RITUXIMAB IN THE TREATMENT OF PATIENTS WITH DERMATOMYOSITIS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Dermatomyositis is an autoimmune disorder resulting from inflammation of the muscles and/or skin. Evidence has accumulated that B cells play a pathogenic role in dermatomyositis. Rituximab is a genetically engineered, chimeric, murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant pre-B and mature B cells. The objectives of this study are: 1. To evaluate if selective destruction of B cells using Rituximab will reduce the signs and symptoms of dermatomyositis. 2. To determine the safety and tolerability of Rituximab therapy in patients with dermatomyositis. 3. To explore the pharmacokinetics and pharmacodynamics of Rituximab in this patient population (e.g. extent of duration of B-cell depletion). Study Design: This prospective open-label trial will enroll 8 patients with dermatomyositis. Each subject will undergo a screening evaluation up to 4 weeks prior to study drug administration. Each subject will receive Rituximab at a dose of 1000 mg intravenously (IV) on day 1 (baseline treatment day) and day 15 for a total of two infusions. Follow-up evaluations will be performed at weeks 4, 8, 12, 16, 20, 24, 36, and 48. All patients who withdraw from this study must return for follow-up safety evaluations at weeks 4, 12, 24, 36, and 48 from the date of withdrawal from the study. Adverse events will be collected in all withdrawn patients together with lymphocyte counts in those patients who remain B-cell depleted. After week 48, further follow-up visits every 2 months should continue in any patient who remains B cell depleted, until these cells evaluations at weeks 4, 12, 24, 36, and 48 from the date of withdrawal from the study. Adverse events will be collected in all withdrawn patients together with lymphocyte counts in those patients who remain B-cell depleted. After week 48, further follow-up visits every 2 months should continue in any patient who remains B cell depleted, until these cells have returned to their original baseline or normal levels. Patient Withdrawals All patients who withdraw from this study will be followed for a minimum of 48 weeks or until B cell levels have returned to their original baseline or normal levels.