title: Effectiveness of adalimumab in perianal fistulas in crohn's disease patients naive to anti-TNF therapy.
abstract: BACKGROUND
  Data regarding the effectiveness of adalimumab (ADA) in the treatment of perianal fistula in patients with Crohn's disease (CD) naive to antitumor necrosis factor (TNF) therapy are scarce.
  
  
  OBJECTIVE
  : To assess the effectiveness of ADA in the treatment of perianal fistulas in CD patients naive to anti-TNF therapy.
  
  
  METHODS
  A retrospective multicenter study was designed. The Fistula Drainage Assessment Index was used to assess the clinical response, and the Van Assche and Ng indexes to classify radiologic response (magnetic resonance imaging).
  
  
  RESULTS
  A total of 46 patients (83% women, 83% complex fistula) were included. At 6 months, 72% of patients responded to ADA (54% remission, 18% partial response) and at 12 months 49% responded (41% remission, 8% partial response). Among patients with complex fistula, the response rate was 66% at 6 months and 39% at 12 months. Nine patients escalated the ADA dose to 40 mg weekly, 6 for partial response and 3 for absence of response. Thirty-three percent of these patients achieved remission after dose escalation. There was a good correlation between clinical and radiologic assessment of response (κ=0.68). In the multivariate analysis, complex fistula was the only predictor of a worse response (hazard ratio 0.083; 95% confidence interval, 0.0009-0.764; P=0.028). Adverse effects were recorded in 11% of patients.
  
  
  CONCLUSIONS
  ADA was effective for the treatment of perianal fistulas in CD patients naive to anti-TNF drugs. We found a good correlation between clinical and radiologic assessment of therapy response.
authors.affiliation: *Services of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP) †Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD) **Hospital Universitario de La Paz §§Hospital Infanta Sofía ‡‡‡Hospital Infanta Cristina §§§Hospital Universitario de Fuenlabrada, Madrid ‡Hospital de Cabueñes, Gijón, Asturias §Hospital Clínico Universitario de Santiago, Santiago de Compostela, Galicia ∥Hospital Universitario Reina Sofía, Murcia ¶Hospital de Donostia, Instituto Biodonostia, Universidad del País Vasco, Leioa †††Hospital de Galdakao-Usánsolo, Galdakao, Bizkaia #Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), San Sebastián ††Complejo Hospitalario de Pontevedra, Pontevedra ‡‡Hospital de León, León ∥∥Hospital de la Santa Creu i Sant Pau ##Departament de Medicina, Corporació Sanitària Universitària Parc Taulí, Universitat Autònoma de Barcelona, Sardañola del Vallés ¶¶Consorci Sanitari de Terrassa, Terrassa ***Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Sabadell, Barcelona, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Castaño-Milla
authors.forename: María
authors.initials: M
authors.lastname: Chaparro
authors.forename: Cristina
authors.initials: C
authors.lastname: Saro
authors.forename: Manuel
authors.initials: M
authors.lastname: Barreiro-de Acosta
authors.forename: Ana M
authors.initials: AM
authors.lastname: García-Albert
authors.forename: Luis
authors.initials: L
authors.lastname: Bujanda
authors.forename: María D
authors.initials: MD
authors.lastname: Martín-Arranz
authors.forename: Daniel
authors.initials: D
authors.lastname: Carpio
authors.forename: Fernando
authors.initials: F
authors.lastname: Muñoz
authors.forename: Noemí
authors.initials: N
authors.lastname: Manceñido
authors.forename: Esther
authors.initials: E
authors.lastname: García-Planella
authors.forename: Marta
authors.initials: M
authors.lastname: Piqueras
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvet
authors.forename: José L
authors.initials: JL
authors.lastname: Cabriada
authors.forename: Belén
authors.initials: B
authors.lastname: Botella
authors.forename: Fernando
authors.initials: F
authors.lastname: Bermejo
authors.forename: Javier P
authors.initials: JP
authors.lastname: Gisbert
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D017577:Cutaneous Fistula / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D012003:Rectal Fistula / Q000188:drug therapy* / Q000209:etiology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab