Impact of age on the efficacy and safety of peficitinib (ASP015K) for the treatment of rheumatoid arthritis.
Mod Rheumatol
; 32(4): 696-707, 2022 Jul 01.
Article
em En
| MEDLINE
| ID: mdl-34850095
ABSTRACT
OBJECTIVES:
To evaluate peficitinib efficacy and safety in Asian patients with rheumatoid arthritis (RA), stratified by age (≥20-<50, ≥50-<65, and ≥65 years).METHODS:
Efficacy data from two Phase 3 studies were analysed. Safety data from one Phase 2, two Phase 3, and one open-label extension study were pooled. Incidence rates per 100 patient-years of adverse events of special interest were calculated, and Cox proportional hazard analysis was conducted.RESULTS:
1052 patients received peficitinib for 2 years (median). Peficitinib demonstrated efficacy improvements versus placebo across all age categories. Incidence rates (95% confidence interval) per 100 patient-years for ≥20-<50, ≥50-<65, and ≥65 years were 0.8 (0.4, 1.9), 2.6 (1.8, 3.7), and 4.7 (3.1, 7.0) for serious infections and 3.7 (2.5, 5.4), 6.4 (5.0, 8.2), and 11.2 (8.5, 14.7) for herpes zoster-related disease, respectively. Twenty patients reported malignancies in pooled Phase 2/3 studies. Incidences of serious infections and herpes zoster-related disease increased significantly with age, but there was no association with baseline estimated glomerular filtration rate.CONCLUSIONS:
Peficitinib was efficacious in adult Asian RA patients of all ages. Age, but not estimated glomerular filtration rate, was associated with serious infections and herpes zoster-related disease, demonstrating the importance of an appropriate RA treatment strategy in older patients.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Artrite Reumatoide
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Adamantano
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Fatores Etários
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Niacinamida
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Antirreumáticos
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article