title: Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab.
abstract: OBJECTIVE
  Patients with moderate to severe Crohn's disease who receive infliximab may experience secondary failure (loss of response and/or hypersensitivity). Data on the utility of switching to certolizumab pegol in these patients are limited.
  
  
  METHODS
  A total of 539 patients with active Crohn's disease and secondary failure to infliximab were enrolled in a 26-week trial. Patients received open-label induction with subcutaneous certolizumab pegol 400 mg at weeks 0, 2, and 4. Those in clinical response at week 6 were randomized to certolizumab pegol 400 mg every 2 or every 4 weeks through week 24. The primary end point was response at week 6. Secondary end points included remission at week 6 and response and remission at week 26.
  
  
  RESULTS
  At week 6, 334 of 539 patients (62.0%) achieved response and 212 of 539 (39.3%) achieved remission. A total of 329 patients were randomized and received maintenance therapy. At week 26, 39.9% (67 of 168) and 36.6% (59 of 161) of patients in the every-4-weeks and every-2-weeks groups were in clinical response, respectively (P = .55). Corresponding remission rates at week 26 were 29.2% and 30.4%, respectively (P = .81). Serious infections occurred in 9 of 539 (1.7%) and 12 of 373 (3.2%) of patients during induction and maintenance, respectively. A single malignancy (skin carcinoma) occurred in a patient receiving every-4-weeks maintenance therapy.
  
  
  CONCLUSIONS
  Response to open-label induction therapy with certolizumab pegol was achieved by 62% of patients with moderate to severely active Crohn's disease and secondary failure to infliximab. Among these patients, certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remission.
authors.affiliation: Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Maria T
authors.initials: MT
authors.lastname: Abreu
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.forename: Severine
authors.initials: S
authors.lastname: Vermeire
authors.forename: Krassimir
authors.initials: K
authors.lastname: Mitchev
authors.forename: Corinne
authors.initials: C
authors.lastname: Jamoul
authors.forename: Richard N
authors.initials: RN
authors.lastname: Fedorak
authors.forename: Martina E
authors.initials: ME
authors.lastname: Spehlmann
authors.forename: Douglas C
authors.initials: DC
authors.lastname: Wolf
authors.forename: Scott
authors.initials: S
authors.lastname: Lee
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000068582:Certolizumab Pegol; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000627:therapeutic use*; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D007155:Immunologic Factors; D011092:Polyethylene Glycols; D000069285:Infliximab; D000068582:Certolizumab Pegol