COVID-19 Antibody Response by Vaccine Type and Lymphocyte Count in RMS Patients on Ponesimod: Results From Phase 2 Long-term Extension Study AC-058B202
Janice Wong1, Nina Hertoghs2, Alexandre Lemle3, Philippe Linscheid3, Nandini Raghavan1, Amita Singh3, Tatiana Sidorenko3
1Janssen Research & Development, LLC, Titusville, United States, 2Janssen Research & Development, LLC, Leiden, Netherlands, 3Actelion Pharmaceuticals, Part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Allschwil, Switzerland
Objective:
To characterize the SARS-CoV-2 humoral response by vaccine type and pre-vaccination lymphocyte count in relapsing multiple sclerosis (RMS) patients who have received coronavirus disease 2019 (COVID-19) vaccination while on ponesimod treatment.
Background:
Various factors may impact the humoral response to COVID-19 vaccination in MS patients treated with sphingosine 1-phosphate receptor modulators, including ponesimod.
Design/Methods:
Patients in the Phase 2 extension study AC-058B202 receiving ponesimod 20 mg who reported COVID-19 vaccination were included in this analysis. Blood samples collected before and ≥3 weeks after vaccination were evaluated with Human SARS-CoV-2 PreSpike IgG (spike antibody) enzyme-linked immunoassay (Nexelis). A responder to vaccination was defined as seroconversion in case of negative pre-vaccination antibody testing, or a 4-fold antibody concentration increase in case of positive pre-vaccination antibody result. Responder analysis was performed by vaccine type and by pre-vaccination lymphocyte count.
Results:
49 COVID-19-vaccinated patients had both pre- and post-vaccination blood samples available for analysis and were on uninterrupted ponesimod treatment during the course of vaccination. Response to COVID-19 vaccination varied by vaccination type: of 32 participants who received mRNA vaccines, 29 (90.6%) met responder criteria. Of 7 participants who received viral vector vaccines, 5 (71.4%) were responders. Of 6 participants who received inactivated virus vaccines, 2 (33.3%) were responders. Of 4 participants who received mixed or unspecified vaccine types, 4 (100%) were responders. Response to COVID-19 vaccination also varied by lymphocyte count: of 16 participants with pre-vaccination lymphocyte count <500/mm3, 9 (56.3%) were responders. Of 32 participants with lymphocyte count ≥500/mm3, 30 (93.8%) were responders.
Conclusions:
Humoral response to COVID-19 vaccines in RMS patients on ponesimod in the Phase 2 study varied by vaccine type and pre-vaccination lymphocyte count. In patients who received mRNA COVID-19 vaccines and/or who had pre- vaccination lymphocyte count ≥500/mm3, most (>90%) met antibody concentration responder criteria.