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

Evgenia Papathanasiou; Alexandros Ioannou; Pavlos Pardalis; Giorgos Leonidakis; George Michalopoulos; Spilios Manolakopoulos; Spyridon Siakavellas; Angeliki Theodoropoulou; Athanasia Tasovasili; Olga Giouleme; Maria Tzouvala; Eftychia Tsironi; Nikos Viazis; Spyridon Michopoulos; Evanthia Zampeli

Authors Evgenia Papathanasiou, Alexandros Ioannou, Pavlos Pardalis, Giorgos Leonidakis, George Michalopoulos, Spilios Manolakopoulos, Spyridon Siakavellas, Angeliki Theodoropoulou, Athanasia Tasovasili, Olga Giouleme, Maria Tzouvala, Eftychia Tsironi, Nikos Viazis, Spyridon Michopoulos, Evanthia Zampeli.

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 Upadacitinib, Crohn’s disease, Greece

Ann Gastroenterol 2025; 38 (3): 306-310