American college of rheumatology preliminary definition of improvement in rheumatoid arthritis

Abstract

Objective. Trials of rheumatoid arthritis (RA) treatments report the average response in multiple outcome measures for treated patients. It is more clinically relevant to test whether individual patients improve with treatment, and this identifies a single primary efficacy measure. Multiple definitions of improvement are currently in use in different trials. The goal of this study was to promulgate a single definition for use in RA trials. Methods. Using the American College of Rheumatology (ACR) core set of outcome measures for RA trials, we tested 40 different definitions of improvement, using a 3‐step process. First, we performed a survey of rheumatologists, using actual patient cases from trials, to evaluate which definitions corresponded best to rheumatologists' impressions of improvement, eliminating most candidate definitions of improvement. Second, we tested 20 remaining definitions to determine which maximally discriminated effective treatment from placebo treatment and also minimized placebo response rates. With 8 candidate definitions of improvement remaining, we tested to see which were easiest to use and were best in accord with rheumatologists' impressions of improvement. Results. The following definition of improvement was selected: 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acutephase reactant. Additional validation of this definition was carried out in a comparative trial, and the results suggest that the definition is statistically powerful and does not identify a large percentage of placebo‐treated patients as being improved. Conclusion. We present a definition of improvement which we hope will be used widely in RA trials.

Extracts ofTripterygium wilfordiiHook F in the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis of Randomised Controlled Trials

“…However, no effects were found for TJC ( P = 0.60; MD = 1.26; 95% CI: −3.52 to 6.05), SJC ( P = 0.72; MD = −0.37; 95% CI: −2.35 to 1.61), DMS ( P = 0.94; MD = −2.50 min; 95% CI: −67.08 to 62.08), RF ( P = 0.79; SMD = 0.11; 95% CI: −0.70 to 0.92), ESR ( P = 0.54; MD = 5.28 mm/H; 95% CI: −11.62 to 22.17), or CRP ( P = 0.73; SMD = −0.22; 95% CI: −1.47 to 1.03). Only one trial [36] described the results, which were a 20% improvement in RA as defined by ACR (ACR 20) [39], ACR 50, and ACR 70, so we did not pool these results.…”

Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease‐Modifying Antirheumatic Drug Treatment

“…The primary end point assessment was a noninferiority comparison of baricitinib monotherapy to MTX monotherapy based on the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) 11 at week 24. Major secondary end points assessed at week 24 included superiority comparisons of baricitinib monotherapy or baricitinib plus MTX to MTX monotherapy based on the ACR20 response, Health Assessment Questionnaire disability index (HAQ DI) 12, 13, Simplified Disease Activity Index (SDAI) remission (score of ≤3.3) 14, Disease Activity Score in 28 joints 15 based on C‐reactive protein level (DAS28‐CRP) 16, and modified Sharp/van der Heijde score (SHS) 17.…”

Phase II Study of ABT‐122, a Tumor Necrosis Factor– and Interleukin‐17A–Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate

“…The primary efficacy end point was a ≥20% improvement in disease activity based on the American College of Rheumatology improvement response criteria (ACR20) 36 compared to placebo at week 12. A secondary end point was to compare the ACR20 response rates between ABT‐122 and adalimumab at week 12, although the study was not powered for these comparisons.…”