Adding Azathioprine to Remission‐Induction Glucocorticoids for Eosinophilic Granulomatosis With Polyangiitis (Churg‐Strauss), Microscopic Polyangiitis, or Polyarteritis Nodosa Without Poor Prognosis Factors
Authors: Xavier Puechal, Christian Pagnoux, Gabriel Baron, Thomas Quemeneur, Antoine Néel, Christian Agard, François Lifermann, Eric Liozon, Marc Ruivard, Pascal Godmer, Nicolas Limal, Arsène Mekinian, Thomas Papo, Anne Ruppert, Anne Bourgarit, Boris Bienvenu, Loïc Geffray, Luc Saraux, Elisabeth Diot, Bruno Crestani, Xavier Delbrel, Laurent Sailler, Pascal Cohen, Véronique Le Guern, Benjamin Terrier, Matthieu Groh, Claire Le Jeunne, Luc Mouthon, Philippe Ravaud, Loïc Guillevin, Marc Pineton de Chambrun, Charles-Edouard Luyt, Francois Beloncle, Marie Gousseff, Wladimir Mauhin, Laurent Argaud, Stanislas Ledochowski, Anne-Sophie Moreau, Romain Sonneville, Bruno Verdière, Sybille Merceron, Nathalie Zappella, Mickael Landais, Damien Contou, Alexandre Demoule, Sylvie Paulus, Bertrand Souweine, Bernard Lecomte, Antoine Vieillard-Baron, Nicolas Terzi, Elie Azoulay, Raymond Friolet, Marc Puidupin, Jérôme Devaquet, Jean-Marc Mazou, Yannick Fédun, Jean-Paul Mira, Jean-Herlé Raphalen, Alain Combes, Zahir Amoura, Jean-Christophe Lega, Marc Lambert, Sophie Rivière, Antoine Dossier, François Lhote, Gilles Blaison, Laurent Alric, David Saadoun, Julie Graveleau, Martin Soubrier, Marie-Josée Lecomte, Christine Christides, Annick Bosseray, Hervé Lévesque, François Viallard, Nathalie Tieulie, Pierre-Yves Lovey, Sylvie Le Moal, Béatrice Bibes, Giuseppe Malizia, Pierre Abgueguen, François Liferman, Jacques Ninet, Pierre-Yves Hatron, Arnaud Hot, Romain Hernu, Sylvie de La Salle, Thomas Similowski, Julien Haroche, Julien Boileau, Thomas Hanslik, Caroline Bulte, Aline Talasczka, Eric Hachulla, Olivier Decaux, Florent Ibouanga, Bertrand Arnulf, Marc Benedit, Assaad Maalouf, Bruno Moulin, Fleur Cohen-Aubart, Micheline Pha, Georges-Etienne Rivard, Eric Rondeau, Philippe Debourdeau, Claire Presne, Maude Andrieu, Oscar Len Abad, Hervé Devilliers, Alister Rogers, Miguel Hie, Alexis Mathian, Valentine Heidelberger, Saskia Ingen-Housz-Oro, Alicia Marquet, Matthieu Mahevas, Didier Bessis, Laurence Bouillet, Frédéric Caux, Catherine Chapelon-Abric, Sebastien Debarbieux, Emmanuel Delaporte, Anne-Bénédicte Duval-Modeste, Olivier Fain, Pascal Joly, Marc Marchand-Adam, Jean-Benoît Monfort, Nicolas Noel, Thierry Passeron, Françoise Sarrot-Reynauld, Denis Verrot, Diane Bouvry, Laurence Fardet, Olivier Chosidow, Pascal Sève, Dominique Valeyre, Sophie Moreau
Journal: Arthritis & Rheumatology (2017)

In most patients with nonsevere systemic necrotizing vasculitides (SNVs), remission is achieved with glucocorticoids alone, but one-third experience a relapse within 2 years. This study was undertaken to determine whether the addition of azathioprine (AZA) to glucocorticoids could achieve a higher sustained remission rate of newly diagnosed nonsevere eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA), microscopic polyangiitis (MPA), or polyarteritis nodosa (PAN).All patients included in this double-blind trial received glucocorticoids, gradually tapered over 12 months, and were randomized to receive AZA or placebo for 12 months, with stratification according to SNV (EGPA or MPA/PAN). The primary end point was the combined rate of remission induction failures and minor or major relapses at month 24.Ninety-five patients (51 with EGPA, 25 with MPA, and 19 with PAN) met the inclusion criteria, were randomized, and received at least 1 dose of AZA (n = 46) or placebo (n = 49). At month 24, 47.8% of the patients receiving AZA versus 49% of the patients receiving placebo had remission induction failures or relapses (P = 0.86). Secondary end points were comparable between the AZA and placebo arms. These included initial remission rate (95.7% versus 87.8%), total relapse rate (44.2% versus 40.5%), and glucocorticoid use. Two patients in the placebo arm died; 22 patients in the AZA arm (47.8%) and 23 patients in the placebo arm (46.9%) experienced ≥1 severe adverse event. For EGPA patients, the primary end point (48% in the AZA arm versus 46.2% in the placebo arm) and the percent of patients who experienced asthma/rhinosinusitis exacerbations (24% in the AZA arm versus 19.2% in the placebo arm) were comparable between treatment arms.Addition of AZA to glucocorticoids for the induction of remission of nonsevere SNVs does not improve remission rates, lower relapse risk, spare steroids, or diminish the EGPA asthma/rhinosinusitis exacerbation rate.