Tessa Straatmijer1, Vince B C Biemans1, Frank Hoentjen2, Nanne K H de Boer3, Alexander G L Bodelier4, Gerard Dijkstra5, Willemijn A van Dop2, Jeoffrey J L Haans6, Jeroen M Jansen7, P W Jeroen Maljaars8, Sander van der Marel9, Bas Oldenburg10, Cyriel Y Ponsioen11, Marijn C Visschedijk5, Annemarie C de Vries12, Rachel L West13, C Janneke van der Woude12, Marieke Pierik6, Marjolijn Duijvestein11, Andrea E van der Meulen-de Jong8. 1. Initiative on Crohn and Colitis, Amsterdam/Leiden, The Netherlands. 2. Department of Gastroenterology, Radboud University Medical Centre, Nijmegen, The Netherlands. 3. Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. 4. Department of Gastroenterology, Amphia Hospital, Breda, The Netherlands. 5. Department of Gastroenterology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands. 6. Department of Gastroenterology, Maastricht University Medical Centre, Maastricht, The Netherlands. 7. Department of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 8. Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands. 9. Department of Gastroenterology, Haaglanden Medisch Centre, The Hague, The Netherlands. 10. Department of Gastroenterology, University Medical Centre Utrecht, Utrecht, The Netherlands. 11. Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 12. Department of Gastroenterology, Erasmus Medical Centre, Rotterdam, The Netherlands. 13. Department of Gastroenterology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.
Abstract
AIMS: Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin [IL]-12 and IL-23. It is registered for the treatment of inflammatory bowel diseases. We assessed the 2-year effectiveness and safety of ustekinumab in a real world, prospective cohort of patients with Crohn's disease [CD]. METHODS: Patients who started ustekinumab were prospectively enrolled in the nationwide Initiative on Crohn and Colitis [ICC] Registry. At weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index≤ 4 points], biochemical remission (faecal calprotectin ≤ 200 μg/g and/or C-reactive protein ≤5 mg/L], perianal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104. RESULTS: In total, 252 CD patients with at least 2 years of follow-up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission was 32.3% [81/251], 41.4% [104/251], 39% [97/249] and 34.0% [84/247] at weeks 12, 24, 52 and 104, respectively. In patients with combined clinical and biochemical disease activity at baseline [n = 122], the corticosteroid-free clinical remission rates were 23.8% [29/122], 35.2% [43/122], 40.0% [48/120] and 32.8% [39/119] at weeks 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks in all patients was 64.3% and 54.8%, respectively. The main reason for discontinuing treatment after 52 weeks was loss of response [66.7%]. No new safety issues were observed. CONCLUSION: After 104 weeks of ustekinumab treatment, one-third of CD patients were in corticosteroid-free clinical remission.
AIMS: Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin [IL]-12 and IL-23. It is registered for the treatment of inflammatory bowel diseases. We assessed the 2-year effectiveness and safety of ustekinumab in a real world, prospective cohort of patients with Crohn's disease [CD]. METHODS: Patients who started ustekinumab were prospectively enrolled in the nationwide Initiative on Crohn and Colitis [ICC] Registry. At weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index≤ 4 points], biochemical remission (faecal calprotectin ≤ 200 μg/g and/or C-reactive protein ≤5 mg/L], perianal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104. RESULTS: In total, 252 CD patients with at least 2 years of follow-up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission was 32.3% [81/251], 41.4% [104/251], 39% [97/249] and 34.0% [84/247] at weeks 12, 24, 52 and 104, respectively. In patients with combined clinical and biochemical disease activity at baseline [n = 122], the corticosteroid-free clinical remission rates were 23.8% [29/122], 35.2% [43/122], 40.0% [48/120] and 32.8% [39/119] at weeks 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks in all patients was 64.3% and 54.8%, respectively. The main reason for discontinuing treatment after 52 weeks was loss of response [66.7%]. No new safety issues were observed. CONCLUSION: After 104 weeks of ustekinumab treatment, one-third of CD patients were in corticosteroid-free clinical remission.
Authors: Gala M Godoy Brewer; George Salem; Muhammad A Afzal; Berkeley N Limketkai; Zadid Haq; Maryam Tajamal; Joanna Melia; Mark Lazarev; Florin M Selaru; Alyssa M Parian Journal: BMJ Open Gastroenterol Date: 2021-12
Authors: María Chaparro; Iria Baston-Rey; Estela Fernández Salgado; Javier González García; Laura Ramos; María Teresa Diz-Lois Palomares; Federico Argüelles-Arias; Eva Iglesias Flores; Mercedes Cabello; Saioa Rubio Iturria; Andrea Núñez Ortiz; Mara Charro; Daniel Ginard; Carmen Dueñas Sadornil; Olga Merino Ochoa; David Busquets; Eduardo Iyo; Ana Gutiérrez Casbas; Patricia Ramírez de la Piscina; Marta Maia Boscá-Watts; Maite Arroyo; María José García; Esther Hinojosa; Jordi Gordillo; Pilar Martínez Montiel; Benito Velayos Jiménez; Cristina Quílez Ivorra; Juan María Vázquez Morón; José María Huguet; Yago González-Lama; Ana Isabel Muñagorri Santos; Víctor Manuel Amo; María Dolores Martín Arranz; Fernando Bermejo; Jesús Martínez Cadilla; Cristina Rubín de Célix; Paola Fradejas Salazar; Antonio López San Román; Nuria Jiménez; Santiago García-López; Anna Figuerola; Itxaso Jiménez; Francisco José Martínez Cerezo; Carlos Taxonera; Pilar Varela; Ruth de Francisco; David Monfort; Gema Molina Arriero; Alejandro Hernández-Camba; Francisco Javier García Alonso; Manuel Van Domselaar; Ramón Pajares-Villarroya; Alejandro Núñez; Francisco Rodríguez Moranta; Ignacio Marín-Jiménez; Virginia Robles Alonso; María Del Mar Martín Rodríguez; Patricia Camo-Monterde; Iván García Tercero; Mercedes Navarro-Llavat; Lara Arias García; Daniel Hervías Cruz; Sebastian Kloss; Alun Passey; Cynthia Novella; Eugenia Vispo; Manuel Barreiro-de Acosta; Javier P Gisbert Journal: J Clin Med Date: 2022-08-03 Impact factor: 4.964