title: Effectiveness of adalimumab for the treatment of ulcerative colitis in clinical practice: comparison between anti-tumour necrosis factor-naïve and non-naïve patients.
abstract: BACKGROUND
  Ulcerative colitis (UC) treatment is focused to achieve mucosal healing, avoiding disease progression. The study aimed to evaluate the real-world effectiveness of adalimumab (ADA) in UC and to identify predictors of remission to ADA.
  
  
  METHODS
  This cohort study used data from the ENEIDA registry. Clinical response, clinical remission, endoscopic remission, adverse events (AE), colectomy, and hospitalisations were evaluated; baseline characteristics and biological parameters were compared to determine predictors of response.
  
  
  RESULTS
  We included 263 patients (87 naïve and 176 previously exposed to anti-tumour necrosis factor alpha, TNF). After 12 weeks, clinical response, clinical remission, and endoscopic remission rates were 51, 26, and 14 %, respectively. The naïve group demonstrated better response to treatment than the anti-TNF-exposed group at short-term. Clinical and endoscopic remission within 1 year of treatment was better in the naïve group (65 vs. 49 and 50 vs. 35 %, respectively). The rates of AE, dose-escalation, hospitalisations, and colectomy during the first year were higher in anti-TNF-exposed patients (40, 43, and 27 % vs. 26, 21, and 11 %, respectively). Patients with primary failure and intolerance to the first anti-TNF and severe disease were associated with worse clinical response. Primary non-response to prior anti-TNF treatment and severe disease were predictive of poorer clinical remission. Low levels of C-reactive protein (CRP) and faecal calprotectin (FC) at baseline were predictors of clinical remission.
  
  
  CONCLUSIONS
  In clinical practice, ADA was effective in UC, especially in anti-TNF naïve patients. FC and CRP could be predictors of treatment effectiveness.
authors.affiliation: Gastroenterology Department and CIBEREHD, Hospital Universitari i Politecnic La Fe, Avinguda de Fernando Abril Martorell, no 106, 46026, Valencia, Spain. marisaiborra@hotmail.com.
authors.forename: Marisa
authors.identifier: http://orcid.org/0000-0003-2416-3560
authors.initials: M
authors.lastname: Iborra
authors.affiliation: Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Pérez-Gisbert
authors.affiliation: Gastroenterology Department, Hospital Clínic Universitari de Valencia and INCLIVA Health Research Institute, Valencia, Spain.
authors.forename: Marta Maia
authors.initials: MM
authors.lastname: Bosca-Watts
authors.affiliation: Departamento de Gastroenterología, Hospital Clinic i Provincial, C/Villarroel 170, 08036, Barcelona, Spain.
authors.forename: Alicia
authors.initials: A
authors.lastname: López-García
authors.affiliation: Hospital Reina Sofía, IMIBIC, Universidad de Córdoba, Córdoba, Spain.
authors.forename: Valle
authors.initials: V
authors.lastname: García-Sánchez
authors.affiliation: Gastroenterology Department, Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: López-Sanromán
authors.affiliation: Servicio de Medicina Digestivo, Hospital de Manises, Valencia, Spain.
authors.forename: Esther
authors.initials: E
authors.lastname: Hinojosa
authors.affiliation: Metgessa adjunta. Servei de Digestiu, Parc de Salut Mar, Barcelona, Spain.
authors.forename: Lucía
authors.initials: L
authors.lastname: Márquez
authors.affiliation: Departamento de Gastroenterología, Hospital Universitario Miguel Servet, Saragossa, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: García-López
authors.affiliation: Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Chaparro
authors.affiliation: Hospital Universitari Mútua Terrassa, Plaça Doctor Robert, 08221, Terrassa, Barcelona, Spain.
authors.forename: Montserrat
authors.initials: M
authors.lastname: Aceituno
authors.affiliation: Servei d'Aparell Digestiu, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
authors.forename: Margalida
authors.initials: M
authors.lastname: Calafat
authors.affiliation: Digestive Diseases Department, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Guardiola
authors.affiliation: Hospital San Jorge Huesca, Avenida Martínez de Velasco 36, 22004, Huesca, Spain.
authors.forename: Blanca
authors.initials: B
authors.lastname: Belloc
authors.affiliation: Médico adjunto, Servicio de Aparato Digestivo, Hospital Clínico Universitario "Lozano Blesa", IIS Aragón., CIBEREHD, Saragossa, Spain.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Ber
authors.affiliation: Department of Gastroenterology, Hospital Donostia/Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Universidad del País Vasco (UPV/EHU), San Sebastián, Guipúzcoa, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Bujanda
authors.affiliation: Gastroenterology Department, Hospital Universitari i Politecnic La Fe, CIBEREHD, Valencia, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Beltrán
authors.affiliation: Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Rodríguez-Gutiérrez
authors.affiliation: Servicio de Gastroenterología, Hospital Universitario Río Hortega, C/Dulzaina, no 2, 47012, Valladolid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Barrio
authors.affiliation: Hospital de Galdakao, Galdakao, Bilbao, Spain.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Cabriada
authors.affiliation: Hospital Universitario Marqués de Valdecilla, Santander, Spain.
authors.forename: Montserrat
authors.initials: M
authors.lastname: Rivero
authors.affiliation: Gastroenterology Department, Hospital Clínico Virgen de la Victoria, Málaga, Spain.
authors.forename: Raquel
authors.initials: R
authors.lastname: Camargo
authors.affiliation: Hospital Universitario de Torrejón, C/Mateo Inurria, s/n, 28850, Torrejón de Ardoz, Madrid, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: van Domselaar
authors.affiliation: Servei de Malalties Digestives, Hospital Parc Tauli de Sabadell, Departament de Medicina, Universitat Autònoma de Barcelona, CIBEREHD-Instituto de Salud Carlos III, Barcelona, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Villoria
authors.affiliation: Hospital Nuestra Señora de la Candelaria, Tenerife, Islas Canarias, Spain.
authors.forename: Hugo Salata
authors.initials: HS
authors.lastname: Schuterman
authors.affiliation: Unidad Bioestadística, Instituto de Investigación Sanitaria La Fe, Valencia, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Hervás
authors.affiliation: Gastroenterology Department, CIBEREHD, Hospital Universitari i Politecnic La Fe, Valencia, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Nos
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy* / Q000601:surgery; D018450:Disease Progression; D005243:Feces / Q000737:chemistry; D005260:Female; D006760:Hospitalization; D006801:Humans; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011379:Prognosis; D012074:Remission Induction; D019233:Retreatment; D012189:Retrospective Studies; D012720:Severity of Illness Index; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000893:Anti-Inflammatory Agents; D039841:Leukocyte L1 Antigen Complex; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D000068879:Adalimumab
keywords: Adalimumab; Treatment; Ulcerative colitis