First Oral JAK Inhibitor Approved in the EU: AbbVie’s Upadacitinib (Rinvoq) for Crohn’s Disease

On April 17, AbbVie announced that the European Commission (EC) has approved 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, are intolerant, or have contraindications to conventional therapy or biologics. Upadacitinib is the first oral Janus kinase (JAK) inhibitor approved for the treatment of CD.

The approval by the European Commission was supported by data from two induction therapy studies (U-EXCEED and U-EXCEL) and one maintenance therapy study (U-ENDURE). Upadacitinib demonstrated statistically significant results for the co-primary endpoints and key secondary endpoints in both induction and maintenance therapy studies 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 (45 mg, induction dose) achieved steroid-free clinical remission at week 12; similarly, a higher proportion of patients receiving upadacitinib (15 mg/30 mg, 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)

Rinvoq has rapidly penetrated the market in 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 condition clinically characterized by gastrointestinal inflammation, which during flare-ups causes persistent diarrhea and abdominal pain. It is a progressive disease that worsens over time and can 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 gained an additional therapeutic option.

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