Clinical studyUse of a cyclophosphamide-induction methotrexate-maintenance regimen for the treatment of Wegener’s granulomatosis: extended follow-up and rate of relapse
Section snippets
Patients
Between November 1994 and July 1999, 60 patients who met the eligibility criteria for enrollment in this study were evaluated by physicians at the National Institute of Allergy and Infectious Diseases. Of these, 18 had active but not immediately life-threatening disease and were enrolled in other protocols that used methotrexate as the primary cytotoxic agent to induce remission. The remaining 42 patients are the subjects of this study. Thirty-nine of these patients had biopsy-proven Wegener’s
Results
About two thirds of the patients were men and about half met the criteria for severe disease at study entry (Table 1). Nearly all of the patients with severe disease had renal involvement (Table 2).
Discussion
A prior analysis of this group of patients (3) suggested that a staged regimen using cyclophosphamide for induction and methotrexate for remission maintenance was effective and associated with a favorable toxicity profile at a median follow-up of 16 months. Based on previous studies of daily cyclophosphamide regimens (2), however, we expected more relapses, and perhaps more treatment adverse effects, to occur with longer follow-up.
With extended follow-up, the survival rate of this cohort has
Acknowledgements
The authors wish to thank Kristen E. McCabe, RN, the clinical fellows, and Clinical Center nursing staff at the National Institute of Allergy and Infectious Diseases for the care of our patients, and Dr. Anthony S. Fauci for his work in establishing the National Institute of Allergy and Infectious Diseases Vasculitis Program.
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