Background/Aims Upadacitinib is a novel selective JAK-1 inhibitor that has demonstrated efficacy in the treatment of moderate to severe ulcerative colitis and Crohn’s disease and has received FDA 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 pre-determined intervals at weeks 0, 2, 4, and 8 as part of a formalized treatment protocol at our institution. We used the SCCAI and HBI, as well as CRP and fecal calprotectin to assess efficacy and also recorded treatment-related adverse events and serious AEs. Results 105 patients were followed for 8 weeks on upadacitinib, 84 of whom (44 UC, 40 CD) were initiated due to active luminal or perianal disease and included in the analysis. 100% had previously received anti-TNF therapy, 89.3% had received ≥2 advanced therapies. At 4 and 8 weeks of treatment for UC, 19/25 (76.0%) and 23/27 (85.2%) achieved clinical response and 18/26 (69.2%) and 22/27 (81.5%) achieved clinical remission, respectively. Of those who were previously tofacitinib-exposed, 7/9 (77.8%) achieved clinical remission by 8 weeks. In CD, 13/17 (76.5.%) achieved clinical response and 12/17 (70.6%) achieved clinical remission by 8 weeks. Of those with elevated FCP and CRP, 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 AE, occurring in 24/105 patients (22.9%). Conclusion In this large real-world experience in medically-resistant patients with UC or CD, we describe that upadacitinib is rapidly effective and safe, including in those who had prior tofacitinib exposure.
【저자키워드】 Inflammatory bowel disease, ulcerative colitis, Tofacitinib, Upadacitinib, Crohn’s,