A Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept for the Treatment of Relapsing, Nonsevere Granulomatosis With Polyangiitis.
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Langford Carol A, Khalidi Nader, Springer Jason, Friedman Marcia, Hellmich Bernhard, Pagnoux Christian, Dehghan Natasha, Gewurz-Singer Ora, Koening Curry L, Lin Yih Chang, Monach Paul A, Moreland Larry W, Fifi-Mah Aurore, Flossmann Oliver, Forbess Lindsy J, Lanyon Peter, Molloy Eamonn, Specks Ulrich, Spiera Robert, Yacyshyn Elaine, McAlear Carol A, Burroughs Cristina, Jones Rachel B, Rhee Rennie L, Hajj-Ali Rula, Warrington Kenneth J, Cuthbertson David, Krischer Jeffrey P, Jayne David, Merkel Peter A, Vasculitis Clinical Research Consortium and the European Vasculitis Society
Аннотация
METHODS: In this multicenter trial, eligible patients with relapsing, nonsevere GPA were randomized to receive abatacept 125 mg subcutaneously once a week or placebo, both together with prednisone 30 mg/day (or equivalent), tapered and discontinued at week 12. Patients already taking methotrexate, azathioprine, mycophenolate, or leflunomide continued this medication at a stable dose. Patients achieving remission remained on their randomized assignment until relapse, early termination, or the common close date 12 months after enrollment of the last patient. Those who had a nonsevere relapse, had nonsevere worsening, or were not in remission by month 6 had the option to receive open-label abatacept. The primary end point was the rate of treatment failure, defined as relapse, disease worsening, or failure to achieve a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 or 1 by six months.
RESULTS: Sixty-five patients were randomized; 34 received abatacept and 31 received placebo. No statistical difference in the treatment failure rate was found between those who received abatacept and those who received placebo (P = 0.853). Treatment with abatacept did not demonstrate any statistical difference from placebo in key secondary end points, including time to full remission (BVAS/WG = 0), duration of glucocorticoid-free remission, relapse severity, prevention of damage, and patient-reported quality-of-life outcomes. There was no difference in the frequency or severity of adverse events between treatment arms, including infection.
CONCLUSION: In patients with relapsing, nonsevere GPA, abatacept did not reduce the risk of relapse, severe worsening, or failure to achieve remission.