AbbVie's JAK Inhibitor Upadacitinib Receives FDA Approval as First Oral Treatment for Moderate to Severe Crohn’s Disease

On May 18, the FDA announced the approval of Rinvoq (upadacitinib, 45mg [induction dose], 15mg and 30mg [maintenance dose]) for the treatment of adult patients with moderate to severe active Crohn's disease (CD) who have had an inadequate response to or were intolerant to one or more tumor necrosis factor blockers. Previously, upadacitinib was approved for this indication by the European Commission in April this year, making it the world’s first oral product approved for the treatment of moderate to severe CD.

FDA Approval Supported by Data from Two Induction Therapy Studies (U-EXCEED and U-EXCEL) and One Maintenance Therapy Study (U-ENDURE). Upadacitinib Showed Statistically Significant Results in Both Induction and Maintenance Therapy Studies for Co-Primary and Key Secondary Endpoints Compared to Placebo.

These three Phase III studies are multicenter, randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of upadacitinib induction therapy (45mg once daily) and maintenance therapy (15mg/30mg once daily) in adult patients with moderately to severely active Crohn's disease.

These three studies all met the co-primary endpoints of clinical remission and endoscopic response. Clinical remission was measured using the Crohn's Disease Activity Index (CDAI) or patient-reported stool frequency/abdominal pain symptoms (SF/AP).

Moreover, compared with the placebo group receiving corticosteroids, a higher proportion of patients receiving upadacitinib (45mg, induction dose) achieved steroid-free clinical remission at week 12; likewise, a higher proportion of patients receiving upadacitinib (15mg/30mg, maintenance dose) achieved steroid-free clinical remission at week 52. The safety profile of upadacitinib across the three studies was consistent with previous reports, with no new safety risks observed.

Clinical Results of U-EXCEL (Source: AbbVie Official Website)

Clinical Results of U-EXCEED (Source: AbbVie Official Website)

Clinical Results of U-ENDURE (Source: AbbVie Official Website)

Upadacitinib has been rapidly penetrating the market over the past two years, with seven indications successively approved for marketing in multiple countries, including: (1) moderate to severe active rheumatoid arthritis; (2) active psoriatic arthritis; (3) moderate to severe atopic dermatitis; (4) active ankylosing spondylitis; (5) moderate to severe ulcerative colitis; (6) axial spondyloarthritis; (7) Crohn's disease.

Crohn's disease is a chronic systemic disease, clinically characterized by gastrointestinal inflammation, which causes persistent diarrhea and abdominal pain during flare-ups. It is a progressive disease that worsens over time and may lead to complications requiring urgent medical care, including surgery. The signs and symptoms of Crohn's disease are unpredictable, thus imposing significant physical, emotional, and financial burdens on patients. The approval of upadacitinib for the treatment of Crohn's disease means that these patients have one more treatment option.

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