title: Clinical, biological, and endoscopic responses to adalimumab in antitumor necrosis factor-naive Crohn's disease: predictors of efficacy in clinical practice.
abstract: OBJECTIVE
  Endoscopic healing and clinical remission are important parameters to evaluate therapeutic efficacy in Crohn's disease. The aim of this study was to investigate the clinical effectiveness of adalimumab in terms of clinical and endoscopic response and to identify predictors of efficacy in clinical practice.
  
  
  METHODS
  A prospective analysis was carried out of 68 antitumor necrosis factor-naive Crohn's disease patients treated with adalimumab for 2 years. Clinical and endoscopic response was assessed using the Harvey-Bradshaw index and the Simple Endoscopic Score for Crohn's disease, respectively.
  
  
  RESULTS
  Adalimumab treatment was associated with clinical remission in 76.6, 90.6, and 87.5% of patients at 6, 12, and 24 months. Loss of efficacy occurred in 17.6% of cases after 24 months of therapy. Clinical remission with normal C-reactive protein at 2 months or with endoscopic response at 6 months was predictive of better outcomes. Mucosal healing rates were 17.2, 44.7, and 39.5% and endoscopic responses were 55.1, 76.6, and 76.3% at the respective time points. Mucosal healing was higher in the early treatment group than in the group with disease of at least 5 years' duration (64.7 vs. 19.1%, P=0.004). Inflammatory phenotype showed a higher percentage of mucosal healing (70%) than stricturing (29.4%) or penetrating (27.3%) disease.
  
  
  CONCLUSIONS
  Adalimumab was effective in providing sustained clinical remission. In patients in clinical remission, the C-reactive protein level at 2 months, endoscopic response at 6 months, or inflammatory phenotype and short disease duration could be considered as good predictors of efficacy.
authors: aGastroenterology Department, Complejo Hospitalario Universitario de Ferrol, Ferrol bGastroenterology Department, Hospital Universitario de Santiago, Santiago de Compostela, A Coruña cGastroenterology Department, Hospital Povisa dGastroenterology Department, Complejo Hospitalario Universitario de Vigo eGastroenterology Department, Complejo Hospitalario Universitario de Pontevedra, Vigo, Pontevedra fEIGA Group: Galician Inflammatory Bowel Disease Study Group, Galicia, Spain.
authors: Ana
authors: A
authors: Echarri
authors: Virginia
authors: V
authors: Ollero
authors: Manuel
authors: M
authors: Barreiro-de Acosta
authors: Alberto
authors: A
authors: Fernández-Villaverde
authors: Vicent
authors: V
authors: Hernández
authors: Aurelio
authors: A
authors: Lorenzo
authors: Santos
authors: S
authors: Pereira
authors: Daniel
authors: D
authors: Carpio
authors: Javier
authors: J
authors: Castro
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D007413:Intestinal Mucosa / Q000473:pathology; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab