Abstract

BackgroundThe overall benefit of intensive treatment strategies in rheumatoid arthritis (RA) remains uncertain. We explored how reductions in disability and improvements in quality of life scores are affected by alternative assessments of reductions in disease activity scores for 28 joints (DAS28) in two trials of intensive treatment strategies in active RA.MethodsOne trial (CARDERA) studied 467 patients with early active RA receiving 24 months of methotrexate monotherapy or steroid and disease-modifying anti-rheumatic drug (DMARD) combinations. The other trial (TACIT) studied 205 patients with established active RA; they received 12 months of treatment with DMARD combinations or biologic agents. We compared changes in the health assessment questionnaire (HAQ) and Euroqol-5D (EQ5D) at trial endpoints in European League Against Rheumatism (EULAR) good and moderate EULAR responders in patients in whom complete endpoint data were available.ResultsIn the CARDERA trial 98 patients (26 %) were good EULAR responders and 160 (32 %) were EULAR moderate responders; comparable data in TACIT were 66 (35 %) and 86 (46 %) patients. The magnitude of change in the HAQ and EQ5D was greater in both trials in EULAR good responders than in EULAR moderate responders. HAQ scores had a difference in of –0.49 (95 % CI –0.66, –0.32) in the CARDERA and –0.31 (95 % CI –0.47, –0.13) in the TACIT trial. With the EQ5D comparable differences were 0.12 (95 % CI 0.04, 0.19) and 0.15 (95 % CI 0.05, 0.25). Both exceeded minimum clinically important differences in HAQ and EQ5D scores.ConclusionsWe conclude that achieving a good EULAR response with DMARDs and biologic agents in active RA results in substantially improved mean HAQ and EQ5D scores. Patients who achieve such responses should continue on treatment. However, continuing such treatment strategies is more challenging when only a moderate EULAR response is achieved. In these patients evidence of additional clinically important benefits in measures such as the HAQ should also be sought.

Highlights

  • The overall benefit of intensive treatment strategies in rheumatoid arthritis (RA) remains uncertain

  • Patients studied In the CARDERA trial 121 patients (32 %) were European League Against Rheumatism (EULAR) non-responders, 160 (42 %) moderate responders and 98 (26 %) good responders

  • The trial designs differed, with all patients in TACIT but not CARDERA receiving intensive therapy; differences in response rates were expected. In both trials demographic characteristics, clinical variables like disease activity scores for 28 joints (DAS28) scores and components of the DAS28, health assessment questionnaire (HAQ) and EQ5D scores were similar across groups

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Summary

Introduction

The overall benefit of intensive treatment strategies in rheumatoid arthritis (RA) remains uncertain. We explored how reductions in disability and improvements in quality of life scores are affected by alternative assessments of reductions in disease activity scores for 28 joints (DAS28) in two trials of intensive treatment strategies in active RA. A key goal in treating rheumatoid arthritis (RA) with conventional disease-modifying anti-rheumatic drugs (DMARDs) and biologic agents is reducing inflammatory synovitis, which reduces disability and maximises quality of life. Reductions in synovitis with treatment are assessed using the disease activity score for 28 joints (DAS28) [1]. The European League Against Rheumatism (EULAR) classifies good responders as having DAS28 scores of 3.2 or less with reductions in DAS28 of more than 1.2 [2]. The treat-to-target initiative recommends increasing treatment until patients achieve remission or low disease activity [3]

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