Myositis Outcomes Workshop

NIH Myositis Outcomes Workshop
November 9-10, 2001
San Francisco, CA

Co-sponsored by NIEHS, NINDS and ORD, NIH

The NIH Myositis Outcomes Workshop, co-sponsored by NIEHS, NINDS and ORD, NIH, was held November 9-10, 2001, in San Francisco, California. The idiopathic inflammatory myopathies (IIM) are a heterogeneous group of systemic connective tissue diseases defined by the clinical and pathologic consequences of chronic muscle inflammation. The primary forms of the myositis syndromes: dermatomyositis (DM), polymyositis (PM), and inclusion body myositis (IBM), affect both adults and children. Although the primary focus of myositis research has been on skeletal muscle disease, the frequent involvement of other organs, particularly the cutaneous, gastrointestinal, pulmonary, and cardiac systems, contributes greatly to the morbidity and mortality of the IIM. The DM Disease Activity Collaborative Study Group, and later the International Myositis Outcome Assessment Collaborative Study Group recommended development of validated outcome measures in all forms of IIM in both adults and children, and coordination and facilitation of clinical trials in adult and juvenile myositis. The primary deficiency inhibiting this group from undertaking large multi-center trials in myositis is the lack of validated disease activity and damage indices. For this reason, the first in a series of two workshops were held to address the following: 1. Use of the core set of outcome measures recently identified to develop a myositis disease activity index, a preliminary definition of improvement, and damage index, and 2. to develop consensus on issues related to the general conduct of clinical trials, extend of improvement and damage, development of inclusion and exclusion criteria and appropriate therapy, and recommendations in regard to the trial duration, dropout cryteria, safety assessment, and post-trial evaluations. The synopsis of this workshop will be published.