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We read the letter to the editor ‘Elephant in the room’ by Hartung et al in response to our open-label pilot clinical trial report on the use of repository corticotropin injection (RCI) in refractory polymyositis (PM) and dermatomyositis (DM).1 2
First, the authors believe that the population studied may not be truly resistant given that only 3 of the 10 patients were treated with intravenous immunoglobulin (IVIg) before entering the trial. There are strong data to support that patients with myositis who have failed 40-60mg slow prednisolne taper and an average of 2.6 immunosuppressive drugs in addition to nearly 20 mg of prednisone at study entry are considered. In the largest international multicentre randomised clinical trial done on PM and DM—the Rituximab in Myositis (RIM) trial, which included many international myositis experts, subjects failed an average of 3.1 immunosuppressive drugs in addition to at least 20 mg of prednisone.3 Our pilot cohort is clearly consistent with RIM trial entry criteria in terms of subject refractoriness. Further, there is no clear consensus definition of ‘refractory myositis’ and, in general, patients failing high dose glucocorticoids plus one additional immunosuppressive agent in adequate doses for a reasonable period of time can be considered ‘refractory’. Regarding IVIg, although we agree that IVIg is …
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