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. 2023 Jul;21(7):1913-1923.e2.
doi: 10.1016/j.cgh.2023.03.001. Epub 2023 Mar 8.

Upadacitinib Is Effective and Safe in Both Ulcerative Colitis and Crohn's Disease: Prospective Real-World Experience

Scott Friedberg  1 , David Choi  1 , Thomas Hunold  1 , Natalie K Choi  1 , Nicole M Garcia  1 , Emma A Picker  1 , Nathaniel A Cohen  1 , Russell D Cohen  1 , Sushila R Dalal  1 , Joel Pekow  1 , Atsushi Sakuraba  1 , Noa Krugliak Cleveland  1 , David T Rubin  2
Affiliations

Upadacitinib Is Effective and Safe in Both Ulcerative Colitis and Crohn's Disease: Prospective Real-World Experience

Scott Friedberg et al. Clin Gastroenterol Hepatol. 2023 Jul.

Abstract

Background & aims: Upadacitinib is a novel selective Janus kinase 1 inhibitor that has shown efficacy in the treatment of moderate to severe ulcerative colitis (UC) and Crohn's disease (CD), and has received Food and Drug Administration approval for UC. We report a large real-world experience with upadacitinib in UC and CD.

Methods: We performed a prospective analysis of clinical outcomes on upadacitinib in patients with UC and CD using predetermined intervals at weeks 0, 2, 4, and 8 as part of a formalized treatment protocol at our institution. We used the Simple Clinical Colitis Activity Index and the Harvey-Bradshaw index, as well as C-reactive protein and fecal calprotectin to assess efficacy, and also recorded treatment-related adverse events and serious adverse events.

Results: A total of 105 patients were followed up for 8 weeks on upadacitinib, 84 of whom (44 UC patients, 40 CD patients) were initiated because of active luminal or perianal disease and included in the analysis. One hundred percent previously received anti-tumor necrosis factor therapy, and 89.3% had received 2 or more advanced therapies. At 4 and 8 weeks of treatment for UC, 19 of 25 (76.0%) and 23 of 27 (85.2%) achieved clinical response and 18 of 26 (69.2%) and 22 of 27 (81.5%) achieved clinical remission, respectively. Of those who previously were tofacitinib-exposed, 7 of 9 (77.8%) achieved clinical remission by 8 weeks. In CD, 13 of 17 (76.5.%) achieved clinical response and 12 of 17 (70.6%) achieved clinical remission by 8 weeks. Of those with increased fecal calprotectin and C-reactive protein levels, 62% and 64% normalized by week 8, respectively. Results were seen as early as week 2 in both UC and CD, with clinical remission rates of 36% and 56.3.%, respectively. Acne was the most commonly reported adverse event, occurring in 24 of 105 patients (22.9%).

Conclusions: In this large real-world experience in medically resistant patients with UC or CD, we report that upadacitinib is rapidly effective and safe, including in those who had prior tofacitinib exposure. This study was approved by the Institutional Review Board at the University of Chicago (IRB20-1979).

Keywords: Crohn’s; Inflammatory Bowel Disease; Tofacitinib; Ulcerative Colitis; Upadacitinib.

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Figures

None
Figure 1a. Simple Clinical Colitis Activity Index over time for ulcerative colitis patients started on upadacitinib Figure 1b: Simple Clinical Colitis Activity Index over time for tofacitinib-exposed ulcerative colitis patients started on upadacitinib Figure 1c: Harvey Bradshaw Index over time for Crohn’s Disease patients started on upadacitinib
See this image and copyright information in PMC

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