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 InoueYoshiya Tanaka, Tsutomu Takeuchi

Research output: Contribution to journalArticle

11 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)651-661
Number of pages11
JournalModern rheumatology
Volume26
Issue number5
DOIs
Publication statusPublished - 2016 Sep 2

Keywords

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

ASJC Scopus subject areas

  • Rheumatology

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    Yamanaka, H., Nagaoka, S., Lee, S. K., Bae, S. C., Kasama, T., Kobayashi, H., Nishioka, Y., Ueki, Y., Seto, Y., Nishinarita, M., Tamura, N., Kimura, N., Saito, K., Tomita, T., Nawata, Y., Suzuki, S., Ishigatsubo, Y., Munakata, Y., Makino, Y., ... Takeuchi, T. (2016). 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. Modern rheumatology, 26(5), 651-661. https://doi.org/10.3109/14397595.2015.1123349