The efficacy and safety of the TNF‑α inhibitor etanercept (ETA) as a treatment for rheumatoid arthritis (RA) is well established by randomized controlled trials. The purpose of this study was to evaluate the benefit yielded by ETA within the regular outpatient care.
This prospective non-interventional trial included patients being treated with ETA. Data concerning efficacy, safety and life quality were collected over a period of 52 weeks. Statistical evaluation was done on a solely descriptive level.
From 329 specialized medical centres, 4945 patients were enrolled. Of all patients, 94.4% received a co-medication for RA, additionally to their treatment with ETA. At baseline, 22.1% of all patients fulfilled the criteria for functional remission according to the Funktionsfragebogen Hannover (FFbH) questionnaire (95% CI: 21.0-23.3%); at 52 weeks, functional remission rate accounted for 41.1% (last observation carried forward [LOCF], 95% CI: 39.4-42.9%). The disease activity score (DAS) DAS28 declined from 5.4 ± 1.3 (N = 4304) to 3.3 ± 1.4 (as observed; N = 2608). EuroQol EQ-5D, a measurement of health-related life quality issues, indicated an improvement on the visual analogue scale (VAS) from 53.1 ± 21.3 mm (N = 4718) at baseline to 70.0 ± 20.5 mm (as observed; N = 3036). Generally, ETA has been tolerated well. With regard to the safety profile specified by previous studies, no meaningful deviations concerning the nature, frequency or severity of adverse events were detected.
Based on a large number of patients and in a treatment context that is representative of routine outpatient care in Germany, it was confirmed that patients with RA may benefit from a treatment with ETA.