DMT12
Evaluating Humoral Immune Response to mRNA COVID-19 Vaccines in Siponimod-Treated Patients with Advancing Forms of RMS: A COVID-19 Vaccine Sub-Study of the Exchange Trial

Thursday, June 2, 2022
Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)
Amit Bar-Or, MD , Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Yang Mao-Draayer, MD, PhD , Autoimmunity Center of Excellence, Multiple Sclerosis Center, University of Michigan, Ann Arbor, MI
Silvia R Delgado, MD , Department of Neurology, University of Miami Miller School of Medicine, Miami, FL
Robert J Fox, MD , Cleveland Clinic, Cleveland, OH
Linda-Ali Cruz, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Xiangyi Meng, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Gina Mavrikis Cox, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Stanley L Cohan, MD, PhD , Providence Multiple Sclerosis Center, Providence Brain Institute, Portland, OR
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Background: Siponimod is approved in the USA for treatment of adults with relapsing multiple sclerosis (RMS). Given the ongoing COVID-19 global pandemic, it is important to assess if patients can mount an anti-viral humoral immune response to COVID-19 vaccines while receiving siponimod.

Objectives: To assess humoral immune response to non-live COVID-19 mRNA vaccines (Pfizer/Moderna) in a subset of patients enrolled in EXCHANGE (NCT03623243), a 6-month, open-label, single-arm Phase 3b trial of conversion to siponimod in patients with advancing forms of RMS.

Methods: This is a single-arm pilot sub-study in siponimod-treated patients currently participating in the core EXCHANGE study who have received a full course (2 doses) of mRNA COVID-19 vaccine. EXCHANGE enrolled patients aged 18-65 years with advancing forms of RMS, EDSS score 2.0–6.5, and on continuous oral/injectable/infusion DMTs for ≥3 months at time of consent. Patients with known prior COVID-19 diagnosis will be excluded from the sub-study and evaluation of IgG response to SARS-CoV-2 nucleocapsid protein will be assessed on study. Patients in the sub-study will continue taking siponimod as per the EXCHANGE study protocol. The sub-study will evaluate the number of patients achieving positive IgG response to SARS-CoV-2 spike protein ≥14 days after full course vaccination. Exploratory endpoints include rate of seroconversion and evaluation of magnitude of humoral response to COVID-19 vaccination.

Results: This sub-study plans to enroll up to 20 patients from the EXCHANGE core study. An interim analysis will be performed following collection of sub-study assessments. The following data will be presented together with the detailed sub-study design: sub-study patient demographics including MS history, number of patients achieving vaccination response via the presence of serum SARS-CoV-2 spike IgG antibodies, as well as quantitative humoral response to COVID-19 vaccine.

Conclusions: This sub-study will contribute to a better understanding of humoral immune responses that occur in siponimod-treated patients with advancing forms of RMS after COVID-19 mRNA vaccination.

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