Discontinuation of etanercept after achievement of sustained remission in patients with rheumatoid arthritis who initially had moderate disease activity-results from the ENCOURAGE study, a prospective, international, multicenter randomized study
- Authors
- Yamanaka, Hisashi; Nagaoka, Shouhei; Lee, Soo-Kon; Bae, Sang-Cheol; Kasama, Tsuyoshi; Kobayashi, Hitomi; Nishioka, Yuichi; Ueki, Yukitaka; Seto, Yohei; Nishinarita, Makoto; Tamura, Naoto; Kimura, Noriko; Saito, Kazuyoshi; Tomita, Tetsuya; Nawata, Yasushi; Suzuki, Sadahiro; Ishigatsubo, Yoshiaki; Munakata, Yasuhiko; Makino, Yuichi; Inoue, Eisuke; Tanaka, Yoshiya; Takeuchi, Tsutomu
- Issue Date
- Sep-2016
- Publisher
- TAYLOR & FRANCIS LTD
- Keywords
- Clinical trial; Discontinuation; Etanercept; Remission; Rheumatoid arthritis
- Citation
- MODERN RHEUMATOLOGY, v.26, no.5, pp.651 - 661
- Indexed
- SCIE
SCOPUS
- Journal Title
- MODERN RHEUMATOLOGY
- Volume
- 26
- Number
- 5
- Start Page
- 651
- End Page
- 661
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/4958
- DOI
- 10.3109/14397595.2015.1123349
- ISSN
- 1439-7595
- 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 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 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.
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