RINVOQ（Upadacitinib）获得FDA批准用于治疗中度至严重活动性溃疡性结肠炎

AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has approved (Upadacitinib) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have an inadequate response to or are intolerant to one or more tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for RINVOQ in gastroenterology and is supported by efficacy and safety data from a three-phase randomized, double-blind, placebo-controlled clinical study.

Clinical Study Results

Two induction studies (U-ACHIEVE and U-Complete) used RINVOQ 45 mg once daily for 8 weeks, followed by 15 mg or 30 mg once daily for 52 weeks in a maintenance study (U-ACHIEVE maintenance). Study results showed that patients treated with RINVOQ achieved clinical remission at weeks 8 and 52, based on the primary endpoint of MMS: stool frequency score (SFS) ≤ 1 and not greater than baseline, rectal bleeding score (RBS) = 0, and endoscopic examination score (ES) ≤ 1. Additionally, these studies met all secondary endpoints, including endoscopic improvement and histoendoscopic mucosal improvement (HEMI), as well as clinical remission without corticosteroids in the maintenance study. All primary and secondary endpoints had p-values ​​<0.001 compared to placebo.

Clinical Study Data

In the U-ACHIEVE and U-ACCOMPLISH induction trials at Week 8, 26% and 33% of patients receiving RINVOQ 45 mg achieved clinical response, the primary MMS-based endpoint, compared with 5% and 4% of patients receiving placebo.

A higher proportion of patients who received RINVOQ 45 mg once daily achieved a clinical response at week 2, defined as a ≥1 point and ≥30% reduction from baseline, a ≥1 RBS reduction or a ≤1 absolute RBS reduction compared with placebo.

During the maintenance trial, 42% and 52% of patients receiving RINVOQ 15 mg or 30 mg achieved clinical remission at week 52, compared with 12% of patients receiving placebo.

Additionally, 57% and 68% of patients receiving RINVOQ 15 mg or 30 mg achieved clinical remission and corticosteroid response 90 days before the end of induction therapy, and 52% of patients achieved clinical remission at the end of induction therapy compared with 22% of placebo patients.

RINVOQApproval status

RINVOQ 15mg has been approved in the EU for 4 indications: for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA); for the treatment of adult patients with active psoriatic arthritis (PsA); for the treatment of adult patients with active ankylosing spondylitis (AS); for the treatment of adult patients with moderate to severe atopic dermatitis (AD) and adolescents aged 12 years and above.

AboutUlcerative Colitis

Ulcerative colitis (UC) is an inflammatory intestinal disease characterized by persistent and confluent inflammatory reactions in the colon, rectal mucosa and submucosa, which may be related to family genetics, environmental factors, autoimmunity and other factors. The site of onset is the sigmoid colon and rectum, and may also involve the descending colon. In severe cases, it may cause disease throughout the colon. The main clinical manifestations are recurrent diarrhea, mucus, purulence and bloody stools combined with abdominal pain, and tenesmus. Severe cases will have varying degrees of extraintestinal manifestations and systemic manifestations, and the disease is characterized by alternating recurrence and remission.

The recurrence rate of UC is high and the clinical manifestations vary greatly. The 10-year cumulative recurrence rate of patients is as high as 70% to 80%. Nearly 50% of patients require hospitalization. The 5-year readmission rate is 50%. The colectomy rate 5 and 10 years after diagnosis is 10%-15%. In addition, as UC lesions continue to progress and the disease course is delayed, the risk of poor prognosis for patients is also increasing, such as a significantly increased risk of colorectal cancer, structural intestinal damage, depression and anxiety, etc.