• Rheumatoid Arthritis
• Rheumatology Clinical Trials

• Rheumatology
• Rheumatoid Arthritis
• Rheumatology Clinical Trials

As additional treatments have been approved for rheumatoid arthritis (RA), researchers have used clinical trial data to analyze the cost effectiveness of these new drugs. Since 1998, more than 30 cost-effectiveness analyses (CEAs) have been conducted, with highly variable results. Kaleb Michaud, PhD, National Data Bank for Rheumatic Diseases and the University of Nebraska Medical Center, Omaha, Nebraska, USA, presented the CEA results of patient-level data from the Treatment of Early Aggressive Rheumatoid Arthritis trial [TEAR; NCT00259610], a large, randomized, double-blind clinical study.

The objective of the TEAR trial was to determine the best strategy for treating patients with early RA [Moreland LW et al. Arthritis Rheum 2012]. Eligible patients were adults who had RA for <3 years, limited exposure to disease-modifying antirheumatic drugs, seropositivity or erosions, and at least 4 swollen and 4 tender joints on the 28-joint count. At baseline, patients were randomized to 1 of 4 treatments:

1. immediate treatment with methotrexate (MTX) plus etanercept (IE)

2. immediate triple therapy (IT) consisting of MTX plus sulfasalazine plus hydroxychloroquine

3. MTX monotherapy with a step-up to MTX plus etanercept (SE)

4. MTX monotherapy with a step-up to triple therapy (ST) Step-up occurred at Week 24 in patients with active disease, defined as Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) ≥3.2. Patients were followed for up to 2 years. The primary outcome measure was the mean DAS28-ESR score from Weeks 48 to 102.

A total of 755 patients were randomized in the trial. At baseline, participants had a mean duration of RA of 3.6 months (range, 0 to 41.4), a mean (standard deviation [SD]) DAS28 of 5.8 (1.1), and an average of 14.3 (6.8) painful joints with 12.8 (6.0) swollen joints. At the Week 24 time point, both immediate treatment groups had significant decreases in DAS28 compared with the SE and ST groups (p<0.0001). However, in the primary analysis of results from Weeks 48 to 102 the four treatment arms had comparable improvement (p=0.55) [Moreland LW et al. Arthritis Rheum 2012].

A Markov simulation model with a societal perspective was utilized to estimate the costs and quality-adjusted life years (QALYs). The following inputs were used in the model: discontinuation rate for triple therapy [0.22, (range, 0.11 to 0.46)] and etanercept [0.10 (range, 0.07 to 0.15)], annual cost of triple therapy [$791 (range, $500 to $1200)] and etanercept [$24,446 (range, $12,000 to $26,000)], mean income [$45,552 (range, $30,000 to $60,000)], discounting of 3% (0% to 5%), and quality-of-life mapping using the EQ-5D. At both 1 and 2 years the IT group had the lowest cost and greatest effectiveness. When the model was extended to lifetime, both the IT and IE treatment groups were cost effective, with an incremental cost effectiveness ratio (ICER) of ∼$840,000/QALY.

A sensitivity analysis indicated that the results were the most sensitive to etanercept cost and decreases in the discontinuation rates of triple therapy, but these findings did not change the overall conclusions. “The benefits from all strategies were comparable, but biologics strategies were almost twice as expensive as triple strategies, producing ICERs greater than what most healthcare settings find acceptable,” concluded Dr. Michaud.

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