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

作者：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

来源：Modern Rheumatology, 2016, 26(5): 651-661.

DOI：10.3109/14397595.2015.1123349

• Clinical trial
• Discontinuation
• Etanercept
• Remission
• Rheumatoid arthritis

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.

• 出版日期2016