title: Step up versus early biologic therapy for Crohn's disease in clinical practice.
abstract: BACKGROUND
  Recent studies have demonstrated superior outcomes of early biologic therapy. Our purpose was to evaluate differences in disease course among patients in clinical practice treated with early biologic therapy compared with those receiving conventional Step Up therapy.
  
  
  METHODS
  Patients with Crohn's disease evaluated from July 2004 to November 2010 at a tertiary referral center were included. Demographic data were obtained from a prospectively maintained database. Patients were categorized into 1 of 2 groups: Early Bio group (with or without concomitant immune suppressants) or Step Up group (initial immune suppressants with or without escalation to biologic). Disease activity, quality of life, use of steroids, and number of hospitalizations, and surgeries were assessed.
  
  
  RESULTS
  Ninety-three patients with Crohn's disease met inclusion criteria: 39 (45%) in the Step Up group and 54 (58%) in the Early Bio group. There was no significant difference in demographic and clinical variables between groups. Mean Harvey-Bradshaw index and Short Inflammatory Bowel Disease Questionnaire scores at 3, 6, and 12 months were not different between groups. Response rates were higher in the Step Up group compared with the Early Bio group only at 3 months. Early Bio patients had a greater number of hospitalizations at 1 year (P = 0.04).
  
  
  CONCLUSIONS
  In clinical practice, early biologic therapy did not improve disease activity or quality of life and did not decrease the need for steroids or surgeries 1 year after therapy. Our results suggest that clinical outcomes are not worsened using the conventional approach. Therefore, an accelerated Step Up approach for most patients seems reasonable.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA. lghazi@medicine.umaryland.edu
authors.forename: Leyla J
authors.initials: LJ
authors.lastname: Ghazi
authors.forename: Seema A
authors.initials: SA
authors.lastname: Patil
authors.forename: Ankur
authors.initials: A
authors.lastname: Rustgi
authors.forename: Mark H
authors.initials: MH
authors.lastname: Flasar
authors.forename: Sanam
authors.initials: S
authors.lastname: Razeghi
authors.forename: Raymond K
authors.initials: RK
authors.lastname: Cross
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001691:Biological Therapy; D003424:Crohn Disease / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D000069285:Infliximab; D008297:Male; D010818:Practice Patterns, Physicians'; D011379:Prognosis; D011788:Quality of Life; D012074:Remission Induction; D012189:Retrospective Studies; D012307:Risk Factors; D055502:Secondary Prevention; D062606:Tertiary Care Centers; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab