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Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis.
Lukin, Dana; Faleck, David; Xu, Ronghui; Zhang, Yiran; Weiss, Aaron; Aniwan, Satimai; Kadire, Siri; Tran, Gloria; Rahal, Mahmoud; Winters, Adam; Chablaney, Shreya; Koliani-Pace, Jenna L; Meserve, Joseph; Campbell, James P; Kochhar, Gursimran; Bohm, Matthew; Varma, Sashidhar; Fischer, Monika; Boland, Brigid; Singh, Siddharth; Hirten, Robert; Ungaro, Ryan; Lasch, Karen; Shmidt, Eugenia; Jairath, Vipul; Hudesman, David; Chang, Shannon; Swaminath, Arun; Shen, Bo; Kane, Sunanda; Loftus, Edward V; Sands, Bruce E; Colombel, Jean-Frederic; Siegel, Corey A; Sandborn, William J; Dulai, Parambir S.
  • Lukin D; Montefiore Medical Center, New York, New York.
  • Faleck D; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Xu R; University of California, San Diego, La Jolla, California.
  • Zhang Y; University of California, San Diego, La Jolla, California.
  • Weiss A; Montefiore Medical Center, New York, New York.
  • Aniwan S; Mayo Clinic, Rochester, Minnesota.
  • Kadire S; Indiana University, Indianapolis, Indiana.
  • Tran G; Indiana University, Indianapolis, Indiana.
  • Rahal M; Indiana University, Indianapolis, Indiana.
  • Winters A; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Chablaney S; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Koliani-Pace JL; Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
  • Meserve J; University of California, San Diego, La Jolla, California.
  • Campbell JP; University of Minnesota, Minneapolis, Minnesota.
  • Kochhar G; Cleveland Clinic Foundation, Cleveland, Ohio.
  • Bohm M; Indiana University, Indianapolis, Indiana.
  • Varma S; Indiana University, Indianapolis, Indiana.
  • Fischer M; Indiana University, Indianapolis, Indiana.
  • Boland B; University of California, San Diego, La Jolla, California.
  • Singh S; University of California, San Diego, La Jolla, California.
  • Hirten R; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Ungaro R; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Lasch K; Takeda Pharmaceuticals, Lexington, Massachusetts.
  • Shmidt E; University of Minnesota, Minneapolis, Minnesota.
  • Jairath V; University of Western Ontario, London, Ontario, Canada.
  • Hudesman D; New York University, New York, New York.
  • Chang S; New York University, New York, New York.
  • Swaminath A; Lenox Hill Hospital, New York, New York.
  • Shen B; Cleveland Clinic Foundation, Cleveland, Ohio.
  • Kane S; Mayo Clinic, Rochester, Minnesota.
  • Loftus EV; Mayo Clinic, Rochester, Minnesota.
  • Sands BE; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Colombel JF; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Siegel CA; Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
  • Sandborn WJ; University of California, San Diego, La Jolla, California.
  • Dulai PS; University of California, San Diego, La Jolla, California. Electronic address: pdulai@ucsd.edu.
Clin Gastroenterol Hepatol ; 20(1): 126-135, 2022 01.
Article en En | MEDLINE | ID: mdl-33039584
ABSTRACT
BACKGROUND &

AIMS:

We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice.

METHODS:

A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist-naïve and -exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately.

RESULTS:

A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist-naïve and -exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist-treated patients. However, in TNF-antagonist-naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754).

CONCLUSIONS:

Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist-naïve patients.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Colitis Ulcerosa / Inhibidores del Factor de Necrosis Tumoral Tipo de estudio: Observational_studies Límite: Humans Idioma: En Año: 2022 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Colitis Ulcerosa / Inhibidores del Factor de Necrosis Tumoral Tipo de estudio: Observational_studies Límite: Humans Idioma: En Año: 2022 Tipo del documento: Article