[Etanercept in routine German clinical practice to treat rheumatoid arthritis patients : A\xa0one-year observational study on effectiveness, safety and health economics].

Abstract

BACKGROUND\nThe efficacy and safety of the TNF‑α inhibitor etanercept (ETA) as a\xa0treatment 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.\n\n\nPATIENTS AND METHODS\nThis prospective non-interventional trial included patients being treated with ETA. Data concerning efficacy, safety and life quality were collected over a\xa0period of 52\xa0weeks. Statistical evaluation was done on a\xa0solely descriptive level.\n\n\nRESULTS\nFrom 329 specialized medical centres, 4945 patients were enrolled. Of all patients, 94.4% received a\xa0co-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\xa0weeks, 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\u202f±\u20091.3 (N\u202f=\u20094304) to 3.3\u202f±\u20091.4 (as observed; N\u202f=\u20092608). EuroQol EQ-5D, a\xa0measurement of health-related life quality issues, indicated an improvement on the visual analogue scale (VAS) from 53.1\u202f±\u200921.3\u202fmm (N\u202f=\u20094718) at baseline to 70.0\u202f±\u200920.5\u202fmm (as observed; N\u202f=\u20093036). 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.\n\n\nCONCLUSION\nBased on a\xa0large number of patients and in a\xa0treatment context that is representative of routine outpatient care in Germany, it was confirmed that patients with RA may benefit from a\xa0treatment with ETA.