For moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients.1

EFFICACY

RESULTS.

Rapid relief of rectal bleeding and stool frequency as early as Week 21*†‡

Durable remission

Clinical remission§ at Week 8 and Week 52, and steroid-free clinical remission|| at Week 521

Powerful healing

Endoscopic improvement and histo-endoscopic mucosal improvement** at Week 8 and Week 521

The relationship between histo-endoscopic mucosal improvement to disease progression and long-term outcomes was not evaluated.

*U-ACHIEVE Induction: 60% on RINVOQ 45 mg vs 27% on placebo (P<0.001)2

U-ACCOMPLISH Induction: 63% on RINVOQ 45 mg vs 26% on placebo (P<0.001)3

Clinical response per partial modified Mayo Score is a composite of Mayo stool frequency and rectal bleeding subscores and is defined as a decrease in total score ≥30% and ≥1 point from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0
or 1.

§Clinical remission is defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability.

Steroid-free clinical remission is defined as clinical remission at Week 52 and corticosteroid-free for ≥90 days immediately preceding Week 52 (among patients achieving remission in induction).

Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1 without friability.

**Histo-endoscopic Mucosal Improvement was defined as an endoscopic subscore ≤1 without friability and Geboes score ≤3.1 (indicating neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

Primary endpoints achieved.

Clinical Remission* at Week 8 and Week 521

Primary endpoint

All P-values are RINVOQ treatment arms vs placebo.

*Clinical Remission is defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1
without friability.

RAPID RELIEF

of rectal bleeding and stool frequency at Week 2

Clinical Response at Week 2, 4, 6, 81-3

(Composite of Rectal Bleeding and Stool Frequency Subscores)

Clinical Response at Week 2:

  • U-ACHIEVE Induction: 60% on RINVOQ 45 mg vs 27% on placebo (P<0.001)2
  • U-ACCOMPLISH Induction: 63% on RINVOQ 45 mg vs 26% on placebo (P<0.001)3

Clinical Response at Week 2:

  • U-ACHIEVE Induction: 60% on RINVOQ 45 mg vs 27% on placebo (P<0.001)
  • U-ACCOMPLISH Induction: 63% on RINVOQ 45 mg vs 26% on placebo (P<0.001)

Data Limitations: The pre-specified integrated analysis for Clinical Response at Week 2 and over time is considered supportive of the efficacy results obtained from the individual studies and is intended to be interpreted within this context. No multiplicity adjustment was performed thus no statistical inferences can be made.

Data Limitations: Pooled induction analysis was not adjusted for multiplicity; therefore, statistical significance has not
been established.

DURABLE REMISSION

Clinical Remission at
Week 8 and Week 52

POWERFUL HEALING

Endoscopic Improvement & Histo-endoscopic Mucosal Improvement

Interested to learn about safety data for RINVOQ?

See RINVOQ's safety data across clinical trials