Upadacitinib Achieves Primary and All Secondary Endpoints in Phase 3 Maintenance Trial for Ulcerative Colitis with Significantly Higher Clinical Remission Rates at One Year

AbbVie today announced that its JAK inhibitor upadacitinib met the primary endpoint of clinical remission and all secondary endpoints in a Phase 3 maintenance trial for ulcerative colitis. At Week 52, the proportion of patients achieving clinical remission was significantly higher in the upadacitinib groups compared to the placebo group (15 mg: 42%; 30 mg: 52%, placebo: 12%; p<0.001).

In this study, adult patients with moderate-to-severe ulcerative colitis initially received 8 weeks of induction therapy with upadacitinib (45 mg). Patients who achieved a clinical response were re-randomized to receive upadacitinib at doses of 15 mg or 30 mg, or placebo, for 52 weeks.

In addition to meeting the primary endpoint of the trial, upadacitinib also met all secondary endpoints, including endoscopic improvement, histologic-endoscopic mucosal improvement (HEMI), and corticosteroid-free clinical remission at Week 52. Detailed data are presented in the table below.

▲ Efficacy results of the Phase 3 maintenance therapy clinical trial at Week 52 (Image source: Reference [1])

Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine. It causes abdominal pain, bloody diarrhea, severe bowel urgency, weight loss, and fatigue. The severity of symptoms and the unpredictability of disease relapses place a heavy burden on patients and frequently lead to disability.

Discovered and developed by AbbVie scientists, upadacitinib is a selective and reversible JAK inhibitor administered orally once daily. In August 2019, it was approved by the U.S. FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or are intolerant of methotrexate. The JAK protein family mediates the signaling of multiple inflammatory cytokines. Upadacitinib has demonstrated positive results in Phase 3 clinical trials for various inflammatory diseases, including rheumatoid arthritis, atopic dermatitis, Crohn's disease, and psoriatic arthritis.

Note: The original text has been abridged.

References:

[1] Upadacitinib (RINVOQ®) Met the Primary and All Secondary Endpoints in the 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients. Retrieved June 29, 2021, from https://news.abbvie.com/news/press-releases/upadacitinib-rinvoq-met-primary-and-all-secondary-endpoints-in-52-week-phase-3-maintenance-study-in-ulcerative-colitis-patients.htm?view_id=6227

▽Follow【WuXi AppTecVirtue】`WeChat Official Account`