Background It is unclear which patients with rheumatoid arthritis (RA) may benefit from treatment discontinuation or dose reduction without diminished therapeutic effect. Previously, deep remission (DAS28-ESR ≤1.98) has been demonstrated as a good indicator of sustained remission upon anti-TNF treatment withdrawal.1
Objectives Investigate baseline characteristics and treatment outcomes of patients with RA who achieve deep remission with etanercept (ETN).
Methods Randomised patients with moderate/severe RA who participated in 3 ETN clinical trials2–4 were included in this post-hoc analysis. Patients who achieved deep remission (DAS28-ESR≤1.98), remission (1.98<DAS28-ESR<2.6), or low disease activity (LDA; 2.6≤DAS28-ESR<3.2) during the full-dose ETN open-label (OL) period of each study were randomised into ETN tapering or withdrawal arms. Treatment outcomes (maintenance of response or non-failure) were assessed per the studies' primary endpoints (Table). Last observation carried forward (LOCF) analyses were conducted.
Results 1117 patients were included across clinical trials (n=594 PRESERVE, n=192 PRIZE, n=331 EM T2T). In PRESERVE, patients who achieved deep remission at week 36 were significantly younger at baseline (P<0.001), had lower baseline ESR (P<0.01), and lower baseline mean DAS28 (P<0.01) than those who achieved DAS28 remission or LDA. In PRIZE, demographics and disease characteristics were not significantly different across response categories at week 52. In EM T2T, the week 24 deep remission category had significantly younger patients (P<0.05), more males (P<0.05), and patients had lower mean baseline DAS28-ESR, DAS28-CRP, CDAI, SDAI, CRP, ESR, HAQ, PGA, SGA, and General Health scores (all P<0.01). Generally, patients who achieved deep remission during the OL-period were more likely to sustain their clinical response following ETN dose-tapering than those who achieved remission or LDA, across clinical trials (Table).
Conclusions Sustained clinical response is more likely in patients who achieved deep remission prior to ETN withdrawal.
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Disclosure of Interest Y. Tanaka Grant/research support from: Mitsubishi-Tanabe, Takeda, Chugai, Astellas, Eisai, Taisho-Toyama, Kyowa-Kirin, Abbvie, Bristol-Myers, Speakers bureau: Abbvie, Daiichi-Sankyo, Chugai, Takeda, Mitsubishi-Tanabe, Bristol-Myers, Astellas, Eisai, Janssen, Pfizer, Asahi-kasei, Eli Lilly, GlaxoSmithKline, UCB, Teijin, MSD, Santen, J. Smolen Grant/research support from: Abbvie, Janssen, Lilly, MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Celtrion, Glaxo, ILTOO, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Speakers bureau: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Celtrion, Glaxo, ILTOO, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, H. Jones Shareholder of: Pfizer, Employee of: Pfizer, A. Szumski Employee of: inVentiv Health, L. Marshall Shareholder of: Pfizer, Employee of: Pfizer, P. Emery Consultant for: Pfizer, MSD, Abbvie, BMS, UCB, Roche, Novartis, Samsung, Sandoz and Lilly