In patient-reported outcomes for those with recently diagnosed rheumatoid arthritis (RA), treatment with etanercept 25 mg (ETN25) plus methotrexate (MTX) was superior to MTX plus placebo or placebo alone in maintenance of remission and therapeutic effect. Paul Emery, MD, University of Leeds, Leeds, United Kingdom, presented a poster of the results of A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate [PRIZE; EUCTR2008-00263-85-IT; Emery P et al. EULAR 2013 (poster 0543)].

The open-label, double-blind, 39-week Phase 2 study evaluated patients who had achieved remission by Week 52 in Phase 1 (28-joint disease activity score [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52), during which moderate to severe RA patients diagnosed within ≤1 year without previous MTX or biologic treatment were treated with ETN 50 mg plus MTX. Phase 2 patients were randomized 1:1:1 to ETN25 plus MTX (n=63), MTX plus placebo injection (n=65), or placebo capsules plus placebo injection at Week 52 (n=65). Patient-reportd outcomes in RA have shown significant improvement through treatment with biologic drugs [Bala S-V et al. Musculoskeletal Care 2010].

The patients entering Phase 2 were a mean 49.4 years and 64.8% were women. The mean disease duration was 6.8 months and the mean diagnosis duration was 2.3 months. Almost 41% had taken corticosteroids, 17.1% had taken disease-modifying antirheumatic drugs, and 66.3% had taken nonsteroidal anti-inflammatory drugs.

Of 193 patients entering Phase 2, 144 completed the trial, including 132 responders (ETN25+MTX=56; MTX=50; placebo=38), and 12 nonresponders (ETN25+MTX=3; MTX=4; placebo=35). For the noncompleters, three adverse events occurred in the ETN/MTX group and one occurred in the placebo group. Of the 28 noncompleters in the unsatisfactory response category, 17 were in the placebo group, 11 were in the MTX group, but none was in the ETN/MTX group. No significant radiographic disease progression was reported in any treatment group.

ETN/MTX patients reported significantly greater benefits in maintenance of health, quality of life (QoL), levels of fatigue, and activity impairment compared with placebo patients (p<0.0001), and maintenance of effect was significantly greater at the last observation carried forward for ETN/MTX patients compared with placebo patients. The ETN/MTX group also reported significantly greater low risk of work instability than the placebo group (p=0.0011).

Phase 2 patients reported several clinically meaningful improvements, including scoring 0 to 3 (clinically meaningful Δ ≥0.22) on the Health Assessment Questionnaire-Disability Index (HAQ-DI), scoring 0 to 52 (clinically meaningful Δ ≥3.0) on the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) test, and scoring 0 to 1 (clinically meaningful Δ ≥0.05) for QoL on the EuroQoL-5 Dimensions (EQ-5D) utility score.

PRIZE Phase 2 patients report clinically relevant improvements in quality of life based on EQ-5D utility scores.

Of the responders, 131 entered Phase 3, during which the ETN/MTX dose was tapered for 2 to 4 weeks and the patients are to be observed for the remainder of the 121-week PRIZE trial.

PRIZE Phase 2 patients reported clinically relevant health improvements based on HAQ-DI scores.