P666 Long-term effectiveness and safety of vedolizumab (VDZ) in inflammatory bowel disease (IBD): Results from the Spanish ENEIDA Registry. Chaparro, M., Garre, A., Alfaro, I., Iborra, M., Mesonero, P., Vera Mendoza, I., Rodríguez, A., Miquel-Cusachs, J., Riestra, S., Navarro, P., De Castro Parga, L., González-Muñoza, C., Rivero Tirado, M., Mañosa, M., Fernández Salazar, L., García-Sepulcre, M., Guardiola, J., Cabriada, J., Gutiérrez Casbas, A., Sicilia, B., Calle, P., L, J., Piqueras, M., Guerra, I., Roncero, O., Navarro-Llavat, M., Sainz, E., Barrio, J., Calvet, X., García, A., Llorente Barrio, M., Lorente, R., Almela, P., Madrigal, R., Villarín, L., J, A., Pajares, R., Van Domselaar, M., Legido Gil, J., & Gisbert, J. P. Journal of Crohn's and Colitis, 12(supplement_1):S447–S448, 2018.
P666 Long-term effectiveness and safety of vedolizumab (VDZ) in inflammatory bowel disease (IBD): Results from the Spanish ENEIDA Registry [link]Paper  doi  abstract   bibtex   
BackgroundThe long-term benefit of VDZ in IBD patients in clinical practice is almost unknown. The aims of this study were (i) to assess the overall durability of VDZ response in IBD patients who initially responded to the induction doses; (ii) to identify predictive factors for loosing response to the treatment; and (iii) to assess the safety of VDZ in clinical practice.MethodsIBD patients [Crohn’s disease (CD) and ulcerative colitis (UC)] that had received at least three induction doses with VDZ in the ENEIDA registry, a large prospectively maintained Spanish database promoted by GETECCU, were included. Patients with inactive disease at the initiation of VDZ treatment were excluded. Active disease, response, and remission were defined based on Harvey–Bradshaw index in CD or Partial Mayo score in UC. The Kaplan–Meier method was used to evaluate the long-term durability of VDZ treatment; curves were compared with the log-rank test. The Cox model was used to identify factors associated with discontinuation of treatment. In addition, variables associated with the loss of response to the standard dose of VDZ were evaluated with the same statistical methods.ResultsA total of 182 patients (50% CD) met inclusion criteria (73% remission, 27% response at week 14). Of them, 8% were anti-TNF naïve, and 24% had failed to one anti-TNF agent, and 68% to ≥2 anti-TNF. A total of 37 patients (20%) discontinued VDZ (54% due to lose of response and 24% to partial response) after a median follow-up of 12 months (7–18 months), with an incidence rate of discontinuation of 18% per patient-year of follow-up. The proportion of patients that remained on VDZ were: 97% at 6 months, 83% at 12 months, 77% at 18 months, and 64% at 24 months. No variable (including previous anti-TNF treatment, response vs. remission at week 14, and type of IBD) was associated with a higher risk of VDZ discontinuation in the multivariate analysis. A total of 66 patients (36%) lost response during a median follow-up of 10 months (6–16 months); the incidence rate of loss of response was 37% per patient-year. Cumulative incidence of loss of response was 10% at 6 months, 33% at 12 months, and 47% at 18 months. No variable was associated with lose of response to the treatment in the multivariate analysis. Ten patients (6%) had adverse events during follow-up, leading to the interruption of the treatment in one patient (due to skin lesions).ConclusionsOver 60% of patients with initial response to VDZ after the induction remain on VDZ after 2 years in this refractory IBD cohort. Two-thirds of patients maintained response after the first year of treatment. Once the patient responds to the drug, no variable was associated with lose of response or discontinuation of the treatment. VDZ is safe in clinical practice.
@article{chaparro_p666_2018,
	title = {P666 {Long}-term effectiveness and safety of vedolizumab ({VDZ}) in inflammatory bowel disease ({IBD}): {Results} from the {Spanish} {ENEIDA} {Registry}},
	volume = {12},
	issn = {1873-9946},
	shorttitle = {P666 {Long}-term effectiveness and safety of vedolizumab ({VDZ}) in inflammatory bowel disease ({IBD})},
	url = {https://academic.oup.com/ecco-jcc/article/12/supplement_1/S447/4807753},
	doi = {10.1093/ecco-jcc/jjx180.793},
	abstract = {BackgroundThe long-term benefit of VDZ in IBD patients in clinical practice is almost unknown. The aims of this study were (i) to assess the overall durability of VDZ response in IBD patients who initially responded to the induction doses; (ii) to identify predictive factors for loosing response to the treatment; and (iii) to assess the safety of VDZ in clinical practice.MethodsIBD patients [Crohn’s disease (CD) and ulcerative colitis (UC)] that had received at least three induction doses with VDZ in the ENEIDA registry, a large prospectively maintained Spanish database promoted by GETECCU, were included. Patients with inactive disease at the initiation of VDZ treatment were excluded. Active disease, response, and remission were defined based on Harvey–Bradshaw index in CD or Partial Mayo score in UC. The Kaplan–Meier method was used to evaluate the long-term durability of VDZ treatment; curves were compared with the log-rank test. The Cox model was used to identify factors associated with discontinuation of treatment. In addition, variables associated with the loss of response to the standard dose of VDZ were evaluated with the same statistical methods.ResultsA total of 182 patients (50\% CD) met inclusion criteria (73\% remission, 27\% response at week 14). Of them, 8\% were anti-TNF naïve, and 24\% had failed to one anti-TNF agent, and 68\% to ≥2 anti-TNF. A total of 37 patients (20\%) discontinued VDZ (54\% due to lose of response and 24\% to partial response) after a median follow-up of 12 months (7–18 months), with an incidence rate of discontinuation of 18\% per patient-year of follow-up. The proportion of patients that remained on VDZ were: 97\% at 6 months, 83\% at 12 months, 77\% at 18 months, and 64\% at 24 months. No variable (including previous anti-TNF treatment, response vs. remission at week 14, and type of IBD) was associated with a higher risk of VDZ discontinuation in the multivariate analysis. A total of 66 patients (36\%) lost response during a median follow-up of 10 months (6–16 months); the incidence rate of loss of response was 37\% per patient-year. Cumulative incidence of loss of response was 10\% at 6 months, 33\% at 12 months, and 47\% at 18 months. No variable was associated with lose of response to the treatment in the multivariate analysis. Ten patients (6\%) had adverse events during follow-up, leading to the interruption of the treatment in one patient (due to skin lesions).ConclusionsOver 60\% of patients with initial response to VDZ after the induction remain on VDZ after 2 years in this refractory IBD cohort. Two-thirds of patients maintained response after the first year of treatment. Once the patient responds to the drug, no variable was associated with lose of response or discontinuation of the treatment. VDZ is safe in clinical practice.},
	language = {en},
	number = {supplement\_1},
	urldate = {2018-03-05},
	journal = {Journal of Crohn's and Colitis},
	author = {Chaparro, M. and Garre, A. and Alfaro, I. and Iborra, M. and Mesonero, P. and Vera Mendoza, I. and Rodríguez, A. and Miquel-Cusachs, J. and Riestra, S. and Navarro, P. and De Castro Parga, L. and González-Muñoza, C. and Rivero Tirado, M. and Mañosa, M. and Fernández Salazar, L. and García-Sepulcre, M. and Guardiola, J. and Cabriada, J. and Gutiérrez Casbas, A. and Sicilia, B. and Calle, Pérez and L, J. and Piqueras, M. and Guerra, I. and Roncero, O. and Navarro-Llavat, M. and Sainz, E. and Barrio, J. and Calvet, X. and García, A. and Llorente Barrio, M. and Lorente, R. and Almela, P. and Madrigal, R. and Villarín, Lucendo and J, A. and Pajares, R. and Van Domselaar, M. and Legido Gil, J. and Gisbert, J. P.},
	year = {2018},
	keywords = {Article, Digestiu},
	pages = {S447--S448},
}
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