Rinvoq (Upadacitinib) Achieves Primary and Key Secondary Endpoints in First Phase 3 Induction Study for Crohn's Disease

December 15, 2021 /BioValleyBIOON/ -- AbbVie recently announced positive topline results from the Phase 3 induction study U-EXCEED (NCT03345836) of Rinvoq (upadacitinib), a novel oral JAK1 inhibitor, for the treatment of moderate to severe Crohn's disease (CD). This study is the first of two Phase 3 induction studies designed to evaluate the safety and efficacy of Rinvoq in adult patients with moderate to severe CD. The U-EXCEED study enrolledAdult patients with moderate to severe CD who have an inadequate response to or are intolerant of biologics, of whom more than 60% had previously received treatment with two or more biologics. The results showed,At Week 12 of treatment, Rinvoq (45mg, once daily) achieved the primary endpoints of clinical remission and endoscopic response.

In the study, clinical remission was measured using the Crohn's Disease Activity Index (CDAI) and patient-reported stool frequency/abdominal pain symptoms (SF/AP). The data showed that, compared with placebo, patients who received a 12-week induction regimen of Rinvoq (45mg, once daily),The proportion of patients achieving CDAI clinical remission at Week 12 significantly increased (39% vs 21%; p<0.0001).。The clinical remission rate evaluated by SF/AP also showed similar results (40% vs 14%; p<0.0001).In the study, all patients also assessed the improvement of intestinal mucosa through endoscopy. At week 12, compared with the placebo group, the Rinvoq (45mg, once daily) treatment group,A higher proportion of patients achieved endoscopic response (35% vs 4%; p<0.0001).。

Among patients who were receiving corticosteroid therapy at baseline,At Week 12, a significantly higher proportion of patients in the Rinvoq (45mg, once daily) treatment group achieved steroid-free clinical remission (assessed by CDAI and SF/AP) compared to the placebo group.. In addition, compared with the placebo group, the Rinvoq treatment groupA significantly higher proportion of patients achieved early symptom improvement at Week 2 (evaluated by CR-100, defined as a reduction in CDAI score from baseline by ≥100 points) and clinical remission at Week 4.

During the 12-week, double-blind, placebo-controlled period, the safety of Rinvoq 45mg was consistent with the safety profile observed in previous studies for the indicated conditions, with no new safety risks identified. The most common adverse events were nasopharyngitis in the Rinvoq treatment group and CD exacerbation in the placebo group. In this study, no adjudicated cardiovascular events or malignancies were reported in any treatment group.Tumor, thromboembolic events or death and other treatment period events.

The full results of the U-EXCEDE study will be presented at an upcoming medical conference.MeetingPublished. Michael Severino, M.D., Vice Chairman and President of AbbVie, said, "Data from the first Phase 3 induction study in Crohn's disease demonstrate that Rinvoq has the potential to address the needs of patients with Crohn's disease, as evidenced by rigorous endpoints such as endoscopic response. We will continue to leverage our expertise in inflammatory bowel disease (IBD) to drive R&D, help shape the IBD landscape, and raise the standard of patient care."

Crohn's disease (CD) is a chronic systemic disease characterized by inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain, and rectal bleeding. It is a progressive disease, meaning that the condition worsens over time. Because the signs and symptoms of CD are unpredictable, it imposes a tremendous burden on patients not only physically but also emotionally and financially.

The active pharmaceutical ingredient in Rinvoq is upadacitinib, which was discovered and developed by AbbVie.Oral selective and reversible JAK1 inhibitor, is being developed to treat several immune-mediated inflammatory diseases. JAK1 is a kinase that plays a critical role in the pathophysiological processes of various inflammatory diseases.

To date, in the European Union, Rinvoq 15mg has been approved for four indications: (1) for the treatment of moderate to severe rheumatoid arthritis.Rheumatoid Arthritis(RA) adult patients; (2) for the treatment of active psoriatic arthritis (PsA) in adult patients; (3) for the treatment of active ankylosing spondylitis (AS) in adult patients; (4) for the treatment of moderate to severe atopic dermatitis (AD) in adult patients and pediatric patients aged 12 years and older. In the EU, Rinvoq 30mg has been approved for one indication: for the treatment of moderate to severe AD in adult patients under 65 years of age.

In the United States, Rinvoq 15mg has been approved for only one indication: the treatment of moderate to severe rheumatoid arthritis.Rheumatoid Arthritis(RA) adult patients. Rinvoq's supplemental New Drug Applications (sNDAs) for AD, PsA, AS, and ulcerative colitis (UC) are still under review in the United States.FDAThe review. In addition, the European Medicines Agency (EMA) is also reviewing Rinvoq's new indication application for the treatment of UC. UC is another type of inflammatory bowel disease (IBD).

Currently, multiple Phase 3 clinical trials of Rinvoq for the treatment of CD, UC, RA, PsA, AD, axial spondyloarthritis (axSpA), giant cell arteritis (GCA), and Takayasu arteritis (TAK) are ongoing. (Bioon.com)

Source of the original text:Upadacitinib (RINVOQ) Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients with Crohn's Disease