Novartis
East Hanover, New Jersey, 07936, United States
NCT Number: NCT06760624
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.
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Notify Me18 year and older
All sexes
Observational
East Hanover, New Jersey, 07936, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Time frame: Baseline
Demographic categories included:
Time frame: 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).
Time frame: Baseline
PDG captures a list of mental health disorders a patient may have at study baseline. The following are the list of PDGs:
Time frame: Baseline
Top five selected comorbidities included osteoarthritis, dyslipidemia, depression, hypertension, and sleep disorders.
Time frame: Baseline
Top five MS-related symptoms and secondary conditions included anxiety, fatigue or malaise, sensory problems, eye symptoms, and urinary tract infection.
Time frame: 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.
Time frame: Baseline
DMT categories included:
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Novartis Pharmaceuticals
Industry
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