The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis
Open accessAbstract
BACKGROUND & AIMS: integrin, is administered intravenously. Some patients might prefer a subcutaneous formulation of vedolizumab for maintenance treatment. Subcutaneous vedolizumab was investigated as maintenance treatment in patients with moderately to severely active ulcerative colitis. METHODS: We performed a phase 3, double-blind, double-dummy trial at 141 sites in 29 countries from December 18, 2015 through August 21, 2018. Patients with moderately to severely active ulcerative colitis received open-label treatment with intravenous vedolizumab 300 mg at weeks 0 and 2. At week 6, patients with clinical response were randomly assigned maintenance treatment with subcutaneous vedolizumab 108 mg every 2 weeks, intravenous vedolizumab 300 mg every 8 weeks, or placebo. The primary end point was clinical remission at week 52, which was defined as a total Mayo score of ≤2 and no subscore >1. RESULTS: Among the randomized 216 patients, clinical remission at week 52 was achieved by 46.2%, 42.6%, and 14.3% of patients in the subcutaneous vedolizumab, intravenous vedolizumab, and placebo groups, respectively (subcutaneous vedolizumab vs placebo: Δ32.3%; 95% confidence interval, 19.7%-45.0%; P < .001). The subcutaneous vedolizumab group also had greater endoscopic improvement and durable clinical response at week 52 compared with placebo (both P < .001). The incidence of injection-site reactions was more frequent in patients given subcutaneous vedolizumab (10.4%) than intravenous vedolizumab (1.9%) or placebo (0%); these were not treatment limiting, most were mild, and none resulted in discontinuation. Subcutaneous and intravenous vedolizumab safety profiles were otherwise similar. CONCLUSIONS: Subcutaneous vedolizumab is effective as maintenance therapy in patients with moderately to severely active ulcerative colitis who had a clinical response to intravenous vedolizumab induction therapy. It has a favorable safety and tolerability profile. ClinicalTrials.gov ID: NCT02611830; EudraCT 2015-000480-14.
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Ungaro, R., Mehandru, S., Allen, P. B., Peyrin-Biroulet, L., & Colombel, J.-F. (2017) · The Lancet · doi:10.1016/s0140-6736(16)32126-2 · Cited by 3,531
Coated Oral 5-Aminosalicylic Acid Therapy for Mildly to Moderately Active Ulcerative Colitis
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Ford Alexander, C., Paul, M., Hanauer Steven, B., 谭蓓, & Dong, W. Z. (2001) · Cited by 3,021
Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis
Feagan, B. G., Rutgeerts, P., Sands, B. E., Hanauer, S., Colombel, J.-F., Sandborn, W. J., Van Assche, G., Axler, J., Kim, H.-J., Danese, S., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1215734 · Cited by 2,888
Self-citationVedolizumab as Induction and Maintenance Therapy for Crohn's Disease
Sandborn, W. J., Feagan, B. G., Rutgeerts, P., Hanauer, S., Colombel, J.-F., Sands, B. E., Lukas, M., Fedorak, R. N., Lee, S., Bressler, B., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1215739 · Cited by 2,719
Self-citationHarbord, M., Eliakim, R., Bettenworth, D., Karmiris, K., Katsanos, K., Kopylov, U., Kucharzik, T., Molnár, T., Raine, T., Sebastian, S., et al. (2017) · Journal of Crohn's and Colitis · doi:10.1093/ecco-jcc/jjx009 · Cited by 1,180
The safety of vedolizumab for ulcerative colitis and Crohn's disease
Colombel, J.-F., Sands, B. E., Rutgeerts, P., Sandborn, W., Danese, S., D'Haens, G., Panaccione, R., Loftus, E. V., Sankoh, S., Fox, I., et al. (2017) · Gut · doi:10.1136/gutjnl-2015-311079 · Cited by 806
Self-citationOral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis
Wang, Y., Parker, C. E., Feagan, B. G., & MacDonald, J. K. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000544.pub4 · Cited by 483
Soler, D., Chapman, T., Yang, L.-L., Wyant, T., Egan, R., & Fedyk, E. R. (2009) · The Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.109.153973 · Cited by 456
Immunogenicity of biologics in inflammatory bowel disease
Vermeire, S., Gils, A., Accossato, P., Lula, S., & Marren, A. (2018) · Therapeutic Advances in Gastroenterology · doi:10.1177/1756283x17750355 · Cited by 232
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Kobayashi, T., Siegmund, B., Le Berre, C., Wei, S. C., Ferrante, M., Shen, B., Bernstein, C. N., Danese, S., Peyrin-Biroulet, L., & Hibi, T. (2020) · Nature Reviews Disease Primers · doi:10.1038/s41572-020-0205-x · Cited by 1,649
Self-citationLe Berre, C., Honap, S., & Peyrin-Biroulet, L. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00966-2 · Cited by 1,643
Lasa, J. S., Olivera, P. A., Danese, S., & Peyrin-Biroulet, L. (2022) · The Lancet Gastroenterology & Hepatology · doi:10.1016/s2468-1253(21)00377-0 · Cited by 384
Self-citationLong-term safety of approved biologics for ulcerative colitis
D’Amico, F., Parigi, T. L., Bonovas, S., Peyrin-Biroulet, L., & Danese, S. (2020) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2020.1773430 · Cited by 29
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Metadata
- Authors
- Sandborn, W. J., Baert, F., Danese, S., Krznarić, Ž., Kobayashi, T., Yao, X., Chen, J., Rosario, M., Bhatia, S., Kisfalvi, K., D’Haens, G., & Vermeire, S.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2020-02
- Volume
- 158
- Issue
- 3
- Pages
- 562-572.e12
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2970843227
- Cited by
- 331
- References
- 21
- FWCI
- 15.30
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Sandborn, W. J., Baert, F., Danese, S., Krznarić, Ž., Kobayashi, T., Yao, X., Chen, J., Rosario, M., Bhatia, S., Kisfalvi, K., D’Haens, G., & Vermeire, S. (2020). Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. https://doi.org/10.1053/j.gastro.2019.08.027
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