Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis in the Real-World

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Ofatunumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ofatumumab<br>all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort | Other: Ofatunumab<br>* All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort<br>|
| Non-ofatumumab<br>patients with no evidence of ofatumumab during the index period were included in the non-ofatumumab cohort and included in subgroups based on the index medication: Siponimod, Ocrelizumab, Dimethyl fumarate, Glatiramer acetate | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age information was reported | Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) | 
| Gender | Gender information was reported | 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 | 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. | 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 | Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) | 
| Number of patients: Payer | CVS, Aetna etc | 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. | 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) | 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 | 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 | 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 | 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 | 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 | 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. | 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+ | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Multiple sclerosis,, ofatumumab,, disease-modifying therapy,