Efficacy and Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis: A Post-Hoc Analysis of Randomized Controlled Trials
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Elderly individuals are disproportionately affected by rheumatoid arthritis (RA), but few studies have addressed the efficacy and safety of treatments in this population.
Our objective was to assess the efficacy and safety of etanercept in elderly patients (aged ≥ 65 years) with RA.
The efficacy analysis was a post hoc analysis of data from the open-label period of three phase IV clinical trials of etanercept for RA. Least squares (LS) change from baseline (cfb) in 28-joint Disease Activity Score (DAS28), Health Assessment Questionnaire Disability Index (HAQ-DI), and modified Total Sharp Scores (mTSS) were analyzed by age (< 65 vs. ≥ 65 years) for each study. The safety analyses were of data pooled from the double-blind, placebo-controlled periods of 19 phase I–IV randomized studies of etanercept in patients with RA. The percentage occurrence of adverse events (AEs) in placebo- and etanercept-treated patients was analyzed by age (< 65 vs. ≥ 65 years).
There were no significant differences in LS mean cfb in DAS28 or mTSS between the two age groups. LS mean cfb in HAQ-DI scores was consistently lower in elderly than in non-elderly patients, although significant differences were not observed in all trials. Overall, AE occurrence was higher in elderly than non-elderly patients, regardless of treatment. In etanercept-treated patients, there were small yet statistically significant increases in the occurrence of congestive heart failure, serious infections, and non-melanoma skin cancers in elderly versus non-elderly patients. For most AEs, occurrence did not significantly differ between elderly and non-elderly patients.
Overall, there were no substantial differences in the efficacy or safety of etanercept between elderly and non-elderly patients with RA.
Compliance with Ethical Standards
This study was funded by Pfizer. Medical writing support was provided by Lorna Forse, PhD, of Engage Scientific Solutions and was funded by Pfizer.
Conflict of Interest
Professor Edwards has received honoraria for advisory boards and speakers’ bureau and research support from AbbVie, BMS, Biogen, Celgene, Fresenius, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, and UCB. Ms. Roshak was an employee of Pfizer at the time of data generation and manuscript initiation. Dr. Thakur is an employee of RegSafe Consulting Limited and was contracted by Pfizer in connection with the development of the manuscript. Mr. Pedersen, Dr. Borlenghi, and Dr. Curiale are employees of and own stock in Pfizer. Dr. Bukowski, Ms. Jones, and Dr. Marshall were employees of Pfizer at the time of data generation and manuscript development and own stock in Pfizer.
As a non-interventional study, ethical approval was not required for this analysis. This article does not contain any studies with human participants or animals performed by any of the authors.
Upon request, and subject to certain criteria, conditions, and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
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