Induction with upadacitinib in Crohn's disease: real-world experience from an early-access program in Greece

Abstract

Background: Upadacitinib is a selective Janus kinase-1 inhibitor, approved for the management of Crohn's disease (CD) by the United States Food & Drug Administration. In Greece, upadacitinib was initially available through an early-access program. Our goal was to describe the real practice experience.

Methods: This was a multicenter retrospective cohort study of patients with moderate-to-severe CD. The primary endpoint was clinical response, defined as a reduction ≥3 in the Harvey-Bradshaw index. Secondary endpoints included biochemical improvement. Outcomes were assessed at 4, 8 and 12 weeks.

Results: A total of 24 CD patients received upadacitinib and were included in the analysis. Their mean age was 42.2 years (range 24-63). Eleven patients (45.8%) had ileocolonic CD and 5 (20.8%) CD colitis. Fourteen patients had active extraintestinal manifestations. The majority of patients (19/24) had ≥3 failed biologics. All of them had failed treatment with anti-tumor necrosis factor and 19 (79%) with ustekinumab. At 12 weeks, nearly all patients achieved a clinical response (85%). Of 13 patients with C-reactive protein >5 mg/L at baseline, 11 (84.6%) achieved normalization by week 8. Adverse events occurred in 3 patients (14.2%).

Conclusion: In a small cohort of resistant CD patients, the short-term clinical efficacy of upadacitinib was high.

Keywords: Crohn’s disease; Greece; Upadacitinib.

Figure 1

(A) Changes in Harvey-Bradshaw index (HBI) during follow up; (B) changes in fecal calprotectin during follow up; (C) changes in C-reactive protein (CRP) during follow up