Rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to or intolerance of other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one tumour necrosis factor alpha (TNF-alpha) inhibitor therapy. This combination treatment is FDA indicated.
However, in a situation in which ,methotrexate is contraindicated, literature supports Rituxan alone. In the phase II trial, the ACR responses of patients treated with rituximab in combination with MTX (ACR20, ACR50 and ACR70: 73%, 43% and 23%, respectively) were numerically superior to those receiving rituximab monotherapy (65%, 33% and 15%, respectively). As the difference between responses to rituximab monotherapy and the placebo control arm (ACR20, ACR50 and ACR70: 38%, 13% and 5%, respectively) did not reach statistical significance for ACR50 and ACR70 responses14 (category Ib), rituximab is licensed only in combination with MTX. Nevertheless, rituximab monotherapy was also shown to be more effective (ACR20 response) than placebo (category Ib).
National Institute for Health and Clinical Excellence (NICE). Rituximab for the treatment of rheumatoid arthritis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Aug. 26 p. (Technology appraisal guidance; no. 126).
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