Abstract

ObjectiveTo evaluate the responsiveness in terms of correlation of the Hospital Universitario La Princesa Index (HUPI) comparatively to the traditional composite indices used to assess disease activity in rheumatoid arthritis (RA), and to compare the performance of HUPI-based response criteria with that of the EULAR response criteria.MethodsSecondary data analysis from the following studies: ACT-RAY (clinical trial), PROAR (early RA cohort) and EMECAR (pre-biologic era long term RA cohort). Responsiveness was evaluated by: 1) comparing change from baseline (Δ) of HUPI with Δ in other scores by calculating correlation coefficients; 2) calculating standardised effect sizes. The accuracy of response by HUPI and by EULAR criteria was analyzed using linear regressions in which the dependent variable was change in global assessment by physician (ΔGDA-Phy).ResultsΔHUPI correlation with change in all other indices ranged from 0.387 to 0.791); HUPI’s standardized effect size was larger than those from the other indices in each database used. In ACT-RAY, depending on visit, between 65 and 80% of patients were equally classified by HUPI and EULAR response criteria. However, HUPI criteria were slightly more stringent, with higher percentage of patients classified as non-responder, especially at early visits. HUPI response criteria showed a slightly higher accuracy than EULAR response criteria when using ΔGDA-Phy as gold standard.ConclusionHUPI shows good responsiveness in terms of correlation in each studied scenario (clinical trial, early RA cohort, and established RA cohort). Response criteria by HUPI seem more stringent than EULAR’s.

Highlights

  • Objective evaluation of disease activity in rheumatoid arthritis (RA) has become a keystone of disease management

  • In ACT-RAY, depending on visit, between 65 and 80% of patients were classified by Hospital Universitario La Princesa Index (HUPI) and EULAR response criteria

  • HUPI criteria were slightly more stringent, with higher percentage of patients classified as non-responder, especially at early visits

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Summary

Introduction

Objective evaluation of disease activity in rheumatoid arthritis (RA) has become a keystone of disease management. During the last 10 years, a fair amount of evidence suggested that both, DAS28 and SDAI, present a gender bias, derived from differences between men and women in terms of pain perception and levels of erythrocyte sedimentation rate (ESR)[6,7,8,9,10]. Using these indices, the implementation of T2T strategy would be biased, leading to over-treatment in women, or under-treatment of men. Assessment of response to treatment in clinical trials might be biased [11]

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