Patients' Perceptions of Subcutaneous Delivery of Darbepoetin Alfa by Autoinjector Prefilled Pen Versus Prefilled Syringe: A Randomized, Crossover Study

Lim, Wai H.; Chan, Doris; Boudville, Neil; Pellicanò, S; Herson, Helen; Moody, Harry; Hutchison, Brian; Snedeker, Marianne; Dogra, Gursharan

doi:10.1016/j.clinthera.2012.07.012

Cited by 20 publications

(15 citation statements)

References 29 publications

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“…Overall, the subjective-measures questionnaire indicated that patients felt the MTX pen was easy to use and their overall impression was favorable. Other studies of autoinjector pens in patients with chronic disorders (including RA) requiring long-term injection treatments have also reported favorable patient opinions, 24 – 26 and that autoinjector pens were preferred by patients over syringes mostly because of their ease of use and convenience. In this study, some patients remarked that they felt the MTX pen was even more convenient than taking oral MTX.…”

Section: Discussionmentioning

confidence: 97%

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Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis

Pachon¹,

Kivitz

Heuer

et al. 2014

SAGE Open Medicine

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Objective:To assess usability, bioavailability, and safety of subcutaneous self-administration of 0.3 mL of methotrexate 50 mg/mL solution via a prefilled autoinjector pen (methotrexate pen) in patients with rheumatoid arthritis.Methods:The study enrolled methotrexate-naïve and methotrexate-experienced patients aged ≥16 years. Visit 1 (Day 1) included methotrexate pen usage training with documentation, patient self-injection, and a patient-training questionnaire completed by the healthcare professional. Visit 2 (Days 8–10) included evaluation of patient self-injection through four scenarios: holding needle in place for 5 s, confirming methotrexate delivery, skin pinch, and pen disposal. At Visit 2, patient opinion and training retention (since Visit 1) were also assessed. Pharmacokinetic parameters were assessed in 25 patients, who were stratified by body weight and randomized to receive injections in the abdomen or the upper thigh.Results:At Visit 1, 12 of 106 patients had questions about the pen, and 4 required self-injection assistance. At Visit 2, the mean performance rating for all scenarios was ≥9.8 (scale: 1 (very difficult)−10 (very easy)). Successful completion rates were 96.2%–100%; 91.3%–100% of patients required no assistance. Impressions of the pen were favorable; 98.1% of patients passed the written examination. All methotrexate pens effectively delivered 0.3 mL methotrexate and were intact after use. Body weight >100 kg significantly decreased total and peak methotrexate exposure when administered abdominally. No adverse effects resulted in drug discontinuation.Conclusion:The methotrexate pen was used with a high degree of effectiveness, satisfaction, and safety, indicating that this delivery system may be a viable option for patients requiring subcutaneous methotrexate.

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Section: Discussionmentioning

confidence: 97%

“… 23 Importantly, patients with RA and other chronic disorders have been found to prefer autoinjection pen devices versus more conventional treatments (e.g. vial and syringe, prefilled syringe) in clinical trials because of their ease of use and convenience, 24 – 26 with some patients reporting improved quality of life. 27 , 28 …”

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confidence: 99%

Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis

Pachon¹,

Kivitz

Heuer

et al. 2014

SAGE Open Medicine

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“…Participants had normal or corrected-to-normal vision. Participants were recruited anew for each experiment (n 1 = 10, n 2 = 14, n 3 = 11) to control for learning effects [62,63]. During simulated self-injection, all participants wore eye-tracking glasses.…”

Section: Methodsmentioning

confidence: 99%

Toward a new age of patient centricity? The application of eye-tracking to the development of connected self-injection systems

Lohmeyer

Schneider

Jordi

et al. 2019

Expert Opinion on Drug Delivery

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Background: Increasing interest in digitally enhanced drug delivery tools urges both industry and academia to rethink current approaches to product usability testing. This article introduces mobile eyetracking, generating detailed contextual data about user engagement with connected self-injection systems as a new methodological approach to formative usability assessment. Methods: A longitudinal case study with a total of 35 injection-naïve participants was conducted. In three consecutive experiments, eye-tracking was applied to formative usability testing of a novel connected self-injection device. Three eye-tracking derived usability indicators were established to assess product effectiveness, efficiency, and ease of use. Results: Analysis of the data revealed events of user hesitation, process interruption and unintended action, and these occurrences could either be completely eliminated or significantly reduced throughout the process (product effectiveness). At the same time, the overall use duration decreased from 86.1 to 58.7 sec (product efficiency). Analysis revealed that product modifications successfully guided user attention to those interface elements most relevant during each task, thereby improving product easeof-use. Conclusions: The step-wise improvement in the usability indicators demonstrates that iteratively applying eye-tracking methods effectively supports the user-centered design of connected selfinjection systems. The results highlight how eye-tracking can be employed to gain an in-depth understanding of patient engagement with novel healthcare technologies. ARTICLE HISTORY

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“…By contrast, the PFS‐U may be more difficult for patients to grip, the plunger must be pushed from the top, and the needle remains outside the device. In several studies that examined patient preferences, the majority of patients reported that they preferred autoinjector administration compared with their prior device or nurse‐administered SC injections with a syringe, and that autoinjector administration was associated with lower levels of injection‐related pain and discomfort . Thus, these features may make the autoinjector more desirable as a delivery system for sirukumab than the prefilled syringe.…”

mentioning

confidence: 99%

Absolute Bioavailability and Pharmacokinetic Comparability of Sirukumab Following Subcutaneous Administration by a Prefilled Syringe or an Autoinjector

Zhuang

Vries

Marciniak

et al. 2017

Clinical Pharm in Drug Dev

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This phase 1, randomized, open-label study assessed the absolute bioavailability and pharmacokinetic comparability of sirukumab, a human anti-interleukin-6 monoclonal antibody, following subcutaneous (SC) administration via Prefilled Syringe-UltraSafe Passive® Delivery System (PFS-U) or Prefilled Syringe-SmartJect® Autoinjector (PFS-AI; Janssen Research & Development, LLC, Spring House, Pennsylvania). A total of 144 healthy male subjects were randomized to 5 single-dose treatment groups: sirukumab 50 mg and 100 mg (each by PFS-U and PFS-AI) and sirukumab 100 mg intravenous (IV) infusion. Pharmacokinetic parameters were calculated using noncompartmental analysis. Following SC administration, maximum serum concentrations (C ) and area under the concentration-vs-time curve (AUC) increased in an approximately dose-proportional manner. Median time to reach C was 5 days, and mean half-life ranged from 16 to 19 days. Mean absolute bioavailability of sirukumab by PFS-AI and PFS-U, respectively, was estimated at 92.4% and 81.4% with 100 mg and 88.4% and 94.7% with 50 mg. Ratios of geometric means (90% confidence intervals) of C and AUC for PFS-AI:PFS-U were 1.13 (1.03, 1.25) and 1.14 (1.05, 1.24), respectively, indicating comparable systemic exposures of sirukumab following a single 100-mg SC dose by PFS-U or PFS-AI. The incidence of antibodies to sirukumab was low (1.4%). No new safety concerns associated with sirukumab were identified at either dose.

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Patients' Perceptions of Subcutaneous Delivery of Darbepoetin Alfa by Autoinjector Prefilled Pen Versus Prefilled Syringe: A Randomized, Crossover Study

Cited by 20 publications

References 29 publications

Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis

Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis

Toward a new age of patient centricity? The application of eye-tracking to the development of connected self-injection systems

Absolute Bioavailability and Pharmacokinetic Comparability of Sirukumab Following Subcutaneous Administration by a Prefilled Syringe or an Autoinjector

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