Vedolizumab Experience in Children and Adolescents With Inflammatory Bowel Disease: A Multicenter Observational Study
| Autor: | James Markowitz, Gabriele Hunter, Monica Shukla-Udawatta, Kaitlin G. Whaley, María Honrubia Pérez, Carmine Suppa, Cary G. Sauer, Meghan Gibson, Michael J. Rosen, Maua H. Mosha, Brendan M. Boyle, Temara Hajjat, Derica Sams, Jeffrey S. Hyams, Jason Shapiro, Lauren Dufour, Francisco A. Sylvester |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
business.industry Gastroenterology medicine.disease Inflammatory bowel disease Vedolizumab 03 medical and health sciences 0302 clinical medicine Internal medicine Disease remission Medicine 030211 gastroenterology & hepatology Observational study 030212 general & internal medicine business medicine.drug |
| Zdroj: | Crohn's & Colitis 360. 3 |
| ISSN: | 2631-827X |
| DOI: | 10.1093/crocol/otab039 |
| Popis: | Background Vedolizumab is increasingly used off-label to treat children and adolescents with inflammatory bowel disease (IBD). In the absence of rigorous clinical trial experience, multicenter observational data are important to establish expectations for efficacy and safety. We examined 1-year outcomes following vedolizumab therapy in a large multicenter pediatric IBD cohort. Methods We performed a retrospective study of 159 pediatric patients (4–17 years old) with IBD [78, Crohn disease (CD); 81, ulcerative colitis/IBD-unspecified (UC/IBD-U)] treated with vedolizumab for 1 year at 8 pediatric medical centers in the United States. Demographics, clinical outcomes, laboratory data, and vedolizumab dosing were recorded. The primary outcome was corticosteroid (CS)-free clinical remission at 1 year. Other measured outcomes were clinical remission at 12 and/or 24 weeks, laboratory outcomes at 1 year, and endoscopy/histology results at 1 year. Results Among the 159 patients (mean age, 14.5 ± 2.4 years; 86% anti-TNF experienced), 68/159 (43%) achieved CS-free clinical remission at 1 year (CD, 35/78, 45%; UC/IBD-U, 33/81, 40%). Vedolizumab therapy failed and was discontinued in 33/159 (21%) patients prior to 1 year (CD, 18/78, 23%; UC/IBD-U, 15/81, 19%). While week 12 clinical remission was not predictive of 1-year clinical remission in either CD or UC/IBD-U, week 24 clinical remission was predictive of 1-year clinical remission only in CD patients. No infusion reactions or serious side effects were noted. Conclusions Vedolizumab was safe and effective in this pediatric population with approximately 43% achieving CS-free clinical remission at 1 year. Similar efficacy was noted in both CD and UC. |
| Databáze: | OpenAIRE |
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