No coin nor oath required. For personal study only.
Background/Purpose: Subjects with moderately active rheumatoid arthritis (RA) have been shown to achieve and maintain low disease activity (LDA) and remission with anti-TNF therapy more successfully than subjects with high disease activity. 1 Due to reimbursement and safety concerns, there has been growing interest in strategies involving treatment dose reduction or discontinuation once subjects achieve adequate response. The PRESERVE trial compared the efficacy and safety of continuing etanercept (ETN) 50 mg QW ฯฉ methotrexate (MTX) (E50/M), reducing ETN from 50 mg to 25 mg QW ฯฉ MTX (E25/M), and withdrawing ETN and giving placebo QW ฯฉ MTX (P/M) over 52 weeks after sustained LDA had been induced during 9 months of E50/M treatment.
Methods: Subjects with moderately active RA (3.2ฯฝDAS28ี 5.1) who achieved DAS28 LDA (DAS28 ี 3.2, avg wk 12-36 ฯฉ at wk 36) or remission (DAS28 ฯฝ2.6) on E50/M at wk 36 of Period 1 entered the double-blind Period 2. 604 subjects were randomized based on DAS28 LDA/remission to E50/M (nฯญ202), E25/M (nฯญ202), or P/M (nฯญ200) for 52 wks. MTX was maintained at same dose throughout (15-25 mg). All statistical analyses were stratified by geographic region and DAS28 strata at randomization. Proportions were tested with chi-square tests; continuous endpoints with ANCOVA using Period 2 baseline DAS28 value as covariate; radiographic endpoints with rank-transformed ANCOVA.
Results: 497 subjects completed Period 2. The % of subjects maintaining DAS28 LDA at wk 88 was significantly higher in the E50/M (82.6%) and E25/M (79.1%) groups than P/M group (42.6%; Pฯฝ0.0001 vs either ETN group). Significantly more subjects had a DAS28 score ฯฝ2.6 at wk 88 on E50/M (66.7%) and E25/M (60.2%) than on P/M (29.4%; Pฯฝ0.0001 vs either ETN group). Significantly more subjects on E50/M and E25/M achieved SDAI LDA and remission, ACR 20/50/70 responses, and a normal HAQ score (ี 0.5) than on P/M (Table ). The mTSS (units/y) change from baseline was significantly different between the E50/M (ฯช0.06) and P/M (0.60; Pฯญ0.0259) groups, but not between the E25/M (0.05) and P/M (0.60; Pฯญ0.0696) groups, or the E50/M and E25/M (Pฯญ0.6737) groups. No significant differences in safety were observed. 35 subjects (5.8%) reported serious adverse events, including 2 deaths (0.3%) in the E50/M group due to pulmonary embolism and septicemia during Period 2.
Sarilumab for the Treatment of Moderate-to-Severe Rheumatoid Arthritis: Results of a Phase 2, Randomized, Double-Blind, Placebo-Controlled, International Study.
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