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.

Hisashi Yamanaka; Shouhei Nagaoka; Soo-Kon Lee; Sang-Cheol Bae; Tsuyoshi Kasama; Hitomi Kobayashi; Yuichi Nishioka; Yukitaka Ueki; Yohei Seto; Makoto Nishinarita; Naoto Tamura; Noriko Kimura; Kazuyoshi Saito; Tetsuya Tomita; Yasushi Nawata; Sadahiro Suzuki; Yoshiaki Ishigatsubo; Yasuhiko Munakata; Yuichi Makino; Eisuke Inoue

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 duration55 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 DAS2852.6 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.

JAPAN; ETANERCEPT; RHEUMATOID arthritis; DISEASE remission; CLINICAL trials

Modern Rheumatology, 2016, Vol 26, Issue 5, p651

1439-7595

Academic Journal

10.3109/14397595.2015.1123349