Abstract | OBJECTIVE: METHODS: 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. RESULTS: 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. CONCLUSION:
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Authors | Xavier Puéchal, Christian Pagnoux, Gabriel Baron, Thomas Quémeneur, Antoine Néel, Christian Agard, François Lifermann, Eric Liozon, Marc Ruivard, Pascal Godmer, Nicolas Limal, Arsène Mékinian, Thomas Papo, Anne-Marie Ruppert, Anne Bourgarit, Boris Bienvenu, Loïck Geffray, Jean-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, French Vasculitis Study Group |
Journal | Arthritis & rheumatology (Hoboken, N.J.)
(Arthritis Rheumatol)
Vol. 69
Issue 11
Pg. 2175-2186
(11 2017)
ISSN: 2326-5205 [Electronic] United States |
PMID | 28678392
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2017, American College of Rheumatology. |
Chemical References |
- Glucocorticoids
- Immunosuppressive Agents
- Azathioprine
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Topics |
- Adult
- Aged
- Asthma
(chemically induced)
- Azathioprine
(therapeutic use)
- Churg-Strauss Syndrome
(drug therapy)
- Disease Progression
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Glucocorticoids
(therapeutic use)
- Humans
- Immunosuppressive Agents
(therapeutic use)
- Male
- Microscopic Polyangiitis
(drug therapy)
- Middle Aged
- Polyarteritis Nodosa
(drug therapy)
- Recurrence
- Remission Induction
- Rhinitis
(chemically induced)
- Sinusitis
(chemically induced)
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