title: Early remission status predicts long-term outcomes in patients with Crohn's disease treated with certolizumab pegol.
abstract: In Crohn's disease (CD), rapid response to anti-tumor necrosis factor therapy improves short- and medium-term outcomes, but the relationship between early remission (ER) and long-term remission is unclear.
  
  
  
  This exploratory analysis of PRECiSE 3 (NCT00160524) assessed whether ER after initiation of certolizumab pegol predicted long-term remission.
  
  
  
  Patients enrolled in PRECiSE 3 had completed PRECiSE 1 or 2, two randomized placebo-controlled studies for moderate to severe CD, and received open-label certolizumab pegol 400 mg every 4 weeks for a total treatment duration of ≤7.5 years. Time to loss of remission between patients with and without ER (Harvey-Bradshaw Index ≤4 at or before Week 6 of PRECiSE 1 or 2) was compared by log-rank test of Kaplan-Meier estimates.
  
  
  
  At baseline, patients with (n = 242) and without (n = 148) ER had mean (standard deviation [SD]) durations of CD of 6.8 (6.6) and 7.4 (7.8) years, mean (SD) CD Activity Index scores of 280.3 (53.4) and 311.1 (55.5), with 45.5% and 41.9% of patients having ileocolonic CD, and median C-reactive protein concentrations of 8.0 and 5.0 mg/L, respectively. Median certolizumab pegol plasma concentrations during the first 6 weeks of therapy were similar in both groups. Mean time to loss of remission was significantly longer in patients with versus without ER (2.77 vs. 1.14 years, p < 0.0001).
  
  
  
  In certolizumab pegol-treated patients with CD, ER appears to be an important predictor of long-term clinical remission. Prospective trials are needed to determine whether ER improves other long-term outcomes.
authors: a F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute , Los Angeles , CA , USA.
authors: Gil Y
authors: GY
authors: Melmed
authors: a F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute , Los Angeles , CA , USA.
authors: Dermot
authors: D
authors: McGovern
authors: b Christian-Albrechts University , Kiel , Germany.
authors: Stefan
authors: S
authors: Schreiber
authors: c UCB Pharma , Raleigh , NC , USA.
authors: Gordana
authors: G
authors: Kosutic
authors: d UCB Pharma , Smyrna , GA , USA.
authors: Marshall
authors: M
authors: Spearman
authors: c UCB Pharma , Raleigh , NC , USA.
authors: Jason
authors: J
authors: Coarse
authors: e University of California San Diego , La Jolla , CA , USA.
authors: William J
authors: WJ
authors: Sandborn
mesh_terms: D000328:Adult; D002097:C-Reactive Protein; D000068582:Certolizumab Pegol / Q000008:administration & dosage / Q000627:therapeutic use; D003424:Crohn Disease / Q000188:drug therapy / Q000401:mortality; D018450:Disease Progression; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D002097:C-Reactive Protein; D000068582:Certolizumab Pegol
keywords: Anti-TNFα therapy; Certolizumab pegol; Crohn’s disease; Early remission; PRECiSE 3