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

Author information

• ¹Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Gastroenterology, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.
• ²Division of Gastroenterology and Inflammatory Bowel Diseases Center, Washington University in Saint Louis School of Medicine, St. Louis, Missouri; Division of Internal Medicine, St. Luke's Hospital, St. Louis, Missouri.
• ³Division of Gastroenterology and Inflammatory Bowel Diseases Center, Washington University in Saint Louis School of Medicine, St. Louis, Missouri.
• ⁴University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois.
• ⁵Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
• ⁶Division of Gastroenterology and Inflammatory Bowel Diseases Center, Washington University in Saint Louis School of Medicine, St. Louis, Missouri; Steward Center for Inflammatory Bowel Diseases, Rockledge, Florida; University of Central Florida College of Medicine, Orlando, Florida.
• ⁷Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
• ⁸Division of Digestive and Liver Diseases, Cedars Sinai Medical Center, Los Angeles, California.
• ⁹Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.
• ¹⁰Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Gastroenterology, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio.
• ¹¹Division of Gastroenterology, Brooke Army Medical Center, Fort Sam Houston, Texas.
• ¹²Division of Gastroenterology and Inflammatory Bowel Diseases Center, Washington University in Saint Louis School of Medicine, St. Louis, Missouri.

Abstract

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).