Pauline Rivière1, Andreas Münch2, Pierre Michetti3, Nilesh Chande4, Gert de Hertogh5, Patrick Schoeters6, Marc Ferrante1, Séverine Vermeire1, Gert Van Assche1. 1. Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Herestraat, Leuven, Belgium. 2. Division of Gastroenterology, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden. 3. Gastro-entérologie La Source-Beaulieu, Lausanne, Switzerland. 4. Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada. 5. Department of Pathology, University Hospitals Leuven, KU Leuven, Herestraat, Leuven, Belgium. 6. Department of Gastroenterology, AZA Herentals, Herentals, Belgium.
Abstract
BACKGROUND: Evidence for second-line therapy in patients with microscopic colitis [MC] failing budesonide is scarce, although anti-tumour necrosis factors [anti-TNFs], methotrexate and azathioprine have been reported to be effective in small cohort studies. Vedolizumab, a monoclonal antibody targeting α4β7-integrin, prevents homing of T-cells to the gut. We evaluated clinical remission with vedolizumab in budesonide-refractory MC patients. METHODS: We solicited gastroenterologists in Europe and Canada for cases of MC treated with vedolizumab. Vedolizumab 300 mg IV was administered at weeks 0, 2 and 6, and then every 8 weeks. Clinical remission and histological remission were defined as less than three stools per day and normalization of histology, respectively, after induction treatment. RESULTS: Eleven cases were retrieved (nine females, lymphocytic colitis [LC] n = 5, collagenous colitis [CC] n = 6). Median [interquartile range] disease duration at vedolizumab initiation was 51 [29-70] months. Nine of 11 patients had failed one immunosuppressant and ten of 11 at least one anti-TNF agent. After three infusions of vedolizumab, clinical remission was observed in 5/11 patients [two LC and three CC] of whom three remained well with maintenance therapy [median duration of 13 months]. Biopsies were obtained from 9/11 patients. Histological remission was observed in 3/4 patients with clinical remission [2/3 CC, 1/1 LC] and 0/5 patients without clinical improvement. CONCLUSION: In a series of highly refractory MC patients, vedolizumab induced clinical remission in 5/11 subjects, of whom 75% showed normalized histology. Larger randomized trials are needed to assess the efficacy of vedolizumab in patients with MC.
BACKGROUND: Evidence for second-line therapy in patients with microscopic colitis [MC] failing budesonide is scarce, although anti-tumour necrosis factors [anti-TNFs], methotrexate and azathioprine have been reported to be effective in small cohort studies. Vedolizumab, a monoclonal antibody targeting α4β7-integrin, prevents homing of T-cells to the gut. We evaluated clinical remission with vedolizumab in budesonide-refractory MC patients. METHODS: We solicited gastroenterologists in Europe and Canada for cases of MC treated with vedolizumab. Vedolizumab 300 mg IV was administered at weeks 0, 2 and 6, and then every 8 weeks. Clinical remission and histological remission were defined as less than three stools per day and normalization of histology, respectively, after induction treatment. RESULTS: Eleven cases were retrieved (nine females, lymphocytic colitis [LC] n = 5, collagenous colitis [CC] n = 6). Median [interquartile range] disease duration at vedolizumab initiation was 51 [29-70] months. Nine of 11 patients had failed one immunosuppressant and ten of 11 at least one anti-TNF agent. After three infusions of vedolizumab, clinical remission was observed in 5/11 patients [two LC and three CC] of whom three remained well with maintenance therapy [median duration of 13 months]. Biopsies were obtained from 9/11 patients. Histological remission was observed in 3/4 patients with clinical remission [2/3 CC, 1/1 LC] and 0/5 patients without clinical improvement. CONCLUSION: In a series of highly refractory MC patients, vedolizumab induced clinical remission in 5/11 subjects, of whom 75% showed normalized histology. Larger randomized trials are needed to assess the efficacy of vedolizumab in patients with MC.
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Authors: Stephan Miehlke; Danila Guagnozzi; Yamile Zabana; Gian E Tontini; Anne-Marie Kanstrup Fiehn; Signe Wildt; Johan Bohr; Ole Bonderup; Gerd Bouma; Mauro D'Amato; Peter J Heiberg Engel; Fernando Fernandez-Banares; Gilles Macaigne; Henrik Hjortswang; Elisabeth Hultgren-Hörnquist; Anastasios Koulaouzidis; Jouzas Kupcinskas; Stefania Landolfi; Giovanni Latella; Alfredo Lucendo; Ivan Lyutakov; Ahmed Madisch; Fernando Magro; Wojciech Marlicz; Emese Mihaly; Lars K Munck; Ann-Elisabeth Ostvik; Árpád V Patai; Plamen Penchev; Karolina Skonieczna-Żydecka; Bas Verhaegh; Andreas Münch Journal: United European Gastroenterol J Date: 2021-02-22 Impact factor: 4.623