Abstract

Background:Anti-tumour necrosis factor (anti-TNF) adherence is suboptimal and impacted by multiple psychological, practical and physical barriers, such as patient needle phobia, lack of confidence in self-administration skills and forgetting injection dates (1,2). ava®, a reusable electro-mechanical self-injection device (e-Device) developed for certolizumab pegol (CZP) administration, aims to overcome some of these barriers.Objectives:The objective of this study was to explore the clinical retention rate of an e-Device aimed at empowering chronic arthritis patients using CZP.Methods:Patients treated with CZP were recruited from the Netherlands, Denmark and Sweden through rheumatology clinics to evaluate patient experience with the e-Device. Patients were adults (aged between 18 and 85 years) with RA, axSpA or PsA. After being trained on how to use the e-Device, patients administered 3 consecutive self-injections on their own. Descriptive statistics for baseline characteristics, retention rates and reasons for withdrawal were assessed. Data on physical function (HAQ) are reported for Denmark and Sweden only due to lack of data from Holland.Results:59 patients participated in the study (Netherlands: 25; Denmark: 15; Sweden: 19). Most patients were women (71%), with a mean age of 55 years [16.2] and an average disease duration of 12 years [8.8]. A total of 42% and 39% had previously been treated with csDMARD(s) or were currently on csDMARD(s), respectively. 12% of the patients were bio-naive. Only 6 (10%) patients started CZP de novo. The remaining switched device. The most used administration form prior to entering the study was pre-filled syringe (78%). At the time of inclusion, patients were mildly disabled with an average HAQ score of 0.5 [0.6] and a moderate VAS-pain score of 32 [25.1] (data not shown).The overall retention rate was 42% after 52 weeks, declining to 38% after 104 weeks (Figure 1). A sharp decline is seen at week 8 which coincides with the end of the project phase. Between week 32 and 112 only 4 patients withdrew from the study (Figure 1). The primary reason for withdrawal was patient’s request (Figure 1). Dropout rates due to lack of efficacy or adverse events were as expected compared to other cohorts of biologic therapies. When stratified by country the analysis showed no significant differences between countries (data not shown).Figure 1.Overall retention rate and reasons for withdrawalConclusion:An initial large drop-out was evident within the first 8 weeks, whereas almost no drop-out was seen in the extension phase (after week 8). The reasons for withdrawal was primarily patient request. Thus, the injection experience must be tailored carefully when selecting patients for new autoinjector e-Devices to enhance retention on device and patient satisfaction. Not one device fits all.

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