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      Addition Of A Sleeve To The Etanercept Autoinjector (Enbrel ® MyClic ®) Improves Ease Of Use In Patients With Rheumatoid Arthritis

      1 , 1 , 2

      Medical Devices (Auckland, N.Z.)

      Dove

      human factors, usability, user study

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          Abstract

          Purpose

          A novel device (sleeve) has been developed that attaches to compatible autoinjectors and is designed to improve the patient experience, particularly for those with limited manual dexterity. This study was designed to explore whether user experience is improved when using the Enbrel ® MyClic ® autoinjector in conjunction with the sleeve. The Enbrel MyClic autoinjector contains etanercept (Enbrel ®), a biologic drug that patients self-administer subcutaneously for the treatment of rheumatoid arthritis (RA).

          Patients and methods

          Twenty-four adult patients (16 female) with RA and varying degrees of manual dexterity impairment took part in this user study. Written informed consent was supplied by each patient prior to performing the study. They each performed two simulated injections into skin pads, one with the Enbrel MyClic alone and the other with the Enbrel MyClic + sleeve. Following the simulated injections, participants answered questions about their experience of using the sleeve and rated the following on a scale of 1 (poor experience) to 7 (optimal experience): overall use; ease of preparation; ease of administration; ease of learning to use; look, feel and size of the device; overall experience.

          Results

          Participants rated the Enbrel MyClic + sleeve more highly than the Enbrel MyClic alone for overall use, ease of administration, feel, size and overall experience. Participants with severe dexterity impairment (n = 12) were more likely to rate these features as better with the sleeve in place than those with mild dexterity impairment (n = 10). Three-quarters of participants said they would request the sleeve if it became available and all said that they would recommend it to others. The main benefits cited by participants were better grip and a better feeling of control.

          Conclusion

          Addition of the sleeve improved patients’ experience of using the Enbrel MyClic. The benefits of the sleeve outweighed any inconvenience associated with the additional steps needed to prepare the device.

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          Most cited references 7

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          Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial.

          Adalimumab is a therapeutic monoclonal antibody for SC administration by 2 single-use injection devices providing bioequivalent amounts of adalimumab: a ready-to-use, prefilled syringe and an integrated, disposable delivery system, the autoinjection Pen. Although pens have been shown to be preferred over syringes by patients requiring long-term SC administration of medications, there are no data on preference and pain in the use of biologics in patients with chronic inflammatory diseases. The aim of this study was to assess injection-site pain, tolerability, and patient preference of 2 delivery systems of adalimumab. Patients with rheumatoid arthritis were enrolled in a Phase II, multicenter, open-label, single-arm, sequential trial. Patients self-administered a standard dose of adalimumab 40 mg SC every other week at each of 3 monitored clinical visits: visit 1 (syringe), visits 2 and 3 (Pen). At each visit, patients rated their pain on an 11-point scale (0 = none to 10 = pain as bad as it could be) immediately after injection and 15-30 minutes after injection and provided their impressions of and preferences for each delivery system. Safety events were recorded throughout the study and 70 days after final study dose. Fifty-two patients were enrolled in the trial and completed all 3 visits (32 women, 20 men; mean [SD] age, 53.8 [12.1] years). Forty (76.9%) patients reported that the Pen was less painful than the syringe, 4 (7.7%) patients found the syringe to be less painful, and 8 (15.4%) patients had no preference. Patients had statistically significant reductions in injection-pain scores from visit 1 to visit 2 and from visit 1 to visit 3. No new safety signals or apparent differences regarding tolerability between the syringe and Pen were observed. In addition, 46 (88.5%) patients preferred the Pen, 3 (5.8%) preferred the syringe, and 3 (5.8%) had no preference. Overall, patients evaluated the Pen as easier to use (94.2%), more convenient (92.3%), requiring less time to inject (82.7%), and safer (88.5%). Patients experienced less pain self-administering adalimumab via the Pen and preferred it versus the syringe. Further, patients perceived the Pen to be easier to use and more convenient. Both delivery systems were generally well tolerated.
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            The Purdue Pegboard: norms and studies of reliability and validity.

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              An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects

              Background The ability to self-inject in patients with multiple sclerosis (MS) has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patients' independence. However, injection anxiety, needle phobia and disease-related disability are major barriers to a patient's ability to self-administer treatment. Use of an autoinjector may improve patients' ability to self-inject. This study evaluated the safe and effective use of Avonex Pen™ (prefilled pen), a single use autoinjector, for intramuscular delivery of interferon beta-1a (IM IFNβ-1a, Avonex) in MS patients. Methods This was a Phase IIIb, open-label, single-country, multicenter trial in MS patients currently using IM IFNβ-1a prefilled syringes. Patients received weekly 30 mcg IM IFNβ-1a treatment over 4 weeks. On Day 1, patients self-administered IM IFNβ-1a using a prefilled syringe at the clinic. On Day 8, patients received training on the prefilled pen and self-administered IM IFNβ-1a using the device. On Day 15, patients self-administered IM IFNβ-1a at home using the prefilled pen. A final injection occurred at the clinic on Day 22 when patients self-administered IM IFNβ-1a using the prefilled pen while clinic staff observed and completed a detailed questionnaire documenting patients' ability to self-inject with the device. Serum neopterin levels were evaluated pre and post-injection on Days 1 and 8. Adverse events were monitored throughout. Results Seventy-one (96%) patients completed the study. The overall success rate in safely and effectively using the prefilled pen was 89%. No device malfunctions occurred. One unsuccessful administration occurred at Day 22 due to patient error; no patient injury resulted. Patients gave the prefilled pen high ratings (8.7-9.3) on a 10-point scale for ease of use (0 = extremely difficult, 10 = extremely easy). Ninety-four percent of patients preferred the prefilled pen over the prefilled syringe. Induction of serum neopterin levels, serving as a biomarker for type 1 interferon action, was similar to that of the prefilled syringe. The prefilled pen demonstrated a safety profile comparable to the prefilled syringe. Conclusions The prefilled pen is a safe and effective device for administration of IM IFNβ-1a and represents an alternative method for self-injection for MS patients using this therapy. Trial registration This study is registered at clinicaltrials.gov, identifier: NCT00828204
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                Author and article information

                Journal
                Med Devices (Auckl)
                Med Devices (Auckl)
                MDER
                mder
                Medical Devices (Auckland, N.Z.)
                Dove
                1179-1470
                25 October 2019
                2019
                : 12
                : 443-450
                Affiliations
                [1 ]Pfizer R&D Ltd, Device Centre of Excellence , Cambridge, UK
                [2 ]Harvey Medical Consulting Ltd , Cambridge, UK
                Author notes
                Correspondence: Naceur Rekaya Pfizer R&D Ltd, Device Centre of Excellence , Granta Park, Great Abington, CambridgeCB21 6GP, UKTel +44 1304 616 161 Email naceur.rekaya@pfizer.com
                Article
                216649
                10.2147/MDER.S216649
                6818675
                © 2019 Rekaya et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 2, Tables: 2, References: 8, Pages: 8
                Funding
                Funded by: Pfizer Ltd
                The study was funded by Pfizer Ltd. Pfizer had input into the design of the study and preparation of the manuscript.
                Categories
                Original Research

                Biotechnology

                user study, usability, human factors

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