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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576779
• Other study ID #: COMB157GUS11
• Status: Completed
• Start date: December 3, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2101
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Age	Age information was reported	Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Secondary	Gender	Gender information was reported	Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Results for COMB157GUS11 from the Novartis Clinical Trials Website