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Real-World Effectiveness of Ustekinumab in Ulcerative Colitis in a United States Multicenter Cohort Consortium.
Yarur, Andres J; Ungaro, Ryan; Huang, Katherine; Wang, Wenfei; Sasankan, Priya; Zulqarnain, Mir; Johnson, Amanda M; Bader, Geoffrey; Kay, Carl; Costable, Nicholas; Dulaney, David; Fenster, Marc; Beniwal-Patel, Poonam; Syal, Gaurav; Patel, Anish; Loftus, Edward; Pekow, Joel; Cohen, Benjamin; Deepak, Parakkal.
Afiliación
  • Yarur AJ; Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, WI, USA.
  • Ungaro R; Division of Gastroenterology and Hepatology, Inflammatory Bowel Disease Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.
  • Huang K; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mt. Sinai, New York, NY, USA.
  • Wang W; Inflammatory Bowel Disease Center, Division of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
  • Sasankan P; Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, IL, USA.
  • Zulqarnain M; Department of Gastroenterology, Hepatology, and Nutrition, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA.
  • Johnson AM; Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, WI, USA.
  • Bader G; Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.
  • Kay C; Division of Gastroenterology, Brooke Army Medical Center, Fort Sam Houston, TX, USA.
  • Costable N; Division of Gastroenterology, Brooke Army Medical Center, Fort Sam Houston, TX, USA.
  • Dulaney D; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mt. Sinai, New York, NY, USA.
  • Fenster M; Division of Gastroenterology, Brooke Army Medical Center, Fort Sam Houston, TX, USA.
  • Beniwal-Patel P; Division of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.
  • Syal G; Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, WI, USA.
  • Patel A; Division of Gastroenterology and Hepatology, Inflammatory Bowel Disease Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.
  • Loftus E; Division of Gastroenterology, Brooke Army Medical Center, Fort Sam Houston, TX, USA.
  • Pekow J; Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.
  • Cohen B; Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, IL, USA.
  • Deepak P; Department of Gastroenterology, Hepatology, and Nutrition, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA.
Inflamm Bowel Dis ; 2024 Mar 26.
Article en En | MEDLINE | ID: mdl-38531068
ABSTRACT

BACKGROUND:

Pivotal trials have shown that ustekinumab is effective in ulcerative colitis (UC). However, the population included in these trials do not represent the cohort of patients treated in the real world. In this study, we aimed to describe the effectiveness and safety of ustekinumab in a clinical cohort of patients with UC.

METHODS:

We performed a multicenter retrospective cohort study and included patients with active UC starting ustekinumab. Variables collected included demographics, clinical data, and disease activity (measured using partial Mayo score [PMS] and endoscopic Mayo score) at follow-up. The primary outcomes were cumulative rates of steroid-free clinical and biochemical remission (SFCBR), defined as a PMS <2 while off steroids and a normal C-reactive protein and/or fecal calprotectin.

RESULTS:

A total of 245 patients met inclusion criteria. The median time of follow-up was 33 (interquartile range, 17-53) weeks, and 214 (87.3%) had previous exposure to a biologic and/or tofacitinib. Rates of SFCBR, clinical remission, and endoscopic remission at 6 and 12 months were 12.0% (n = 16 of 139), 29.0% (n = 71 of 175), and 18.0% (n = 7 of 39), and 23.8% (n = 15 of 63), 54.3% (n = 57 of 105), and 31.0% (n = 9 of 29), respectively. Non-Hispanic White race, higher baseline PMS, and the use of concomitant corticosteroids were independently associated with failure to achieve SFCBR. Of the 73 that were dose escalated, 28.4% did not respond, 49.3% experienced a benefit, and 21.6% achieved remission.

CONCLUSIONS:

In a population enriched with refractory UC, ustekinumab was well tolerated and induced remission in a significant number of patients. Larger studies with a longer follow-up are warranted.
Ustekinumab was shown to be efficacious and safe in a population of patients with refractory ulcerative colitis. Those patients with exposure to multiple drug classes and higher disease burden at baseline are less likely to respond.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Inflamm Bowel Dis Asunto de la revista: GASTROENTEROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Inflamm Bowel Dis Asunto de la revista: GASTROENTEROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido