The Japanese experience with biologic therapies for rheumatoid arthritis

Abstract

The unique genetic, environmental and medical backgrounds of people in Japan might influence the effectiveness and safety of biologic agents in patients with rheumatoid arthritis (RA). Indeed, clinical trials revealed higher response rates to some biologic agents (including infliximab, etanercept and tocilizumab) in patients with RA in Japan than patients treated with the same agents in Western countries, although response rates to adalimumab were comparable in both populations. The reasons why response rates to some biologic agents differ in Japanese individuals is currently under investigation. Post-marketing surveillance data have been collected for all patients with RA who were treated with biologic agents in Japan to monitor drug safety. These data clearly demonstrated that only ∼5% of these patients experienced adverse drug reactions to biologic agents, which were well tolerated. Pneumonia, tuberculosis, Pneumocystis jirovecii pneumonia and interstitial pneumonitis are considered important severe adverse reactions and risk factors for these adverse effects have been identified. Adverse drug reactions could exaggerate the risks associated with biologic therapy in Japanese patients with RA. Attempts have, therefore, been made to predict clinical response and adverse effects to enable personalized therapy with biologic agents and to optimize the outcomes of these patients.

Phase II study of tofacitinib (CP‐690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate

“…Regarding medication differences there was, for example, no direct comparison of high and low MTX doses between this Japanese study and the global tofacitinib studies. Differences in efficacy responses between Japanese and Western populations have also been observed in clinical trials of biologic DMARDs, including infliximab, etanercept, and tocilizumab (reviewed extensively by Takeuchi and Kameda [17]). Alternatively, these observations could be due to differences in MTX dosing.…”

Clinical and Radiological Features of Acute-Onset Diffuse Interstitial Lung Diseases in Patients with Rheumatoid Arthritis Receiving Treatment with Biological Agents: Importance of <i>Pneumocystis</i> Pneumonia in Japan Revealed by a Multicenter Study

“…Importantly, they typically developed AoDILD within several months of successful biological treatment in addition to MTX and low-dose glucocorticoids. TNF inhibitors infliximab and etanercept were the predominant biological agents, chiefly because both adalimumab and tocilizumab had only been approved in Japan for RA in April 2008 (19), and no patients treated with adalimumab were found in the present study.…”

Treatment trends of rheumatoid arthritis in Japan: Changes toward globalization and its unique innovation

“…Clinical trials revealed higher response rates to some biologics including infliximab, etanercept and tocilizumab 16) . Treatment guidelines for TNF-α blocking agents in Japan were firstly published by JCR in 2005 17) .…”