Analysis of a double-blind, randomized, controlled therapeutic trial of apheresis in the treatment of polymyositis or dermatomyositis was completed. Neither plasmapheresis nor lymphapheresis led to a better outcome than a sham procedure. In an attempt to find a better way to treat steroid-resistant myositis (other than inclusion body myositis), we have carried out a randomized crossover trial of intravenous methotrexate with leukovorin rescue and a combination of methotrexate and azathioprine. Accrual of patients is about two-thirds complete. We have carried out two extensive retrospective analyses of the therapy of myositis. One, well over 100 patients on whom thorough records of responses were available, was analyzed for the factors that influence the responses to prednisone, methotrexate, and azathioprine. The other was a close analysis of the responses to steroid and cytotoxic therapy in almost 30 patients with inclusion body myositis, including an analysis of the first ever controlled therapeutic trial in that condition which we carried out over the past several years.
