Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Initial COVID-19 vaccination. 2. Booster vaccination. * Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following: 1. Full COVID-19 vaccination course. 2. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status | From 2 weeks up to 6 months post-vaccine | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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). |
| Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT) | From 2 weeks up to 6 months post-vaccine | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gender at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Gender at Index Date by Prior DMT | Index date | 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. |
| Race at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Race at Index Date by Prior DMT | Index date | 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. |
| Number of Patients per United States Region at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Number of Patients per United States Region at Index Date by Prior DMT | Index date | 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. |
| Time since MS Diagnosis at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Time since MS Diagnosis at Index Date by Prior DMT | Index date | 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. |
| Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT | Index date | 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. |
| Mean Age at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Number of Patients with Secondary Progressive MS at Index Date by Prior DMT | Index date | 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. |
| Number of Patients with Primary Progressive MS at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Number of Patients with Primary Progressive MS at Index Date by Prior DMT | Index date | 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. |
| Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status | Within 12 months preceding index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT | Within 12 months preceding index date | 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. |
| Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status | Within 12 months preceding index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT | Within 12 months preceding index date | 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. |
| Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status | Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination) | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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). |
| Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT | Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination) | DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. |
| Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status | Index date | Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. 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. |
| Mean Age at Index Date by Prior Disease Modifying Therapy (DMT) | Index date | 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. |
Countries
United States
Outcome results
None listed