Diego Casas Deza1, Santiago García López2, Miguel Lafuente Blasco3, Raquel Vicente Lidón2, Juan Nerín de la Puerta4, Elena Peña Gonzalez4, Yolanda Ber Nieto5, Mara Charro Calvillo6, María José Alcalá Escriche7, Fernando Gomollón García8, Maite Arroyo Villarino8. 1. Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, España. Electronic address: diegocasas8@gmail.com. 2. Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, España. 3. Departamento de Métodos Estadísticos, Universidad de Zaragoza, Zaragoza, España. 4. Servicio de Aparato Digestivo, Hospital Royo Villanova, Zaragoza, España. 5. Servicio de Aparato Digestivo, Hospital San Jorge, Huesca, España. 6. Servicio de Aparato Digestivo, Hospital de Barbastro, Barbastro, Huesca, España. 7. Servicio de Aparato Digestivo, Hospital Obispo Polanco, Teruel, España. 8. Servicio de Aparato Digestivo, Hospital Clínico Lozano Blesa, Zaragoza, España.
Abstract
INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response.
INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response.
Authors: Anna Viola; Marco Muscianisi; Fabio S Macaluso; Marco Ventimiglia; Maria Cappello; Antonino C Privitera; Antonio Magnano; Dario Pluchino; Giovanni Magrì; Concetta Ferracane; Filippo Mocciaro; Serena Garufi; Enrica Giuffrida; Giuseppe Costantino; Gabriele Fiocco; Mauro Grova; Laura Guida; Angela Alibrandi; Ambrogio Orlando; Walter Fries Journal: JGH Open Date: 2021-02-02
Authors: Sailish Honap; Susanna Meade; Hajir Ibraheim; Peter M Irving; Michael P Jones; Mark A Samaan Journal: Dig Dis Sci Date: 2021-03-16 Impact factor: 3.199