Analysis of improvement in individual rheumatoid arthritis patients treated with disease‐modifying antirheumatic drugs, based on the findings in patients treated with placebo

作者：Harold E. Paulus, Marlene J. Egger, John R Ward, H. James Williams · 发表于：Arthritis & Rheumatism · 年份：1990 · DOI：10.1002/art.1780330403 · 被引用次数：285 · 研究领域：Rheumatoid Arthritis Research and Therapies、Statistical Methods in Clinical Trials、Biosimilars and Bioanalytical Methods

A composite index for estimating improvement in individual rheumatoid arthritis (RA) patients during trials of slow-acting, disease-modifying antirheumatic drugs (DMARDs) was developed by analyzing the responses of 130 placebo-treated participants in Cooperative Systematic Studies of Rheumatic Diseases studies. If responses in 4 of 6 selected measures were required for improvement (by greater than or equal to 20% for morning stiffness, Westergren erythrocyte sedimentation rate, joint pain/tenderness score, and joint swelling score, and by greater than or equal to 2 grades on a 5-grade scale, or from grade 2 to grade 1 for patient's and physician's overall assessments of current disease severity), few placebo-treated patients qualified as improved, whereas significantly more DMARD-treated patients demonstrated improvement. The proposed index appears to be useful in estimating the probability that an RA patient will improve if taking a placebo during a DMARD trial, and may be a useful tool for analysis of DMARD studies.