Gauthier Pellet1, Carmen Stefanescu2, Franck Carbonnel3, Laurent Peyrin-Biroulet4, Xavier Roblin5, Christophe Allimant6, Maria Nachury7, Stephane Nancey8, Jerome Filippi9, Romain Altwegg10, Hedia Brixi11, Ginette Fotsing12, Laure de Rosamel1, Sarah Shili1, David Laharie13. 1. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Bordeaux, Hôpital Haut-Lévêque, Universite Bordeaux, Bordeaux, Pessac, France. 2. Service d'Hépato-gastro-entérologie, assistance publique des hopitaux de Paris, Hôpital Beaujon, Clichy, France. 3. Service de Gastro-entérologie, assistance publique des hopitaux de Paris, Hôpital du Kremlin-Bicêtre, Université Paris Sud, Le Kremlin-Bicêtre, France. 4. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Nancy, Hôpital de Nancy, Nancy Cedex, France. 5. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Saint-Etienne, Hôpital Bellevue, Saint-Etienne Cedex 2, France. 6. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire Estaing, Clermont-Ferrand, Clermont Ferrand, France. 7. Service des Maladies de l'Appareil Digestif, centre hospitalier regional universitaire de Lille, Hôpital Claude Huriez, Lille Cedex, France. 8. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Lyon hospices civiques de Lyon Sud, Pierre-Benite Cedex, France. 9. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Nice, Hopital Archet, Nice, France. 10. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Montpellier, Hôpital Saint Eloi, Montpellier Cedex 5, France. 11. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Reims, Hôpital Robert Debré, Reims, France. 12. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Poitiers, Hôpital la Milétrie, Poitiers, France. 13. Service d'Hépato-gastro-entérologie, centre hospitalo-universitaire de Bordeaux, Hôpital Haut-Lévêque, Universite Bordeaux, Bordeaux, Pessac, France. Electronic address: david.laharie@chu-bordeaux.fr.
Abstract
BACKGROUND & AIMS: Vedolizumab is used to treat patients with ulcerative colitis (UC), although there is a delay before it is effective. Induction therapy with a calcineurin inhibitor (cyclosporine or tacrolimus) in combination with vedolizumab as maintenance therapy could be an option for patients with an active steroid-refractory UC. We assessed the efficacy and safety of this combination. METHODS: We performed a retrospective observational study, collecting data from 12 referral centers in France that were included in the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif. We collected information on 39 patients with an active steroid-refractory UC (31 with active severe UC and 36 failed by treatment with a tumor necrosis factor antagonist) who received a calcineurin inhibitor as induction therapy along with vedolizumab as maintenance therapy. Inclusion date was the first vedolizumab infusion. The outcomes were survival without colectomy, survival without vedolizumab discontinuation, and safety. RESULTS: After a median follow-up period of 11 months, 11 patients (28%) underwent colectomy. At 12 months, 68% of the patients survived without colectomy (95% CI, 53%-84%) and 44% survived without vedolizumab discontinuation (95% CI, 27%-61%). No deaths occurred and 4 severe adverse events were observed. CONCLUSIONS: In a retrospective analysis of 39 patients with an active steroid-refractory UC (most refractory to a tumor necrosis factor antagonist), we found that initial treatment with a calcineurin inhibitor in combination with vedolizumab allowed more than two thirds of patients to avoid colectomy. Further studies are needed to assess the safety of this strategy.
BACKGROUND & AIMS:Vedolizumab is used to treat patients with ulcerative colitis (UC), although there is a delay before it is effective. Induction therapy with a calcineurin inhibitor (cyclosporine or tacrolimus) in combination with vedolizumab as maintenance therapy could be an option for patients with an active steroid-refractory UC. We assessed the efficacy and safety of this combination. METHODS: We performed a retrospective observational study, collecting data from 12 referral centers in France that were included in the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif. We collected information on 39 patients with an active steroid-refractory UC (31 with active severe UC and 36 failed by treatment with a tumornecrosis factor antagonist) who received a calcineurin inhibitor as induction therapy along with vedolizumab as maintenance therapy. Inclusion date was the first vedolizumab infusion. The outcomes were survival without colectomy, survival without vedolizumab discontinuation, and safety. RESULTS: After a median follow-up period of 11 months, 11 patients (28%) underwent colectomy. At 12 months, 68% of the patients survived without colectomy (95% CI, 53%-84%) and 44% survived without vedolizumab discontinuation (95% CI, 27%-61%). No deaths occurred and 4 severe adverse events were observed. CONCLUSIONS: In a retrospective analysis of 39 patients with an active steroid-refractory UC (most refractory to a tumornecrosis factor antagonist), we found that initial treatment with a calcineurin inhibitor in combination with vedolizumab allowed more than two thirds of patients to avoid colectomy. Further studies are needed to assess the safety of this strategy.
Authors: Roni Weisshof; Jacob E Ollech; Katia El Jurdi; Olivia V Yvellez; Russell D Cohen; Atsushi Sakuraba; Sushila Dalal; Joel Pekow; David T Rubin Journal: J Crohns Colitis Date: 2019-09-19 Impact factor: 9.071