CLINICAL TRIAL: RITUXIMAB WITH OR WITHOUT METHOTREX IN PSORIATIC ARTHRITIS AND P

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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. Psoriatic arthritis (PsA) is a chronic inflammatory arthritis of unknown etiology. Currently, methotrexate (MTX), cyclosporine and sulfasalazine have demonstrated modest efficacy in the treatment of PsA, although sulfasalazine had no significant effect on associated psoriatic skin lesions. Anti-TNF medications have benefited both the arthritis and psoriasis components of the disease, however a significant portion of patients do not achieve adequate benefit and some do not respond at all. Thus, there remains an unmet need for adequate treatment of PsA in a substantial number of patients. Rituximab is a chimeric, murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant pre-B and mature B cells. It is approved for the treatment of relapsed or refractory low grade or follicular, CD20+, B-cell non-Hodgkin's lymphoma. Therapy with rituximab, especially in combination with methotrexate or cyclophosphamide, has also been shown to be efficacious in the treatment of rheumatoid arthritis (RA), a condition with considerable overlapping features with the inflammatory synovitis of PsA. It is known that the synovial infiltrate of PsA and skin lesions of psoriasis contain numerous B cells, the target cell of rituximab therapy. This study will assess the safety and efficacy of rituximab as a potential alternative treatment for PsA in those patients where other therapies have proven inadequate.