title: Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation: 7-Year Data from the PRECiSE 4 Study.
abstract: Patients with Crohn's disease in whom tumor necrosis factor antagonist therapy fails have limited treatment options, and the benefit of reintroducing the same therapy remains unclear. Here, we report results from PRECiSE 4 (NCT00160706), an open-label extension study of certolizumab pegol in patients who withdrew from the placebo-controlled studies PRECiSE 1 or 2.
  
  
  
  Patients eligible for PRECiSE 4 had Crohn's disease exacerbation on placebo or primary or secondary failure to certolizumab pegol in PRECiSE 1 or 2, and received 400 mg certolizumab pegol subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter up to 360 weeks. We assessed safety (adverse events) and efficacy (clinical remission) of extended certolizumab pegol therapy.
  
  
  
  Patients enrolled in PRECiSE 4 (N = 310; mean age, 37 yr; 58% female; 95% white) had a mean Crohn's disease duration of 8.5 years before entering the qualifying studies. At weeks 52, 104, and 156, remission rates were 28.5%, 17.5%, and 12.6% by nonremitter imputation, and 63.8%, 60.0%, and 63.5% by observed cases, with 47.4%, 31.9%, and 23.2% of patients, respectively, remaining on therapy. By study end (7.5 yr), 92.3% of patients discontinued therapy, 49% on account of adverse events. No new safety signals emerged. Incidence rate (new cases)/100 patient-years was 6.11 for serious infections and 1.29 for malignancies.
  
  
  
  Certolizumab pegol was effective in many patients who previously discontinued certolizumab pegol for lack or loss of response. Thus, discontinuation of therapy may not always be necessary. Safety was consistent with previous findings.
authors.affiliation: 1University of Washington School of Medicine, Seattle, Washington;2University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois;3University of California San Diego, San Diego, California;4Gastroenterology Research of America and University of Texas, San Antonio, Texas;5Gastro One, Memphis, Tennessee;6Christian-Albrechts University, Kiel, Germany;7Vanderbilt University Medical Center, Nashville, Tennessee;8Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts;9University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania;10Baylor University Medical Center, Dallas, Texas;11Morristown Medical Center, Morristown, New Jersey;12Washington University, St Louis, Missouri;13New York Presbyterian Hospital, New York, New York;14UCB Pharma, Raleigh, North Carolina;15UCB Pharma, Smyrna, Georgia; and16Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Lee
authors.forename: David T
authors.initials: DT
authors.lastname: Rubin
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Charles
authors.initials: C
authors.lastname: Randall
authors.forename: Ziad
authors.initials: Z
authors.lastname: Younes
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.forename: David A
authors.initials: DA
authors.lastname: Schwartz
authors.forename: Robert
authors.initials: R
authors.lastname: Burakoff
authors.forename: David
authors.initials: D
authors.lastname: Binion
authors.forename: Themos
authors.initials: T
authors.lastname: Dassopoulos
authors.forename: Razvan
authors.initials: R
authors.lastname: Arsenescu
authors.forename: Alexandra
authors.initials: A
authors.lastname: Gutierrez
authors.forename: Ellen
authors.initials: E
authors.lastname: Scherl
authors.forename: Cem
authors.initials: C
authors.lastname: Kayhan
authors.forename: Iram
authors.initials: I
authors.lastname: Hasan
authors.forename: Gordana
authors.initials: G
authors.lastname: Kosutic
authors.forename: Marshall
authors.initials: M
authors.lastname: Spearman
authors.forename: David
authors.initials: D
authors.lastname: Sen
authors.forename: Jason
authors.initials: J
authors.lastname: Coarse
authors.forename: Stephen
authors.initials: S
authors.lastname: Hanauer
mesh_terms: D000328:Adult; D000906:Antibodies / Q000097:blood; D000068582:Certolizumab Pegol / Q000009:adverse effects / Q000097:blood / Q000276:immunology / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007239:Infections / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced*; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D019233:Retreatment; D000067251:Symptom Flare Up; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000906:Antibodies; D007166:Immunosuppressive Agents; D000068582:Certolizumab Pegol