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To clarify the efficacy of infliximab (INF) for active rheumatoid arthritis (RA) in Japan by nationwide postmarketing surveillance (PMS) data.The data of 5000 cases with active RA, despite treatment with methotrexate, were collected to Tanabe Seiyaku Co., Ltd and all of these were analysed in detail for efficacy and adverse reactions. Overall efficacy was evaluated by physicians to three grades: markedly improved, improved and unchanged.Overall efficacy was 34.0% markedly improved, 57.6% improved and 8.4% unchanged at 22 weeks after INF therapy, respectively. Overall of adverse reactions were 28.0% and serious adverse reactions were 6.2%.Iinfliximab was proven to be very effective and safe by nationwide PMS data in Japan. Longer observation is needed for further evaluation of INF therapy, especially efficacy forpreventing joint damage.