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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05576779

Collaborator

(none)

2,101

Enrollment

Location

12.9

Actual Duration (Months)

162.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Ofatunumab

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.

Study Design

Study Type:

Observational

Actual Enrollment :

2101 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 3, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Ofatumumab all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort	Other: Ofatunumab All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
Non-ofatumumab 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

Arm

Intervention/Treatment

Ofatumumab

all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

Other: Ofatunumab

All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

Non-ofatumumab

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

Outcome Measures

Primary Outcome Measures

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

Age [Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)]
Age information was reported
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: 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: 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.
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: Payer [Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)]
CVS, Aetna etc
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: 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: 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
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 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
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
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 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+
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
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
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
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
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
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
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
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.
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
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
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 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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.