What percentage of adult patients with moderate to severe ulcerative colitis, who have a history of inadequate response or intolerance to conventional therapies such as aminosalicylates, corticosteroids, or immunomodulators, achieved clinical response and passed the induction period with Rinvoq (upadacitinib) 45mg once daily for 8 weeks in the U-ACHIEVE RINVOQ trial?

U-ACHIEVE Induction Response Rate

In the U-ACHIEVE induction trial, 278 out of 319 patients (87%) who received upadacitinib 45mg once daily achieved clinical response after 8 weeks and passed the induction period to enter the maintenance study. 1

Detailed Trial Design and Patient Flow

The U-ACHIEVE induction study (UC-1) randomized 474 patients in a 2:1 ratio to receive either upadacitinib 45mg once daily (n=319) or placebo (n=155) for 8 weeks. 1

Clinical Response Rates at Week 8

• Total population receiving upadacitinib 45mg: 74% achieved clinical response (defined as decrease ≥2 points and ≥30% from baseline in modified Mayo Score, with decrease in rectal bleeding subscore ≥1 or absolute rectal bleeding subscore ≤1) 2
• Patients with prior biologic failure: 69% achieved clinical response 2
• Patients without prior biologic failure: 80% achieved clinical response 2

Progression to Maintenance Study

Of the 451 total patients who entered the U-ACHIEVE maintenance study (UC-3), 278 came specifically from the U-ACHIEVE induction trial, representing 87% of the original 319 patients who received upadacitinib 45mg. 1 The remaining patients in the maintenance study came from U-ACCOMPLISH (n=152) and a phase IIb study (n=21). 1

Clinical Remission Rates at Week 8

While clinical response determined eligibility for maintenance therapy, clinical remission rates provide additional context:

• U-ACHIEVE induction: 26% achieved clinical remission (defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding score = 0, endoscopic subscore ≤1 without friability) compared to 5% with placebo 1, 2
• Adjusted treatment difference: 21.6% (95% CI: 15.8-27.4) 3

Extended Induction for Non-Responders

For the 13% of patients who did not achieve clinical response at week 8, extended induction data shows that 59.1% (75/127 patients across both induction studies) subsequently achieved clinical response after an additional 8 weeks of upadacitinib 45mg therapy. 4, 5 This extended induction approach is supported by the American College of Gastroenterology and American Gastroenterological Association. 4

Early Response Patterns

Initial clinical response occurred as early as week 2, with a greater proportion of upadacitinib-treated patients showing improvement in partial modified Mayo Score compared to placebo at this early timepoint. 2, 6 Real-world data confirms clinical remission rates of 36% by week 2 in ulcerative colitis patients. 6