Cyclosporine in systemic sclerosis. Results of a forty-eight-week open safety study in ten patients.
OBJECTIVE
To evaluate safety and efficacy of cyclosporin A (CSA) treatment in systemic sclerosis (SSc).


METHODS
Ten patients with < or = 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 > or = 3-4 mg/kg/day. Skin thickening decreased significantly (P < 0.001), while pulmonary and cardiac involvement remained unchanged.


CONCLUSIONS
CSA should undergo blinded controlled study in patients with SSc.
Clements
P J
PJ
Department of Medicine, University of California, Los Angeles School of Medicine 90024.
Lachenbruch
P A
PA
Sterz
M
M
Danovitch
G
G
Hawkins
R
R
Ippoliti
A
A
Paulus
H E
HE
D000328:Adult; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use* / Q000633:toxicity; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D004369:Pentetic Acid / Q000009:adverse effects / Q000627:therapeutic use; D012595:Scleroderma, Systemic / Q000188:drug therapy*
D004369:Pentetic Acid; D016572:Cyclosporine