title: Comparison of patient satisfaction with two different etanercept delivery systems. A randomised controlled study in patients with rheumatoid arthritis.
abstract: The objective of this study was to investigate patients' perceptions of the acceptability of two devices delivering etanercept for rheumatoid arthritis (RA) treatment and to explore whether specific patients' attributes are associated with device preferences. Two similar multicenter, open-label, randomised, parallel-design studies were conducted in a total of 13 European countries. A total of 640 adult patients with RA were randomised to receive etanercept 50 mg once-weekly subcutaneously for 12 weeks in either a pre-filled syringe (PFS) or a pre-filled pen (PFP). Patient satisfaction at week 12 was measured on a 0- to 10-point Likert scale (primary endpoint). The study was powered to demonstrate non-inferiority of a PFP over PFS for the primary endpoint. At week 12, mean patient satisfaction was 8.3 (± 2.4) points in the pen group and 7.2 (± 2.6) points in the syringe group. Non-inferiority and even superiority of the pen over the syringe was demonstrated. In conclusion, this study showed higher patient satisfaction in the group of patients injecting etanercept with a PFP compared with the group of patients using a PFS.
authors.affiliation: Department for Rheumatology and Clinical Immunology, Justus-Liebig University Giessen, Kerckhoff Clinic, 61231, Bad Nauheim, Germany. U.Mueller-Ladner@kerckhoff-klinik.de
authors.forename: U
authors.initials: U
authors.lastname: Müller-Ladner
authors.forename: R M
authors.initials: RM
authors.lastname: Flipo
authors.forename: P
authors.initials: P
authors.lastname: Vincendon
authors.forename: Y
authors.initials: Y
authors.lastname: Brault
authors.forename: D
authors.initials: D
authors.lastname: Kielar
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D000068800:Etanercept; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage*; D008297:Male; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D015995:Prevalence; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D012646:Self Administration / Q000295:instrumentation* / Q000706:statistics & numerical data*; D013594:Syringes / Q000145:classification / Q000706:statistics & numerical data*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept