Effectiveness of Ofatumumab in Real-world Practice

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT06760624

COMB157AUS21

Details and patient eligibility

About

This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administration [FDA] approval date) and 01 July 2023 (patient identification window) were included in the study population. The date of the first OMB claim within the patient identification window was defined as the index date. Outcomes, including annualized relapse rate (ARR) and MS-related healthcare resource utilization (HCRU), were measured across two distinct periods. The pre-index period was defined as the fixed 12-month period prior to the index date, during which demographic and clinical characteristics were also assessed. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy [DMT]), discontinuation of enrollment, or end of study period on 31 December 2023.

Enrollment: 779 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
2. One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
3. One claim or more with a diagnosis of MS (International Classification of Diseases, Tenth Revision [ICD-10] code G35.xx) any time before the index date and up to 6 months after the index date.
4. Continuous healthcare plan enrollment from ≥12 months prior to the index date (pre-index period) to ≥12 months following the index date (post-index period).
5. Persistent use of OMB therapy throughout the post-index period, defined as the absence of a discontinuation of OMB or switch to another MS treatment.

Exclusion criteria

None.

Trial design

779 participants in 3 patient groups

Ofatumumab MS Cohort

Description:

Adult patients diagnosed with MS who were treated with ofatumumab.

Anti-CD20-naïve Sub-cohort

Description:

Adult patients diagnosed with MS who were treated with ofatumumab and had not received anti-CD20 treatment.

Anti-CD20-experienced Sub-cohort

Description:

Adult patients diagnosed with MS who were treated with ofatumumab and had previously received anti-CD20 treatment.