An Integrated Summary of the Long-Term Safety of Etanercept (Enbrel®)
in Elderly and Younger Subjects Who Participated in Rheumatology
Clinical Trials
Category: 17. RA — clinical aspects
Author(s): Roy M. Fleischmann1, Scott W. Baumgartner2, Michael H.
Weisman3, Thomas Liu4, Barbara White4, Paul M. Peloso4. 1University of
Texas Southwestern Medical Center at Dallas, Dallas, TX; 2Physicians
Clinic of Spokane, Spokane, WA; 3Cedars-Sinai Medical Center, Los
Angeles, CA; 4Amgen Inc, Thousand Oaks, CA  
Presentation Number: 1464
Poster Board Number: 240
Introduction: Elderly subjects are at heightened risk for adverse
events related to multiple concomitant medications and make up an
important subset of those with rheumatic diseases. This analysis
compares the safety profile of etanercept in elderly clinical trial
subjects (= 65 years of age) and younger subjects (< 65 years of age)
with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and
ankylosing spondylitis (AS).
Methods. Safety data from an integrated database of 4322 subjects
enrolled in 18 RA trials, 2 PsA trials, and 2 AS trials formed the
analysis cohort. Safety events examined included adverse events (AE),
serious adverse events (SAE), infectious events (IE), medically
important infections (MII), and deaths. Other safety event of interest
in patients receiving TNF inhibitors are described, including
demyelinating diseases, tuberculosis, lymphoma, and cardiovascular
disease. Most patients were initially enrolled in controlled
randomized trials comparing placebo (or methotrexate) versus
etanercept and subsequently enrolled into long-term extensions where
they received etanercept (25 mg twice weekly). The incidence of
treatment-related events was determined by subtracting event rates in
the control groups from event rates in the treated groups. Differences
between the incidence in the etanercept-treated and control groups are
reported with 95% confidence intervals. The number of deaths reported
during studies was compared to the National Vital Statistics Report
for 1999.
Results. Rates of SAEs, AEs and withdrawals due to AEs (with 95% CI)
for elderly and younger subjects are shown in the Figure. The
incidence of AE, SAE, IE, MII, and malignancies were not significantly
elevated in elderly subjects when compared with younger subjects.
There were no cases of tuberculosis reported in the trials.
Demyelinating diseases were seen only in younger subjects. The
incidence and causes of deaths in elderly subjects were consistent
with the general population.

Conclusions. Etanercept treatment is a generally safe and
well-tolerated biologic therapy in the elderly. The risk of adverse
events from these studies was no greater in subjects = 65 years of age
compared with younger subjects.

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