Effectiveness of Ofatumumab in Real-world Practice

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT06760624
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 779

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annualized Relapse Rate (ARR) in the Pre-Index Period	12 months	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.
ARR in the Post-index Period	An average of approximately 16 months	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.
Incidence Rate Ratio	An average of approximately 16 months	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.

Secondary Outcome Measures

Name	Time	Method
Age	Baseline
Number of Patients per Demographic Category	Baseline	Demographic categories included: * Age Group (18-34, 35-44, 45-54, 55-64, and 65+ years); * Gender; * Race; * Region; * Insurance Payer type; * Year of Index date (2020, 2021, 2022)
Mean Deyo-Charlson Comorbidity Index	Baseline	Deyo-Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the Charlson Comorbidity Index (CCI), categorized as low (0-1) and high (≥2).
Mean Number of Psychiatric Diagnostic Group (PDG) Mental Health Disorders	Baseline	PDG captures a list of mental health disorders a patient may have at study baseline. The following are the list of PDGs: * Adult personality disorders; * Anxiety disorders; * Behavioral syndromes; * Childhood and adolescent psychiatric syndromes; * Intellectual disabilities; * Psychiatric disorders with known physiological causes; * Mood disorders; * Pervasive disorders; * Schizophrenia; * Substance use
Number of Patients Categorized by Top Five Selected Comorbidities	Baseline	Top five selected comorbidities included osteoarthritis, dyslipidemia, depression, hypertension, and sleep disorders.
Number of Patients Categorized by Top Five MS-related Symptoms and Secondary Conditions	Baseline	Top five MS-related symptoms and secondary conditions included anxiety, fatigue or malaise, sensory problems, eye symptoms, and urinary tract infection.
Number of Patients Categorized by MS Disability Level	Baseline	MS disability level was based on observance of Expanded Disability Status Scale (EDSS)-related symptoms and durable medical equipment (DME) use observed in claims data weighted by severity score. Disability levels and definitions were as follows: Severe = Defined as having ≥1 EDSS-related symptom with severity score = 3 in any functional system; Moderate: Defined as having ≥1 EDSS-related symptom with severity score = 2 in any functional system, or having ≥2 functional systems with severity score = 1; Mild: Defined as having only one EDSS-related symptom with severity score = 1 or having no EDSS-related symptoms observed during the measurement period.
Number of Patients Categorized by DMT Used in the Pre-index Period	Baseline	DMT categories included: * Any DMT; * Low/moderate efficacy therapy; * High efficacy therapy; * No DMT
Pre-index Healthcare Resource Utilization (HCRU): Number of MS-related Hospitalizations per Person-year (PPY)	12 months	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.
Pre-index HCRU: Number of Days of MS-related Hospitalization PPY	12 months	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.
Pre-index HCRU: Number of MS-related Healthcare Visits PPY	12 months	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. MS-related healthcare visits included emergency department visits and outpatient visits.
Post-index HCRU: Number of MS-related Hospitalizations PPY	An average of approximately 16 months	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. The index date was the date of the first OMB claim.
Post-index HCRU: Number of Days of MS-related Hospitalization PPY	An average of approximately 16 months	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. The index date was the date of the first OMB claim.
Post-index HCRU: Number of MS-related Healthcare Visits PPY	An average of approximately 16 months	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. The index date was the date of the first OMB claim. MS-related healthcare visits included emergency department visits and outpatient visits.
Incidence Rate Ratio of MS-related Hospitalizations	An average of approximately 16 months	Incidence rate ratio was measured to evaluate the change in MS-related hospitalizations 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.
Incidence Rate Ratio of Days of MS-related Hospitalizations	An average of approximately 16 months	Incidence rate ratio was measured to evaluate the change in days of MS-related hospitalizations 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.
Incidence Rate Ratio of MS-related Emergency Department Visits	An average of approximately 16 months	Incidence rate ratio was measured to evaluate the change in MS-related emergency department visits 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.
Incidence Rate Ratio of MS-related Outpatient Visits	An average of approximately 16 months	Incidence rate ratio was measured to evaluate the change in MS-related outpatient visits 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.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States