THE COURSE OF SKIN INVOLVEMENT IN SYSTEMIC-SCLEROSIS OVER 3 YEARS IN A TRIAL OF CHLORAMBUCIL VERSUS PLACEBO

Objective. To describe the course of cutaneous involvement in systemic sclerosis (SSc; scleroderma) over 3 years, in the context of a placeb o-controlled drug trial. Methods. The course of skin tethering (assess ed by a semiquantitative skin scoring technique) was documented annual ly for 3 years in 64 SSc patients with early (<3 years duration at ent ry), intermediate (3-8 years duration), or late (>8 years duration) di ffuse or limited SSc. Results. Mean +/- SD entry skin scores were sign ificantly greater in the 33 diffuse SSc patients (13.1 +/- 5.0) than i n the 31 limited SSc patients (4.3 +/- 2.1) (P<0.001). In patients wit h diffuse SSc, the skin score remained stable for the first 12 months, but had decreased significantly by 24 months (P<0.022) and 36 months (P<0.004). In those with limited SSc, the skin score did not change si gnificantly over 3 years. Conclusion. Trials of treatments designed to affect skin thickening/tethering should be conducted in patients who have diffuse SSc (of short, intermediate, or long duration) at entry. The best time to study therapies designed to affect skin thickening ma y be in the first year after entry.