Cyclosporin A and iloprost treatment of systemic sclerosis: clinical results and interleukin-6 serum changes after 12 months of therapy.
OBJECTIVE
The main aim was to analyse the long-term therapeutic effects on systemic sclerosis (SSc) patients of treatment with either (i) iloprost alone 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 patients before and after 1 yr of treatment.


METHODS
A clinical trial was performed in which 20 consecutive SSc patients 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) associated with iloprost administration (Group II). IL-6 concentrations were evaluated by ELISA in the sera of each patient before and after 1 yr of therapy and in 20 healthy subjects.


RESULTS
After 1 yr of therapy, a significant improvement of skin (P=0.008), 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-dose CyA with iloprost administration may be of clinical utility in SSc and that a mechanism of action of CyA in SSc may include the decrease in IL-6 production.
Filaci
G
G
Division of Internal Medicine, Department of Internal Medicine, University of Genoa, Genoa, Italy.
Cutolo
M
M
Scudeletti
M
M
Castagneto
C
C
Derchi
L
L
Gianrossi
R
R
Ropolo
F
F
Zentilin
P
P
Sulli
A
A
Murdaca
G
G
Ghio
M
M
Indiveri
F
F
Puppo
F
F
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D016572:Cyclosporine / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D016285:Iloprost / Q000008:administration & dosage*; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D015850:Interleukin-6 / Q000032:analysis / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D012595:Scleroderma, Systemic / Q000097:blood / Q000188:drug therapy*
D007166:Immunosuppressive Agents; D015850:Interleukin-6; D010975:Platelet Aggregation Inhibitors; D016572:Cyclosporine; D016285:Iloprost