PROGRESS TOWARDS OPTIMAL TRIAL END-POINTS IN RHEUMATOID-ARTHRITIS

Trials in rheumatoid arthritis have been difficult to perform and inte rpret due to disagreement over what to measure. This paper reviews the most frequently used measures and their validity against the backgrou nd of the Outcome Measures in Rheumatology (OMERACT) consensus confere nces. These conferences have resulted in the adoption of a core set of end-points to be used as a minimum in all clinical trials in rheumato id arthritis. These are known as the World Health Organization/Interna tional League of Associations for Rheumatology (WHO/ILAR) core set. Th is set of measures comprises: (i) pain; (ii) patient global assessment ; (iii) physical disability; (iv) swollen joints; (v) tender joints; ( vi) acute phase reactants; (vii) physician (assessor) global assessmen t; and, in studies of 1 or more years duration, (viii) radiographs of joints. Other developments include a renewed interest in aggregate end -points (indices) such as response criteria, and in the measurement of adverse effects and economic costs. In sum, measurement methodology i n rheumatoid arthritis has been improved in time to take advantage of expected important advances in treatment.