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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT06460324
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-20
• Primary Completion: 2023-07-03
• Study Completion: 2023-07-03
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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).

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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 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.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States