A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab
NCT Number: NCT06460324
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-20
Completion Date: 2023-07-03
Locations: Novartis, East Hanover, New Jersey, 07936, United States

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.

Primary Outcome Measures: 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)., 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
Secondary Outcome Measures: 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., 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:

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., 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:

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., 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:

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., 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:

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., 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:

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., 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:

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., 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:

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., 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:

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., 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:

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., 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:

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)., 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)