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.
Study Type
OBSERVATIONAL
Enrollment
38
Novartis
East Hanover, New Jersey, United States
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: 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).
Time frame: 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.
Time frame: From 2 weeks up to 6 months post-vaccine
Mean Age at Index Date by Vaccination Status
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 frame: Index date
Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)
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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 frame: Index date
Gender at Index Date by Vaccination Status
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 frame: 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.
Time frame: Index date
Race at Index Date by Vaccination Status
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 frame: 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.
Time frame: 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: 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 frame: 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.
Time frame: 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: 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 frame: 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.
Time frame: 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: 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 frame: 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.
Time frame: 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: 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 frame: 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.
Time frame: 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: 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 frame: 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.
Time frame: 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: 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 frame: 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.
Time frame: 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: 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 frame: 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.
Time frame: 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: 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).
Time frame: 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.
Time frame: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)