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Adding Azathioprine is not Beneficial for Induction Therapy in Non-Severe Necrotizing Vasculitis
November 9 2015 5:15 PM ET — via RheumReports
There is a lack of studies investigating treatment options for non-severe eosinophilic granulomatosis (EGPA), microscopic polyangiitis (MPA) and polyarteritis nodosa (PAN), which is a cause of great frustration since the relapse rate when these patients are treated with corticosteroids alone is very high.
In a double-blind, randomized, controlled trial lead by the French Vasculitis Study Group (abstract #1086), the effect of adding azathioprine to corticosteroids vs corticosteroids alone for induction therapy was evaluated in 95 patients with these diseases. Patients received 2 mg/kg of azathioprine for 12 months plus 1 mg/kg of prednisone on tapering schedule for 12 months, or prednisone alone at the same dose and tapering schedule. The primary outcome, failure of remission induction or any relapse, was assessed at 24 months.
Unfortunately, there were no significant differences in the rate of relapse or failure of primary induction (50%) between the two treatment groups. However, there were more adverse events in the azathioprine group. Relapses occurred both before and after discontinuation of azathioprine. Multiple subgroup analyses failed to reveal any significant differences between the two treatment groups.
This study highlights the difficulty in conducting trials in rare diseases. The three diseases that were combined are highly heterogeneous with respect to organ involvement and pathogenesis. The majority of patients had EGPA (50%) and it is unclear whether the results can be translated to the other two conditions.
In addition, some non-severe manifestations may be more responsive to immunosuppression than others, for example, neuropathy versus asthma.
Despite its multicentre design, it would not have been possible to recruit sufficient patients for these subgroup analyses. Larger international studies, innovative trial designs, and therapies that more specifically target pathogenic processes, are required to improve management of these challenging diseases.
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About the Author
Dr. Lillian Barra
Lillian Barra is an Assistant Professor at Western University. Her research interests include autoimmune vascular disease and the role of autoantibodies in rheumatoid arthritis.
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