A Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Registration Number
- NCT06897657
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This was a retrospective non-interventional study (NIS) of adult (≥18 years) multiple sclerosis (MS) patients on ofatumumab therapy in the United Kingdom (UK) using secondary data. UK MS centers with National Health Service (NHS) databases and/or homecare and pharmacy services prescribing ofatumumab were identified and recruited for study participation using a feasibility assessment exercise. The study index identification window spanned from 26 March 2021 to 30 June 2023 (or latest data available prior to start of study data extraction). The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window. From index date, patients were followed up until death, up to 13 months after index date, loss to follow-up, or end of study index identification window (whichever came first).
For patients who consented to the use of their data, participating sites transcribed protocol required patient data from existing individual patient medical records into an electronic case report form (eCRF). The end of study was defined as the date of last data query resolution (i.e., all data had been recorded in the eCRF and all data queries resolved to allow database lock to occur). This ensured that all data was available to answer the research questions in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Medical Possession Ratio (MPR) Up to 13 months MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period.
Number of Patients by MPR Category Up to 13 months MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
* High MPR: MPR = 1.0
* Intermediate MPR: 0.8 ≤ MPR \<1.0
* Low MPR: MPR \<0.8.
- Secondary Outcome Measures
Name Time Method Number of Patients by Demographic Category Baseline Demographic categories included:
* Age group
* Gender
* Ethnicity
* Socioeconomic status (most deprived to least deprived)
* Decade of MS diagnosis
* Prior disease modifying treatment (DMT) treatment status (treatment naïve or received prior DMT)Time From MS Diagnosis to Ofatumumab Initiation Baseline Number of Patients by Comorbidity Baseline Number of Patients who Received at Least one DMT Prior to Ofatumumab Initiation Up to 13 months Number of Prior DMTs Reported Up to 13 months Individual Annualized Relapse Rate (ARR) Before Ofatumumab Initiation Up to 13 months Individual ARR was derived per patient as \[(number of confirmed MS relapses) / (time at risk (years)\].
Individual ARR After Ofatumumab Initiation Up to 13 months Individual ARR was derived per patient as \[(number of confirmed MS relapses) / (time at risk (years)\].
Total ARR After Ofatumumab Initiation Up to 13 months Total ARR was derived as \[(total number of confirmed MS relapses) / (total number of person-years at risk)\].
Number of Patients by Prior DMT Category Up to 13 months DMT categories included:
* Type of prior DMT
* Efficacy of DMT (moderate efficacy, more effective, high efficacy)
* Use of injectable DMT
* Type of injectable DMTAbsolute Change in Average EDSS Score Up to 26 months Absolute change in average EDSS score between 2 study periods was derived as: \[mean EDSS score during the follow-up period\] - \[mean EDSS score during the pre-index period\]. The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window.
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).Average Number of T1 and T2 Lesions Before Ofatumumab Initiation Up to 13 months Average Number of T1 and T2 Lesions After Ofatumumab Initiation Up to 13 months Number of Patients by Reason for Switch from Other DMT to Ofatumumab Up to 13 months Total ARR Before Ofatumumab Initiation Up to 13 months Total ARR was derived as \[(total number of confirmed MS relapses) / (total number of person-years at risk)\].
Average Expanded Disability Status Scale (EDSS) Score Before Ofatumumab Initiation Up to 13 months The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
Average EDSS Score After Ofatumumab Initiation Up to 13 months The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
Individual ARR After Ofatumumab Initiation by MPR Category Up to 13 months Individual ARR was derived per patient as \[(number of confirmed MS relapses) / (time at risk (years)\].
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
* High MPR: MPR = 1.0
* Intermediate MPR: 0.8 ≤ MPR \<1.0
* Low MPR: MPR \<0.8.Total ARR After Ofatumumab Initiation by MPR Category Up to 13 months Total ARR was derived as \[(total number of confirmed MS relapses) / (total number of person-years at risk)\].
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
* High MPR: MPR = 1.0
* Intermediate MPR: 0.8 ≤ MPR \<1.0
* Low MPR: MPR \<0.8.Average EDSS Score Before Ofatumumab Initiation by MPR Category Up to 13 months The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
* High MPR: MPR = 1.0
* Intermediate MPR: 0.8 ≤ MPR \<1.0
* Low MPR: MPR \<0.8.Average EDSS Score After Ofatumumab Initiation by MPR Category Up to 13 months The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
* High MPR: MPR = 1.0
* Intermediate MPR: 0.8 ≤ MPR \<1.0
* Low MPR: MPR \<0.8.Absolute Change in Average EDSS Score by MPR Category Up to 26 months Absolute change in average EDSS score between 2 study periods was derived as: \[mean EDSS score during the follow-up period\] - \[mean EDSS score during the pre-index period\]. The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window.
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score was determined between 0 (normal) and 10 (death due to MS).
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
* High MPR: MPR = 1.0
* Intermediate MPR: 0.8 ≤ MPR \<1.0
* Low MPR: MPR \<0.8.Number of Patients per MPR Category by Type of KC PSP Services Received Up to 13 months KC PSP services included face-to-face nurse visits, virtual nurse visits, and mobile text reminders.
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
* High MPR: MPR = 1.0
* Intermediate MPR: 0.8 ≤ MPR \<1.0
* Low MPR: MPR \<0.8.Number of Medical Visits After Ofatumumab Initiation Up to 13 months Medical visits included accident and emergency (A\&E) visits, inpatient visits, and outpatient visits.
Annualized Medical Visit Rate After Ofatumumab Initiation Up to 13 months Annualized medical visit rate per patient was calculated as \[(number of events during follow-up period) / (time at risk (years) during follow-up period)\]. Rates were calculated for the following types of medical visits: A\&E visits, inpatient visits, and outpatient visits.
Number of MS-related Medical Visits After Ofatumumab Initiation Up to 13 months MS-related medical visits included A\&E visits, inpatient visits, and outpatient visits.
Annualized MS-related Medical Visit Rate After Ofatumumab Initiation Up to 13 months Annualized MS-related medical visit rate per patient was calculated as \[(number of events during follow-up period) / (time at risk (years) during follow-up period)\]. Rates were calculated for the following types of MS-related medical visits: A\&E visits, inpatient visits, and outpatient visits.
Number of Patients With Medically Reported Adherence (MRA) After Ofatumumab Initiation Up to 13 months Full adherence was defined as no record of dose/s missed between ofatumumab initiation and the point at which the patient was censored. Partial adherence was defined as a record of at least one dose missed between ofatumumab initiation and the point at which the patient was censored. The date of censoring was defined as the earliest of the following:
* End of the study follow-up (13 months)
* Death
* Lost to follow-up
* End of study index identification periodNumber of Patients by Reason for Discontinuation of Ofatumumab Up to 13 months Number of Patients who Switched From Ofatumumab to an Alternative DMT Up to 13 months
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Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States