Skin involvement as a relevant outcome measure in clinical trials of systemic sclerosis.

Advances in our understanding of the pathobiology of scleroderma and the ever-increasing availability of rational candidate therapies have brought the clinical study of scleroderma to the forefront. In the 1990s, consensus measures of outcome have been developed for common disorders such as rheumatoid arthritis. With decisions founded on extensive and validated data, the clinical research community and regulatory agencies have accepted the importance of a demonstration of small degrees of change over relatively short periods of time. The current level of sophistication in scleroderma research is reminiscent of our approach to the study of rheumatoid arthritis in the early 1970s. Accessible, reproducible, and cost-effective measures of outcome are needed in scleroderma. These measures should incorporate clinical meaningfulness and be relevant to quality of life. This review discusses some of the more recent studies of outcome measures in scleroderma, some or all of which are considered relevant to both drug development and clinical care of the individual patients.