Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Ofatunumab
- Registration Number
- NCT05576779
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2101
-
Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.
-. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
-
Patients with linkage to the Dx database.
Exclusion criteria
- No exclusion criteria were applied to patients in the study.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ofatumumab Ofatunumab all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
- Primary Outcome Measures
Name Time Method Proportion of patients initiating ofatumumab based on DMT use 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) 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.
- Secondary Outcome Measures
Name Time Method Age Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) Age information was reported
Number of patients: Pre-index Charlson comorbidity index (CCI) 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) 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)
Number of patients: Geographic region Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) Northeast, Midwest, South, West, Unknown
Number of patients: Payer Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) CVS, Aetna etc
Post-index: Number of patients with COVID-19 vaccination 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) Yes/No
Gender Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) Gender information was reported
Number of patients: Insurance type Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) Cash, Commercial, Medicare, Medicare Part D, Medicaid, Unknown
Number of patients: Pre-index comorbidities 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 list of comorbidities were reported
Number of patients with a relapse in inpatient settings 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 MS relapses were reported
Claims-Based Disability Score 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 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.
Number of patients: Hepatitis B virus screening 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) Yes/No
Post-index: Number of patients with COVID-19 diagnosis 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) Yes/No
Number of patients: State level (Geographic region) Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) The geographical heat map of ofatumumab utilization at the state level was presented.
Follow-up time 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) Ofatumumab persistence was assessed over the variable follow-up time.
Number of patients with a relapse in outpatient settings 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 MS relapses were reported
Number of relapses in patients with at least 1 relapse 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 MS relapses were reported
Days between COVID-19 diagnosis and initiation of ofatumumab 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 were reported
Days between COVID-19 vaccination and initiation of ofatumumab 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 were reported.
Post-index HCRU: Number of patients with an outpatient visit 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 with an outpatient visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Number of patients: Quantitative serum immunoglobulin screening 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) Yes/No
Number of patients: Pre-index flu shot 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) Yes/No
Number of patients: Post-index flu shot 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) Yes/No
Number of pre-index Brain and Spinal MRI scans 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) Categorized as: No MRI, 1, 2, 3+
Pre-index: Number of patients with COVID-19 vaccination 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) Yes/No
Number of relapses in all patients 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 MS relapses were reported
Pre-index: Number of patients with COVID-19 diagnosis 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) Yes/No
Proportion of patients with steroid use or antihistamine as pre-medication with ofatumumab first dose 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) E.g. diphenhydramine, dexamethasone and other steroids. pre-medication was defined as medication observed within two days of ofatumumab initiation.
Pre-index HCRU: Number of patients with an inpatient visit 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 an inpatient visits were reported to report the pre-index healthcare resource utilization
Post-index HCRU: Number of patients with an ED visit 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 with an ED visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Pre-index HCRU: Number of patients with an ED visit 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 an ED visit were reported to report the pre-index healthcare resource utilization
Post-index HCRU: Number of patients with an inpatient visit 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 with an inpatient visits were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Pre-index HCRU: Number of patients with an outpatient visit 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 an outpatient visit were reported to report the pre-index healthcare resource utilization
Pre-index HCRU: Number of patients with a pharmacy claim 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 pharmacy claim were reported to report the pre-index healthcare resource utilization
Post-index HCRU: Number of patients with a pharmacy claim 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 with a pharmacy claim were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸East Hanover, New Jersey, United States