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SAT0543 Reduced/Withdrawn Dose of Etanercept-Methotrexate Therapy of Early Rheumatoid Arthritis has a Favorable Impact on Patient-Reported Outcomes Compared with MTX Alone or Placebo: the Prize Study
  1. P. Emery1,
  2. P. Wiland2,
  3. J. Dudler3,
  4. R. M. Ionescu4,
  5. B. Vlahos5,
  6. J. Bukowski5,
  7. R. Pedersen5,
  8. T. Williams5,
  9. S. Gaylord5,
  10. S. Kotak5
  1. 1Department of Rheumatology, Leeds General Infirmary, Leeds, United Kingdom
  2. 2Department of Rheumatology and Internal Diseases, Wroclaw Medical University, Wroclaw, Poland
  3. 3Department of Rheumatology, University Hospital of Lausanne, Lausanne, Switzerland
  4. 4Department of Rheumatology, St Mary’s Hospital, Bucharest, Romania
  5. 5Department of Specialty Care, Pfizer Inc, Collegeville, PA, United States

Abstract

Background Open-label etanercept (ETN) + methotrexate (MTX) therapy in early rheumatoid arthritis (RA) yielded high clinical remission and improvements in patient-reported outcomes (PROs) in PRIZE Phase 1 (moderate-severe RA ≤1yr; MTX and biologic naïve pts).1 PRIZE (121-wks, 3-phases) evaluates ETN/MTX efficacy/efficacy maintenance and PROs with reduced/withdrawn therapy in Phase 2.

Objectives To assess PROs in PRIZE Phase 2, a 39-wk, 3-arm, double-blind comparison of therapy reduction after a 52 wk induction of 50 mg QW ETN/MTX (Phase 1).

Methods Pts achieving DAS28 remission (≤3.2 at wk 39, <2.6 at wk 52) in Phase 1 (n=193) were randomized 1:1:1 for 25 mg ETN + MTX: MTX+PBO injection: PBO capsules + PBO injection. PROs assessed included the Health Assessment Questionnaire disability index (HAQ-DI); EuroQol-5 Dimensions utility score (EQ-5D); Short Form Health Survey P/MCS Physical/Mental Component Summary; Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue); Work Productivity and Activity Impairment Questionnaire (WPAI:RA) and Work Instability Scale for Rheumatoid Arthritis (RA-WIS).

Results With dose reductions/withdrawals in Phase 2, the maintenance of effect in PROs was greater at LOCF in the ETN25 + MTX treatment group compared with the PBO group for: HAQ-DI, EQ-5D utility, EQ-5D VAS, SF-36 MCS/PCS, FACIT, and WPAI sub-scales. Additionally, at Phase 2 LOCF clinically meaningful improvements, relative to start of trial, in HAQ-DI (≥0.22); EQ-5D utility (≥0.05) and VAS >82; SF-36 P/MCS (>5) and statistically significantly greater proportions of pts with low and low/medium risk RA-WIS score (≤9 and ≤17) were observed in favor of ETN + MTX vs PBO; the relative benefits of MTX vs PBO were less.

Conclusions ETN25 + MTX had a favorable impact on PROs compared to PBO, with greater maintenance of therapeutic effect from baseline to LOCF.

References Emery P, et al. American College of Rheumatology/ARHP Annual Scientific Meeting - 2012;64(10):S1077; Abstract 2549.

Acknowledgements The PRIZE study was funded by Pfizer Inc.

Disclosure of Interest P. Emery Consultant for: Abbott, Bristol-Myers Squibb, Merck, Novartis, Pfizer Inc, Roche-Chugai, UCB Pharma Ltd, P. Wiland: None Declared, J. Dudler Consultant for: Swiss Pfizer Advisory Board, R. Ionescu: None Declared, B. Vlahos Employee of: Pfizer Inc, J. Bukowski Employee of: Pfizer Inc, R. Pedersen Employee of: Pfizer Inc, T. Williams Employee of: Pfizer Inc, S. Gaylord Employee of: Pfizer Inc, S. Kotak Employee of: Pfizer Inc

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