue ETN for 12 months (Period 2). RESULTS: A total of 222 patients were enrolled in Period 1 and clinical remission was achieved in 106/157 (67.5%) and 5/28 (17.9%) patients in the ETN + MTX and MTX groups, respectively. In Period 2, sixty-seven patients were randomized and finally 28/32 (87.5%) and 15/28 (53.6%) patients who continued or discontinued ETN maintained clinical remission. Baseline disease activity and the presence of comorbid diseases influenced the maintenance of remission after ETN discontinuation. CONCLUSIONS: ETN + MTX was efficient for RApatients with moderate disease activity into remission. After achieving sustained remission, a half of the patients who discontinued ETN could maintain remission for 1 year.
Authors: Lise M Verhoef; Bart Jf van den Bemt; Aatke van der Maas; Johanna E Vriezekolk; Marlies E Hulscher; Frank Hj van den Hoogen; Wilco Ch Jacobs; Noortje van Herwaarden; Alfons A den Broeder Journal: Cochrane Database Syst Rev Date: 2019-05-24
Authors: Ernest Choy; Nick Freemantle; Clare Proudfoot; Chieh-I Chen; Laurence Pollissard; Andreas Kuznik; Hubert Van Hoogstraten; Erin Mangan; Paulo Carita; Thi-Minh-Thao Huynh Journal: RMD Open Date: 2019-02-18
Authors: Fowzia Ibrahim; Beatriz Lorente-Cánovas; Caroline J Doré; Ailsa Bosworth; Margaret H Ma; James B Galloway; Andrew P Cope; Ira Pande; David Walker; David L Scott Journal: Rheumatology (Oxford) Date: 2017-11-01 Impact factor: 7.580