EXTENDED REPORTS

Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis

T Takeuchi^1,14, Y Tatsuki², Y Nogami³, N Ishiguro^1,14, Y Tanaka^5,14, H Yamanaka^6,14, N Kamatani^6,14, M Harigai^7,14, J Ryu^8,14, K Inoue^9,14, H Kondo^10,14, S Inokuma^11,14, T Ochi^12,14, T Koike^13,14

¹ Division of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
² Pharmaceuticals Sales & Marketing Headquarters, Tanabe Seiyaku Co., Ltd, Osaka, Japan
³ Compliance & Assurance Headquarters, Tanabe Seiyaku Co., Ltd, Osaka, Japan
⁴ Department of Orthopaedic Surgery, Nagoya University School of Medicine, Aichi, Japan
⁵ The First Department of Internal Medicine, University of Occupational & Environmental Health, School of Medicine, Fukuoka, Japan
⁶ Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan
⁷ Department of Pharmacovigilance and Department of Medicine and Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan
⁸ Department of Orthopaedic Surgery, Nihon University School of Medicine, Tokyo, Japan
⁹ Department of Orthopaedic Surgery, Tokyo Women’s Medical University, Medical Center East, Tokyo, Japan
¹⁰ Kitasato Institute Medical Center Hospital, Saitama, Japan
¹¹ Department of Allergy and Immunological Diseases, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan
¹² National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan
¹³ Department of Medicine II, Hokkaido University Graduate School of Medicine, Hokkaido, Japan
¹⁴ Member of the Committee on Post-Marketing Surveillance of Japan College of Rheumatology

Tsutomu Takeuchi, Division of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama 350-8550, Japan; tsutake{at}saitama-med.ac.jp

Objectives: A large-scale postmarketing 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 5000 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 1 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 postmarketing 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.

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