TY - JOUR
T1 - Comparative Risk of Serious Infections With Tumor Necrosis Factor α Antagonists vs Vedolizumab in Patients With Inflammatory Bowel Diseases
AU - Singh, Siddharth
AU - Heien, Herbert C.
AU - Herrin, Jeph
AU - Dulai, Parambir S.
AU - Sangaralingham, Lindsey
AU - Shah, Nilay D.
AU - Sandborn, William J.
N1 - Funding Information:
Funding This project was supported by the National Institutes of Health / National Institute of Diabetes and Digestive and Kidney Diseases K23DK117058 (to Siddharth Singh) and International Organization for the Study of Inflammatory Bowel Disease Operating Grant 2019 (to Siddharth Singh). William J. Sandborn is partially supported by National Institute of Diabetes and Digestive and Kidney Diseases –funded San Diego Digestive Diseases Research Center (P30 DK120515). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health .
Funding Information:
Funding This project was supported by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases K23DK117058 (to Siddharth Singh) and International Organization for the Study of Inflammatory Bowel Disease Operating Grant 2019 (to Siddharth Singh). William J. Sandborn is partially supported by National Institute of Diabetes and Digestive and Kidney Diseases?funded San Diego Digestive Diseases Research Center (P30 DK120515). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Conflicts of interest These authors disclose the following: Siddharth Singh reports research grants from AbbVie and Janssen. Jeph Herrin reports working under contract to Centers for Medicare and Medicaid Services to develop quality measures. Parambir S. Dulai reports research support from Takeda, Pfizer, AbbVie, Janssen, Polymedco, ALPCO, Buhlmann, and Prometheus; and consulting fees from Takeda, Pfizer, AbbVie, and Janssen. William J. Sandborn reports research grants from Atlantic Healthcare Limited, Amgen, Genentech, Gilead Sciences, AbbVie, Janssen, Takeda, Lilly, Celgene/Receptos, Pfizer, and Prometheus Laboratories (now Prometheus Biosciences); reports consulting fees from AbbVie, Allergan, Amgen, Arena Pharmaceuticals, Avexegen Therapeutics, BeiGene, Boehringer Ingelheim, Celgene, Celltrion, Conatus, Cosmo, Escalier Biosciences, Ferring, Forbion, Genentech, Gilead Sciences, Gossamer Bio, Incyte, Janssen, Kyowa Kirin Pharmaceutical Research, Landos Biopharma, Lilly, Oppilan Pharma, Otsuka, Pfizer, Progenity, Prometheus Biosciences (merger of Precision IBD and Prometheus Laboratories), Reistone, Ritter Pharmaceuticals, Robarts Clinical Trials (owned by Health Academic Research Trust, HART), Series Therapeutics, Shire, Sienna Biopharmaceuticals, Sigmoid Biotechnologies, Sterna Biologicals, Sublimity Therapeutics, Takeda, Theravance Biopharma, Tigenix, Tillotts Pharma, UCB Pharma, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals; and stock or stock options from BeiGene, Escalier Biosciences, Gossamer Bio, Oppilan Pharma, Prometheus Biosciences (merger of Precision IBD and Prometheus Laboratories), Progenity, Ritter Pharmaceuticals, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences; and his spouse is a consultant for Iveric Bio, Progenity, and Oppilan Pharma; owns stock options in Iveric Bio, Progenity, Oppilan Pharma, Escalier Biosciences, Prometheus Biosciences (merger of Precision IBD and Prometheus Laboratories), Shoreline Biosciences, Ventyx Biosciences, and Vimalan Biosciences; is a prior employee of Escalier Biosciences; is an employee of Prometheus Biosciences (merger of Precision IBD and Prometheus Laboratories). The remaining authors disclose no conflicts.
Publisher Copyright:
© 2022 AGA Institute
PY - 2022/2
Y1 - 2022/2
N2 - Background and Aims: We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-a (TNFa) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD). Methods: Using an administrative claims database, we identified patients with IBD who were new-users of either TNFa antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFa antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates. Results: We included 4881 patients treated with TNFa antagonists (age, 41 ± 15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44 ± 16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFa antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD. Conclusions: In an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFa antagonists, in patients with UC, but not in patients with CD.
AB - Background and Aims: We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-a (TNFa) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD). Methods: Using an administrative claims database, we identified patients with IBD who were new-users of either TNFa antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFa antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates. Results: We included 4881 patients treated with TNFa antagonists (age, 41 ± 15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44 ± 16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFa antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD. Conclusions: In an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFa antagonists, in patients with UC, but not in patients with CD.
KW - Biologics
KW - Choice
KW - Colitis
KW - Infections
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85108961560&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85108961560&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2021.02.032
DO - 10.1016/j.cgh.2021.02.032
M3 - Article
C2 - 33640480
AN - SCOPUS:85108961560
SN - 1542-3565
VL - 20
SP - e74-e88
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 2
ER -