Comparison of patient satisfaction with two different etanercept delivery systems
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U. Müller-Ladner, Bad Nauheim U. Lange, Bad Nauheim
U. Müller-Ladner1 · R. M. Flipo2 · P. Vincendon3 · Y. Brault4 · D. Kielar5 1 Department for Rheumatology and Clinical Immunology, Justus-Liebig University Giessen,
Kerckhoff Clinic, Bad Nauheim 2 Department of Rheumatology, Hospital Roger Salengro-CHU -Lille, University of Lille 2, Lille 3 Formerly of Wyeth Research, Paris 4 Pfizer Global Research and Development, Paris 5 Clinical Affairs, Specialty Business Unit, Pfizer Inc, Kent
Comparison of patient satisfaction with two different etanercept delivery systems A randomised controlled study in patients with rheumatoid arthritis
Rheumatoid arthritis (RA) is a progressive inflammatory disease with serious negative impact on the patient’s life. Worldwide, the prevalence rate of RA is approximately 1% [1]. The approach to management of RA emphasises aggressive control of inflammation to prevent long-term joint damage using disease-modifying antirheumatic drugs (DMARDs), particularly methotrexate, alone or in combination with other DMARDs in early stages of the disease. Highly effective biologic DMARDs have continued to emerge recently, including tumor necrosis factor-alpha (TNF-α) inhibitors [2]. The anti-TNF-α biologic, etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage and improve physical function [3]. In chronic conditions such as RA requiring long-term treatment, it is important to empower the patients to achieve independence in everyday administration of their treatment and to improve management of their disease. The development of readyto-use devices for subcutaneous (sc) injections has given more options to adminis-
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Zeitschrift für Rheumatologie 10 · 2012
ter long-term treatments such as insulin, hormones, or biologic DMARDs [4, 5, 6, 7]. This can give patients with chronic disease greater freedom in their social life and improved self-esteem, which can also have a potentially beneficial effect on treatment adherence. Nevertheless, some patients are reluctant to perform self-injection as they lack the confidence to do so correctly and feel safer in a hospital environment, being reassured by the pre sence of a doctor [8]. Therefore, research has been conducted to improve the design and ease of use of self-injection devices [9, 10, 11]. At the time this study was proposed, etanercept was available in a lyophilised formulation; however, two new devices were planned: a pre-filled syringe (PFS) and a pre-filled pen (PFP). In the intervening period, the PFS has become available throughout the European Union while the PFP is available in at least 12 European countries. The main objective of this study was to compare patients’ acceptance of the two devices: the PFS and PFP. There is no single validated measure that captures all patients’ perceptions of an injection device. However, the concept of patient satis faction has been widely used in previous
device studies [12, 13, 14] and was therefore chosen as the primary endpoint
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