Masayoshi Harigai1, Naoki Ishiguro2, Shigeko Inokuma3, Tsuneyo Mimori4, Junnosuke Ryu5, Syuji Takei6, Tsutomu Takeuchi7, Yoshiya Tanaka8, Yoshinari Takasaki9, Hisashi Yamanaka1, Yuri Yoshizawa10, Ichino Chinen10, Toru Nakao10, Takao Koike11. 1. Division of Epidemiology and Pharmacoepidemiology, Department of Rheumatology, School of Medicine, Tokyo Women's Medical University , Tokyo , Japan. 2. Graduate School & Faculty of Medicine, Nagoya University School of Medicine , Nagoya , Japan. 3. Chiba Central Medical Center , Chiba , Japan. 4. Kyoto University Graduate School of Medicine , Kyoto , Japan. 5. Nihon University School of Medicine , Tokyo , Japan. 6. Faculty of Medicine, Kagoshima University School of Health Science , Kagoshima , Japan. 7. Keio University School of Medicine , Tokyo , Japan. 8. University of Occupational and Environmental Health , Fukuoka , Japan. 9. Juntendo University School of Medicine , Tokyo , Japan. 10. Bristol-Myers Squibb K.K. , Tokyo , Japan. 11. Sapporo Medical Center NTT EC , Sapporo , Japan.
Abstract
Objectives: To investigate the safety, effectiveness, and risk-benefit balance of intravenous abatacept (ABA) in non-elderly (<65 years: NEG) and elderly (≥65 years: EG) rheumatoid arthritis patients. Methods: This sub-analysis of an all-cases postmarketing surveillance in Japan assessed safety in all enrolled patients and effectiveness in those with Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) measurements at ≥2 time points including baseline. Risk-benefit was evaluated based on infections and DAS28-CRP improvement >1.2. Results: The NEG and EG of the safety analysis set comprised 2,170 and 1,712 patients, respectively; corresponding 6-month ABA retention rates were 80.2% and 77.1%. The NEG had fewer adverse drug reactions (14.5% vs. 17.2%, p = .021) and infections (4.8% vs. 7.2%, p = .002) than the EG. DAS28-CRP changed similarly between groups. The proportion of patients with low-risk/high-benefit and high-risk/low-benefit were 33.1% and 6.9% (NEG) and 29.7% and 9.0% (EG). Low-risk/high-benefit patients were younger, had shorter disease duration and fewer comorbidities, and were with less use of oral glucocorticoid and prior biologics, more use of methotrexate and higher DAS28-CRP than high-risk/low-benefit patients at baseline. Conclusion: ABA was well tolerated and similarly efficacious in the EG and NEG. Identification of factors related to low-risk/high-benefit may aid appropriate patient selection.
Objectives: To investigate the safety, effectiveness, and risk-benefit balance of intravenous abatacept (ABA) in non-elderly (<65 years: NEG) and elderly (≥65 years: EG) rheumatoid arthritispatients. Methods: This sub-analysis of an all-cases postmarketing surveillance in Japan assessed safety in all enrolled patients and effectiveness in those with Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) measurements at ≥2 time points including baseline. Risk-benefit was evaluated based on infections and DAS28-CRP improvement >1.2. Results: The NEG and EG of the safety analysis set comprised 2,170 and 1,712 patients, respectively; corresponding 6-month ABA retention rates were 80.2% and 77.1%. The NEG had fewer adverse drug reactions (14.5% vs. 17.2%, p = .021) and infections (4.8% vs. 7.2%, p = .002) than the EG. DAS28-CRP changed similarly between groups. The proportion of patients with low-risk/high-benefit and high-risk/low-benefit were 33.1% and 6.9% (NEG) and 29.7% and 9.0% (EG). Low-risk/high-benefit patients were younger, had shorter disease duration and fewer comorbidities, and were with less use of oral glucocorticoid and prior biologics, more use of methotrexate and higher DAS28-CRP than high-risk/low-benefit patients at baseline. Conclusion: ABA was well tolerated and similarly efficacious in the EG and NEG. Identification of factors related to low-risk/high-benefit may aid appropriate patient selection.