The HSE has approved reimbursement of upadacitinib (Rinvoq) for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Reimbursement is restricted to adult patients who fail to respond to a TNF-a inhibitor. 

This follows European Commission (EC) approval in April, 2023 of upadacitinib (45mg induction dose; 15mg and 30mg maintenance doses) as the first oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

EC approval was supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study. Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with upadacitinib 45mg in the induction studies, and upadacitinib 15mg and 30mg in the maintenance study compared to placebo.

Upadacitinib in Crohn’s disease was well tolerated, with no new safety risks observed compared to the known safety profile of upadacitinib. Similar rates of serious adverse events, including serious infections, were observed between patients receiving upadacitinib and placebo. Among patients who received 45mg upadacitinib, the most common adverse events (≥ 5% of patients) were acne (6.9%) and anaemia (6.3%) in U-EXCEL, and nasopharyngitis (7.1%), headache (6.2%), worsening of Crohn’s disease (5.9%) and upper respiratory tract infections (5.2%) in U-EXCEED. Reports of malignancy, major cardiovascular events, venous thromboembolic events and gastrointestinal perforation were infrequently observed (< 1.3 events/100 patient years). 

Upadacitinib is also approved in the EU for the treatment of adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and adults and adolescents with atopic dermatitis.

This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA pharmacovigilance website www.hpra.ie