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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 2101

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with prescription claims for ofatumumab or other DMTs of interest.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for COMB157GUS11 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Multiple sclerosis,; ofatumumab,; disease-modifying therapy,
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: COMB157GUS11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No