Effectiveness of Ofatumumab in Real-world Practice

NCT06760624 | Completed

• 1 other identifier: COMB157AUS21
• Study Type: observational
• Target: 779
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Annualized Relapse Rate (ARR) in the Pre-Index Period

  The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.

  12 months

• ARR in the Post-index Period

  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. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.

  An average of approximately 16 months

• Incidence Rate Ratio

  Incidence rate ratio was measured to evaluate the change in MS-related ARR in the pre- versus the post-index period. The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. 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 DMT), discontinuation of enrollment, or end of study period.

  An average of approximately 16 months

Secondary Outcomes (18)

• Age

  Baseline

• Number of Patients per Demographic Category

  Baseline

• Mean Deyo-Charlson Comorbidity Index

  Baseline

• Mean Number of Psychiatric Diagnostic Group (PDG) Mental Health Disorders

  Baseline

• Number of Patients Categorized by Top Five Selected Comorbidities

  Baseline

Study Arms (3)

Ofatumumab MS Cohort

Adult patients diagnosed with MS who were treated with ofatumumab.

Anti-CD20-naïve Sub-cohort

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

Anti-CD20-experienced Sub-cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
• One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
• 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.
• 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).
• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Results for COMB157AUS21 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 7, 2025
• Study Start: October 24, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

US (1)