This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.
The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed. Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics. The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.
Study Type
OBSERVATIONAL
Enrollment
2,101
All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
Novartis Investigative Site
East Hanover, New Jersey, United States
Proportion of patients initiating ofatumumab based on DMT use
The primary measure was pre-index treatment status of patients initiating ofatumumab, measured as proportion (n, %) of DMT-naïve and DMT-experienced patients among patients initiating ofatumumab based on DMT use in the 12-month pre-index period.
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Age
Age information was reported
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Gender
Gender information was reported
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Geographic region
Northeast, Midwest, South, West, Unknown
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: State level (Geographic region)
The geographical heat map of ofatumumab utilization at the state level was presented.
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Insurance type
Cash, Commercial, Medicare, Medicare Part D, Medicaid, Unknown
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
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Number of patients: Payer
CVS, Aetna etc
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Follow-up time
Ofatumumab persistence was assessed over the variable follow-up time.
Time frame: Variable Post-index period, where index date was defined as date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Number of patients: Pre-index Charlson comorbidity index (CCI)
Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. omorbidity was assessed using the Charlson Comorbidity Index (CCI), categorized as low (0-1) and high (≥2)
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Pre-index comorbidities
Number of patients with list of comorbidities were reported
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients with a relapse in inpatient settings
Number of patients with MS relapses were reported
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients with a relapse in outpatient settings
Number of patients with MS relapses were reported
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of relapses in all patients
Number of patients with MS relapses were reported
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of relapses in patients with at least 1 relapse
Number of patients with MS relapses were reported
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Claims-Based Disability Score
Pre-index MS-related symptoms and secondary conditions (n, %) based on a Claims-Based Disability Score (e.g., sensory problems, eye symptoms, pyramidal symptoms, bladder/bowel symptoms, fatigue/malaise, muscular weakness, durable medical equipment utilization.
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of pre-index Brain and Spinal MRI scans
Categorized as: No MRI, 1, 2, 3+
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Hepatitis B virus screening
Yes/No
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Quantitative serum immunoglobulin screening
Yes/No
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Pre-index flu shot
Yes/No
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Post-index flu shot
Yes/No
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index: Number of patients with COVID-19 diagnosis
Yes/No
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index: Number of patients with COVID-19 diagnosis
Yes/No
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Days between COVID-19 diagnosis and initiation of ofatumumab
Days between COVID-19 diagnosis and initiation of ofatumumab were reported
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index: Number of patients with COVID-19 vaccination
Yes/No
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index: Number of patients with COVID-19 vaccination
Yes/No
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Days between COVID-19 vaccination and initiation of ofatumumab
Days between COVID-19 vaccination and initiation of ofatumumab were reported.
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Proportion of patients with steroid use or antihistamine as pre-medication with ofatumumab first dose
E.g. diphenhydramine, dexamethasone and other steroids. pre-medication was defined as medication observed within two days of ofatumumab initiation.
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index HCRU: Number of patients with an inpatient visit
Number of patients with an inpatient visits were reported to report the pre-index healthcare resource utilization
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with an ED visit
Number of patients with an ED visit were reported to report the pre-index healthcare resource utilization
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with an outpatient visit
Number of patients with an outpatient visit were reported to report the pre-index healthcare resource utilization
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with a pharmacy claim
Number of patients with a pharmacy claim were reported to report the pre-index healthcare resource utilization
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index HCRU: Number of patients with an inpatient visit
Number of patients with an inpatient visits were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with an ED visit
Number of patients with an ED visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with an outpatient visit
Number of patients with an outpatient visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with a pharmacy claim
Number of patients with a pharmacy claim were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)