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document
A randomised double-blind trial of cyclosporin and azathioprine in refractory rheumatoid arthritis . Fifty-two patients with severe rheumatoid arthritis ( RA ) from four Australian centres were randomised to receive cyclosporin A ( CSA ) ( n = 25 ) or azathioprine ( AZA ) ( n = 27 ) for six months . Initial mean doses of CSA and AZA were 4.2 mg/kg and 1.7 mg/kg respectively . The mean doses of CSA and AZA at six months were 3.4 mg/kg and 1.9 mg/kg . Assessments of side-effects and outcomes of benefit were made monthly by independent , blinded observers . Both treatment groups exhibited statistically significant improvement in standard outcome parameters when compared with baseline values . However , there were no statistically significant differences in these parameters between the two groups . There was a mean increase in serum creatinine concentration associated with CSA ; no persons were withdrawn from the study for this reason . Seven CSA recipients ( three gastrointestinal symptoms , two neurological symptoms , two other ) and 12 AZA recipients ( six gastrointestinal symptoms , four inefficacy , two other ) withdrew from treatment prematurely . Seven CSA recipients became hypertensive and four required anti-hypertensive therapy . Adverse events not requiring cessation of therapy were more commonly seen among CSA patients . In this group of severely affected patients with RA both cyclosporin and azathioprine were effective therapies . CSA toxicities were predictable and manageable but required close monitoring .
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Intervention_Pharmacological
cyclosporin
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Intervention_Pharmacological
azathioprine
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Intervention_Pharmacological
cyclosporin A ( CSA )
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Intervention_Pharmacological
azathioprine ( AZA )
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Intervention_Pharmacological
CSA
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Intervention_Pharmacological
AZA
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Intervention_Pharmacological
CSA
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Intervention_Pharmacological
AZA
34198
Intervention_Pharmacological
CSA
34199
Intervention_Pharmacological
AZA
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Intervention_Pharmacological
CSA
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Intervention_Pharmacological
CSA
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Intervention_Pharmacological
cyclosporin
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Intervention_Pharmacological
azathioprine
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Intervention_Pharmacological
CSA
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Outcome_Physical
serum creatinine concentration
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Outcome_Physical
( three gastrointestinal symptoms , two neurological symptoms , two other )
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Outcome_Physical
six gastrointestinal symptoms
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Outcome_Physical
four inefficacy
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Outcome_Physical
two other
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Outcome_Physical
hypertensive
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Outcome_Physical
anti-hypertensive therapy
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Outcome_Physical
CSA toxicities
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Participant_Condition
refractory rheumatoid arthritis
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Participant_Sample-size
Fifty-two
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Participant_Condition
with severe rheumatoid arthritis ( RA ) from four Australian centres