Double-blind withdrawal trial of azathioprine as maintenance treatment for Crohn's disease

• Published in: The Lancet (British edition) Vol. 2; no. 8097; p. 955
• Main Authors: O'Donoghue, D P, Dawson, A M, Powell-Tuck, J, Bown, R L, Lennard-Jones, J E
• Format: Journal Article
• Language: English
• Published: England 04-11-1978
• Subjects: Adult; Aged; Azathioprine - administration & dosage; Azathioprine - toxicity; Clinical Trials as Topic; Crohn Disease - drug therapy; Double-Blind Method; Drug Evaluation; Female; Follow-Up Studies; Humans; Male; Middle Aged; Placebos; Recurrence; Remission, Spontaneous; Substance Withdrawal Syndrome - epidemiology; Time Factors
• ISSN: 0140-6736
• DOI: 10.1016/s0140-6736(78)92524-2

51 patients with Crohn's disease who were in good health while taking azathiprine, 2 mg/kg body-weight/day, for at least six months were allocated either to a group in which azathioprine was continued or to one in which a control tablet was substituted. The trial lasted one year unless relapse recurred earlier. The cumulative probability of relapse was nil at six months and 5% (+/-5 S.D.) at a year among those on azathioprine, compared with 25% (+/-9 S.D.) at six months and 41% (+/-11 S.D.) at a year among those in the control group (P less than 0.01). 1 patient in whom azathioprine was continued died of pancytopenia in the fourth month of the trial. Azathioprine is potentially toxic but appears to reduce the relapse-rate in Crohn's disease.