A comparison of incidence and risk factors for serious adverse events in rheumatoid arthritis patients with etanercept or adalimumab in Korea and Japan.

Abstract

OBJECTIVE:

To compare the incidence and risk factors of serious adverse events (SAEs) in rheumatoid arthritis (RA) patients treated with etanercept (ETN) or adalimumab (ADA) between Korean and Japanese registries.

METHODS:

We recruited 416 RA patients [505.2 patient-years (PYs)] who started ETN or ADA from Korean registry and 537 RA patients (762.0 PY) from Japanese registry. The patient background, incidence rate (IR) of SAE in 2 years, and risk factors for SAEs were compared.

RESULTS:

Korean patients were younger and used more nonbiologic DMARDs, higher doses of methotrexate, and lower doses of prednisolone (PSL). The IR of SAEs (/100 PY) was higher in the Japanese registry compared to the Korean [13.65 vs. 6.73]. In both registries, infection was the most frequently reported SAE. The only significant risk factor for SAEs in Korean registry was age by decade [1.45]. In Japanese registry, age by decade [1.54], previous use of nonbiologic DMARDs ≥ 4 [1.93], and concomitant use of oral PSL ≥ 5 mg/day [2.20] were identified as risk factors for SAEs.

CONCLUSIONS:

The IR of SAE in Japan, especially infection, was higher than that of Korea, which was attributed to the difference of demographic and clinical characteristics of RA patients and treatment profiles.

• Authors: Soo-Kyung Cho, Ryoko Sakai, Toshihiro Nanki, Ryuji Koike, Kaori Watanabe, Hayato Yamazaki, Hayato Nagasawa, Yoshiya Tanaka, Atsuo Nakajima, Shinsuke Yasuda, Atsushi Ihata, Kazuhiko Ezawa, Soyoung Won, Chan-Bum Choi, Yoon-Kyoung Sung, Tae-Hwan Kim, Jae-Bum Jun, Dae-Hyun Yoo, Nobuyuki Miyasaka, Sang-Cheol Bae, Masayoshi Harigai, RESEARCH investigators, REAL Study Group
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 24 Issue 4 Pg. 572-9 (Jul 2014) ISSN: 1439-7609 [Electronic] England
• PMID: 24320747 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• Immunoglobulin G
• Receptors, Tumor Necrosis Factor
• Adalimumab
• Etanercept

Topics

• Adalimumab
• Age Factors
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Antirheumatic Agents (adverse effects, therapeutic use)
• Arthritis, Rheumatoid (drug therapy)
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Etanercept
• Female
• Humans
• Immunoglobulin G (adverse effects, therapeutic use)
• Incidence
• Japan (epidemiology)
• Male
• Middle Aged
• Receptors, Tumor Necrosis Factor (therapeutic use)
• Registries
• Republic of Korea (epidemiology)
• Risk Factors
• Treatment Outcome