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This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Vaccination Cohort | Patients with multiple sclerosis (MS) who were receiving ofatumumab at the time of full COVID-19 vaccination and/or first booster vaccination. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). | From 2 weeks up to 6 months post-vaccine |
| Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT) | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. | From 2 weeks up to 6 months post-vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Age at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. |
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Inclusion criteria:
Aged at least 18 years of age upon receipt of first COVID-19 vaccination.
Fully vaccinated with any FDA-authorized COVID-19 vaccination.
Diagnosed with MS.
Receiving ofatumumab at the time of either (or both) of the following:
Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:
Full COVID-19 vaccination course.
Booster vaccine (among patients receiving ofatumumab at the time of the booster).
Exclusion criteria:
Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Index date |
| Mean Age at Index Date by Prior Disease Modifying Therapy (DMT) | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Gender at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Gender at Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Race at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Race at Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients per United States Region at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients per United States Region at Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Time since MS Diagnosis at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Time since MS Diagnosis at Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients with Secondary Progressive MS at Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients with Primary Progressive MS at Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Number of Patients with Primary Progressive MS at Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Index date |
| Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Within 12 months preceding index date |
| Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Within 12 months preceding index date |
| Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Within 12 months preceding index date |
| Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination. | Within 12 months preceding index date |
| Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson). | Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination) |
| Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. | Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |