Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, MS, NIS, KESIMPTA, ofatumumab
Brief summary
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.
Detailed description
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.
Interventions
OTHERKesimpta
There was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Patients with MS Inclusion Criteria: * Adult aged eighteen (18) years of age or over at the time of the survey * Prescribed KESIMPTA within the prior 12 months and currently self-administering treatment using the Sensoready® pen * MS diagnosis based on 2017 McDonald criteria Care Partner Inclusion Criteria: * Adult aged eighteen (18) years of age or over * Formal or informal care partner of patient with MS prescribed KESIMPTA within the prior 12 months * Is currently administering KESIMPTA using the Sensoready® pen on their patient's behalf Patients with MS
Exclusion criteria
* Previously used injection as a part of inclusion in any ofatumumab (OMB) randomized clinical trial * Active Hepatitis B virus (HBV) * Cognitive impairment that would impact their ability to participate in a survey study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready | Up to 6 months, at the time of survey completion | Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients by educational level | Up to 6 months, at the time of survey completion | Proportion of patients by educational level was collected |
| Patients Determined Disease Steps (PDDS) | Up to 6 months, at the time of survey completion | 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. |
| General Health | Up to 6 months, at the time of survey completion | 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. |
| Proportion of patients by Multiple Sclerosis Phenotype | Up to 6 months, at the time of survey completion | Proportion of patients by Multiple Sclerosis Phenotype was collected: * RRMS: Relapsing-Remitting Multiple Sclerosis * SPMS: Secondary Progressive Multiple Sclerosis |
| Proportion of patients with co-morbidities | Up to 6 months, at the time of survey completion | Proportion of patients with co-morbidities was collected |
| Importance of healthcare provider (HCP) instructions for first injection | Up to 6 months, at the time of survey completion | 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. |
| Level of anxiety with injections, in general | Up to 6 months, at the time of survey completion | 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? |
| Proportion of patients performing preparation activities for injection | Up to 6 months, at the time of survey completion | 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) |
| Proportion of patients by US region of residence | Up to 6 months, at the time of survey completion | Census US geographic region of residence (Northeast, Midwest, South, or West) |
| Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) | Up to 6 months, at the time of survey completion | Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) was collected among DMT experienced patients |
| Proportion of patients who are DMT naïve or experienced | Up to 6 months, at the time of survey completion | Proportion pf patients who are DMT naïve or experienced was collected. |
| Proportion of participants by reasons for starting KESIMPTA | Up to 6 months, at the time of survey completion | 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 |
| Proportion of participants by reasons to switch from most recent therapy | Up to 6 months, at the time of survey completion | 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. |
| Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration | Up to 6 months, at the time of survey completion | 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 |
| Patient Confidence | Up to 6 months, at the time of survey completion | 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 |
| Overall device satisfaction by treatment duration | Up to 6 months, at the time of survey completion | 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. |
| Overall device satisfaction score of the study participants by DMT experience | Up to 6 months, at the time of survey completion | Percentage of patients by overall satisfaction score (extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, extremely satisfied) by DMT experience |
| Proportion of participants by site of administration | Up to 6 months, at the time of survey completion | Proportion of participants by site of administration was collected: * thigh * abdomen * upper outer arm |
Countries
United States
Outcome results
None listed