Long-term efficacy of vedolizumab for ulcerative colitis

Edward V. Loftus, Jean Frédéric Colombel, Brian G. Feagan, Severine Vermeire, William J. Sandborn, Bruce E. Sands, Silvio Danese, Geert R. D'Haens, Arthur Kaser, Remo Panaccione, David T. Rubin, Ira Shafran, Megan McAuliffe, Arpeat Kaviya, Serap Sankoh, Reema Mody, Brihad Abhyankar, Michael Smythm

Research output: Contribution to journalArticle

80 Scopus citations

Abstract

Background and Aims: The GEMINI long-term safety [LTS] study is a continuing phase 3 trial investigating the safety and efficacy of vedolizumab, an α 4 ß 7 integrin antagonist for ulcerative colitis [UC] and Crohn's disease. We provide an interim analysis of efficacy in patients with UC. Methods: Patients from the C13004 and GEMINI 1 studies and a cohort of vedolizumab-naïve patients received open-label vedolizumab every 4 weeks. Interim data were collected from May 22, 2009 to June 27, 2013. Clinical response and remission, evaluated using partial Mayo scores, and health-related quality of life [HRQL] were assessed for up to 152 weeks of cumulative treatment in the efficacy population. Results: As of June 27, 2013, 63% of the efficacy population [n = 532/845] were continuing treatment. Among patients who responded to vedolizumab induction and had data available, 88% [n = 120/136] were in remission after 104 weeks of exposure (96% [n = 70/73] after 152 weeks). Among patients who withdrew from every-8-week vedolizumab maintenance in GEMINI 1 [n = 32] before week 52, increased dosing to every 4 weeks in GEMINI LTS resulted in response and remission rates of 41% and 28%, respectively, after 52 weeks, an increase from 19% and 6%, respectively, from before the dose increase. Similar benefits were demonstrated regardless of prior tumour necrosis factorantagonist exposure. Durable benefits on HRQL were also observed. Conclusions: Patients with UC experienced clinical and HRQL improvements with continued vedolizumab treatment. Increased dosing frequency to every 4 weeks was beneficial in patients who had loss of response to 8-weekly dosing.

Original languageEnglish (US)
Pages (from-to)400-411
Number of pages12
JournalJournal of Crohn's and Colitis
Volume11
Issue number4
DOIs
StatePublished - 2017

Keywords

  • Long-term efficacy
  • Ulcerative colitis
  • Vedolizumab

ASJC Scopus subject areas

  • Gastroenterology

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  • Cite this

    Loftus, E. V., Colombel, J. F., Feagan, B. G., Vermeire, S., Sandborn, W. J., Sands, B. E., Danese, S., D'Haens, G. R., Kaser, A., Panaccione, R., Rubin, D. T., Shafran, I., McAuliffe, M., Kaviya, A., Sankoh, S., Mody, R., Abhyankar, B., & Smythm, M. (2017). Long-term efficacy of vedolizumab for ulcerative colitis. Journal of Crohn's and Colitis, 11(4), 400-411. https://doi.org/10.1093/ecco-jcc/jjw177