Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial

@article{Vermeire2014EtrolizumabAI,
  title={Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial},
  author={S{\'e}verine Vermeire and Sharon O’Byrne and Mary E. Keir and Marna B. Williams and Timothy T. Lu and John C Mansfield and Christopher Andrew Lamb and Brian G. Feagan and Juli{\'a}n Pan{\'e}s and Azucena Salas and Daniel C. Baumgart and Stefan Schreiber and Iris Dotan and William J Sandborn and Gaik Wei Tew and Diana Luca and M T Tang and Lauri Diehl and Jeffrey Eastham‐Anderson and Gert de Hertogh and Clémentine Perrier and Jackson G. Egen and John Andrew Kirby and Gert Van Van Assche and Paul J. Rutgeerts},
  journal={The Lancet},
  year={2014},
  volume={384},
  pages={309-318}
}
BACKGROUND Etrolizumab is a humanised monoclonal antibody that selectively binds the β7 subunit of the heterodimeric integrins α4β7 and αEβ7. [...] Key MethodMETHODS In this double-blind, placebo-controlled, randomised, phase 2 study, patients with moderately-to-severely active ulcerative colitis who had not responded to conventional therapy were recruited from 40 referral centres in 11 countries.Expand
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Highly Influential Citations
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331 Citations

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Etrolizumab in moderate-to-severe ulcerative colitis
TLDR
The immunohistochemistry analysis of colonic biopsies in Vermeire and colleagues’ study showed an apparent decrease in the proportion of αE+ cells in the intestinal crypt epithelium of patients in the etrolizumab groups, especially in those who achieved clinical remission. Expand
Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis.
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Abrilumab treatment for 8 weeks induced remission, clinical response, and mucosal healing in patients with moderate-to-severe ulcerative colitis in a randomized, phase 2b, placebo-controlled, double-blind study. Expand
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TLDR
The overall quality of evidence for the clinical remission outcomes was moderate and the efficacy and safety of etrolizumab for induction of remission in ulcerative colitis was assessed. Expand
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TLDR
There were no significant differences in clinical remission and serious adverse events between etrolizumab and infliximab and there are still a need to develop new effective medications for the treatment of ulcerative colitis, particularly for patients who are intolerant or resistant to first line therapies. Expand
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PF-00547659 was safe and well tolerated in this patient population, and better than placebo for induction of remission in patients with moderate to severe ulcerative colitis. Expand
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TLDR
The primary endpoint of clinical remission was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in patients with UC, and trends towards clinical remission and response were observed in the overall population and were more pronounced in anti-TNF naïve patients. Expand
Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis.
TLDR
In a randomized trial of patients with UC, mirikizumab was effective in inducing a clinical response after 12 weeks and demonstrated durable efficacy throughout the maintenance period. Expand
Etrolizumab for the Treatment of Ulcerative Colitis and Crohn’s Disease: An Overview of the Phase 3 Clinical Program
TLDR
The etrolizumab phase 3 clinical program is the largest and most comprehensive in inflammatory bowel disease, enrolling more than 3000 patients and explores both induction and maintenance regimens. Expand
Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis
TLDR
This study confirms findings of the 12-week interim analysis and demonstrates that GMA apheresis provides a safe and beneficial long-term outcome for patients with chronic active UC resistant/intolerant to IS and/or TNF inhibitors. Expand
Etrolizumab for ulcerative colitis: the new kid on the block?
TLDR
Etrolizumab is a humanized monoclonal antibody that selectively blocks lymphocyte trafficking and retention in the gut that appears to be a promising molecule that can benefit UC patients. Expand
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