Background: Rheumatoid arthritis (RA) presents a substantial socioeconomic burden that is potentially reduced by individualized, appropriate management strategies. Integral to such strategies is recognizing the need for treatment changes when patients inadequately respond or do not respond to treatment. However, there might be little or no agreement as to what constitutes treatment failure or an adequate response. Currently used American College of Rheumatology response criteria and the disease activity score may underestimate the magnitude of treatment failure when applied in clinical practice, and, having been designed to differentiate responses between large groups, they may be of limited value in monitoring individual patients.
Objective: The aim of this commentary was to assess how treatment failure and clinical remission/response have been defined in clinical studies.
Methods: A PubMed search (1948-2009) was conducted to identify clinical studies or reviews containing the following search terms: rheumatoid arthritis and treatment failure, inadequate response, biologic therapy, DMARD, radiographic response, and remission. Select clinical reports in patients with RA were included if remission or treatment failure, radiographic or other, was a study end point.
Results: Thirty-three studies were identified. The present assessment found no consensus as to what represents a practical definition of treatment failure or clinical remission in the clinical studies assessed. The definitions varied from the complete absence of any clinical disease to computer-generated numeric scales. The variability in clinical definitions of treatment failure or remission seems to have been mainly attributed to the time at which assessments were made, making it difficult to determine what treatment failure or remission means in individual patients with RA in clinical practice.
Conclusions: Based on the findings of the present commentary, standard definitions of treatment failure or clinical remission/response are needed. Aggressive treatment strategies with specific clinical goals may result in better long-term outcomes. Early evidence of treatment effect may serve to improve clinical outcomes, including remission, and help define and align treatment goals in patients with RA.