Guillaume Pineton de Chambrun1, Aurélien Amiot2, Guillaume Bouguen3, Stéphanie Viennot4, Romain Altwegg5, Edouard Louis6, Michael Collins7, Mathurin Fumery8, Florian Poullenot9, Laura Armengol10, Anthony Buisson11, Vered Abitbol12, David Laharie9, Philippe Seksik13, Stéphane Nancey14, Pierre Blanc5, Yoram Bouhnik15, Benjamin Pariente16, Laurent Peyrin-Biroulet17. 1. Department of Gastroenterology, Saint-Eloi Hospital, Montpellier University, Montpellier, France. Electronic address: g-pinetondechambrun@chu-montpellier.fr. 2. Department of Gastroenterology, Henri Mondor Hospital, Creteil University, Creteil, France. 3. CHU Rennes, Univ Rennes, INSERM, CIC1414, Institut NUMECAN (Nutrition Metabolisms and Cancer), F-35000 Rennes, France. 4. Department of Gastroenterology, University Hospital of Caen, Caen, France. 5. Department of Gastroenterology, Saint-Eloi Hospital, Montpellier University, Montpellier, France. 6. Department of Gastroenterology, Liège University Hospital, Liège, Belgium. 7. Department of Gastroenterology, Bicêtre University Hospital, Le Kremlin-Bicêtre, France. 8. Department of Gastroenterology, Amiens University Hospital, Amiens, France. 9. Department of Gastroenterology, Haut-Leveque Hospital, Bordeaux University, Pessac, France. 10. Department of Gastroenterology, Rouen University Hospital, Rouen, France. 11. Department of Gastroenterology, Estaing Hospital, Clermont-Ferrand University, Clermont-Ferrand, France. 12. Department of Gastroenterology, Cochin Hospital, Paris Descartes University, Paris, France. 13. Département de Gastroentérologie, Hôpital Saint Antoine, AP-HP, Paris, France. 14. Department of Gastroenterology, Lyon-Sud Hospital, Lyon University, Lyon, France. 15. Department of Gastroenterology, Beaujon Hospital, Paris Diderot University, Clichy, France. 16. Department of Gastroenterology, Claude Huriez Hospital, Lille 2 University, Lille, France. 17. Department of Gastroenterology, Brabois Hospital, Nancy University, Nancy les Vandoeuvre-lès-Nancy, France.
Abstract
BACKGROUND & AIMS: It is a challenge to manage patients with ulcerative proctitis (UP) refractory to standard therapy. We investigated the effectiveness of tumor necrosis factor (TNF) antagonists in a large cohort of patients with refractory UP. METHODS: We conducted a nationwide retrospective cohort study of 104 consecutive patients with active UP refractory to conventional therapies, treated at 1 of 15 centers in France or 1 center in Belgium (the GETAID cohort). Patients received at least 1 injection of anti-TNF (infliximab, adalimumab, golimumab) from October 2006 through February 2017. Clinical response was defined as significant improvement in UC-related symptoms, and remission as complete disappearance of UC-related symptoms, each determined by treating physicians. We collected demographic, clinical, and treatment data. The median duration of follow-up was 24 months (interquartile range, 13-51 months). The primary outcome was clinical response of UP to anti-TNF treatment. RESULTS: Overall, 80 patients (77%) had a clinical response to anti-TNF therapy and 52 patients (50%) achieved clinical remission. Extra-intestinal manifestations (odds ratio OR, 0.24; 95% CI, 0.08-0.7), ongoing treatment with topical steroids (OR, 0.14; 95% CI, 0.03-0.73), and ongoing treatment with topical 5-aminosalycilates (OR, 0.21; 95% CI, 0.07-0.62) were significantly associated with the absence of clinical remission. Sixty percent (38/63) of the patients who had endoscopic assessment during follow up had mucosal healing. Among the overall population (n = 104), the cumulative probabilities of sustained clinical remission were 87.6% ± 3.4% at 1 year and 74.7% ± 4.8% at 2 years. CONCLUSIONS: In a retrospective study of 104 patients with refractory UP, anti-TNF therapy induced clinical remission in 50% and mucosal healing in 60%. About two thirds of the patients were still receiving anti-TNF therapy at 2 years.
BACKGROUND & AIMS: It is a challenge to manage patients with ulcerative proctitis (UP) refractory to standard therapy. We investigated the effectiveness of tumor necrosis factor (TNF) antagonists in a large cohort of patients with refractory UP. METHODS: We conducted a nationwide retrospective cohort study of 104 consecutive patients with active UP refractory to conventional therapies, treated at 1 of 15 centers in France or 1 center in Belgium (the GETAID cohort). Patients received at least 1 injection of anti-TNF (infliximab, adalimumab, golimumab) from October 2006 through February 2017. Clinical response was defined as significant improvement in UC-related symptoms, and remission as complete disappearance of UC-related symptoms, each determined by treating physicians. We collected demographic, clinical, and treatment data. The median duration of follow-up was 24 months (interquartile range, 13-51 months). The primary outcome was clinical response of UP to anti-TNF treatment. RESULTS: Overall, 80 patients (77%) had a clinical response to anti-TNF therapy and 52 patients (50%) achieved clinical remission. Extra-intestinal manifestations (odds ratio OR, 0.24; 95% CI, 0.08-0.7), ongoing treatment with topical steroids (OR, 0.14; 95% CI, 0.03-0.73), and ongoing treatment with topical 5-aminosalycilates (OR, 0.21; 95% CI, 0.07-0.62) were significantly associated with the absence of clinical remission. Sixty percent (38/63) of the patients who had endoscopic assessment during follow up had mucosal healing. Among the overall population (n = 104), the cumulative probabilities of sustained clinical remission were 87.6% ± 3.4% at 1 year and 74.7% ± 4.8% at 2 years. CONCLUSIONS: In a retrospective study of 104 patients with refractory UP, anti-TNF therapy induced clinical remission in 50% and mucosal healing in 60%. About two thirds of the patients were still receiving anti-TNF therapy at 2 years.
Authors: Evelyne Dubois; Annick Moens; Rob Geelen; João Sabino; Marc Ferrante; Séverine Vermeire Journal: United European Gastroenterol J Date: 2020-07-06 Impact factor: 4.623