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
U-ACHIEVE Study
aBio-naive 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.
U-ACCOMPLISH Study
aBio-naive 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.
POWERFUL HEALING
Endoscopic Improvement & Histo-endoscopic Mucosal Improvement
Endoscopic Improvement1
(Endoscopy subscore of 0 or 1,
without friability)
All P-values are RINVOQ treatment arms vs placebo.
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.
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.
Explore RINVOQ videos to see experts
showcase the latest clinical data.
Interested to learn about safety data for RINVOQ?
See RINVOQ's safety data across clinical trials
Daily Patient Diary Data
Rectal Bleeding
Subscore (RBS) data by day1,2
At Day 1, 22% of patients on RINVOQ 45 mg reported no rectal bleeding vs 15% on placebo.2
At Week 1, 53% of patients on RINVOQ 45 mg reported no rectal bleeding vs 23% on placebo.2
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.
References: 1. Vermeire S, Colombel JF, Takeuchi K, et al. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1. ECCO 2022 UPA Daily symptom abstract. 2. Data on File. AbbVie. ABVRRTI73596
Stool Frequency
Subscore (SFS) data by day1,2
At Day 1, 21% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 12% on placebo.2
At Week 1, 43% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 17% on placebo.2
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.
References: 1. Vermeire S, Colombel JF, Takeuchi K, et al. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1. ECCO 2022 UPA Daily symptom abstract. 2. Data on File. AbbVie. ABVRRTI73596
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Stool Frequency Subscore (SFS) by Day1,2
Some patients starting RINVOQ reported a reduction in stool frequency as early as Day 1 (21% RINVOQ 45 mg, 12% placebo).2
By Week 1, 43% of patients on RINVOQ 45 mg reported a reduction in stool frequency compared to 17% of patients on placebo.2
DATA LIMITATIONS: Post-hoc analyses were not adjusted for multiplicity; therefore, statistical significance has not been established.
References: 1. Vermeire S, Colombel, JF, Takeuchi K, et al. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1. ECCO 2022 UPA Daily symptom abstract. 2. Data on File. ABVRRTIXXXX 3. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
Some patients starting RINVOQ reported normal stool frequency (SFS=0) as early as Day 1 (3% of patients on RINVOQ 45 mg vs 1% on placebo).2
By Week 1, 15% of patients on RINVOQ 45 mg reported normal stool frequency (SFS=0) compared to 4% on placebo.2
DATA LIMITATIONS: Post-hoc analyses were not adjusted for multiplicity; therefore, statistical significance has not been established.
References: 1. Vermeire S, Colombel, JF, Takeuchi K, et al. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1. ECCO 2022 UPA Daily symptom abstract. 2. Data on File. ABVRRTIXXXX 3. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
Subgroup Analysis
Endoscopic improvement
at Week 521
(Endoscopy subscore of 0 or 1)
Endoscopic Improvement
at Week 521
(Endoscopy subscore of 0 or 1, without friability)
*Bio-naïve patients include patients who were exposed to a biologic but did not experience treatment failure.
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.
U-ACHIEVE MAINTENANCE Study Design Intro:1
52-week, double-blind, placebo-controlled Phase 3 clinical study of 746 patients enrolled were randomized to the maintenance study. The primary efficacy analysis population was the first randomized 451 patients. Patients were randomized to receive RINVOQ 15 mg, 30 mg or placebo once daily for up to 52 weeks. The primary endpoint was clinical remission per modified Mayo Score at Week 52.
Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, depending on the extent of disease at study entry.
Reference: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
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Subgroup Analysis
Histo-endoscopic
Mucosal Improvement
at Week 521*
(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.
†Bio-naïve patients include patients who were exposed to a biologic but did not experience treatment failure.
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.
U-ACHIEVE MAINTENANCE Study Design Intro:1
52-week, double-blind, placebo-controlled Phase 3 clinical study of 746 patients enrolled were randomized to the maintenance study. The primary efficacy analysis population was the first randomized 451 patients. Patients were randomized to receive RINVOQ 15 mg, 30 mg or placebo once daily for up to 52 weeks. The primary endpoint was clinical remission per modified Mayo Score at Week 52.
*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.
Reference: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
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Treatment Targets
An evolution of treatment targets in UC
MUCOSAL
HEALING
MUCOSAL HEALING
The definition of
mucosal healing in UC
has evolved to include
both endoscopic &
histologic outcomes2
HISTO-ENDOSCOPIC
MUCOSAL IMPROVEMENT
Normal or Mild Disease
Endoscopic Subscore 0 OR 1
and Histologic Improvement
at the Microscopic Level2,3
References: 1. Ungaro R, Colombel JF, Lissoos T, Peyrin-Biroulet L. A Treat-to-Target Update in Ulcerative Colitis: A Systematic Review. Am J Gastroenterol. 2019;114(6):874-883. 2. Stidham RW, Liu W, Bishu S, et al. Performance of a Deep Learning Model vs Human Reviewers in Grading Endoscopic Disease Severity of Patients With Ulcerative Colitis. JAMA Netw Open. 2019;2(5):e193963. 3. Jauregui-Amezaga A, Geerits A, Das Y, et al. A Simplified Geboes Score for Ulcerative Colitis. J Crohns Colitis. 2017;11(3):305-313.
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Endoscopy Subscores
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Endoscopic Remission
Endoscopic remission
at Week 521
(Endoscopy subscore of 0)
Endoscopic remission
at Week 521
(Endoscopy subscore of 0)
All P-values are RINVOQ treatment arms vs placebo.
ES=endoscopic score
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.
Reference: 1. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113‑2128.
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Study Details
Study Design and Baseline Characteristics
For adult patients with moderately to severely active ulcerative colitis (UC).1
U-ACHIEVE Induction & U-ACCOMPLISH Induction
Primary Endpoint1
- Clinical remission at Week 8*
Select Secondary Endpoints1,2
- Clinical response at Week 2†
- Clinical response at Week 8‡
- Endoscopic improvement at Week 8§
- Histo-endoscopic mucosal improvement at Week 8II
*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.
†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 response per modified Mayo Score is a composite of Mayo stool frequency, rectal bleeding, and endoscopy subscores and is defined as a decrease in total score ≥30% and ≥2 points from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1.
§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.
IIHisto-endoscopic mucosal improvement was defined as Mayo endoscopy subscore of 0 or 1 without friability and Geboes score ≤3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue). Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, depending on the extent of disease at study entry, and histology results are based on a set of 2 biopsies.
aStratification factors for randomization.
bBio-naïve patients include patients who were exposed to a biologic but did not experience treatment failure.
RINVOQ is indicated for TNFi-IR patients.
References: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc. 2. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113‑2128.
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U-ACHIEVE Maintenance
Primary Endpoint1
- Clinical remission at Week 52*
Select Secondary Endpoints at Week 521
- Corticosteroid-free clinical remission at Week 52†
- Endoscopic improvement at Week 52‡
- Histo-endoscopic mucosal improvement at Week 52§
*Clinical remission is defined as Mayo 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 Mayo endoscopy subscore of 0 or 1 without friability and Geboes score ≤3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue). Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, depending on the extent of disease at study entry, and histology results are based on a set of 2 biopsies.
aStratification factors for randomization.
bBio-naïve patients include patients who were exposed to a biologic but did not experience treatment failure.
RINVOQ is indicated for TNFi-IR patients.
References: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc. 2. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113‑2128.
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