A Randomized Trial of Maintenance Therapy for Vasculitis Associated with Antineutrophil Cytoplasmic Autoantibodies

Jayne, David; Rasmussen, Niels; Andrássy, K.; Bacon, P. A.; Tervaert, Jan Willem Cohen; Dadonienė, Jolanta; Ekstrand, Agneta; Gaskin, G.; Gregorini, Gina; Groot, Kirsten de; Gross, Wolfgang L.; Hagen, E. Christiaan; Mirapeix, E; Pettersson, E; Siegert, C. E. H.; Sinico, A.; Tesař, Vladimı́r; Westman, Kerstin; Pusey, Charles D.

doi:10.1056/nejmoa020286

Cited by 1,237 publications

(844 citation statements)

References 39 publications

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“…These protocols were designed to choose an appropriate treatment regimen and to promote prediction of the outcome for each patient. The rates of remission, death, ESRD, and relapse obtained in the trial were comparable to those reported previously in European RCTs [7, 8] with minor differences. Thus, tailor-made treatment based on patients’ disease severity and disease type seemed to be useful in determining treatment regimens.…”

Section: Discussionsupporting

confidence: 86%

“…Compared with VDI values in the CYCAZAREM trial [7], where the mean VDI (95% confidence interval) values at baseline and at 18 months were 1.3 (1.0–1.6) and 2.5 (2.1–3.0), respectively, those in the present trial were higher by 0.9 and 0.7, respectively.…”

Section: Resultscontrasting

confidence: 68%

“…The relapse rate in the JMAAV trial was 19%, which was higher than that in the MPA subgroup (8%) and as high as that in the WG subgroup (18%) in the CYCAZAREM trial [7]. In our trial, the relapse rate was highest in patients with the mild form, especially in those with the pulmonary-limited type (3 cases of relapse in 6 patients), followed by those with the renal-limited type (1 relapse in 3 patients).…”

Section: Discussionmentioning

confidence: 99%

“…Randomized controlled trials (RCTs) have indicated a rate of AAV remission induction of approximately 90% in 6 months with the standard regimen [7, 8]. As cyclophosphamide induces severe toxicity, there have been many attempts to develop less toxic regimens.…”

Section: Introductionmentioning

confidence: 99%

“…The European CYCAZAREM (cyclophosphamide vs. azathioprine as remission maintenance therapy for AAV) RCT compared the effectiveness of cyclophosphamide and azathioprine in the maintenance of remission [7]. The study population consisted of 155 patients (WG, n = 95; MPA, n = 60) who achieved remission after induction therapy with oral cyclophosphamide plus prednisolone.…”

Section: Introductionmentioning

confidence: 99%

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Severity-based treatment for Japanese patients with MPO-ANCA-associated vasculitis: the JMAAV study

et al. 2011

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We (JMAAV [Japanese patients with MPO-ANCA-associated vasculitis] Study Group) performed a prospective, open-label, multi-center trial to evaluate the usefulness of severity-based treatment in Japanese patients with myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA)-associated vasculitis. Patients with MPO-ANCA-associated vasculitis received a severity-based regimen according to the appropriate protocol: low-dose corticosteroid and, if necessary, cyclophosphamide or azathioprine in patients with mild form; high-dose corticosteroid and cyclophosphamide in those with severe form; and the severe-form regimen plus plasmapheresis in those with the most severe form. We followed up the patients for 18 months. The primary end points were the induction of remission, death, and end-stage renal disease (ESRD). Fifty-two patients were registered, and 48 patients were enrolled in this study (mild form, n = 23; severe form, n = 23; most severe form, n = 2). Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD. Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period. The JMAAV trial is the first prospective trial for MPO-ANCA-associated vasculitis to be performed in Japan. The remission and death rates were comparable to those in several previous clinical trials performed in western counties. The regimen employed in this trial was tailor-made based on patients’ disease severity and disease type, and it seems that standardization can be consistent with treatment choices made according to severity.

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Section: Discussionsupporting

confidence: 86%

Section: Resultscontrasting

confidence: 68%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Severity-based treatment for Japanese patients with MPO-ANCA-associated vasculitis: the JMAAV study

et al. 2011

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Mycophenolate Mofetil vs Azathioprine for Remission Maintenance in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Hiemstra

Walsh²,

Mahr³

et al. 2010

JAMA

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551

228

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NTINEUTROPHIL CYTOPLASmic antibodies (ANCAs) are frequently found in patients with Wegener granulomatosis and microscopic polyangiitis. Together, Wegener granulomatosis and microscopic polyangiitis are considered ANCA-associated vasculitis (AAV) due to their similarity in clinical and histological features, prognosis, and treatment. Standard therapy for patients with AAV consists of induction of remission with cyclophosphamide and glucocorticoids, followed by remission maintenance with azathioprine or methotrexate and a tapering course of glucocorticoids. 1,2 Relapses of AAV occur in 50% of patients within 5 years of diagnosis, and treatment toxicity is common. 3,4 Safe and effective therapies to maintain remission of AAV are a priority. For editorial comment see p 2413.

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Therapeutic Interventions for Systemic Vasculitis

Hoffman¹

2010

JAMA

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A Randomized Trial of Maintenance Therapy for Vasculitis Associated with Antineutrophil Cytoplasmic Autoantibodies

Abstract: In patients with generalized vasculitis, the withdrawal of cyclophosphamide and the substitution of azathioprine after remission did not increase the rate of relapse. Thus, the duration of exposure to cyclophosphamide may be safely reduced.

Cited by 1,237 publications

References 39 publications

Severity-based treatment for Japanese patients with MPO-ANCA-associated vasculitis: the JMAAV study

Severity-based treatment for Japanese patients with MPO-ANCA-associated vasculitis: the JMAAV study

Mycophenolate Mofetil vs Azathioprine for Remission Maintenance in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Therapeutic Interventions for Systemic Vasculitis

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