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 placebo-controlled drug trial. Methods. The course of skin tethering (assessed by a semiquantitative skin scoring technique) was documented annually for 3 years in 64 SSc patients with early (<3 years duration at entry), intermediate (3-8 years duration), or late (>8 years duration) diffuse or limited SSc. Results. Mean +/- SD entry skin scores were significantly greater in the 33 diffuse SSc patients (13.1 +/- 5.0) than in the 31 limited SSc patients (4.3 +/- 2.1) (P<0.001). In patients with 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 significantly 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 may be in the first year after entry.