An observational study demonstrating the adherence and ease of use of the injector device, RebiSmart®

Vališ, Martin; Šarláková, Jana; Halúsková, Simona; Klímová, Blanka; Potužník, Pavel; Peterka, Marek; Kuča, Kamil; Šťourač, Pavel; Mareś, Jan; Pavelek, Zbyšek

doi:10.1080/17425247.2020.1742694

Cited by 10 publications

(8 citation statements)

References 20 publications

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“…Several studies have shown that RebiSmart autoinjector device helps pwMS to adhere to the sc IFN therapy and consequently, may help to improve their clinical outcomes. [8,12,[17][18][19][20] The design of the device has continuously evolved to meet the evolving needs of pwMS. In this quest of unrelenting improvement, a recent formative usability study aimed at identifying recommendations for improvement to the existing RebiSmart device.…”

Section: Discussionmentioning

confidence: 99%

Preferences and perspectives of MS nurses and patients with multiple sclerosis regarding the new RebiSmart® 3.0 autoinjector versus other assistive devices

Colten,

Cantogno,

Jack

2023

Preprint

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Background RebiSmart® is an electromechanical multidose autoinjector developed for administering subcutaneous interferon β-1a in patients with multiple sclerosis (pwMS). This online survey aimed to understand MS nurses’ and pwMS preferences and perceptions regarding the features of an upgraded version of the RebiSmart device (RebiSmart 3.0) compared to other assistive devices used for multiple sclerosis (MS) therapy. Patients and methods: Eligible MS nurses and pwMS from Germany, Italy, and the United Kingdom completed a double-blind, 30-minute online self-administered questionnaire, including a 10-minute video describing the features of RebiSmart 3.0 and its use in administering interferon β-1a. Results In total, 102 participants (MS nurses, n = 52; patients, n = 50) completed the survey. Overall, 70% respondents found the RebiSmart 3.0 device “very”/“extremely” appealing, 53% were “very”/“extremely” interested in learning more, and 71% stated they would be “very”/“extremely” comfortable using (pwMS) or educating (MS nurses) on it. Respondents ranked customizable injection process (including injection speed, hold time, depth and rotation guide), self-injection process, and hidden needle as the most important self-assistive device features. RebiSmart 3.0 was rated higher than other self-injecting devices on all tested features. After reviewing the video, 52% respondents had no questions, 67% nurses recommended providing more information on the customizable injection process feature of RebiSmart 3.0 to patients, and 88% nurses considered patient demonstration materials to be the most helpful type of information for them when initiating and educating pwMS on self-assistive devices. Conclusions The overall reactions of MS nurses and pwMS to the RebiSmart 3.0 device features were positive. The incremental advances over previous versions of the device as well as in comparison with other currently available assistive devices were welcomed. The MS nurses identified key needs for patient education on the use of the device and the suitable approaches (training videos and educational leaflets) to support MS nurses and pwMS.

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Section: Discussionmentioning

confidence: 99%

Preferences and perspectives of MS nurses and patients with multiple sclerosis regarding the new RebiSmart® 3.0 autoinjector versus other assistive devices

Colten,

Cantogno,

Jack

2023

Preprint

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“…The most common reasons for failure to adherence to treatment are forgetting to take the medication, patient-perceived lack of efficacy, injection anxiety, as well as AEs related to injection site reactions, flu-like symptoms, and fatigue ( 28 ). The use of support strategies ( 15 , 29 ) and treatment maintenance methods ( 14 , 30 , 31 ) are being investigated to overcome poor adherence.…”

Section: Discussionmentioning

confidence: 99%

“…The treatment gap associated with DMD use is frequently influenced by patient beliefs and choices, resulting in an unmet need for effective long-term treatment support and management. Several strategies have been investigated and implemented to improve drug adherence, including patient support programmes (PSPs) and innovative injectable devices ( 13 , 14 ). PSPs may improve treatment adherence as well as clinical outcomes ( 13 , 15 ).…”

Section: Introductionmentioning

confidence: 99%

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Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study

Al-Roughani,

Zakaria,

Cupler

et al. 2023

Front. Neurol.

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Introduction and backgroundAdherence is a critical factor for optimal clinical outcomes in multiple sclerosis (MS) treatment. This study investigated the adherence and clinical outcomes of MS patients treated with subcutaneous (sc) interferon (IFN) (β)-1a, an established immunomodulatory treatment for relapsing MS. The benefits of a patient support programme (PSP) were also studied.MethodsThis phase-IV prospective, observational multicentre study enrolled patients with relapsing MS who were treated with sc IFN β-1a for 24 months was conducted at 53 centres across 17 countries. The primary endpoint was adherence to sc IFN β-1a treatment, as assessed using Morisky Green Levine Medication Adherence Scale (MGLS) scores at 24 months. The MGLS is a self-reported diagnostic tool to address medication non-adherence, with a score ranging from 0 to 4, with 0 representing high adherence, 1–2 representing medium adherence, and 3–4 representing low adherence. Other endpoints included time to study and treatment discontinuation over 24 months, the proportion of relapse-free patients, and Expanded Disability Status Scale (EDSS) progression (defined as ≥1.0 point increase sustained for 3 months) at 24 months. A subgroup analysis was performed for endpoints based on patients assigned to PSP (yes/no—PSP versus non-PSP subgroup).ResultsOf the 577 patients enrolled, 408 had evaluable MGLS scores at 24 months. A total of 336 (58.2%; 95% confidence interval [CI]: 54.1–62.3%) patients reported high adherence, 57 (9.9%; 95% CIs: 7.6–12.7%) reported medium adherence, and 15 (2.6%; 95% CI: 1.5–4.3%) reported low adherence at 24 months. The PSP subgroup reported higher adherence (n = 206; 65.8%) than the non-PSP subgroup (n = 130; 56.5%). By 24 months, 52.2% of the patients were relapse-free and 17.2% patients experienced ≥1 relapse. Expanded Disability Status Scale progression was observed in 12.3% of patients. Over the 24-month period, 30.8% of the patients discontinued treatment, and the most common reasons for treatment discontinuation were adverse events (AEs, 10.4%), being lost to followup (7.1%), and a lack of efficacy (5.5%). Overall, 39.6% patients experienced ≥1 AE, which ranged from mild to moderate.ConclusionThe study demonstrated high adherence to sc IFN β-1a treatment with an added benefit of PSP participation. More than half of the patients remained relapse-free over a 24-month period. No new safety concerns to sc IFN β-1a treatment were observed.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT02921035, NCT02921035.

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“…However, the key fact for MS patients remains the timely initiation of immunomodulatory therapy with an effective and registered drug, regardless of the mechanism of action. The goal of effective treatment is primarily to attenuate immunopathological processes and slow down the progression of the disease [1, 10, 11]. It is known that the first-line disease-modifying drugs (DMDs), which include interferon beta-1a (INF) and glatiramer acetate (GA) studied in this article, affect immune processes at multiple levels.…”

Section: Introductionmentioning

confidence: 99%

Interferon Beta-1a versus Glatiramer Acetate: Changes of Innate Immunity in a Group of Women with Multiple Sclerosis

Peterka¹,

Vališ²,

Souček³

et al. 2023

Eur Neurol

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Introduction: Multiple sclerosis is a chronic inflammatory autoimmune demyelinating disease that secondarily leads to the axonal loss and associated brain atrophy. Disease-modifying drugs (DMDs) have previously been studied for their ability to affect specific immunity. This study investigates the effect of interferon beta-1a (INF) and glatiramer acetate (GA) administration on changes in innate immunity cell populations. Methods: Sixty Caucasian female patients with relapsing-remitting multiple sclerosis undergo blood sample testing for 15 blood parameters at baseline, 1M, 3M and 6M after treatment by GA or IFN (started as their first line DMD). Results: A statistically significant difference in the change after 6 months was found in the parameter monocytes (relative count) in the group of patients treated with IFN. The median increase was 27.8%. Changes in many of the other 15 parameters studied were 10-20%. Conclusion: Innate immunity has long been neglected in MS immunopathology. The findings of this study show that innate immunity cells, especially monocytes may contribute significantly to MS immunopathology.

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An observational study demonstrating the adherence and ease of use of the injector device, RebiSmart®

Cited by 10 publications

References 20 publications

Preferences and perspectives of MS nurses and patients with multiple sclerosis regarding the new RebiSmart® 3.0 autoinjector versus other assistive devices

Preferences and perspectives of MS nurses and patients with multiple sclerosis regarding the new RebiSmart® 3.0 autoinjector versus other assistive devices

Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study

Interferon Beta-1a versus Glatiramer Acetate: Changes of Innate Immunity in a Group of Women with Multiple Sclerosis

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