TY - JOUR
T1 - Real-World Effectiveness and Safety of Tofacitinib in Crohn's Disease and IBD-U
T2 - A Multicenter Study From the TROPIC Consortium
AU - Fenster, Marc
AU - Alayo, Quazim A.
AU - Khatiwada, Aava
AU - Wang, Wenfei
AU - Dimopoulos, Christina
AU - Gutierrez, Alexandra
AU - Ciorba, Matthew A.
AU - Christophi, George P.
AU - Hirten, Robert P.
AU - Ha, Christina
AU - Beniwal-Patel, Poonam
AU - Cohen, Benjamin L.
AU - Syal, Gaurav
AU - Yarur, Andres
AU - Patel, Anish
AU - Colombel, Jean Frederic
AU - Pekow, Joel
AU - Ungaro, Ryan C.
AU - Rubin, David T.
AU - Deepak, Parakkal
N1 - Funding Information:
Funding Parakkal Deepak is supported by a Junior Faculty Development Award from the American College of Gastroenterology . Matthew A. Ciorba is supported by DK109384, a Crohn’s and Colitis Foundation Daniel H Present Senior Research Award (Ref. 370763), and philanthropic support from the Givin’ it all for Guts Foundation ( https://givinitallforguts.org ) and the Lawrence C. Pakula MD IBD Research Innovation and Education Fund. Additional grant support for the REDCap database was provided by the Clinical and Translational Science Award (UL1 TR000448) and Siteman Cancer Center Support Grant (P30-CA091842). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Center for Translational Medicine, the National Center for Advancing Translational Sciences, or the National Institutes of Health. Ryan C. Ungaro is supported by a Career Development Award from the Crohn’s and Colitis Foundation and a National Institutes of Health K23 Career Development Award (K23KD111995-01A1). Robert P. Hirten is supported by a Career Development Award from the Crohn’s and Colitis Foundation
Funding Information:
Funding Parakkal Deepak is supported by a Junior Faculty Development Award from the American College of Gastroenterology. Matthew A. Ciorba is supported by DK109384, a Crohn's and Colitis Foundation Daniel H Present Senior Research Award (Ref. 370763), and philanthropic support from the Givin? it all for Guts Foundation (https://givinitallforguts.org) and the Lawrence C. Pakula MD IBD Research Innovation and Education Fund. Additional grant support for the REDCap database was provided by the Clinical and Translational Science Award (UL1 TR000448) and Siteman Cancer Center Support Grant (P30-CA091842). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Center for Translational Medicine, the National Center for Advancing Translational Sciences, or the National Institutes of Health. Ryan C. Ungaro is supported by a Career Development Award from the Crohn's and Colitis Foundation and a National Institutes of Health K23 Career Development Award (K23KD111995-01A1). Robert P. Hirten is supported by a Career Development Award from the Crohn's and Colitis Foundation
PY - 2021/10
Y1 - 2021/10
N2 - The safety and efficacy of tofacitinib in Crohn's disease (CD) has been studied in 2 phase II trials in patients with moderate-to-severe CD with no new safety signals observed, but no significant difference from placebo in the primary efficacy endpoint of clinical response.1–3 However, post hoc analyses and smaller studies have observed clinical and biologic response to tofacitinib in patients with CD.2,4,5 There is a paucity of real-world effectiveness and safety data for tofacitinib in non–Food and Drug Administration label usage in patients with CD and patients with inflammatory bowel disease–unclassified (IBD-U).
AB - The safety and efficacy of tofacitinib in Crohn's disease (CD) has been studied in 2 phase II trials in patients with moderate-to-severe CD with no new safety signals observed, but no significant difference from placebo in the primary efficacy endpoint of clinical response.1–3 However, post hoc analyses and smaller studies have observed clinical and biologic response to tofacitinib in patients with CD.2,4,5 There is a paucity of real-world effectiveness and safety data for tofacitinib in non–Food and Drug Administration label usage in patients with CD and patients with inflammatory bowel disease–unclassified (IBD-U).
UR - http://www.scopus.com/inward/record.url?scp=85100538239&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2020.10.025
DO - 10.1016/j.cgh.2020.10.025
M3 - Short survey
C2 - 33068786
AN - SCOPUS:85100538239
SN - 1542-3565
VL - 19
SP - 2207-2209.e3
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 10
ER -