Long-term efficacy of vedolizumab for Crohn's disease

Severine Vermeire, Edward Vincent Loftus, Jr, Jean Frédéric Colombel, Brian G. Feagan, 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 Smyth

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Abstract

Background and Aims: Vedolizumab is a gut-selective a4ß7 integrin antagonist therapy for ulcerative colitis and Crohn's disease. The GEMINI long-term safety [LTS] trial is an ongoing open-label study investigating the safety of vedolizumab. We present interim exploratory analyses of efficacy in patients with Crohn's disease. Methods: Patients from the C13004, GEMINI 2 and GEMINI 3 studies and vedolizumab-naïve patients could enrol in GEMINI LTS and received vedolizumab every 4 weeks. Data were collected from May 22, 2009 to June 27, 2013. Outcomes of clinical response and remission, defined by the Harvey-Bradshaw Index, and health-related quality of life [HRQL] were assessed for up to 152 weeks of treatment in the efficacy population. Results: Among patients with response at week 6 in GEMINI 2 who received vedolizumab continuously, 83% [n=100/120] and 89% [n=62/70] of patients with available data were in remission after 104 and 152 weeks, respectively. Increased dosing frequency from every 8 weeks [GEMINI 2] to every 4 weeks [GEMINI LTS] improved outcomes in patients who had withdrawn early from GEMINI 2, with 47% [n=27/57] experiencing clinical response and 32% [n=18/57] in remission at week 52 of GEMINI LTS [up from 39% and 4% before the dose increase]. Similar improvements were observed regardless of prior tumour necrosis factor [TNF] antagonist exposure. Long-term benefits of HRQL were also observed. Conclusions: The clinical benefits of vedolizumab continued with long-term treatment regardless of prior TNF antagonist exposure. Increased dosing frequency might improve outcomes in patients who lose response to conventional 8-weekly dosing.

Original languageEnglish (US)
Pages (from-to)412-424
Number of pages13
JournalJournal of Crohn's and Colitis
Volume11
Issue number4
DOIs
StatePublished - 2017

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Keywords

  • Crohn's disease
  • Long-term efficacy
  • Vedolizumab

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Vermeire, S., Loftus, Jr, E. V., Colombel, J. F., Feagan, B. G., 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., & Smyth, M. (2017). Long-term efficacy of vedolizumab for Crohn's disease. Journal of Crohn's and Colitis, 11(4), 412-424. https://doi.org/10.1093/ecco-jcc/jjw176