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Real-world satisfaction and experience with injection and autoinjector device for ofatumumab indicated for multiple sclerosis
BMC Neurology volume 25, Article number: 28 (2025)
Abstract
Background
To evaluate the overall satisfaction, device usability, and injection experience of MS patients self-administering ofatumumab using the Sensoready® autoinjector device in the United States (US).
Methods
This US-based, cross-sectional survey study included patients with MS (≥ 18 years) who self-administered ofatumumab using the Sensoready device within the previous 12 months of the survey. Eligible patients were administered a 30-item de novo questionnaire that focused on overall device satisfaction, device usability, convenience/flexibility for travel with the device, user confidence, injection experience, and time to administer the injection. Ratings were measured on Likert and numeric rating scales, with higher scores indicating positive responses.
Results
Overall, 105 patients with MS (disease-modifying therapy [DMT]-experienced: 65; DMT-naïve: 40) were included. The mean (standard deviation [SD]) age was 42.5 (12.2) years. The majority of patients (86.7%) expressed high satisfaction (i.e., rated either 4 [satisfied] or 5 [extremely satisfied] on a 5-point Likert scale) in study population. The overall mean (SD) satisfaction score with Sensoready device was 4.4 (0.7), with a higher device satisfaction reported in the DMT-experienced vs. DMT-naïve group (4.6 [0.66] vs. 4.1 [0.69]). A higher proportion of DMT-experienced patients reported high satisfaction scores as compared to DMT-naïve patients (90.8% vs. 80.0%). The most common reasons for high satisfaction included reasonable administration time (90.5%), overall ease of use (89.5%), a monthly dosing schedule of ofatumumab (89.5%), the time required for device preparation (86.7%), ease of device preparation (81.9%), device ergonomics (76.2%), and portability (73.3%). Regardless of prior DMT experience, the majority of patients felt confident to self-administer ofatumumab using the Sensoready device; moreover, the majority expressed their intention to continue with the Sensoready device and would recommend ofatumumab to others. Furthermore, 77.1% reported that the use of Sensoready device to self-administer ofatumumab was not found to interfere with their daily activities; patients reporting non-interference with their daily activities were higher in the DMT-experienced vs. DMT-naïve group (83.1% vs. 67.5%).
Conclusions
Regardless of prior DMT experience, patients with MS report high satisfaction levels and positive experiences with the use of the ofatumumab Sensoready device in real-world practice, mostly driven by reasonable administration time and ease-of-use.
Introduction
Multiple sclerosis (MS) is a chronic disabling neurological disease that typically affects approximately 1Â million individuals in the United States (US) [1]. Evidence suggests that MS is twice as common among women than men and more often affects adults during their prime working years [2, 3]. In addition to the clinical impact on disability, MS negatively impacts the health-related quality of life of the affected individuals [4].
Traditionally, treatment with moderate-efficacy disease-modifying therapies (DMTs; β-interferons, glatiramer acetate, dimethyl fumarate, and teriflunomide) is the most accepted treatment approach in clinical practice for patients with relapsing MS (RMS) [5,6,7]. However, there has been a discernible shift in the treatment paradigm with the advent of more potent DMTs (cladribine, fingolimod, ponesimod, and ozanimod) and monoclonal antibodies (natalizumab, alemtuzumab, ocrelizumab, and ofatumumab) [8, 9].
Ofatumumab (Kesimpta®) is a high-efficacy DMT approved in August 2020 for the treatment of RMS in the US. Data from pivotal clinical trials (ASCLEPIOS I and II) have demonstrated the therapeutic benefits of ofatumumab in overall and treatment-naïve RMS patients [10, 11]. Evidence from real-world studies suggests a positive perception of ofatumumab by patients and neurologists [12, 13]. Ofatumumab is self-administered subcutaneously once a month via a pre-filled syringe or single-use Sensoready autoinjector pen [14]. Autoinjector devices have an edge over prefilled syringes and other conventional devices owing to their ease of use, convenience, less pain, and shorter administration time [15,16,17]. Furthermore, studies have shown that autoinjectors reduce treatment burden, enhance adherence, and increase satisfaction [12, 15, 18,19,20,21,22]. However, there is a paucity of real-world studies focused on patients’ satisfaction and experiences with the Sensoready device used to administer ofatumumab. Therefore, this is the first study to evaluate the overall satisfaction, device usability, and injection experience of MS patients self-administering ofatumumab using the Sensoready device in the US.
Methods
Study design
This was a US-based, cross-sectional study with primary data collection via a questionnaire directly administered to patients with MS who initiated ofatumumab using the Sensoready device within the previous 12 months. The protocol and questionnaire used for this study were reviewed and granted exemption by the Western Institutional Review Board-Copernicus Group (Puyallup, WA, USA).
Inclusion and exclusion criteria
Patients aged ≥ 18 years at the time of the survey, having a diagnosis of MS based on 2017 McDonald criteria [23], newly prescribed ofatumumab within the prior 12 months, and currently self-administering treatment using the Sensoready autoinjector device, were eligible for inclusion. Neurologists and advanced practice providers specializing in MS treatment, who were likely to prescribe ofatumumab based on a referral survey response, were targeted for recruitment onto the IQVIA Research Network (a leading panel of healthcare providers in the US). Patients who had received ofatumumab injection as part of the randomized clinical trial and/or those with active hepatitis B virus and/or cognitive impairment at the time of the survey were excluded.
Variables
Socio-demographic and clinical characteristics of the overall study population and by DMT status viz., DMT-naïve (i.e., had not been treated with any DMT in the past) and DMT-experienced (i.e., had previously received treatment with any DMT except ofatumumab) were assessed at the time of survey participation. Eligible patients were administered a 30-item de novo questionnaire that focused on overall device satisfaction, device usability, convenience/flexibility for travel with the device, user confidence, and injection experience (Supplementary file 1). Ratings were measured on Likert and numeric rating scales, with higher scores indicating positive responses.
Statistical analyses
Socio-demographic and clinical characteristics of the overall study population and stratified by DMT status were analyzed descriptively. Continuous measures were summarized as mean and standard deviation (SD), and categorical measures were summarized as frequency counts and percentages. All analyses were performed by IQVIA using SAS® statistical software.
Results
Study population
Overall, 105 patients met the study eligibility criteria and were included in the analysis (Fig. 1). Of these, 40 (38.1%) patients were DMT-naïve and 65 (61.9%) patients were DMT-experienced.
Patient characteristics
The mean (SD) age of patients was 42.5 (SD: 12.2) years and 63.8% were female. Most patients were Caucasian (51.4%), resided in the Northeast US geographic region (72.4%), and had commercial insurance (66.7%). Most patients were married (61.0%) and had a bachelor’s/advanced degree (40.1%). There were subtle differences in demographic characteristics of DMT-naïve and experienced groups (Table 1).
Table 2 summarizes the clinical characteristics of the overall study population and by DMT status. The mean time since MS diagnosis was 33.6 (SD: 36.8) months, with most patients having relapsing-remitting MS (41.9%). Approximately one-third of patients reported normal to mild disability; the majority of patients (78.1%) rated their general health status as good to excellent. The average number of comorbid conditions in the overall study population was 2.0 (SD: 1.3) per patient. With few exceptions, clinical characteristics differed across DMT-naïve and experienced groups. The proportion of patients with relapsing-remitting MS (RRMS) was higher in the DMT-experienced (52.3%) vs DMT-naïve group (25.0%). The proportion of patients who received care at the MS center was relatively lower in DMT-experienced vs DMT-naïve group (13.8% vs 30.0%). The proportion of patients who rated their general health status as good to excellent was lower in the DMT-experienced group than those in the DMT-naïve group (75.5% vs 82.5%). In DMT-experienced patients, 41.5% had previously received a self-injectable DMT, which could include interferons beta 1a/1b, glatiramer acetate, or peginterferons; 30.8% had previously received an oral DMT and 40% had received an infusion-based DMT. Among the DMT-naïve patients, the main reasons for initiating ofatumumab were ease-of-use/convenience (35%) followed by safety concerns by physicians with the other DMTs (22.5%), and their preference to avoid infusion clinics (15%). In the DMT-experienced group, patients switched to ofatumumab primarily due to a lack of symptomatic benefits with the previous DMTs (29.2%), worsening of MS symptoms (24.6%), and patients reported side effects from the previous DMTs and/or physicians had safety concerns with the other DMTs (20.0%).
Patient satisfaction
The overall mean (SD) device satisfaction score was 4.4 (0.7) in the study population, with a higher device satisfaction reported in the DMT-experienced than DMT-naïve group (4.6 [0.7] vs 4.1 [0.7]). The vast majority of the patients (86.7%) expressed high satisfaction (i.e., rated either 4 [satisfied] or 5 [extremely satisfied] on a 5-point Likert scale) with the autoinjector device used for ofatumumab administration. A higher proportion of DMT-experienced patients reported high satisfaction scores as compared to DMT-naïve patients (90.8% vs 80.0%). To note, none of the patients were dissatisfied or extremely dissatisfied with the Sensoready device used for ofatumumab administration. The most common reasons for high satisfaction included reasonable administration time (90.5%), overall ease of use (89.5%), a monthly dosing schedule of ofatumumab (89.5%), the time required for device preparation (86.7%), ease of device preparation (81.9%), device ergonomics (76.2%), and portability (73.3%). Overall satisfaction with the other injectable DMT(s) prior to ofatumumab initiation was found to be low (mean: 2.8); however, with a couple of exceptions, higher rating for reasons for device satisfaction were observed in DMT-experienced patients versus DMT-naïve patients (Fig. 2).
Overall device satisfaction1,2 and reasons for device satisfaction. Abbreviation: DMT disease-modifying therapy. Notes: 1Assessed using a 5-point Likert scale (1 = extremely dissatisfied to 5 = extremely satisfied). 2Assessed using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree)
Regardless of prior DMT experience, the majority of patients felt confident to self-administer ofatumumab using the Sensoready device (85.7%). Higher proportion of patients expressed their intention to continue with the ofatumumab Sensoready device and would recommend ofatumumab to others (89.5%) (Fig. 3). Overall, 77.1% reported that the ofatumumab Sensoready device was not found to interfere with their daily activities. The proportion of patients reporting non-interference with their daily activities was higher in the DMT-experienced compared with the DMT-naïve group (83.1% vs 67.5%).
Discussion
To our knowledge, this is the first study to provide early insights into treatment satisfaction and experience with the Sensoready device used for the self-administration of ofatumumab in the US. The results of this study suggest that patients with MS, regardless of prior DMT experience, report high satisfaction levels and positive experiences with the use of the ofatumumab Sensoready device in real-world practice, mostly driven by reasonable administration time and ease of use.
Evidence from the published literature suggests Sensoready device is simple, safe, convenient, and effective for the administration of ofatumumab in patients with MS [16, 18, 22]. Understanding the patient’s perspective (i.e., satisfaction and experience) with the use of ofatumumab Sensoready device has the potential to impact therapeutic management and improve health outcomes in patients with MS. Overall, 105 patients with MS who self-administered ofatumumab using the Sensoready device in the US were analyzed. Patients included in this study were predominantly female (63.8%), which is in line with the reported higher predisposition of MS in females than males [1, 24]. Consistent with a previously published retrospective study [24], patients in the survey predominantly hailed from the Northeast US Census region (72.4%). Moreover, most survey patients (40%) were over 45 years of age [1, 24, 25], and were Caucasians (51.4%) with over 40% diagnosed with RRMS [26]. These findings indicate that the characteristics of the patients included in this study were largely consistent with those reported in the literature [1, 24,25,26].
Findings from this study indicate that approximately 90% of patients with MS who self-administered ofatumumab using a Sensoready pen had high device satisfaction, with majority reporting extremely satisfied scores. Approximately 60% of MS patients had prior DMT use, with many of them using an autoinjector who switched due to lack of improvement or worsening of symptoms and side effects (73.8%). Among patients with prior DMT experience, device satisfaction with prior DMT was low (mean: 2.8), whereas satisfaction with ofatumumab Sensoready device in the same group of patients was extremely high (mean: 4.6), showing improved patient satisfaction with the Sensoready device as compared to prior DMTs. Similar findings were observed in recent studies where patients and providers preferred ofatumumab Sensoready pen over other DMTs [12, 16]. Using an online questionnaire, European neurologists considered the benefit-risk ratio of ofatumumab as favorable. Moreover, the majority of the neurologists (83%) believed that self-administration of ofatumumab at home reduced the time burden for patients with MS [12]. Similarly, another survey-based study suggested that both MS patients and nurses preferred the Sensoready autoinjector device for ofatumumab administration over other autoinjectors for their treatment, mostly driven by the factors of being easy to perform the self-injection and independent use [16].
In addition to assessing treatment satisfaction and experience with the autoinjector device, this study assessed the reasons for initiating/switching to ofatumumab. Among the DMT-naïve group, the ease of use/convenience was the primary reason when making a decision. This finding is in line with the prior survey-based study that reported ease of administration was the highly ranked attribute of the Sensoready device by both patients and nurses over other injectable DMTs [16]. The mean score of overall ease of use with the Sensoready device observed in the present study (4.4; maximum possible score, 5.0), however, was lower than the responses by both patients and nurses (9.3 and 9.5, respectively; maximum possible score, 10.0) observed in the previous study [16]. The slightly lower score observed in the current vs the previous study could be attributed to the differences in the study population, the country of patients, interventions, the questionnaire used, and the scale used to measure the variables. Among the DMT-experienced group, the primary reasons for switching included suboptimal management of MS symptoms and concerns about side effects from prior DMTs. These findings are consistent with the previous studies that reported switching to a more efficacious therapy to be driven by an array of factors, including lack of efficacy of the current DMT, progression of disability, inadequate response to prior DMTs, or lack of tolerability, safety, or convenience with their previous DMT exposure [27, 28]. Patient preferences and responses to DMT treatment for MS vary significantly, thus flexibility in treatment choice is key in meeting patients’ needs [29,30,31]. In the current survey, we found the ofatumumab Sensoready device could be a promising option that fulfills the need from different perspectives (i.e., ease of administration and favorable clinical profile). When stratified by DMT status, satisfaction levels with the Sensoready device were higher among patients with prior DMT experience vs DMT-naïve patients. The high satisfaction in the DMT-experienced group could be because patients with prior DMT experience had suffered longer from MS than those in the DMT-naïve group (39.5 vs 24.2 months). Additionally, the DMT-experienced group better perceived therapeutic benefits (i.e., treatment effectiveness of ofatumumab, convenience, favorable risk-benefit profile, and better health-related quality of life) than the DMT-naïve group.
Given the small sample size of ofatumumab users in the current study, there is a continued need to promote awareness of the important attributes of the Sensoready device to enhance the patient experience of ofatumumab administration in routine clinical practice.
The results of this study should be interpreted in the context of its limitations. As this was a cross-sectional study, longitudinal data were not available to describe the patients’ satisfaction or treatment experience over time. Further, at the time of study conduct, no other DMTs were available that possessed the convenience of auto-injection or self-administration and had a similar level of efficacy to ofatumumab. This limited patients' options for initiating or switching treatments. Initiation of ofatumumab in patients may be influenced by insurance and thus may not fully represent the intended target ofatumumab patients and may affect the satisfaction score. MS nurses generally train patients to use autoinjector devices [32], and the ability to use the Sensoready device independently as well as ease of performing self-injection are important autoinjector attributes for patients [16]. However, the impact of patient education on how to use the autoinjector from an MS nurse on patient satisfaction was not assessed. Hence, data should be cautiously interpreted to understand the initial landscape of DMT use within the evaluated time period. Given that the enrolled patients had initiated treatment at varying time points during the prior 12 months, the possibility of recall bias cannot be excluded. Moreover, the presence of selection bias cannot be ruled out as patients currently self-administering ofatumumab at the time of the survey were included in the study. However, the high satisfaction with the ofatumumab Sensoready device observed in the study is in line with the high adherence and persistence with ofatumumab reported in the real-world studies [33], thus, making these results representative of the majority of MS patients being treated with ofatumumab in the US. Finally, the questionnaire used to assess patients’ satisfaction had not been previously validated in another patient sample. However, the study was properly designed and discussed by clinical experts and was straightforward to capture the patient experience of using the ofatumumab Sensoready device. Further research is warranted to elicit patient preference when presenting a set of two or more discrete alternatives to reflect treatment decision-making process.
Despite limitations, this study was unique as it evaluated MS patients and was broadly representative of the US population. Moreover, this study addresses a key knowledge gap by providing data on treatment satisfaction and experience with the autoinjector device used for ofatumumab administration in real-world practice.
Conclusions
In summary, results from this study provide evidence of real-world satisfaction and experience with the Sensoready device for ofatumumab administration in patients with MS. Device satisfaction level and experience ratings were higher in the DMT-experienced versus the DMT-naïve group, mostly driven by reasonable administration time and ease of use. Further studies may be needed to understand the long-term experience with the Sensoready device used for ofatumumab administration in patients with MS.
Data availability
The datasets generated and analyzed during the current study are available upon reasonable request from the corresponding author.
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Acknowledgements
The authors would like to acknowledge Santosh Tiwari, PhD (Novartis Healthcare Pvt. Ltd., Hyderabad) for providing medical writing support for this manuscript.
Funding
This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
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Authors and Affiliations
Contributions
APR, JN, MHT, SY, NFS, HC, MF, AC, and KH have made substantial contributions to the collection, analysis, and interpretation of data. All authors critically reviewed the manuscript for intellectual content and all authors approved the final version for publication submission. All authors agree to be accountable for all aspects of the work.
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Ethics approval and consent to participate
Approval for this study was waived by WIRB-Copernicus Group Institutional Review Board who waived the approval due to the study only including interactions involving survey procedures, having adequate provisions to protect the privacy of subjects and maintain confidentiality of data, following review under the Common Rule and based on Code of Federal Regulations Title 45, Part 46, Subpart A, Sect. 46.104d, Category 2 criteria. Informed consent was taken from each study participant before initiating the survey. The study was conducted in compliance with the Declaration of Helsinki and its amendments.
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Not applicable.
Competing interests
Amy Perrin Ross has received consulting fees from Alexion, BMS, EMD Serono, Horizon, Novartis, Roche, Sanofi, and TG Therapeutics. Jacqueline Nicholas has received research grants from Biogen, Genentech, Novartis, PCORI, and the University of Buffalo; has received consulting fees from EMD Serono, Genentech, Greenwich Biosciences, Novartis, Sanofi, and TG Therapeutics; and has received speaking honoraria from BMS, EMD Serono, Horizon, and TG Therapeutics. Ming-Hui Tai and Stephen Yeung are employees of Novartis Pharmaceuticals Corporation. Nazneen Fatima Shaikh, Helen Chen, Mariana Fernandes, Aaron Cortright, and Kevin Hawkins are employees of Real World Solutions, IQVIA.
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Ross, A.P., Nicholas, J., Tai, MH. et al. Real-world satisfaction and experience with injection and autoinjector device for ofatumumab indicated for multiple sclerosis. BMC Neurol 25, 28 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12883-024-04007-1
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DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12883-024-04007-1