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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.
Acknowledgements
The authors thank all the medical institutions and physicians who participated in this PMS for their cooperation. The authors would also like to thank Toru Yada of EPS Corporation for providing statistical analysis, and Keyra Martinez Dunn, MD, and JL Croxford, PhD, of Edanz Medical Writing for providing medical writing assistance, which was funded by Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co. Ltd. The PMS was funded by Bristol-Myers Sruibb K.K.
Conflict of interest
YY, IC, and TN are employees of Bristol-Myers Squibb K.K.
MH, NI, SI, TM, JR, ST, TT, Y. Tanaka, Y. Takasaki, HY, and TK are members of the Postmarketing Surveillance (PMS) Committee of the Japan College of Rheumatology. It is the belief of the authors that this does not constitute a conflict of interest. The authors participated in review and analysis of the PMS data in their capacity as committee members.