CYCLOSPORINE IN SYSTEMIC-SCLEROSIS - RESULTS OF A 48-WEEK OPEN SAFETY STUDY IN 10 PATIENTS

Objective. To evaluate safety and efficacy of cyclosporin A (CSA) treatment in systemic sclerosis (SSc). Methods. Ten patients with less-than-or-equal-to 60 months of SSc were entered into a 48-week open study of CSA. Patients with hypertension or azotemia were excluded. Concurrent use of nonsteroidal antiinflammatory agents or diuretics was not permitted. The extent of cutaneous and visceral involvement at 48 weeks and at study entry were compared. Results. Adverse reactions (especially nephrotoxicity) were frequent, usually transient, often dose-limiting, and usually associated with CSA doses greater-than-or-equal-to 3-4 mg/kg/day. Skin thickening decreased significantly (P < 0.001), while pulmonary and cardiac involvement remained unchanged. Conclusion. CSA should undergo blinded controlled study in patients with SSc.