Tofacitinib Safety and Effectiveness in Canadian Patients with Rheumatoid Arthritis by Cardiovascular Risk Enrichment: Subanalysis of the CANTORAL Study

Autor: Boulos Haraoui, Majed Khraishi, Denis Choquette, Isabelle Fortin, Cassandra D. Kinch, Corina Galos, Patrice Roy, David Gruben, Julie Vaillancourt, John S. Sampalis, Edward C. Keystone
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Rheumatology and Therapy, Vol 11, Iss 6, Pp 1629-1648 (2024)
Druh dokumentu: article
ISSN: 2198-6576
2198-6584
DOI: 10.1007/s40744-024-00719-5
Popis: Abstract Introduction ORAL Surveillance, a post-authorisation safety study of patients with rheumatoid arthritis (RA) enriched for cardiovascular (CV) risk, demonstrated increased risk of major adverse CV events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) for tofacitinib versus tumour necrosis factor inhibitors (TNFi). This analysis of a real-world Canadian observational study evaluated tofacitinib safety/effectiveness in patients meeting or not meeting CV risk criteria. Methods CANTORAL included patients with moderate-to-severe RA initiating tofacitinib (10/2017–07/2020; N = 504). Interim data (data-cut: 07/2021) were stratified as CV risk-enriched (CV+ ; patients ≥ 50 years with ≥ 1 additional CV risk factor) or not CV risk-enriched (CV−; ≥ 50 years without additional CV risk factors and 18–49 years with/without CV risk factors). Safety and persistence were evaluated to month (M) 36. Effectiveness outcomes to M18 included Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA)/remission (CANTORAL co-primary endpoints) and Disease Activity Score in 28 joints, C-reactive protein (DAS28-4[CRP])
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