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Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease: A CA-IBD Cohort Study.
Singh, Siddharth; Kim, Jihoon; Luo, Jiyu; Paul, Paulina; Rudrapatna, Vivek; Park, Sunhee; Zheng, Kai; Syal, Gaurav; Ha, Christina; Fleshner, Phillip; McGovern, Dermot; Sauk, Jenny S; Limketkai, Berkeley; Dulai, Parambir S; Boland, Brigid S; Eisenstein, Samuel; Ramamoorthy, Sonia; Melmed, Gil; Mahadevan, Uma; Sandborn, William J; Ohno-Machado, Lucila.
Afiliação
  • Singh S; Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California. Electronic address: sis040@ucsd.edu.
  • Kim J; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California.
  • Luo J; Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.
  • Paul P; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California.
  • Rudrapatna V; Division of Gastroenterology, Department of Medicine, University of California San Francisco, California.
  • Park S; Division of Gastroenterology, Department of Medicine, University of California Irvine, Orange, California.
  • Zheng K; Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California Irvine, Orange, California.
  • Syal G; Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical System, Los Angeles, California.
  • Ha C; Division of Gastroenterology, Department of Medicine, Mayo Clinic, Scottsdale, Arizona.
  • Fleshner P; Division of Colorectal Surgery, Department of Surgery, Cedars-Sinai Medical System, Los Angeles, California.
  • McGovern D; Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical System, Los Angeles, California.
  • Sauk JS; Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, California.
  • Limketkai B; Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, California.
  • Dulai PS; Division of Gastroenterology, Department of Medicine, Northwestern University, Chicago, Illinois.
  • Boland BS; Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
  • Eisenstein S; Division of Colon and Rectal Surgery, Department of Surgery, University of California San Diego, La Jolla, California.
  • Ramamoorthy S; Division of Colon and Rectal Surgery, Department of Surgery, University of California San Diego, La Jolla, California.
  • Melmed G; Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical System, Los Angeles, California.
  • Mahadevan U; Division of Gastroenterology, Department of Medicine, University of California San Francisco, California.
  • Sandborn WJ; Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
  • Ohno-Machado L; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California.
Clin Gastroenterol Hepatol ; 21(9): 2359-2369.e5, 2023 08.
Article em En | MEDLINE | ID: mdl-36343846
ABSTRACT
BACKGROUND &

AIMS:

We compared the safety and effectiveness of tumor necrosis factor α (TNF-α) antagonists vs vedolizumab vs ustekinumab in patients with Crohn's disease (CD) in a multicenter cohort (CA-IBD).

METHODS:

We created an electronic health record-based cohort of adult patients with CD who were initiating a new biologic agent (TNF-α antagonists, ustekinumab, vedolizumab) from 5 health systems in California between 2010 and 2017. We compared the risk of serious infections (safety) and all-cause hospitalization and inflammatory bowel disease-related surgery (effectiveness) between different biologic classes using propensity score (PS) matching.

RESULTS:

As compared with TNF-α antagonists (n = 1030), 21 PS-matched, ustekinumab-treated patients with CD (n = 515) experienced a lower risk of serious infections (hazard ratio [HR], 0.36; 95% CI, 0.20-0.64), without any difference in the risk of hospitalization (HR, 0.99; 95% CI, 0.89-1.21) or surgery (HR, 1.08; 95% CI, 0.69-1.70). Compared with vedolizumab (n = 221), 11 PS-matched, ustekinumab-treated patients with CD (n = 221) experienced a lower risk of serious infections (HR, 0.20; 95% CI, 0.07-0.60), without significant differences in risk of hospitalization (HR, 0.76; 95% CI, 0.54-1.07) or surgery (HR, 1.42; 95% CI, 0.54-3.72). Compared with TNF-α antagonists (n = 442), 21 PS-matched, vedolizumab-treated patients with CD (n = 221) had a similar risk of serious infections (HR, 1.53; 95% CI, 0.84-2.78), hospitalization (HR, 1.32; 95% CI, 0.98-1.77), and surgery (HR, 0.63; 95% CI, 0.27-1.47). High comorbidity burden, concomitant opiate use, and prior hospitalization were associated with serious infections and hospitalization in biologic-treated patients with CD.

CONCLUSION:

In a multicenter cohort of biologic-treated patients with CD, ustekinumab was associated with a lower risk of serious infections compared with TNF-α antagonists and vedolizumab, without any differences in risk of hospitalization or surgery. The risk of serious infections was similar for TNF-α antagonists vs vedolizumab.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Doenças Inflamatórias Intestinais / Doença de Crohn Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Doenças Inflamatórias Intestinais / Doença de Crohn Idioma: En Ano de publicação: 2023 Tipo de documento: Article