title: Remission maintained by monotherapy after biological + immunosuppressive combination for Crohn's disease in clinical practice.
abstract: OBJECTIVE
  The optimal time to withdraw combined biological + immunosuppressive therapy in Crohn's disease is debated. Following remission of 6 months with the combined therapy, we assessed the efficacy of monotherapy in maintaining remission.
  
  
  METHODS
  Crohn's disease patients (n = 75) were retrospectively selected from clinical records for having achieved remission within 6 months of receiving combined biological + immunosuppressive therapy. Treatment continued for a further year with one or the other of the combination drugs withdrawn. Clinical remission was defined as Crohn's Disease Activity Index (CDAI) < 150 and endoscopic remission as CDAI < 150 + absence of mucosal lesions + no signs of active inflammation on ileocolonoscopy. Crohn's disease relapse was defined as CDAI > 250.
  
  
  RESULTS
  Twenty-eight percent (21/75) patients were relapsers. Withdrawal of biological therapy was more frequent than immunosuppressive (73.3% vs 26.7%) with no significant differences in relapse rates (30.9% vs 20%; P = 0.401). Endoscopic remission was more accurate than clinical remission (relapse rates: 10.5% vs 33.9%; P = 0.05). C-reactive-protein was higher in relapsers (19.2 ± 23.7 mg/L vs 2.5 ± 4.7 mg/L; P = 0.009). Multivariate analysis indicated C-reactive protein > 5 mg/L (odds ratios [OR]: 30.12; 95% confidence intervals [95% CI]: 5.91-153.38; P = 0.0001) and younger age at diagnosis (OR: 1.10; 95% CI: 1.01-1.19; P =  .047) as independent factors predicting relapse. There was a strong trend toward a protective effect of endoscopic remission (OR: 0.17; 95% CI: 0.02-1.22; P = 0.077).
  
  
  CONCLUSIONS
  A subgroup of Crohn's disease patients treated with combination therapy can be identified (C-reactive protein < 5 mg/L, endoscopic remission, and older age at Crohn's disease diagnosis) who would continue in remission despite cessation of the biological (expensive) component of the combination therapy.
authors.affiliation: Unit for the Clinical Management of Digestive Diseases, Valme University Hospital, Sevilla, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Ampuero
authors.affiliation: Unit for the Clinical Management of Digestive Diseases, Valme University Hospital, Sevilla, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Rojas-Feria
authors.affiliation: Unit for the Clinical Management of Digestive Diseases, Valme University Hospital, Sevilla, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Castro-Fernández
authors.affiliation: Unit for the Clinical Management of Digestive Diseases, Valme University Hospital, Sevilla, Spain.
authors.forename: Marina
authors.initials: M
authors.lastname: Millán-Lorenzo
authors.affiliation: Unit for the Clinical Management of Digestive Diseases, Valme University Hospital, Sevilla, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Guerrero-Jiménez
authors.affiliation: Unit for the Clinical Management of Digestive Diseases, Valme University Hospital, Sevilla, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero-Gómez
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001379:Azathioprine / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D002097:C-Reactive Protein / Q000032:analysis; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D060828:Induction Chemotherapy; D000069285:Infliximab / Q000008:administration & dosage*; D060046:Maintenance Chemotherapy; D008297:Male; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D002097:C-Reactive Protein; D000069285:Infliximab; D001379:Azathioprine
keywords: Crohn's disease; biological therapy; immunosuppressive therapy; inflammatory bowel disease; relapse