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

doi:10.3109/14397595.2015.1123349

Randomized Controlled Trial

. 2016 Sep;26(5):651-61.

doi: 10.3109/14397595.2015.1123349. Epub 2015 Dec 23.

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 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; ENCOURAGE study group

Affiliations

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.

PMID: 26698929
DOI: 10.3109/14397595.2015.1123349

Randomized Controlled Trial

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 et al. Mod Rheumatol. 2016 Sep.

. 2016 Sep;26(5):651-61.

doi: 10.3109/14397595.2015.1123349. Epub 2015 Dec 23.

Authors

Affiliations

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.

PMID: 26698929
DOI: 10.3109/14397595.2015.1123349

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.

Keywords: Clinical trial; Discontinuation; Etanercept; Remission; Rheumatoid arthritis.

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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

Affiliations

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

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Abstract

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