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Post-marketing surveillance of the safety profile of infliximab in 5,000 Japanese patients with rheumatoid arthritis
  1. Tsutomu Takeuchi (tsutake{at}saitama-med.ac.jp)
  1. Saitama Medical University, Japan
    1. Yoshihiko Tatsuki (tatsuki{at}tanabe.co.jp)
    1. Tanabe Seiyaku Co., LTD, Japan
      1. Yoshihide Nogami
      1. Tanabe Seiyaku Co., LTD, Japan
        1. Naoki Ishiguro
        1. Nagoya University, Japan
          1. Yoshiya Tanaka
          1. University of Occupational & Environmental Health, School of Medicine, Japan
            1. Hisashi Yamanaka
            1. Tokyo Women's Medical University, Japan
              1. Masayoshi Harigai
              1. Tokyo Medical and Dental University, Japan
                1. Junnosuke Ryu
                1. Nihon University School of Medicine, Japan
                  1. Kazuhiko Inoue
                  1. Tokyo Women's Medical University, Medical Center East, Japan
                    1. Hirobumi Kondo
                    1. Kitasato Institute Medical Center Hospital, Japan
                      1. Shigeko Inokuma
                      1. Tokyo Metropolitan Komagome Hospital, Japan
                        1. Naoyuki Kamatani
                        1. Tokyo Women's Medical University, Japan
                          1. Takahiro Ochi
                          1. National Hospital Organization Sagamihara National Hospital, Japan
                            1. Takao Koike
                            1. Hokkaido University, Japan

                              Abstract

                              Objectives: A large-scale post-marketing surveillance (PMS) study was carried out to determine the safety profile of infliximab in Japanese patients with rheumatoid arthritis (RA).

                              Methods: The PMS study was performed for all patients with RA who were treated with infliximab. They were consecutively registered in the PMS study at the initiation of infliximab treatment and were prospectively monitored with all adverse events noted for a period of 6 months. All case reports, which include safety-related events, were collected monthly.

                              Results: Adverse drug reactions (ADRs) were assessed for 6 months in 5,000 patients who were consecutively enrolled in the PMS study. The incidence rates of total and serious ADRs were 28.0% and 6.2%, respectively. “Infections” or “respiratory disorders” were most commonly observed among serious ADRs. Bacterial pneumonia developed in 2.2%, tuberculosis in 0.3%, suspected Pneumocystis jiroveci pneumonia (PCP) in 0.4%, and interstitial pneumonitis in 0.5%. Bacterial pneumonia (for which individuals of male gender, of older age and those with advanced rheumatoid arthritis and comorbid respiratory disease were most at risk) began to develop immediately after the start of treatment, while tuberculosis, PCP and interstitial pneumonitis developed about one month later. Serious infusion reactions were observed in 0.5% and were more likely to occur in patients who had participated in previous clinical trials of infliximab.

                              Conclusion: This post-marketing surveillance study of patients treated with infliximab showed that infliximab in combination with low dose MTX was well tolerated in Japanese patients with active RA.

                              • bacterial pneumonia
                              • infliximab
                              • post-marketing surveillance
                              • rheumatoid arthritis
                              • tuberculosis

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