This was a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA.
The study aimed to enroll ninety-four (94) patients/care partners. The time period for enrollment was dependent on the uptake of KESIMPTA in the real-world. Data collected for the study was obtained directly from the patient/care partner within the web-based database: De-identified data was stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys were pooled for analysis of study endpoints.
Study Type
OBSERVATIONAL
Enrollment
105
There was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled.
Novartis Investigative Site
East Hanover, New Jersey, United States
Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready
Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready®
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients by US region of residence
Census US geographic region of residence (Northeast, Midwest, South, or West)
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients by educational level
Proportion of patients by educational level was collected
Time frame: Up to 6 months, at the time of survey completion
Patients Determined Disease Steps (PDDS)
PDDS was used as a proxy to Expanded Disability Status Scale (EDSS). People were asked to choose one out of nine options that best describes how well they walk. 0 is "normal" and 8 is "bedridden."
Time frame: Up to 6 months, at the time of survey completion
General Health
Participants were asked "How is your general health today?" and they had to choose one out of five options that best describes how well they feel from "Poor", "Fair" ,"Good", "Very Good" to "Excellent".
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients by Multiple Sclerosis Phenotype
Proportion of patients by Multiple Sclerosis Phenotype was collected: * RRMS: Relapsing-Remitting Multiple Sclerosis * SPMS: Secondary Progressive Multiple Sclerosis
Time frame: Up to 6 months, at the time of survey completion
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Proportion of patients with co-morbidities
Proportion of patients with co-morbidities was collected
Time frame: Up to 6 months, at the time of survey completion
Importance of healthcare provider (HCP) instructions for first injection
Participants were asked to rate their level of agreement with each statement related to their first Kesimpta injection. 1) I felt it was essential to have a healthcare provider instruct me on how to perform my first KESIMPTA injection using the Sensoready® pen, 2) I felt I needed to have a healthcare provider watch me administer my first KESIMPTA injection using the Sensoready® pen, and 3) I felt comfortable receiving instructions from my healthcare provider in the clinic on how to administer my first KESIMPTA injection using the Sensoready® pen and did not need my healthcare provider to be present to administer it at home. Participants were asked to choose five options toward each statement from "Strongly Disagree" to "Strongly Agree".
Time frame: Up to 6 months, at the time of survey completion
Level of anxiety with injections, in general
Participants were asked "Using a scale of 0 to 10, 0 being Not at All Confident and 10 being Extremely Confident, how confident do you feel about your ability to administer KESIMPTA using the Sensoready® pen on your own?"
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients performing preparation activities for injection
Proportion of patients performing preparation activities for injection: * Time to take KESIMPTA Sensoready® pen out of the refrigerator and allow it to reach room temperature prior to injection (minutes) (step A) * Time to perform the injection including picking up the Sensoready® pen, injecting and disposing in the sharps container (minutes) (step B)
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by site of administration
Proportion of participants by site of administration was collected: * thigh * abdomen * upper outer arm
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT)
Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) was collected among DMT experienced patients
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients who are DMT naïve or experienced
Proportion pf patients who are DMT naïve or experienced was collected.
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by reasons for starting KESIMPTA
Proportion of participants by reasons for starting KESIMPTA was collected: * ease of dosing schedule * avoidance of infusion clinics * at home convenience * enhanced efficacy and safety profile * HCP recommendation * lack of insurance coverage for other DMTs * Other
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by reasons to switch from most recent therapy
Proportion of participants by reasons to switch from most recent therapy (insurance, lack of efficacy/wear off effect, side-effects and tolerability, adherence concerns etc.) was collected among DMT experienced patients.
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration
Percentage of patients who agree with each attribute of the device Usability Characteristics during self-administration, based on patient self-report was collected: * Overall ease of use * Device ergonomics ("feeling" in the hand ) * Steps for preparing and using device * Time required for preparation and use of device * Convenience/Flexibility for travel with device
Time frame: Up to 6 months, at the time of survey completion
Patient Confidence
Percentage o patients who agree with each attribute regarding confidence, based on patient self-report, was collected: * Confidence to self-administer KESIMPTA using the device * Intention to continue use of device * Recommendation of KESIMPTA device use to others * Ease of KESIMPTA's monthly dosing schedule
Time frame: Up to 6 months, at the time of survey completion
Overall device satisfaction by treatment duration
Overall device satisfaction. Participants choose between five options from 1: Extremely Dissatisfied, 2 Dissatisfied, 3: Neither Satisfied nor Dissatisfied, 4: Satisfied, 5: Extremely Satisfied. The higher score means a better overall devise satisfaction.
Time frame: Up to 6 months, at the time of survey completion
Overall device satisfaction score of the study participants by DMT experience
Percentage of patients by overall satisfaction score (extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, extremely satisfied) by DMT experience
Time frame: Up to 6 months, at the time of survey completion