A multicenter, open-label study to evaluate the safe and effective use of a new electromechanical auto-injection device for self-injection of certolizumab pegol

Tatla, Daljit; Mountian, Irina; Szegvari, Boglarka; VanLunen, B.; Schiff, Michael

doi:10.1080/17425247.2020.1747430

Cited by 7 publications

(9 citation statements)

References 19 publications

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“…Tatla et al reported a similar study to evaluate the safe and effective use of electromechanical auto‐injection device for self‐injection of CZP in adult patients. After 4 weeks of CZP administration by the AVA®, 89.2% of the patients reported a preference for the e‐Device compared to the prefilled syringe as well as our results 8 …”

Section: Discussionsupporting

confidence: 84%

“…After 4 weeks of CZP administration by the AVA ® , 89.2% of the patients reported a preference for the e-Device compared to the prefilled syringe as well as our results. 8 The main technical problems with AVA ® device that have occurred during the study have been the clogging of the AVA ® devices with used cartridges after its injection. This is due to the management of patients during the withdrawal of used cartridges and AVA ® security system, so we conclude that it is very important to have spare AVA ® devices in the hospital pharmacy and/or other CZP devices to avoid delays in doses that can cause problems.…”

Section: Discussionmentioning

confidence: 99%

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Six months multicentre pilot open label single‐arm study to evaluate patient experience, acceptability and satisfaction of switching certolizumab pegol from a prefilled syringe or autoinjection pen to an AVA ® e‐Device in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis patients

Borrás-Blasco

Vicente-Escrig

Lucena

et al. 2022

Clinical Pharmacy Therapeu

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What Is Known and Objective: The study aimed to assess acceptability and patient experience of Certolizumab (CZP) self-injection with AVA ® and clarify patient device preference after switching CZP from the syringe or auto-injection pen to AVA ® in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients. Method:A multicentre open-label, cross-sectional and prospective study among four Spanish hospitals was performed. Adult RA, PsA, axSpA patients treated for at least 6 months with the CZP syringe or pen were recruited. At the first visit, patients completed Pre-AVA ® questionnaire. Patients were instructed on proper administration of CZP by AVA ® . After 2 and 6 months of CZP self-injections using the AVA ® , patient experience, adherence, preference and safety of each administration was assessed using post-AVA ® questionnaire.Results and Discussion: Thirty four patients were included (28 women). All patients self-administered CZP AVA ® the full dose of CZP was injected. Patients reported >90% adherence to CZP AVA ® assessed with the injection log. Pain at the injection site was reduced after switching to AVA ® . Twenty nine patients preferred CZP AVA ® and five patients preferred the CZP pen. No safety-related findings related to AVA ® CZP administration were identified. What Is New and Conclusion:The AVA ® is an advantageous delivery option for CZP in patients with RA, PsA, axSpA.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Six months multicentre pilot open label single‐arm study to evaluate patient experience, acceptability and satisfaction of switching certolizumab pegol from a prefilled syringe or autoinjection pen to an AVA ® e‐Device in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis patients

Borrás-Blasco

Vicente-Escrig

Lucena

et al. 2022

Clinical Pharmacy Therapeu

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“…Mean age was 52 years (SD: 13 years) and approximately half of patients were in the Q2W schedule treatment group (53%; 37/70). At Visit 1, 68 (100%) patients completed both the pre- and post-injection ASI modules; at Visit 2, 68 (100%) patients completed the pre-injection module, of whom 65 (95.6%) completed the post-injection module; 3 patients did not complete the post-injection module [ 16 ].…”

Section: Resultsmentioning

confidence: 99%

“…The pilot instrument was refined using the patient feedback and administered in RA0098 (NCT03357471), a multicenter, open-label, phase 3 clinical study conducted in the USA that assessed the ability of adult patients already self-injecting CZP using the PFS to safely and effectively self-inject CZP using ava ® [ 16 ]. Administering the instrument in RA0098 enabled qualitative review and evaluation of its psychometric properties.…”

Section: Methodsmentioning

confidence: 99%

Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire

Pompilus

Ciesluk

Strzok

et al. 2020

Health Qual Life Outcomes

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Background Patient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients’ treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties. Methods A mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain’s internal consistency was measured using Cronbach’s ɑ. Results The literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (ɑ > 0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI’s appropriateness and clarity. Conclusions The ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making. Trial registration: NCT03357471

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“…Furthermore, e-Device aims to minimize the patient needle phobia, and the concern about safety in the treatment administration, giving the patient an electronic device that provide the administration (57). Some patients reported a higher satisfaction, self-confidence, safety, and feasibility of e-Device, compared with pre-filled pen and syringes (55,58,59). The use of e-Device could both assess the adherence to treatment, enable patients to track their own data, perform self-assessments, and deliver questionnaires.…”

Section: Pso Patients At Higher Medium/long-term Risk Of Developing Psamentioning

confidence: 99%

The Digital Way to Intercept Psoriatic Arthritis

et al. 2021

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Psoriasis (PsO) and Psoriatic Arthritis (PsA) are chronic, immune-mediated diseases that share common etiopathogenetic pathways. Up to 30% of PsO patient may later develop PsA. In nearly 75% of cases, skin psoriatic lesions precede arthritic symptoms, typically 10 years prior to the onset of joint symptoms, while PsO diagnosis occurring after the onset of arthritis is described only in 15% of cases. Therefore, skin involvement offers to the rheumatologist a unique opportunity to study PsA in a very early phase, having a cohort of psoriatic “risk patients” that may develop the disease and may benefit from preventive treatment. Progression from PsO to PsA is often characterized by non-specific musculoskeletal symptoms, subclinical synovio-entheseal inflammation, and occasionally asymptomatic digital swelling such as painless toe dactylitis, that frequently go unnoticed, leading to diagnostic delay. The early diagnosis of PsA is crucial for initiating a treatment prior the development of significant and permanent joint damage. With the ongoing development of pharmacological treatments, early interception of PsA has become a priority, but many obstacles have been reported in daily routine. The introduction of digital technology in rheumatology may fill the gap in the physician-patient relationship, allowing more targeted monitoring of PsO patients. Digital technology includes telemedicine, virtual visits, electronic health record, wearable technology, mobile health, artificial intelligence, and machine learning. Overall, this digital revolution could lead to earlier PsA diagnosis, improved follow-up and disease control as well as maximizing the referral capacity of rheumatic centers.

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A multicenter, open-label study to evaluate the safe and effective use of a new electromechanical auto-injection device for self-injection of certolizumab pegol

Cited by 7 publications

References 19 publications

Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire

The Digital Way to Intercept Psoriatic Arthritis

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