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Higher Entyvio Serum Levels Linked to Mucosal Healing in Crohn’s
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Patients with Crohn’s disease who had higher serum drug levels of Entyvio experienced better rates of endoscopic remission, according to study results published in Gastroenterology.
Geert D’Haens, MD, PhD, of the department of gastroenterology and hepatology at Amsterdam UMC, and colleagues sought to explore endoscopic histologic outcomes in patients with CD treated with Entyvio (vedolizumab, Takeda) for 52 weeks.
“Although the efficacy and safety of [vedolizumab] induction and maintenance therapy in CD has been confirmed in real life cohorts, only limited data are available on endoscopic and histological remission,” they wrote. “Endoscopic remission is an important treatment goal in CD, that is associated with improved clinical outcomes, including reduced hospitalization and surgery rates.”
Researchers conducted a study comprising 110 patients with active CD, defined as CD Activity Index (CDAI) scores greater than 220 and mucosal ulcerations. Eighty-eight percent of patients had previously undergone anti-TNF treatment. Patients received open-label 300 mg vedolizumab infusions at weeks 0, 2 and 6, and then every 8 weeks through week 52. Any patients who did not experience a CDAI decrease of at least 70 points by week 10 received an additional infusion that week.
Patients underwent ileocolonoscopies at baseline and weeks 26 and 52. Investigators assessed endoscopic response using the Simple Endoscopic Index for CD (SES-CD) and assessed histological features at week 26.
D’Haens and colleagues found that 36 patients were in corticosteroid-free remission (CDAI < 150) at week 26 (29%), and 34 patients were in remission at week 52 (31%).
In an intent-to-treat analysis, researchers determined that 36 patients at week 26 (33%) and 40 patients at week 52 (36%) achieved endoscopic remission — defined as an SES-CD score less than 4. Additionally, 44 patients at week 26 (40%) and 5 patients at week 52 (45%) achieved endoscopic response.
Researchers also found that at week 26, 64% of patients achieved histologic remission based on Geboes score, and 66% achieved histologic remission based on Robarts histopathology index scores.
Patients who had lower SES-CD scores had higher serum concentrations of vedolizumab at weeks 2, 10 and 22. Also, serum concentrations of vedolizumab above 10 mg/L at week 22 were associated with endoscopic remission at week 26.
“This study shows that [vedolizumab] is effective in achieving endoscopic and histological remission in CD, and improved endoscopic outcomes are associated with higher [vedolizumab] serum concentrations,” D’Haens and colleagues concluded. – by Alex Young
Disclosures: D’Haens reports serving as advisor for AbbVie, Ablynx, Allergan, Amakem, Amgen, AM Pharma, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol-MyersSquibb, Boehringer Ingelheim, Celgene/Receptos, Celltrion, Cosmo, Covidien/Medtronic, Ferring, Dr. Falk Pharma, Eli Lilly, Engene, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Hospira/Pfizer, Immunic, Johnson and Johnson, Lycera, Medimetrics, Millennium/Takeda, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novo Nordisk, Otsuka, Pfizer/Hospira, Photopill, Prometheus laboratories/Nestle, Progenity, Protagonist, Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor. He also reports receiving speaker fees from AbbVie, Biogen, Ferring, Johnson and Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millennium/Takeda, Tillotts and Vifor. Please see the full study for all other authors’ relevant financial disclosures.
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