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.
Study Type
OBSERVATIONAL
Enrollment
155
Novartis
East Hanover, New Jersey, United States
Medical Possession Ratio (MPR)
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.
Time frame: Up to 13 months
Number of Patients by MPR Category
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.
Time frame: Up to 13 months
Number of Patients by Demographic Category
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 frame: Baseline
Time From MS Diagnosis to Ofatumumab Initiation
Time frame: Baseline
Number of Patients by Comorbidity
Time frame: Baseline
Number of Patients who Received at Least one DMT Prior to Ofatumumab Initiation
Time frame: Up to 13 months
Number of Prior DMTs Reported
Time frame: Up to 13 months
Number of Patients by Prior DMT Category
DMT categories included: * Type of prior DMT * Efficacy of DMT (moderate efficacy, more effective, high efficacy) * Use of injectable DMT * Type of injectable DMT
Time frame: Up to 13 months
Number of Patients by Reason for Switch from Other DMT to Ofatumumab
Time frame: Up to 13 months
Individual Annualized Relapse Rate (ARR) Before Ofatumumab Initiation
Individual ARR was derived per patient as \[(number of confirmed MS relapses) / (time at risk (years)\].
Time frame: Up to 13 months
Total ARR Before Ofatumumab Initiation
Total ARR was derived as \[(total number of confirmed MS relapses) / (total number of person-years at risk)\].
Time frame: Up to 13 months
Individual ARR After Ofatumumab Initiation
Individual ARR was derived per patient as \[(number of confirmed MS relapses) / (time at risk (years)\].
Time frame: Up to 13 months
Total ARR After Ofatumumab Initiation
Total ARR was derived as \[(total number of confirmed MS relapses) / (total number of person-years at risk)\].
Time frame: Up to 13 months
Average Expanded Disability Status Scale (EDSS) Score Before Ofatumumab Initiation
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).
Time frame: Up to 13 months
Average EDSS Score After Ofatumumab Initiation
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).
Time frame: Up to 13 months
Absolute Change in Average EDSS Score
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).
Time frame: Up to 26 months
Average Number of T1 and T2 Lesions Before Ofatumumab Initiation
Time frame: Up to 13 months
Average Number of T1 and T2 Lesions After Ofatumumab Initiation
Time frame: Up to 13 months
Individual ARR After Ofatumumab Initiation by MPR Category
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.
Time frame: Up to 13 months
Total ARR After Ofatumumab Initiation by MPR Category
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.
Time frame: Up to 13 months
Average EDSS Score Before Ofatumumab Initiation by MPR Category
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.
Time frame: Up to 13 months
Average EDSS Score After Ofatumumab Initiation by MPR Category
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.
Time frame: Up to 13 months
Absolute Change in Average EDSS Score by MPR Category
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.
Time frame: Up to 26 months
Number of Patients per MPR Category by Type of KC PSP Services Received
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.
Time frame: Up to 13 months
Number of Medical Visits After Ofatumumab Initiation
Medical visits included accident and emergency (A\&E) visits, inpatient visits, and outpatient visits.
Time frame: Up to 13 months
Annualized Medical Visit Rate After Ofatumumab Initiation
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.
Time frame: Up to 13 months
Number of MS-related Medical Visits After Ofatumumab Initiation
MS-related medical visits included A\&E visits, inpatient visits, and outpatient visits.
Time frame: Up to 13 months
Annualized MS-related Medical Visit Rate After Ofatumumab Initiation
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.
Time frame: Up to 13 months
Number of Patients With Medically Reported Adherence (MRA) After Ofatumumab Initiation
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 period
Time frame: Up to 13 months
Number of Patients by Reason for Discontinuation of Ofatumumab
Time frame: Up to 13 months
Number of Patients who Switched From Ofatumumab to an Alternative DMT
Time frame: Up to 13 months
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