Effect of SARS-CoV-2 mRNA Vaccination in MS Patients Treated With Disease Modifying Therapies

Background: In patients with Multiple Sclerosis (pwMS) disease-modifying therapies (DMTs) are known to affect immune response antigens and possibly SARS-CoV2 vaccine. Therefore, post-vaccination serological assessments needed evaluate the effect of vaccine on SARS-CoV-2 antibody response. Methods: We designed a prospective multicenter cohort study enrolling pwMS who were scheduled for SARS-Cov-2 vaccination mRNA vaccines (BNT162b2, Pfizer/BioNTech, Inc or mRNA-1273, Moderna Tx, Inc). A blood collection measure before first dose 4 weeks after second was planned, centralized assessment (electrochemiluminescence immunoassay, ECLIA, Roche Diagnostics). Findings: 780 (76% BNT162b2 24% mRNA-1273) had pre- 4-week assessments. 87 (11·2%) untreated, 154 (19·7%) ocrelizumab, 25 (3·2%) rituximab, 85 (10·9%) fingolimod, cladribine 404 (51·7%) other DMTs. 677 (86·8%) detectable antibodies. At multivariate analysis, levels ocrelizumab (178-fold decrease, p<0·001), fingolimod (26-fold p<0·001) rituximab (17-fold significantly reduced as compared untreated patients. mRNA-1273 resulted in systematically 3·5-fold higher level than (p<0·001). Interpretation: pwMS, therapy anti-CD20 led humoral vaccines. As elicits 3·5-higher titers BNT162b2, this may be preferentially considered under fingolimod. Since it is still unknown role T-cells response, further information required about cellular immunity triggered by better define most appropriate strategy vaccinate specific DMTs. Funding Information: FISM [2021/Special-Multi/001]; Italian Ministry Health grant ‘Progetto Z844A 5x1000’. Declaration Interests: MPS reports grants from Roche, during conduct study; personal fees Biogen, Merck, Sanofi, Novartis, Medday, Geneuro, Celgene, Mylan, outside submitted work; MI consulting Merck-Serono, Sanofi-Genzyme, Biogen; AL has received compensation Sanofi Genzyme, public speaking advisory boards. funding research Fondazione Italiana Sclerosi Multipla, Health, University; CC Biogen Idec, Almirall, Merck Serono, DL Teva, fess boards Bristol-Celgene, JF fromSanofi, Admirall; ADS Genzyme; MS support Merk, Roche; AU Genzyme European Community. IS, LC, CL, GDR, CS, IG, TT, GP, PG, GPB, AM, MLS, MC, ES, MTF, LP, MU, FM, GC, RI, GL, AMR, FC, SC, MAB, DF, have nothing dislcose. Ethics Approval Statement: The done compliance principles Declaration Helsinki. protocol approved regional (CER Liguria: 5/2021 - DB id 11169- 21/01/2021) national ethical committee AIFA/Spallanzani (Parere n 351, 2020/21). Written informed consent obtained all participants starting any procedures.