PAR10 IMPROVING THE SENSITIVITY OF PHYSICAL FUNCTION MEASURES IN RHEUMATOID ARTHRITIS: USE OF ITEM RESPONSE THEORY IN PATIENTS TREATED WITH ABATACEPT (CTLA4IG)

Abstract

PAR10 IMPROVING THE SENSITIVITY OF PHYSICAL FUNCTION MEASURES IN RHEUMATOID ARTHRITIS: USE OF ITEM RESPONSE THEORY IN PATIENTS TREATED WITH ABATACEPT (CTLA4IG) Martin M, Emery P, Kosinski M,Ware J, Li T,Williams R, Maclean R, Bjorner J Quality Metric, Inc, Lincoln, RI, USA; University of Leeds, Leeds, United Kingdom; Bristol-Myers Squibb, Princeton, NJ, USA; Bristol-Myers Squibb, Brussels, Belgium OBJECTIVES: The Health Assessment Questionnaire (HAQ) and the Modified HAQ (MHAQ) are examples of common short-forms of physical function used to measure improvement in the treatment of rheumatoid arthritis (RA) which have been associated with ceiling problems. These problems, inherent to short-form surveys, pose risks of failing to detect a treatment response in clinical trials. Item Response Theory (IRT) methods were used to examine the properties of two physical function measures and construct a combined measure to better detect changes in disease activity and treatment response. METHODS: Data were from a 12-month, double-blind, multi-center study of 339 RA patients on a background of methotrexate randomized to Abatacept at 2mg/kg, at 10mg/kg, or placebo. MHAQ and SF-36 (with its Physical Functioning scale, PF10) were administered at pretreatment and 3, 6, and 12 months post-treatment. IRT methods were used to examine the surveys’ measurement properties and compute new IRT-based physical function scores. Analyses of variance were used to assess sensitivity to changes in disease severity and treatment response. Relative validity coefficients were used to compare the measures. RESULTS: A Rasch IRT model fit the data. IRT-based scores successfully lowered the floor and raised the ceiling of the physical function measured. IRT-based scores were 30% more efficient than MHAQ and 50% more efficient than PF10 in discriminating among ACR groups. In discriminating among treatment groups, IRT-based scores were 25% more efficient than MHAQ and 12% more efficient than PF10 at 6-months; and 16% and 17% more efficient at 12-months based on observed effect sizes. CONCLUSIONS: Using IRT methodology to estimate a combined score for physical functioning lead to greater range of the construct measured. The improved measure, with greater measurement precision and sensitivity to treatment response, further confirmed the beneficial effect of Abatacept on physical function in the treatment of RA.