Efficacy and Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis: A Post-Hoc Analysis of Randomized Controlled Trials.
Drugs Aging
; 36(9): 853-862, 2019 09.
Article
in En
| MEDLINE
| ID: mdl-31292906
ABSTRACT
BACKGROUND:
Elderly individuals are disproportionately affected by rheumatoid arthritis (RA), but few studies have addressed the efficacy and safety of treatments in this population.OBJECTIVE:
Our objective was to assess the efficacy and safety of etanercept in elderly patients (aged ≥ 65 years) with RA.METHODS:
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).RESULTS:
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.CONCLUSION:
Overall, there were no substantial differences in the efficacy or safety of etanercept between elderly and non-elderly patients with RA.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Arthritis, Rheumatoid
/
Safety
/
Randomized Controlled Trials as Topic
/
Antirheumatic Agents
/
Etanercept
Type of study:
Clinical_trials
Limits:
Aged
/
Female
/
Humans
/
Male
Language:
En
Journal:
Drugs Aging
Journal subject:
GERIATRIA
/
TERAPIA POR MEDICAMENTOS
Year:
2019
Document type:
Article
Affiliation country:
Reino Unido