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

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Ofatunumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05576779

COMB157GUS11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,101 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

2,101 participants in 2 patient groups

Ofatumumab

Description:

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

Treatment:

Other: Ofatunumab

Non-ofatumumab

Description:

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