Efficacy of Tumor Necrosis Factor Antagonist Treatment in Patients With Refractory Ulcerative Proctitis

Guillaume Pineton de Chambrun (1) , Aurélien Amiot (2) , Guillaume Bouguen (3, 4) , Stéphanie Viennot (5) , Romain Altwegg (1) , Edouard Louis (6) , Michael Collins , Mathurin Fumery , Florian Poullenot , Laura Armengol (7) , Anthony Buisson , Vered Abitbol , David Laharie , Philippe Seksik , Stéphane Nancey , Pierre Blanc , Yoram Bouhnik (8) , Benjamin Pariente (9) , Laurent Peyrin-Biroulet (10)

1 CHRU Montpellier - Hôpital Saint Eloi
2 CHU Henri Mondor
3 CIC - Centre d'Investigation Clinique [Rennes]
4 NuMeCan - Nutrition, Métabolismes et Cancer
5 Hôpital Côte de Nacre [CHU Caen]
6 CHU-Liège - Centre Hospitalier Universitaire de Liège
7 CHU Rouen
8 Hôpital Beaujon [AP-HP]
9 Hôpital Claude Huriez [Lille]
10 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy

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.

Keywords: second-line treatment; trial; immune suppression; inflammatory bowel disease; proctitis

Domains: Life Sciences [q-bio]; Life Sciences [q-bio]; Human health and pathology; Hépatology and Gastroenterology

Guillaume Pineton de Chambrun, Aurélien Amiot, Guillaume Bouguen, Stéphanie Viennot, Romain Altwegg, et al.. Efficacy of Tumor Necrosis Factor Antagonist Treatment in Patients With Refractory Ulcerative Proctitis. Clinical Gastroenterology and Hepatology, 2020, 18 (3), pp.620-627.e1. ⟨10.1016/j.cgh.2019.05.060⟩. ⟨hal-02179668⟩