Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years (CORTAGE)

Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants

The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.

Systemic necrotizing vasculitides are severe diseases associated with a high mortality rate in elderly. Although corticosteroids and immunosuppressants are effective, they can induce some side-effects, especially in this latter patients. Preliminary data indicate that systemic necrotizing vasculitides (SNV) occurring in patients over 65 years have a poorer outcome than in younger patients (mortality rate of 76 % vs. 69 % at 5 years, respectively) and that 68,4 % of the elderly experience treatment side-effects. In this trial, patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants (CYC then azathioprine) or usual regimen with corticosteroids combined with immunosuppressants only if factor(s) of poor prognosis is present (this latter regimen relying on previously published therapeutic guidelines).

Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa

Systemic necrotizing vasculitides, corticosteroids; azathioprine; mycophenolate mofetil;, cyclophosphamide, Elderly patients, Randomized controlled trial

Inclusion Criteria: Newly diagnosed WG, MPA, PAN without HBV infection, or CSS Patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol. within or after the 65th of anniversary Age ≥ 65 years Exclusion Criteria: Any cytotoxic drug within previous year Co-existence of another systemic autoimmune disease, e.g., SLE, RA Virus-associated vasculitides HIV positivity Malignancy (usually excluded unless approved by the trial coordinator) Age < 65 years Inability to give informed consent

Pagnoux C, Quemeneur T, Ninet J, Diot E, Kyndt X, de Wazieres B, Reny JL, Puechal X, le Berruyer PY, Lidove O, Vanhille P, Godmer P, Fain O, Blockmans D, Bienvenu B, Rollot F, Ait el Ghaz-Poignant S, Mahr A, Cohen P, Mouthon L, Perrodeau E, Ravaud P, Guillevin L; French Vasculitis Study Group. Treatment of systemic necrotizing vasculitides in patients aged sixty-five years or older: results of a multicenter, open-label, randomized controlled trial of corticosteroid and cyclophosphamide-based induction therapy. Arthritis Rheumatol. 2015 Apr;67(4):1117-27. doi: 10.1002/art.39011.