Effectiveness of Ofatumumab in Real-world Practice

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 779

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		Baseline
Number of Patients per Demographic Category	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)	Baseline
Mean Deyo-Charlson Comorbidity Index	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).	Baseline
Mean Number of Psychiatric Diagnostic Group (PDG) Mental Health Disorders	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	Baseline
Number of Patients Categorized by Top Five Selected Comorbidities	Top five selected comorbidities included osteoarthritis, dyslipidemia, depression, hypertension, and sleep disorders.	Baseline
Number of Patients Categorized by Top Five MS-related Symptoms and Secondary Conditions	Top five MS-related symptoms and secondary conditions included anxiety, fatigue or malaise, sensory problems, eye symptoms, and urinary tract infection.	Baseline
Number of Patients Categorized by MS Disability Level	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.	Baseline
Number of Patients Categorized by DMT Used in the Pre-index Period	DMT categories included: Any DMT; Low/moderate efficacy therapy; High efficacy therapy; No DMT	Baseline
Pre-index Healthcare Resource Utilization (HCRU): Number of MS-related Hospitalizations per Person-year (PPY)	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.	12 months
Pre-index HCRU: Number of Days of MS-related Hospitalization PPY	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.	12 months
Pre-index HCRU: Number of MS-related Healthcare Visits PPY	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.	12 months
Post-index HCRU: Number of MS-related Hospitalizations PPY	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.	An average of approximately 16 months
Post-index HCRU: Number of Days of MS-related Hospitalization PPY	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.	An average of approximately 16 months
Post-index HCRU: Number of MS-related Healthcare Visits PPY	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.	An average of approximately 16 months
Incidence Rate Ratio of MS-related Hospitalizations	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.	An average of approximately 16 months
Incidence Rate Ratio of Days of MS-related Hospitalizations	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.	An average of approximately 16 months
Incidence Rate Ratio of MS-related Emergency Department Visits	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.	An average of approximately 16 months
Incidence Rate Ratio of MS-related Outpatient Visits	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.	An average of approximately 16 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for COMB157AUS21 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: COMB157AUS21