title: Efficacy and Safety of Adalimumab in Ulcerative Colitis Refractory to Conventional Therapy in Routine Clinical Practice.
abstract: OBJECTIVE
  Adalimumab [ADA] was approved for the treatment of ulcerative colitis [UC] refractory to conventional therapy in 2012 in Europe. Due to the observed discrepancies between clinical trials and practice, data on the outcome of ADA therapy are really needed from the real life. The aim of this study was to estimate the short- and long-term efficacy and safety of ADA in UC patients from each Hungarian biological centre.
  
  
  METHODS
  This prospective study consisted of UC patients treated with ADA in 10 Hungarian inflammatory bowel disease centres. The primary endpoints of the study were rates of continuous clinical response, remission, non-response and loss of response at Weeks 12, 30, and 52.The secondary endpoints included mucosal healing at Week 52 and the comparison of the efficacy of ADA between biological naive and infliximab [IFX]-treated groups. Colonoscopy was performed before starting the therapy and at Week 52.
  
  
  RESULTS
  In all, 73 active UC patients were enrolled in the study: 67.1% of the patients received previous IFX therapy; 75.3% of the patients showed short-term clinical response at Week 12. The probability of maintaining ADA was 48.6% at Week 52 with a continuous clinical response in 92% of these remaining patients. Mucosal healing was achieved in 48.1% of the patients at Week 52. Escalation of ADA was performed in 17.6%, and minor side effects developed in 4% of the patients; 5.4% of the patients underwent colectomy during the 1-year treatment period.
  
  
  CONCLUSIONS
  UC is a progressive disease that may need early aggressive therapy to prevent structural and functional complications. The results of our study demonstrated the favourable efficacy of short- and long-term ADA treatment for patients with UC.
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Anita
authors.initials: A
authors.lastname: Bálint
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Klaudia
authors.initials: K
authors.lastname: Farkas
authors.affiliation: 2nd Department of Medicine, University of Debrecen, Debrecen, Hungary.
authors.forename: Károly
authors.initials: K
authors.lastname: Palatka
authors.affiliation: Markusovszky University Hospital, Szombathely, Hungary.
authors.forename: Lilla
authors.initials: L
authors.lastname: Lakner
authors.affiliation: 2nd Department of Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Pál
authors.initials: P
authors.lastname: Miheller
authors.affiliation: Petz Aladár Country Hospital, Győr, Hungary.
authors.forename: István
authors.initials: I
authors.lastname: Rácz
authors.affiliation: Péterfy Sándor Street Hospital-Clinic and Emergency Center, Budapest, Hungary.
authors.forename: Gábor
authors.initials: G
authors.lastname: Hegede
authors.affiliation: 1st Department of Internal Medicine, University of Pécs, Pécs, Hungary.
authors.forename: Áron
authors.initials: Á
authors.lastname: Vincze
authors.affiliation: Semmelweis Hospital and University Hospital [MISEK], Miskolc, Hungary.
authors.forename: Gábor
authors.initials: G
authors.lastname: Horváth
authors.affiliation: Petz Aladár Country Hospital, Győr, Hungary.
authors.forename: Andrea
authors.initials: A
authors.lastname: Szabó
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Ferenc
authors.initials: F
authors.lastname: Nagy
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Szepes
authors.affiliation: Semmelweis Hospital and University Hospital [MISEK], Miskolc, Hungary.
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Gábor
authors.affiliation: Military Hospital, Budapest, Hungary.
authors.forename: Ferenc
authors.initials: F
authors.lastname: Zsigmond
authors.affiliation: Kazincbarcika Hospital, Kazincbarcika, Hungary.
authors.forename: Ágnes
authors.initials: Á
authors.lastname: Zsóri
authors.affiliation: 2nd Department of Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Márk
authors.initials: M
authors.lastname: Juhász
authors.affiliation: 2nd Department of Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Ágnes
authors.initials: Á
authors.lastname: Csontos
authors.affiliation: Department of Medical Physics and Informatics, University of Szeged, Szeged, Hungary.
authors.forename: Mónika
authors.initials: M
authors.lastname: Szűcs
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Renáta
authors.initials: R
authors.lastname: Bor
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Ágnes
authors.initials: Á
authors.lastname: Milassin
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Mariann
authors.initials: M
authors.lastname: Rutka
authors.affiliation: 1st Department of Medicine, University of Szeged, Szeged, Hungary molnar.tamas@med.u-szeged.hu.
authors.forename: Tamás
authors.initials: T
authors.lastname: Molnár
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006814:Hungary; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000473:pathology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011446:Prospective Studies; D012008:Recurrence; D018570:Risk Assessment; D062606:Tertiary Care Centers; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects / Q000502:physiology; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab
keywords: Ulcerative colitis; adalimumab; continuous clinical response; mucosal healing