Efficacy and Safety of Upadacitinib During Induction in Crohn’s disease: Real-World Experience

Abstract

Abstract Background Upadacitinib is a selective JAK1 inhibitor that has recently been approved for treatment of moderate-severe Crohn’s disease, with Phase III clinical trials showing positive efficacy and safety profiles. Aim Our aim was to evaluate the real-world experience of upadacitinib in a refractory cohort of Canadian patients with Crohn’s disease. Methods This was a two-centre retrospective study looking at 12-week induction data for patients with active Crohn’s disease from McGill University Health Centre and Hamilton Health Sciences. The primary outcome was clinical remission at 12 weeks, with secondary outcomes including clinical response, biochemical remission, and biochemical response. These parameters were all evaluated at 8 and 12 weeks. Adverse events were summarized for patients who had follow up data available and included in the efficacy analysis. Results There were 28 patients who were treated in total. Five patients discontinued upadacitinib due to no response or side effects. Clinical remission was achieved at 12 weeks in nine patients (9/12, 75%). Clinical response was achieved in nine patients (9/12, 75%), biochemical remission was achieved in five patients (5/13, 38.5%), and biochemical response was achieved in seven patients (7/13, 53.8%). Adverse events were observed in three patients (3/15, 20%), with two having non-serious infections (2/15, 13.3%) and one having fevers of unknown origin (1/15, 6.67%). Conclusion This real-world multicentre Canadian induction study shows favourable efficacy and tolerability of upadacitinib in refractory active Crohn’s disease.