Real-world efficacy of Upadacitinib in Crohn disease

Upadacitinib is effective and persistent for highly refractory Crohn’s disease, with 30 mg suggested as a suitable maintenance dose.

To study the efficacy of Upadacitinib (Janus kinase inhibitor) in a real-world Crohn's disease cohort.

This 2-year retrospective, multicentre cohort investigation was performed within the National Health Service (NHS) Lothian and Royal Devon University Healthcare NHS Foundation Trust. The main objective was to assess treatment persistence at week 24, with secondary objectives focused on achieving corticosteroid-free clinical remission (defined as Harvey-Bradshaw Index <5) and biomarker remission (defined as C-reactive protein (CRP) ≤5 mg per L and faecal calprotectin (FCAL) <250 µg per g) at 12, 24, and 52 weeks. The adverse events were also noted.

A total of 135 patients began Upadacitinib treatment. Among them, 93 patients diagnosed with active Crohn’s disease were included, each with a minimum follow-up of 12 weeks. The median follow-up duration was 25 weeks. The cohort exhibited high exposure rates to multiple advanced therapies, with 82% having received a minimum of 2 classes and 52% having received at least 3 classes.

At weeks 12, 24, and 52, treatment persistence rates were 87.1%, 81.7%, and 62.8%, respectively. Clinical remission rates, defined by Harvey-Bradshaw Index scores, were 64% (42/66), 48% (22/46), and 38% (8/21) at these same time points.

Significant decreases in CRP levels and FCAL levels along with HBI were observed over the follow-up period. Hospitalizations due to Crohn’s disease occurred in 14% (13/91) of patients. Forty percent (37/93) of the cohort reported adverse events, with 12% classified as serious.

Upadacitinib proved effective in a real-world cohort of patients with highly refractory Crohn’s disease, showing strong treatment persistence and promising outcomes in achieving clinical remission.