BACKGROUND: Data on the long-term administration of ustekinumab in recommended doses are limited. AIM: To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD). METHODS: Multi-centre study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined. RESULTS: A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNFα agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission. CONCLUSION: After 52 weeks, ustekinumab demonstrated effectiveness in inducing clinical and endoscopic remission in patients with refractory CD.
BACKGROUND: Data on the long-term administration of ustekinumab in recommended doses are limited. AIM: To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD). METHODS: Multi-centre study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined. RESULTS: A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNFα agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission. CONCLUSION: After 52 weeks, ustekinumab demonstrated effectiveness in inducing clinical and endoscopic remission in patients with refractory CD.
Authors: Jonas Halfvarson; Jonas F Ludvigsson; Anders Forss; Mark Clements; Pär Myrelid; Hans Strid; Charlotte Söderman; Agnieszka Wagner; David Andersson; Fredrik Hjelm; Ola Olén Journal: Dig Dis Sci Date: 2022-04-22 Impact factor: 3.199
Authors: Raja Atreya; Christian Bojarski; Anja A Kühl; Zlatko Trajanoski; Markus F Neurath; Britta Siegmund Journal: Curr Res Pharmacol Drug Discov Date: 2022-03-19
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