title: Natalizumab treatment shows no clinically meaningful effects on immunization responses in patients with relapsing-remitting multiple sclerosis.
abstract: Natalizumab is an immunomodulatory drug approved for the treatment of multiple sclerosis. This randomized, multicenter, open-label study evaluated natalizumab's effects on immunization responses to a recall antigen (tetanus toxoid [TT]) and a neoantigen (keyhole limpet hemocyanin [KLH]) in patients with relapsing forms of multiple sclerosis (MS). Natalizumab-naive relapsing MS patients were randomized (1:1; n=30 per group) to receive TT and KLH immunizations either without natalizumab treatment (control) or after 6 months of natalizumab treatment (natalizumab group). An adequate response to immunization was defined as an increase to at least twofold in specific serum immunoglobulin G (IgG) 28 days after the first immunization. All evaluable patients achieved protective levels of anti-TT IgG antibodies, and the proportion of responders to this recall antigen, as well as to primary immunization with KLH, was similar in the presence and absence of natalizumab. This indicates that natalizumab treatment does not appear to affect responses to primary or secondary immunization in a clinically meaningful way.
authors.affiliation: Carolinas Health Care System, Charlotte, NC, USA. Electronic address: michael.kaufman@carolinashealthcare.org.
authors.forename: Michael
authors.initials: M
authors.lastname: Kaufman
authors.affiliation: OMRF Multiple Sclerosis Center of Excellence, 820 NE 15th Street, Oklahoma City, OK 73104, USA. Electronic address: gabriel-pardo@omrf.org.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Pardo
authors.affiliation: Michigan Institute for Neurological Disorders, 28595 Orchard Lake Road, #200, Farmington Hills, MI 48334, USA. Electronic address: HSRossman@aol.com.
authors.forename: Howard
authors.initials: H
authors.lastname: Rossman
authors.affiliation: Biogen Idec Inc., 133 Boston Post Road, Weston, MA 02493, USA. Electronic address: marianne.sweetser@biogenidec.com.
authors.forename: Marianne T
authors.initials: MT
authors.lastname: Sweetser
authors.affiliation: Biogen Idec Inc., 133 Boston Post Road, Weston, MA 02493, USA. Electronic address: fiona.forrestal@biogenidec.com.
authors.forename: Fiona
authors.initials: F
authors.lastname: Forrestal
authors.affiliation: Biogen Idec Inc., 133 Boston Post Road, Weston, MA 02493, USA. Electronic address: petra.duda@biogenidec.com.
authors.forename: Petra
authors.initials: P
authors.lastname: Duda
mesh_terms: D000293:Adolescent; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006433:Hemocyanins; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007156:Immunologic Memory; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000276:immunology*; D000069442:Natalizumab; D013745:Tetanus Toxoid / Q000276:immunology; D013997:Time Factors; D014611:Vaccination / Q000379:methods*; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069442:Natalizumab; D013745:Tetanus Toxoid; D006433:Hemocyanins; C032808:keyhole-limpet hemocyanin
keywords: Humoral; Immunity; Immunization; Immunoglobulins; Lymphocytes; Multiple sclerosis; Natalizumab; Vaccines