Benedicte Caron1, Laurent Peyrin-Biroulet2, Benjamin Pariente3, Yoram Bouhnik4, Philippe Seksik5, Guillaume Bouguen6, Ludovic Caillo7, David Laharie8, Franck Carbonnel9, Romain Altwegg10, Catherine Reenaers11, Melanie Serrero12, Caroline Trang-Poisson13, Stephane Nancey14, Jerome Filippi15, Vered Abitbol16, Guillaume Savoye17, Lucine Vuitton18, Stephanie Viennot19, Mathurin Fumery20, Maud Reymond21, Jean-Pierre Bronowicki2, Jean-Marie Reimund1, Aurelien Amiot22. 1. Department of Gastroenterology, Hôpitaux Universitaires de Strasbourg [Hôpital de Hautepierre] and INSERM U1113 IRFAC, Université de Strasbourg [Faculté de Médecine], Strasbourg, France. 2. INSERM U954 and Department of Gastroenterology, Université de Lorraine, Nancy, France. 3. Department of Gastroenterology, Huriez Hospital, Université of Lille, Lille, France. 4. Department of Gastroenterology, IBD and Nutrition Support, Beaujon Hospital, University Paris 7 Denis Diderot, Clichy, France. 5. Department of Gastroenterology, AP-HP, Hôpital Saint-Antoine, ERL 1057 INSERM/UMRS 7203, UPMC Université Paris 6, Paris, France. 6. Department of Gastroenterology, Pontchaillou Hospital and Rennes University, Rennes, France. 7. Department of Gastroenterology, Nimes University Hospital, Nimes, France. 8. Department of Hepato-Gastroenterology, University Hospital of Bordeaux, Hôpital Haut-Lévêque, Bordeaux, France. 9. Department of Gastroenterology, Bicetre University Hospital, APHP, Université Paris Sud, le Kremlin Bicêtre, Paris, France. 10. Department of Gastroenterology, Hôpital Saint-Eloi, University Hospital of Montpellier, Montpellier, France. 11. Department of Gastroenterology, Liege University Hospital, Liege, Belgium. 12. Hôpital Nord, Centre d'investigation clinique Marseille Nord, Université Méditerranée, Marseille, France. 13. Department of Gastroenterology, Institut des Maladies de l'appareil Digestif [IMAD], University Hospital of Nantes, Nantes University, Nantes, France. 14. Department of Gastroenterology, Hospices Civils de Lyon and University Claude Bernard Lyon 1, Pierre-Benite, France. 15. Department of Gastroenterology and Clinical Nutrition, Nice University Hospital, University of Nice Sophia-Antipolis, Nice, France. 16. Department of Gastroenterology, Cochin Hospital, University Paris 5 Descartes, Paris, France. 17. Department of Gastroenterology, Rouen University and Hospital, Rouen, France. 18. Department of Gastroenterology, Besançon University Hospital, Besançon, France. 19. Department of Gastroenterology, Caen University Hospital, Caen, France. 20. Department of Gastroenterology, Amiens University Hospital, Amiens, France. 21. Department of Hepato-Gastroenterology, University Hospital Estaing of Clermont-Ferrand, Université d'Auvergne, Clermont-Ferrand, France. 22. Department of Gastroenterology, Henri Mondor Hospital, APHP, EC2M3-EA7375, Paris Est-Créteil Val de Marne University, Creteil, France.
Abstract
BACKGROUND: Whether vedolizumab may be effective as a treatment for primary sclerosing cholangitis [PSC] in patients with inflammatory bowel disease [IBD] remains controversial. METHODS: We performed a retrospective observational study of consecutive patients with IBD and PSC, treated with vedolizumab for at least 30 weeks in 22 centres of GETAID from January 2015 to June 2016. The outcomes included a decrease in the serum alkaline phosphatase [ALP] concentration of at least 50% from baseline to Week 30 or 54, a change in any serum liver enzymes concentrations, and an assessment of the efficacy and safety of vedolizumab in IBD. RESULTS: Among 75 patients with active IBD and PSC treated with vedolizumab, 21 patients discontinued vedolizumab before Week 30 [due to lack of efficacy in 19 and malignancy in two patients]. In the remaining 54 patients, a decrease in the serum ALP concentration of at least 50% from baseline to Weeks 30 and 54 was observed in four [7%] and four [11%] patients, respectively. No significant change was observed in serum liver enzyme concentrations at week 30 or 54. After a median follow-up period of 19.4 [14.0-29.9] months, nine cases of digestive neoplasia [colorectal neoplasia in seven and cholangiocarcinoma in two] were reported. CONCLUSIONS: In patients with IBD and PSC, vedolizumab did not improve serum liver enzyme concentrations at week 30 or 54. Nine cases of digestive cancer occurred during the follow-up period, confirming the need for a tight surveillance programme in this population.
BACKGROUND: Whether vedolizumab may be effective as a treatment for primary sclerosing cholangitis [PSC] in patients with inflammatory bowel disease [IBD] remains controversial. METHODS: We performed a retrospective observational study of consecutive patients with IBD and PSC, treated with vedolizumab for at least 30 weeks in 22 centres of GETAID from January 2015 to June 2016. The outcomes included a decrease in the serum alkaline phosphatase [ALP] concentration of at least 50% from baseline to Week 30 or 54, a change in any serum liver enzymes concentrations, and an assessment of the efficacy and safety of vedolizumab in IBD. RESULTS: Among 75 patients with active IBD and PSC treated with vedolizumab, 21 patients discontinued vedolizumab before Week 30 [due to lack of efficacy in 19 and malignancy in two patients]. In the remaining 54 patients, a decrease in the serum ALP concentration of at least 50% from baseline to Weeks 30 and 54 was observed in four [7%] and four [11%] patients, respectively. No significant change was observed in serum liver enzyme concentrations at week 30 or 54. After a median follow-up period of 19.4 [14.0-29.9] months, nine cases of digestive neoplasia [colorectal neoplasia in seven and cholangiocarcinoma in two] were reported. CONCLUSIONS: In patients with IBD and PSC, vedolizumab did not improve serum liver enzyme concentrations at week 30 or 54. Nine cases of digestive cancer occurred during the follow-up period, confirming the need for a tight surveillance programme in this population.