Cyclosporin A and iloprost treatment of systemic sclerosis: clinical results and interleukin-6 serum changes after 12 months of therapy

Objectives. The main aim was to analyse the long-term therapeutic effects o n systemic sclerosis (SSc) patients of treatment with either (i) iloprost a lone or (ii) low-dose oral cyclosporin A (CyA) associated with iloprost. A secondary aim was to analyse interleukin-6 (IL-6) serum levels in SSc patie nts before and after 1 yr of treatment. Methods. A clinical trial was performed in which 20 consecutive SSc patient s were alternately randomized into two homogeneous groups receiving either monthly i.v. iloprost (1 ng/kg/min in 6 h i.v. infusion, for 5 consecutive days, 1 week per month) (Group I) or low-dose CyA (2.5 mg/kg/day) associate d with iloprost administration (Group II). IL-6 concentrations were evaluat ed by ELISA in the sera of each patient before and after 1 yr of therapy an d in 20 healthy subjects. Results. After 1 yr of therapy, a significant improvement of skin (P = 0.00 8), microvascular (P = 0.004) and oesophageal (P = 0.05) morphological and functional parameters was observed only in Group II patients. Furthermore, after 1 yr of treatment, a significant reduction (P = 0.007) of IL-6 serum concentration was observed only in Group II patients. Conclusions. Collectively, our data suggest that the combination of low-dos e CyA with iloprost administration may be of clinical utility in SSc and th at a mechanism of action of CyA in SSc may include the decrease in IL-6 pro duction.