title: Vaccine responses in patients with rheumatoid arthritis treated with certolizumab pegol: results from a single-blind randomized phase IV trial.
abstract: OBJECTIVE
  To evaluate the humoral immune response to pneumococcal and influenza vaccination in adults with rheumatoid arthritis (RA) receiving certolizumab pegol (CZP).
  
  
  METHODS
  In this 6-week, single-blind, placebo-controlled trial with optional 6-month open-label extension (NCT00993668), patients were stratified by concomitant methotrexate (MTX) use and randomized to receive CZP 400 mg (loading dose; according to CZP label) or placebo at weeks 0, 2, and 4. Pneumococcal (polysaccharide 23) and influenza vaccines were administered at Week 2. Satisfactory humoral immune response, defined as ≥2-fold titer increase in ≥3 of 6 pneumococcal antigens and ≥4-fold titer increase in ≥2 of 3 influenza antigens, were assessed independently 4 weeks after vaccination.
  
  
  RESULTS
  Following pneumococcal vaccination, 62.5% of placebo patients and 54.5% of CZP patients without effective titers at baseline achieved a humoral response (difference in proportions was -8.0 percentage points; 95% CI -22.5 to 6.6%). Following influenza vaccination, 61.4% of placebo and 53.5% of CZP patients without effective titers at baseline achieved a humoral response (difference in proportions: -8.0 percentage points; 95% CI -22.9 to 7.0%). In all patients, including those with effective titers at baseline, 58.2% of placebo and 53.3% of CZP patients developed satisfactory pneumococcal titers, and 54.1% of placebo and 50.5% of CZP patients developed satisfactory influenza antibody titers. Vaccine responses to pneumococcal and influenza antigens were reduced similarly in both treatment groups with concomitant MTX use.
  
  
  CONCLUSIONS
  Humoral immune responses to pneumococcal and influenza vaccination are not impaired when given during the loading phase of CZP treatment in patients with RA. (ClinicalTrials.gov NCT00993668).
authors.affiliation: From the Altoona Center for Clinical Research, Duncansville, PA; Sun Valley Arthritis Center, Peoria, AZ; UCB Pharma, Smyrna, GA, USA; UCB Pharma, Monheim, Germany; UCB Pharma, Brussels, Belgium.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Kivitz
authors.forename: Joy
authors.initials: J
authors.lastname: Schechtman
authors.forename: Michele
authors.initials: M
authors.lastname: Texter
authors.forename: Andreas
authors.initials: A
authors.lastname: Fichtner
authors.forename: Marc
authors.initials: M
authors.lastname: de Longueville
authors.forename: Elliot K
authors.initials: EK
authors.lastname: Chartash
mesh_terms: D000328:Adult; D000367:Age Factors; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000917:Antibody Formation / Q000187:drug effects / Q000276:immunology; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology*; D000068582:Certolizumab Pegol; D016001:Confidence Intervals; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D056724:Immunity, Humoral / Q000187:drug effects; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D012016:Reference Values; D018570:Risk Assessment; D012737:Sex Factors; D016037:Single-Blind Method; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D007166:Immunosuppressive Agents; D007252:Influenza Vaccines; D022242:Pneumococcal Vaccines; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol
keywords: CERTOLIZUMAB PEGOL; HUMORAL IMMUNE RESPONSE; INFLUENZA VACCINE; PNEUMOCOCCAL VACCINE; RHEUMATOID ARTHRITIS; TUMOR NECROSIS FACTOR INHIBITOR