AbbVie's JAK Inhibitor Rinvoq Demonstrates Sustained Efficacy in Crohn's Disease with Nearly Half of Patients Achieving Clinical Remission at One Year

Today, AbbVie announced that its JAK inhibitor upadacitinib (brand name: Rinvoq) achieved positive results in a Phase 3 clinical trial for the treatment of patients with moderate to severe Crohn’s disease. Among patients who achieved a clinical response after receiving upadacitinib induction therapy, more patients reached clinical remission, endoscopic response, or endoscopic remission after 52 weeks of treatment.

Crohn's disease is a chronic systemic condition characterized by inflammation in the gastrointestinal or digestive tract, which, during flare-ups, causes persistent diarrhea, abdominal pain, and rectal bleeding. It is a progressive disease that worsens over time. Due to the unpredictable nature of Crohn’s symptoms, it imposes physical, emotional, and financial burdens on patients.

Upadacitinib, discovered and developed by AbbVie scientists, is a selective and reversible JAK inhibitor. In August 2019, it received approval from 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 intolerance to methotrexate. The JAK family of proteins mediates signaling of various inflammatory cytokines. In addition to Crohn's disease, upadacitinib has shown positive results in phase 3 clinical trials for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, ulcerative colitis, and axial spondyloarthritis.

In this maintenance therapy study, patients who responded to 12 weeks of upadacitinib (45 mg) induction therapy were re-randomized to receive different doses of upadacitinib (15 mg, 30 mg) or placebo. Clinical remission was assessed using the Crohn's Disease Activity Index (CDAI) or stool frequency and abdominal pain score (SF/AP).

The test results showed that, according to the CDAI score, at 52 weeks, 37% (15 mg) and 48% (30 mg) of patients treated with upadacitinib achieved clinical remission, compared to 15% in the placebo group (p<0.0001). Similar results were obtained using SF/AP assessments. Moreover, 19% (15 mg) and 29% (30 mg) of patients treated with upadacitinib achieved endoscopic remission, compared to 5% in the placebo group. For specific results, please refer to the table below:

▲ Efficacy results of Upadacitinib (Image source: Reference [1])

"Symptom relief and intestinal mucosal healing are important long-term treatment goals for Crohn's disease, as they may be associated with slowing disease progression and improving patients' quality of life," said Dr. Julian Panes, principal investigator of the clinical trial and a physician at Hospital Clínic de Barcelona. "These results are encouraging and are particularly important for patients who have not achieved remission through conventional or biologic therapies."

References:

[1] Upadacitinib (RINVOQ®) Achieved Clinical Remission and Endoscopic Response at One Year in Phase 3 Maintenance Study in Patients with Crohn's Disease. Retrieved May 11, 2022, from https://www.prnewswire.com/news-releases/upadacitinib-rinvoq-achieved-clinical-remission-and-endoscopic-response-at-one-year-in-phase-3-maintenance-study-in-patients-with-crohns-disease-301544975.html

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