Jihye Park1,2, Jaeyoung Chun3, Hyuk Yoon4,5, Jae Hee Cheon6,2. 1. Department of Internal Medicine, Sinchon Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. 2. Institute of Gastroenterology, Sinchon Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. 3. Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. 4. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. 5. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea. 6. *Department of Internal Medicine, Sinchon Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Abstract
BACKGROUND: Ustekinumab was recently approved for the treatment of moderate to severe Crohn's disease (CD). Although the ustekinumab Clinical Decision Support Tool (UST-CDST) was able to predict ustekinumab responsiveness in a clinical trial, it is not clear whether UST-CDST can also predict a future clinical relapse following ustekinumab therapy in the real-life setting. METHODS: We enrolled patients with moderate to severe CD who were refractory to conventional therapies and who showed a clinical response after induction therapy with ustekinumab and monitored them until the relapse. We performed a Cox proportional hazard analysis to investigate the predictive capability of UST-CDST for a clinical disease relapse. RESULTS: Clinical remission rates at week 20 were 25.0% for low-probability responders, 66.7% for intermediate-probability responders, and 75.0% for high-probability responders. The high-probability responders were more likely to achieve clinical remission at week 20 compared with the low-probability responders. Among 99 patients with moderate to severe CD, 37 (37.4%) experienced a clinical relapse during the median follow-up period of 18.0 months of ustekinumab treatment. The cumulative relapse rates were 70.0% in the low-probability responders, 35.9% in the intermediate-probability responders, and 22.5% in the high-probability responders (P = .001). In a multivariable Cox proportional hazard analysis, the high-probability responders and intermediate-probability responders had a lower risk of clinical relapse than the low-probability responders. Receiver operating characteristic analysis using UST-CDST to predict relapse revealed an area under the curve of 0.698. CONCLUSIONS: The UST-CDST can predict clinical relapse in patients with moderate to severe CD subjected to ustekinumab therapy.
BACKGROUND: Ustekinumab was recently approved for the treatment of moderate to severe Crohn's disease (CD). Although the ustekinumab Clinical Decision Support Tool (UST-CDST) was able to predict ustekinumab responsiveness in a clinical trial, it is not clear whether UST-CDST can also predict a future clinical relapse following ustekinumab therapy in the real-life setting. METHODS: We enrolled patients with moderate to severe CD who were refractory to conventional therapies and who showed a clinical response after induction therapy with ustekinumab and monitored them until the relapse. We performed a Cox proportional hazard analysis to investigate the predictive capability of UST-CDST for a clinical disease relapse. RESULTS: Clinical remission rates at week 20 were 25.0% for low-probability responders, 66.7% for intermediate-probability responders, and 75.0% for high-probability responders. The high-probability responders were more likely to achieve clinical remission at week 20 compared with the low-probability responders. Among 99 patients with moderate to severe CD, 37 (37.4%) experienced a clinical relapse during the median follow-up period of 18.0 months of ustekinumab treatment. The cumulative relapse rates were 70.0% in the low-probability responders, 35.9% in the intermediate-probability responders, and 22.5% in the high-probability responders (P = .001). In a multivariable Cox proportional hazard analysis, the high-probability responders and intermediate-probability responders had a lower risk of clinical relapse than the low-probability responders. Receiver operating characteristic analysis using UST-CDST to predict relapse revealed an area under the curve of 0.698. CONCLUSIONS: The UST-CDST can predict clinical relapse in patients with moderate to severe CD subjected to ustekinumab therapy.
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