title: Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study.
abstract: OBJECTIVE
  To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response.
  
  
  METHODS
  We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician's global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database.
  
  
  RESULTS
  Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted.
  
  
  CONCLUSIONS
  This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Marta Maia
authors.initials: MM
authors.lastname: Bosca-Watts
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Cortes
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Marisa
authors.initials: M
authors.lastname: Iborra
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Jose Maria
authors.initials: JM
authors.lastname: Huguet
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Sempere
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Gloria
authors.initials: G
authors.lastname: Garcia
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Rafa
authors.initials: R
authors.lastname: Gil
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: MariFe
authors.initials: M
authors.lastname: Garcia
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Marga
authors.initials: M
authors.lastname: Muñoz
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Almela
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Maroto
authors.affiliation: Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain.
authors.forename: Jose Maria
authors.initials: JM
authors.lastname: Paredes
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003113:Colonoscopy; D004359:Drug Therapy, Combination; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction; D012720:Severity of Illness Index; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000276:immunology
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab
keywords: Golimumab; Real-life results; Ulcerative colitis