A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab

Assessment of COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab in the United States: A Multicenter Medical Record Review Study

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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

Outcome Measure	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 and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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: full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or; booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or; 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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: COMB157GUS27