Fleischmann RM, Baumgartner SW, Tindall EA, Weaver AL, Moreland LW, Schiff MH, Martin RW, Spencer-Green GT.
University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA.
OBJECTIVE: Approximately 3% of the US population over the age of 65 years has rheumatoid arthritis (RA). We compared the safety and efficacy of etanercept (Enbrel(R)) in patients with RA who were >/= 65 years to those < 65 years in open-label and double-blind, randomized clinical trials.
METHODS: Patients from 4 double-blind, randomized controled trials and 5 open-label trials were included in this retrospective analysis. Patients were grouped by age (/= 65 yrs) at time of study entry. All patients received etanercept subcutaneously twice weekly. Improvement in signs and symptoms was assessed by the proportion of patients who achieved the American College of Rheumatology definition of improvement (ACR 20). The ACR 50 and ACR 70 responses were calculated in an analogous fashion. Safety was assessed at regularly scheduled visits.
RESULTS: Of 1128 patients enrolled in etanercept trials, 197 (17%) were >/= 65 years of age. Clinical response was rapid and sustained and did not differ between age groups. At one year, 69% of patients /= 65 years met the ACR 20. Forty percent of the patients >/= 65 years met the ACR 50 and 17% met the ACR 70. Etanercept was well tolerated. Although injection site reactions, headache, and rhinitis occurred somewhat more frequently in younger patients, the overall rates and types of other adverse events were comparable in both groups.
CONCLUSION: Etanercept is a new treatment option for older patients with RA and has substantial benefit and comparable safety regardless of patient age.
J Rheumatol 2003 Apr;30(4):691-6