CONTROLLED TRIAL OF PULSE VERSUS CONTINUOUS PREDNISOLONE AND CYCLOPHOSPHAMIDE IN THE TREATMENT OF SYSTEMIC VASCULITIS

Although cyclophosphamide and prednisolone are effective in treating s ystemic vasculitis, the optimum treatment regimes and duration of trea tment are unknown. We randomized 54 patients aged 15-70 years (median 57.5 years) with systemic vasculitis (classical polyarteritis n=8, mic roscopic polyarteritis n=17, Wegener's granulomatosis n=29) to treatme nt with either pulse cyclophosphamide and prednisolone (PCYP) (n=24) o r continuous oral and prednisolone and cyclophosphamide, with the latt er followed after a median of 3 months (range 1.5-10 months) by azathi oprine (CCAZP) (n=30). Patients on CCAZP were more likely to develop l eucopenia (13/30) than patients on PCYP, (7/24) although the differenc e was not significant. The numbers of infective episodes during follow up were comparable in the two groups at 1.7/patient for PCYP and 1.66 /patient for CCAZP. Overall, 26/30 patients (87%) treated with CCAZP d eveloped treatment-related toxicity, as did 17/24 patients (71%) treat ed with PCYP. After a median follow-up of 40.4 months (range 0.7-64.8) , there was no difference in the frequency of deaths (PCYP 5, CCAZP 4) , relapses (PCCYP 7, CCAZP 8), treatment failures (PCYP 4, CCAZP 4), i mprovement in disease activity scores or renal function. Survival at t hree years was 77% in patients treated with PCYP, and 90% in patients on CCAZP (p=0.38). There was a tendency towards increased toxicity in patients treated with the continuous regimen.