- Fecal Incontinence
|Real-World Effectiveness and Safety of Tofacitinib in Crohn's Disease and IBD-U: A Multicenter Study From the TROPIC Consortium
Clin Gastroenterol Hepatol. 2021 Oct;19(10):2207-2209.e3.doi: 10.1016/j.cgh.2020.10.025. Epub 2020 Oct 14.
Marc Fenster 1, Quazim A Alayo 2, Aava Khatiwada 3, Wenfei Wang 4, Christina Dimopoulos 5, Alexandra Gutierrez 3, Matthew A Ciorba 3, George P Christophi 6, Robert P Hirten 7, Christina Ha 8, Poonam Beniwal-Patel 9, Benjamin L Cohen 10, Gaurav Syal 8, Andres Yarur 9, Anish Patel 11, Jean-Frederic Colombel 7, Joel Pekow 4, Ryan C Ungaro 7, David T Rubin 4, Parakkal Deepak 12
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).