Publications by authors named "E C Keystone"
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).
Article Synopsis
- The study aimed to show that CT-P47 is as effective as the EU-approved tocilizumab (r-TCZ) in treating rheumatoid arthritis (RA) patients.
- Conducted as a double-blind, phase III trial, 471 patients were randomized to receive either CT-P47 or r-TCZ, with efficacy measured primarily through changes in Disease Activity Score at specified weeks.
- Results indicated that both treatments had similar efficacy, pharmacokinetics, safety, and immunogenicity profiles, confirming CT-P47's equivalence to r-TCZ even after patients switched from r-TCZ to CT-P47.
CT-P47 is a candidate biosimilar of tocilizumab. This 12-week, randomized, double-blind, parallel-design, phase 1 study aimed to demonstrate pharmacokinetic (PK) equivalence of CT-P47 and reference tocilizumab. Participants were healthy Japanese adults aged 18-55 years.
View Article and Find Full Text PDFBackground: This study compared the pharmacokinetics (PK), immunogenicity, and safety of candidate tocilizumab biosimilar, CT-P47, administered via auto-injector (CT-P47 AI) or pre-filled syringe (CT-P47 PFS), in healthy Asian adults.
Research Design And Methods: In this phase I, multicenter, open-label study, participants were randomized 1:1 to receive a single 162 mg/0.9 mL dose of CT-P47 via AI or PFS.
Objective: Hypertension (HTN) is a common comorbidity in RA. This study aimed to explore the prevalence and incidence of HTN and baseline factors associated with incident HTN in early RA (ERA).
Methods: Data were from the Canadian Early Arthritis Cohort (CATCH), an inception cohort of ERA patients having <1 year of disease duration.