A Randomized Trial of Maintenance Therapy for Vasculitis Associated with Antineutrophil Cytoplasmic Autoantibodies
David Jayne, F.R.C.P., Niels Rasmussen, M.D., Konrad Andrassy, M.D., Paul Bacon, F.R.C.P., Jan Willem Cohen Tervaert, Ph.D., Jolanta Dadoniené, Ph.D., Agneta Ekstrand, M.D., Gill Gaskin, Ph.D., Gina Gregorini, M.D., Kirsten de Groot, M.D., Wolfgang Gross, M.D., E. Christiaan Hagen, M.D., Eduardo Mirapeix, M.D., Erna Pettersson, Ph.D., Carl Siegert, M.D., Alberto Sinico, Ph.D., Vladimir Tesar, Ph.D., Kerstin Westman, Ph.D., Charles Pusey, F.R.C.P., for the European Vasculitis Study Group
Background The primary systemic vasculitides usually associatedwith autoantibodies to neutrophil cytoplasmic antigens includeWegener's granulomatosis and microscopic polyangiitis. We investigatedwhether exposure to cyclophosphamide in patients with generalizedvasculitis could be reduced by substitution of azathioprineat remission.
Methods We studied patients with a new diagnosis of generalizedvasculitis and a serum creatinine concentration of 5.7 mg perdeciliter (500 µmol per liter) or less. All patients receivedat least three months of therapy with oral cyclophosphamideand prednisolone. After remission, patients were randomly assignedto continued cyclophosphamide therapy (1.5 mg per kilogram ofbody weight per day) or a substitute regimen of azathioprine(2 mg per kilogram per day). Both groups continued to receiveprednisolone and were followed for 18 months from study entry.Relapse was the primary end point.
Results Of 155 patients studied, 144 (93 percent) entered remissionand were randomly assigned to azathioprine (71 patients) orcontinued cyclophosphamide (73 patients). There were eight deaths(5 percent), seven of them during the first three months. Elevenrelapses occurred in the azathioprine group (15.5 percent),and 10 occurred in the cyclophosphamide group (13.7 percent,P=0.65). Severe adverse events occurred in 15 patients duringthe induction phase (10 percent), in 8 patients in the azathioprinegroup during the remission phase (11 percent), and in 7 patientsin the cyclophosphamide group during the remission phase (10percent, P=0.94 for the comparison between groups during theremission phase). The relapse rate was lower among the patientswith microscopic polyangiitis than among those with Wegener'sgranulomatosis (P=0.03).
Conclusions In patients with generalized vasculitis, the withdrawalof cyclophosphamide and the substitution of azathioprine afterremission did not increase the rate of relapse. Thus, the durationof exposure to cyclophosphamide may be safely reduced.
Source Information
From Addenbrooke's Hospital, Cambridge, United Kingdom (D.J.); Rigshospitalet, Copenhagen, Denmark (N.R.); the University of Heidelberg, Heidelberg, Germany (K.A.); University of Birmingham, Birmingham, United Kingdom (P.B.); the University of Maastricht, Maastricht, the Netherlands (J.W.C.T.); the University of Vilnius, Vilnius, Lithuania (J.D.); the University of Helsinki, Helsinki, Finland (A.E.); Imperial College, London (G. Gaskin, C.P.); Spedali Civili, Brescia, Italy (G. Gregorini); the Medical School, Hannover, Germany (K.G.); the Department of Rheumatology, University of Luebeck, and Rheumaklinik Bad Bramstedt, Luebeck, Germany (W.G.); Eemland Hospital, Amersfoort, the Netherlands (E.C.H.); the Hospital Clinic i Provincial, Barcelona, Spain (E.M.); the Huddinge University Hospital, Stockholm, Sweden (E.P.); the Leiden University Medical Centre, Leiden, the Netherlands (C.S.); the Ospedale San Carlo Borromeo, Milan, Italy (A.S.); the Charles University, Prague, Czech Republic (V.T.); and the University of Lund, Lund Sweden (K.W.).
Address reprint requests to Dr. Jayne at the Department of Medicine, Box 157, Addenbrooke's Hospital, Cambridge CB1 2QQ, United Kingdom.
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