RT Journal Article
SR Electronic
T1 Immune response to vaccines is maintained in patients treated with dimethyl fumarate
JF Neurology - Neuroimmunology Neuroinflammation
JO Neurol Neuroimmunol Neuroinflamm
FD Lippincott Williams & Wilkins
SP e409
DO 10.1212/NXI.0000000000000409
VO 5
IS 1
A1 von Hehn, Christian
A1 Howard, Jonathan
A1 Liu, Shifang
A1 Meka, Ven
A1 Pultz, Joe
A1 Mehta, Devangi
A1 Prada, Claudia
A1 Ray, Soma
A1 Edwards, Michael R.
A1 Sheikh, Sarah I.
YR 2018
UL http://nn.neurology.org/content/5/1/e409.abstract
AB Objectives: To investigate the immune response to vaccinations in patients with relapsing forms of MS treated with delayed-release dimethyl fumarate (DMF) vs nonpegylated interferon (IFN).Methods: In this open-label, multicenter study, patients received 3 vaccinations: (1) tetanus-diphtheria toxoid (Td) to test T-cell–dependent recall response, (2) pneumococcal vaccine polyvalent to test T-cell–independent humoral response, and (3) meningococcal (groups A, C, W-135, and Y) oligosaccharide CRM197 conjugate to test T-cell–dependent neoantigen response. Eligible patients were aged 18–55 years, diagnosed with relapsing-remitting MS (RRMS), and either treated for ≥6 months with an approved dose of DMF or for ≥3 months with an approved dose of nonpegylated IFN. Primary end point was the proportion of patients with ≥2-fold rise in antitetanus serum IgG levels from prevaccination to 4 weeks after vaccination.Results: Seventy-one patients (DMF treated, 38; IFN treated, 33) were enrolled. The mean age was 45.3 years (range 27–55); 86% were women. Responder rates (≥2-fold rise) to Td vaccination were comparable between DMF- and IFN-treated groups (68% vs 73%). Responder rates (≥2-fold rise) were also similar between DMF- and IFN-treated groups for diphtheria antitoxoid (58% vs 61%), pneumococcal serotype 3 (66% vs 79%), pneumococcal serotype 8 (95% vs 88%), and meningococcal serogroup C (53% vs 53%), all p > 0.05. In a post hoc analysis, no meaningful differences were observed between groups in the proportion of responders when stratified by age category or lymphocyte count.Conclusions: DMF-treated patients mount an immune response to recall, neoantigens, and T-cell–independent antigens, which was comparable with that of IFN-treated patients and provided adequate seroprotection.ClinicalTrials.gov identifier: NCT02097849.Classification of evidence: This study provides Class II evidence that patients with RRMS treated with DMF respond to vaccinations comparably with IFN-treated patients.AAAAI=American Academy of Allergy, Asthma & Immunology; AE=adverse event; CI=confidence interval; DMF=delayed-release dimethyl fumarate; IFN=interferon; IgG=immunoglobulin G; RRMS=relapsing-remitting MS; Td=tetanus-diphtheria toxoid; TH=T helper