Advanced Therapy; Biological Therapy; Proctitis; Small Molecule; Ulcerative Colitis
Abstract :
[en] BACKGROUND & AIMS: Several advanced therapies (biologic therapies and small molecules) have been approved for the treatment of moderate-to-severe ulcerative colitis. The registration trials for these agents typically excluded patients with isolated proctitis, leaving an evidence gap. We evaluated efficacy and safety of advanced therapies in patients with ulcerative proctitis (UP). METHODS: This multicenter retrospective cohort study included consecutive patients with active UP (Mayo endoscopy subscore of ≥2, rectal inflammation up to 15 cm) initiating advanced therapy, after failing conventional therapy. The primary end point was short-term steroid-free clinical remission (total Mayo score ≤2 with no individual subscore >1). In addition, drug persistence and relapse-free and colectomy-free survival were assessed. Both binary logistic and Cox regression analyses were performed. RESULTS: In total, 167 consecutive patients (52.0% female; median age 41.0 years; 82.0% bionaive) underwent 223 courses of therapy for UP (38 adalimumab, 14 golimumab, 54 infliximab, 9 ustekinumab, 99 vedolizumab, 9 tofacitinib). The primary end point was achieved with 36.3% of the treatment courses, and based on multivariate analysis, more commonly attained in bionaive patients (P = .001), patients treated with vedolizumab (P = .001), patients with moderate endoscopic disease activity (P = .002), and a body mass index <25 kg/m(2) (P = .018). Drug persistence was significantly higher in patients treated with vedolizumab (P < .001) and patients with a shorter disease duration (P = .006). No new safety signals were observed. CONCLUSIONS: Advanced therapies are also efficacious and safe in patients with ulcerative colitis limited to the rectum. Therefore, the inclusion of patients with UP in future randomized-controlled trials should be considered.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Lemmens, Pauline; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Louis, Edouard ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Van Moerkercke, Wouter; Department of Hepatology and Gastroenterology, AZ Groeninge, Kortrijk, Belgium.
Pouillon, Lieven; Department of Gastroenterology, Imelda Hospital, Bonheiden, Belgium.
Somers, Michael; Department of Gastroenterology, University Hospital Antwerp, Antwerp, Belgium.
Peeters, Harald; Department of Gastroenterology, University Hospital Gent, Gent, Belgium.
Vanden Branden, Stijn; Department of Gastroenterology, Onze Lieve Vrouw Hospital, Aalst, Belgium.
Busschaert, Julie; Department of Gastroenterology, AZ Sint Lucas, Brugge, Belgium.
Baert, Filip; Department of Gastroenterology, AZ Delta, Roeselare, Belgium.
Cremer, Anneline; Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium.
Potvin, Philippe; Department of Gastroenterology, AZ Rivierenland, Bornem, Belgium.
Dewit, Sophie; Department of Gastroenterology, Noorderhart Maria Hospital, Pelt, Belgium.
Colard, Arnaud ; Université de Liège - ULiège > Département des sciences cliniques ; Department of Gastroenterology, Centre Hospitalier Chrétien - Clinique St Joseph, Liege, Belgium.
Swinnen, Jo; Department of Gastroenterology, Sint Franciscus Hospital, Heusden-Zolder, Belgium.
Lambrecht, Guy; Department of Gastroenterology, AZ Damiaan, Oostende, Belgium.
Claessens, Christophe; Department of Gastroenterology, AZ Turnhout, Turnhout, Belgium.
Willandt, Barbara; Department of Gastroenterology, AZ Sint Jan, Brugge, Belgium.
Dewint, Pieter; Department of Gastroenterology, University Hospital Antwerp, Antwerp, Belgium, Department of Gastroenterology, AZ Maria Middelares, Gent, Belgium.
Van Dyck, Evi; Department of Gastroenterology, AZ Klina, Brasschaat, Belgium.
Sabino, Joao; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Department of Chronic Diseases and Metabolism (CHROMETA), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
Vermeire, Séverine; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Department of Chronic Diseases and Metabolism (CHROMETA), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
Ferrante, Marc; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Department of Chronic Diseases and Metabolism (CHROMETA), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium. Electronic address: marc.ferrante@uzleuven.be.
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