EFFICACY
RESULTS.

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

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)2
‡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. Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, depending on the extent of disease at study entry.
**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). Endoscopic results are based on a full colonoscopy of flexible sigmoidoscopy, depending on the extent of disease at study entry, and histology results are based on a set of 2 biopsies.
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

All P-values are RINVOQ treatment arms vs placebo.
Recommended
Maintenance Dosing:
A dose of 30 mg may be
considered in patients
with refractory, severe or
extensive disease. Discontinue
if therapeutic response is not
achieved with the 30 mg dose.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.
*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)2
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)2
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.
Rectal bleeding subscore (RBS) data by day4
(Daily Patient Diary Data)

- At Day 1, 22% of patients on RINVOQ 45 mg reported no rectal bleeding vs 15% on placebo.4
- At Week 1, 54% of patients on RINVOQ 45 mg reported no rectal bleeding vs 22% on placebo.4
- At Day 1, 22% of patients on RINVOQ 45 mg reported no rectal bleeding vs 15% on placebo.4
- At Week 1, 54% of patients on RINVOQ 45 mg reported no rectal bleeding vs 22% on placebo.4
Data Limitations: Post-hoc analyses were not adjusted for multiplicity thus no statistical inferences can be made. These analyses utilized an as observed approach and did not impute values for missing evaluations.
Data Limitations: Post-hoc analyses were not adjusted for multiplicity thus no statistical inferences can be made. These analyses utilized an as observed approach and did not impute values for missing evaluations.
Stool frequency subscore (SFS) data by day4
(Daily Patient Diary Data)

- At Day 1, 21% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 12% on placebo.4
- At Week 1, 43% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 16% on placebo.4
- At Day 1, 21% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 12% on placebo.4
- At Week 1, 43% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 16% on placebo.4
Data Limitations: Post-hoc analyses were not adjusted for multiplicity thus no statistical inferences can be made. These analyses utilized an as observed approach and did not impute values for missing evaluations.
Data Limitations: Post-hoc analyses were not adjusted for multiplicity thus no statistical inferences can be made. These analyses utilized an as observed approach and did not impute values for missing evaluations.
No bowel urgency data by day1,4
(Daily Patient Diary Data)

- At Day 1, 17% of patients on RINVOQ 45 mg reported no bowel urgency vs 13% on placebo.4
- At Week 1, 38% of patients on RINVOQ 45 mg reported no bowel urgency vs 17% on placebo.4
In the induction studies, a greater proportion of patients treated with RINVOQ 45 mg once daily compared to placebo had no bowel urgency (U‑ACHIEVE: 48% vs 21%, U‑ACCOMPLISH: 54% vs 26%) at Week 8.1
- At Day 1, 17% of patients on RINVOQ 45 mg reported no bowel urgency vs 13% on placebo.4
- At Week 1, 38% of patients on RINVOQ 45 mg reported no bowel urgency vs 17% on placebo.4
Data Limitations: Post-hoc analyses were not adjusted for multiplicity thus no statistical inferences can be made. These analyses utilized an as observed approach and did not impute values for missing evaluations.
In the induction studies, a greater proportion of patients treated with RINVOQ 45 mg once daily compared to placebo had no bowel urgency (U‑ACHIEVE: 48% vs 21%, U‑ACCOMPLISH: 54% vs 26%) at Week 8.1
Data Limitations: Post-hoc analyses were not adjusted for multiplicity thus no statistical inferences can be made. These analyses utilized an as observed approach and did not impute values for missing evaluations.
Fecal calprotectin reduction at Week 2 and 85

FECAL CALPROTECTIN <150 MG/KG
- At Week 2, 30% of patients on RINVOQ 45 mg had FC <150 mg/kg compared to 5% on placebo6
- At Week 8, 46% of patients on RINVOQ 45 mg had FC <150 mg/kg compared to 8% on placebo6
Fecal Calprotectin <150 mg/kg
- At Week 2, 30% of patients on RINVOQ 45 mg had FC <150 mg/kg compared to 5% on placebo6
- At Week 8, 46% of patients on RINVOQ 45 mg had FC <150 mg/kg compared to 8% on placebo6
Data Limitations: Fecal calprotectin <150 mg/kg at Week 2 and Week 8 of the integrated induction data was a prespecified analysis. Change from baseline in median fecal calprotectin at Week 2 and Week 8 was a post-hoc analysis. Neither of these analyses were adjusted for multiplicity thus no statistical inferences can be made.
Fecal calprotectin is not validated as a biomarker to monitor disease progression.
Data Limitations: Fecal calprotectin <150 mg/kg over time of the integrated induction data was a prespecified analysis. Change from baseline in median fecal calprotectin over time was a post-hoc analysis. Neither of these analyses were adjusted for multiplicity thus no statistical inferences can be made.
DURABLE REMISSION
Clinical Remission
through Week 52
Clinical Remission through Week 521
U-ACHIEVE Study

aBio-naïve patients include patients who were exposed to a biologic but did not experience treatment failure.
All P-values are RINVOQ treatment arms vs placebo.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients
with refractory, severe or extensive disease.
Discontinue if therapeutic response
is not achieved with the 30 mg dose.
Corticosteroid-free
Clinical Remission at Week 521
Among patients who achieved remission at Week 8
U-ACHIEVE Study

All P-values are RINVOQ treatment arms vs placebo.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients
with refractory, severe or extensive disease.
Discontinue if therapeutic response
is not achieved with the 30 mg dose.
Corticosteroid-free
Clinical Remission Over Time7*
U-ACHIEVE Study

*Clinical remission per partial Mayo score (rectal bleeding, stool frequency, physician's global assessment subscores)
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients
with refractory, severe or extensive disease.
Discontinue if therapeutic response
is not achieved with the 30 mg dose.
Data Limitations: These data are based on a prespecified, nonranked endpoint. No multiplicity adjustment was performed thus no statistical inferences can be made.
Data Limitations: These data are based on a prespecified, nonranked endpoint. No multiplicity adjustment was performed thus no statistical inferences can be made.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.
Clinical Remission at Week 81
POWERFUL HEALING
Endoscopic Improvement & Histo-endoscopic Mucosal Improvement
Endoscopic Improvement1
(Endoscopy subscore of 0 or 1,
without friability)
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients
with refractory, severe or extensive disease.
Discontinue if therapeutic response
is not achieved with the 30 mg dose.
Histo-endoscopic Mucosal Improvement1
(Endoscopic subscore of 0 or 1, without friability and histologic improvement with Geboes score ≤ 3.1)
The relationship between this endpoint to disease progression and long-term outcomes was not evaluated.
All P-values are RINVOQ treatment arms vs placebo.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.
Recommended Maintenance Dosing:
A dose of 30 mg may be considered in patients
with refractory, severe or extensive disease.
Discontinue if therapeutic response
is not achieved with the 30 mg dose.
The relationship between the endpoint to disease progression and long-term outcomes was not evaluated.
Stringent Endpoints
in UC
Dr. Miguel Regueiro and Dr. Remo Panaccione discuss stringent endpoints of RINVOQ clinical trials that include endoscopic improvement and histo-endoscopic mucosal improvement.
The relationship between histo-endoscopic mucosal improvement to disease progression and long-term outcomes was not evaluated.

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