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Clinical response within 4 months may predict sustained UC remission with Entyvio
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Patients with ulcerative colitis who received a full induction course of Entyvio and achieved clinical remission by week 14 of therapy had a better chance of experiencing sustained remission, according to research published in Inflammatory Bowel Diseases.
Brian G. Feagan, MD, of the Robarts Research Institute at the University of Western Ontario, and colleagues wrote that while agents, like Entyvio (vedolizumab, Takeda), have improved the management of UC, data on their ability to sustain remission have been lacking.
“An unmet need in managing moderate-to-severe UC is sustaining clinical remission,” they wrote. “Patients who achieve this outcome should benefit from improved [quality of life], reduced exposure to corticosteroids, and decreased risk of disease-related complications.”
In a post hoc exploratory analysis of patients with UC in the GEMINI 1 study, researchers assessed the long-term efficacy of vedolizumab in a set of patients who were in clinical remission by week 14 after three induction doses at weeks 0, 2 and 6. They evaluated clinical remission using two measures; a partial Mayo Score (pMS) of at least 2 with no subscore greater than 1, and a rectal bleeding subscore (RBS) of 0 throughout weeks 14, 26, 38 and 52. The analysis included 620 patients prescribed vedolizumab and 149 patients prescribed placebo.
A higher percentage of patients who received vedolizumab achieved remission at week 14 compared with patients who received placebo in terms of both pMS (32.7% vs. 20.1%; difference 12.6%; 95% CI, 5.2–20] and RBS (47.3% vs. 28.9%;18.4%; 95% CI, 10.1–26.7). Of the patients in remission at week 14, a higher percentage of vedolizumab patients sustained remission compared with placebo (pMS, 66.5% vs. 26.7%; 39.8%; 95% CI, 22.7–56.9; RBS, 56.7% vs. 20.9%; 35.7%; 95% CI, 22.3–49.1). Additionally, the findings were consistent whether the patients were anti-TNF naive or if they previously failed anti-TNF therapy.
Feagan and colleagues wrote that their findings show the clinical remission at week 14 could be a predictor for sustained remission with vedolizumab.
“These findings support the guidance that the full standard 3-dose induction course of vedolizumab must be completed before a final decision on clinical benefit is assessed at week 10 or 14, dependent on EU or U.S. label,” they wrote. “These data also provide strong evidence for the long-term benefit conferred by vedolizumab on sustained clinical remission in patients with moderate-to-severe UC, independent of prior TNF antagonist treatment history.” – by Alex Young
Disclosures: Feagan reports that the is a consultant for Abbott/AbbVie, ActoGeniX, Akros, Albireo Pharma, Amgen, AstraZeneca, Avaxia Biologics Inc., Avir Pharma, Axcan, Baxter Healthcare Corp., Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, enGene, Ferring Pharma, Roche/Genentech, gICare Pharma, Gilead, Given Imaging Inc., GSK, Ironwood Pharma, Janssen Biotech (Centocor), JnJ/Janssen, Kyowa Hakko Kirin Co Ltd, Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nektar, Nestle, Novartis, Novo Nordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, VHsquared Ltd, Warner Chilcott, Wyeth, Zealand, and Zyngenia. He has received grant and research support from Abbott/AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Janssen Biotech (Centocor), JnJ/Janssen, Roche/Genentech, Millennium, Pfizer, Receptos, Santarus, Sanofi, Tillotts, and UCB Pharma. He is also on the board of directors for Robarts Clinical Trials Inc. Please see the full study for all other authors’ relevant financial disclosures.
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