Three-year safety and two-year effectiveness of etanercept in patients with rheumatoid arthritis in Japan: Results of long-term postmarketing surveillance

Abstract

Objectives: To evaluate the real-world safety and effectiveness of etanercept (ETN) in Japanese patients with rheumatoid arthritis.

Methods: This postmarketing surveillance study (NCT00503139) assessed the safety and effectiveness of ETN treatment over 3 and 2 years (from June 2007 to September 2011), respectively. Safety was evaluated by occurrence and seriousness of adverse drug reactions (ADRs), and of adverse events (AEs) for malignancies. Effectiveness was assessed using the Disease Activity Score in 28 joints based on the erythrocyte sedimentation rate (ESR) with four variables (swollen and tender joint counts, ESR, and patient global assessment; DAS28-4/ESR). Treatment was considered effective if patients had a good/moderate response by the European League Against Rheumatism response criteria.

Results: ADRs occurred in 256/675 (37.9%) patients, the most common being injection site reactions (4.4%) and nasopharyngitis (3.3%). Serious ADRs occurred in 60/675 (8.9%) patients, the most frequent being pneumonia (1.2%). The incident rate of malignancies (AEs) was 1.06 per 100 patient-years. Mean baseline DAS28-4/ESR for the 581 patients included in effectiveness analysis was 5.42, which decreased to 3.32 at 2 years. Eighty-two percent of patients achieved a moderate/good response at 2 years.

Conclusion: Long-term ETN treatment safety and effectiveness were sustained over 3 and 2 years, respectively.

KEYWORDS:

• DAS28-ESR
• etanercept
• mHAQ
• postmarketing surveillance study
• rheumatoid arthritis

Acknowledgements

We wish to thank all patients who participated in this study and medical staff of all participating centers. Medical writing support was provided by Sabrina Giavara, PhD of Engage Scientific Solutions and was funded by Pfizer.

Conflict of interest

H. Yamanaka has received consultant fee, speaker fee, research grant, scholarship donation, or donated research department from MSD, Ayumi, AbbVie, Eisai, Ono, Astellas, Daiichi-Sankyo, Taisho Toyama, Takeda, Mitsubishi Tanabe Pharma, Chugai, Teijin Pharma, Torii, Nippon Shinyaku, Pfizer, UCB, Nippon Kayaku, YL Biologics, Bayer, and Bristol-Myers Squibb. T. Koike has received speaker fees from AbbVie, Asuka Pharma, Bristol-Myers Squibb, Chugai Pharmaceuticals, Daiichi Sankyo, Eisai, Mitsubishi Tanabe Pharma, Pfizer Japan, Teijin Pharma, UCB, and consultant fees from Bristol-Myers Squibb, Eli Lilly Japan, Pfizer Japan, Daiichi Sankyo, and Sanofi. T. Hirose, Y. Endo, N. Sugiyama, Y. Fukuma, N. Sugiyama, N. Yoshii, and Y. Morishima are employees of Pfizer Japan Inc. T. Hirose, N. Sugiyama, E. Yutaka, N. Sugiyama, Y. Morishima, and N. Yoshii are stockholders of Pfizer. N. Miyasaka declared no conflict of interest.

Additional information

Funding

This study was sponsored by Wyeth, which was acquired by Pfizer in October 2009.