BACKGROUND: Recently, ustekinumab a monoclonal antibody targeting interleukin-12 and -23 and successfully used in Crohn's disease also has been shown to be effective in induction and maintaining remission in patients with moderate to severe ulcerative colitis in a large phase 3 trial. However, no observational data on the use of ustekinumab in ulcerative colitis in daily clinical practice is available. AIM: The purpose of this study was to assess the clinical outcomes achieved with ustekinumab as rescue treatment in therapy-refractory or -intolerant ulcerative colitis in a real-life setting. METHODS: A retrospective data analysis was performed in 19 ulcerative colitis patients who were intolerant or refractory to all of the following drugs: steroids, purine-analogues, tumour necrosis factor antibodies and vedolizumab. To all patients ustekinumab was provided as a rescue treatment (intravenous induction with 6 mg/kg, followed by week subcutaneous injection once every eight weeks of 90 mg). The primary outcome was achievement of clinical remission at one year, defined as score of ≤ 3 points in the Lichtiger score (colitis activity index). Patients were evaluated regularly and a colonoscopy was performed before the start and at the end of the observation. Ethical approval was provided by Ethikkommission Ärztekammer Hamburg (PV 5539). RESULTS: In five patients, therapy was stopped due to refractory disease or side effects. In all remaining 14 patients the median colitis activity index dropped from 8.5 points (range 1-12) at start to 2.0 points at one year (range 0-5.5) and Mayo endoscopy scores fell from a median of two points (range 1-3, mean of 2.3) at start to a median of one point (range 1-3, mean of 1.4) at one year. Including the five drop-outs, clinical remission was achieved in 53% of the 19 patients at one year. CONCLUSIONS: In accordance with the UNIFI (A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis) trial our real-life data support ustekinumab as an effective and safe treatment option in therapy refractory moderate to severe ulcerative colitis with a history of biological therapies.
BACKGROUND: Recently, ustekinumab a monoclonal antibody targeting interleukin-12 and -23 and successfully used in Crohn's disease also has been shown to be effective in induction and maintaining remission in patients with moderate to severe ulcerative colitis in a large phase 3 trial. However, no observational data on the use of ustekinumab in ulcerative colitis in daily clinical practice is available. AIM: The purpose of this study was to assess the clinical outcomes achieved with ustekinumab as rescue treatment in therapy-refractory or -intolerant ulcerative colitis in a real-life setting. METHODS: A retrospective data analysis was performed in 19 ulcerative colitispatients who were intolerant or refractory to all of the following drugs: steroids, purine-analogues, tumour necrosis factor antibodies and vedolizumab. To all patientsustekinumab was provided as a rescue treatment (intravenous induction with 6 mg/kg, followed by week subcutaneous injection once every eight weeks of 90 mg). The primary outcome was achievement of clinical remission at one year, defined as score of ≤ 3 points in the Lichtiger score (colitis activity index). Patients were evaluated regularly and a colonoscopy was performed before the start and at the end of the observation. Ethical approval was provided by Ethikkommission Ärztekammer Hamburg (PV 5539). RESULTS: In five patients, therapy was stopped due to refractory disease or side effects. In all remaining 14 patients the median colitis activity index dropped from 8.5 points (range 1-12) at start to 2.0 points at one year (range 0-5.5) and Mayo endoscopy scores fell from a median of two points (range 1-3, mean of 2.3) at start to a median of one point (range 1-3, mean of 1.4) at one year. Including the five drop-outs, clinical remission was achieved in 53% of the 19 patients at one year. CONCLUSIONS: In accordance with the UNIFI (A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis) trial our real-life data support ustekinumab as an effective and safe treatment option in therapy refractory moderate to severe ulcerative colitis with a history of biological therapies.
Authors: Charles O Elson; Yingzi Cong; Casey T Weaver; Trenton R Schoeb; Terrill K McClanahan; Robert B Fick; Robert A Kastelein Journal: Gastroenterology Date: 2007-04-13 Impact factor: 22.682
Authors: Brian G Feagan; William J Sandborn; Christopher Gasink; Douglas Jacobstein; Yinghua Lang; Joshua R Friedman; Marion A Blank; Jewel Johanns; Long-Long Gao; Ye Miao; Omoniyi J Adedokun; Bruce E Sands; Stephen B Hanauer; Severine Vermeire; Stephan Targan; Subrata Ghosh; Willem J de Villiers; Jean-Frédéric Colombel; Zsolt Tulassay; Ursula Seidler; Bruce A Salzberg; Pierre Desreumaux; Scott D Lee; Edward V Loftus; Levinus A Dieleman; Seymour Katz; Paul Rutgeerts Journal: N Engl J Med Date: 2016-11-17 Impact factor: 91.245
Authors: Levente Parragi; N Fournier; Jonas Zeitz; Michael Scharl; Thomas Greuter; Philipp Schreiner; Benjamin Misselwitz; Ekaterina Safroneeva; A M Schoepfer; Stephan R Vavricka; Gerhard Rogler; Luc Biedermann Journal: J Crohns Colitis Date: 2018-06-28 Impact factor: 9.071
Authors: Sophie Hue; Philip Ahern; Sofia Buonocore; Marika C Kullberg; Daniel J Cua; Brent S McKenzie; Fiona Powrie; Kevin J Maloy Journal: J Exp Med Date: 2006-10-09 Impact factor: 14.307