Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance.
Antirheumatic agents
Cardiovascular diseases
Efficacy
North America
Poland
Rheumatoid arthritis
Safety
Tofacitinib
Tumor necrosis factor inhibitors
Journal
Rheumatology and therapy
ISSN: 2198-6576
Titre abrégé: Rheumatol Ther
Pays: England
ID NLM: 101674543
Informations de publication
Date de publication:
26 Jul 2024
26 Jul 2024
Historique:
received:
16
12
2023
accepted:
14
06
2024
medline:
27
7
2024
pubmed:
27
7
2024
entrez:
26
7
2024
Statut:
aheadofprint
Résumé
In ORAL Surveillance, incidence rates (IRs) of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) in cardiovascular (CV)-risk-enriched patients with rheumatoid arthritis (RA) were numerically greater with tofacitinib in North America versus the rest of the world, due to underlying risk factors. Here, we evaluated the safety and efficacy of tofacitinib versus tumor necrosis factor inhibitors (TNFi) among patients with RA across geographical regions. Patients with RA in ORAL Surveillance (NCT02092467), who were aged ≥ 50 years with ≥ 1 additional CV risk factor, received tofacitinib 5 or 10 mg twice daily or TNFi; 45.9% were from either Poland or North America. This post hoc analysis stratified patients by region (Poland, North America, Other countries). Efficacy endpoints included Clinical Disease Activity Index, Disease Activity Score in 28 joints, with C-reactive protein (DAS28-4[CRP]), and Health Assessment Questionnaire-Disability Index (HAQ-DI). IRs and hazard ratios for adverse events were reported. Of 4362 patients (Poland, N = 759; North America, N = 1243; Other countries, N = 2360), more patients from North America versus Poland/Other countries had CV risk factors such as body mass index ≥ 30 kg/m Differences in safety outcomes were driven by the presence of baseline risk factors; North America and Poland demonstrated a higher proportion of patients with some baseline CV risk factors/comorbidities versus Other countries. NCT02092467 (ClinicalTrials.gov).
Identifiants
pubmed: 39060905
doi: 10.1007/s40744-024-00693-y
pii: 10.1007/s40744-024-00693-y
doi:
Banques de données
ClinicalTrials.gov
['NCT02092467']
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2024. The Author(s).
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