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

RINVOQ HELPS DELIVER
LONG-TERM
REMISSION DATA IN UC1

Durable Remission

INDICATION

RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biological therapies for ulcerative colitis, or with potent immunosuppressants such as azathioprine and cyclosporine.

Durable Remission1,2

Clinical remission* at Week 8 and Week 521

Remission data observed at Week 1482†

Bio-IR‡ data available at Week 52 and at Week 1481,2†

†Based on not statistically significant data. No conclusions can be made.

See Clinical Remission Results

Powerful Healing1,2

Endoscopic improvement§ and histo-endoscopic mucosal improvement||¶ at Week 8 and Week 521

Endoscopic data observed at Week 1482†

Bio-IR‡ data available at Week 52 and at Week 1481,2†

†Based on not statistically significant data. No conclusions can be made.

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

See Endoscopic Outcomes

Rapid Relief1

Rapid relief of rectal bleeding and stool frequency at Week 2#

See Symptom Relief Results

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

‡Bio-IR is defined as patients who have an inadequate response to, lose response to, or are intolerant to biologic therapy.

§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.

#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.

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

U-ACHIEVE Induction and U-ACCOMPLISH Induction Study Design Intro1: 8-week, double-blind, placebo-controlled, Phase 3 clinical studies of 988 patients (473 patients for U-ACHIEVE and 515 patients for U-ACCOMPLISH) with moderately to severely active UC and demonstrated prior treatment failure to oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic treatment. Patients were randomized to receive either RINVOQ 45 mg or placebo once daily for 8 weeks. The primary endpoint was clinical remission per modified Mayo Score at Week 8.

U-ACHIEVE Maintenance Study Design Intro1: 52-week, double-blind, placebo-controlled, Phase 3 clinical study of 746 patients who achieved clinical response per modified Mayo Score (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) during induction with 8-week RINVOQ 45 mg once daily and were re-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.

U-ACTIVATE Long-Term Extension (LTE) Open-Label Study2: Data presented at approximately 3 years is an interim analysis at 96 weeks of the U-ACTIVATE study, which is an ongoing 288-week, long-term study evaluating the efficacy and safety from patients who come from the U-ACHIEVE trial. Analysis includes patients from both primary (n=451) and full Maintenance populations (n=681). At the time of analysis, not all patients have reached 96 weeks of the LTE study.

In the LTE analysis, the data was segmented into 2 groups:

  • RINVOQ 15 mg arm: Patients who achieved clinical remission (remitters) on RINVOQ 15 mg at Week 52 of Maintenance Trial and received continuous RINVOQ 15 mg in LTE period (n=101)
  • RINVOQ 30 mg arm: Patients who achieved clinical remission (remitters) on RINVOQ 30 mg at Week 52 of Maintenance Trial and received continuous RINVOQ 30 mg in LTE period (n=141)

Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis, below.

Learn more about these and the full Important Safety Information below 

Durable Remission

at Weeks 8 and 52

Clinical Remission

Maintenance & OLE
Steroid-Free Remission
Induction

Clinical Remission at Week 52 and Up to Week 1481,2
(Composite of Rectal Bleeding, Stool Frequency, and Endoscopy Subscores)

WEEK 52 & OLE
BIO-IR† 15 MG
BIO-IR† 30 MG
Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 42% of patients achieved the primary endpoint of clinical remission on RINVOQ 15 mg and 52% of patients achieved the primary endpoint of clinical remission on RINVOQ 30 mg vs 12% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, reflecting as-observed data, with 78% of patients achieving clinical remission on RINVOQ 15 mg and 77% of patients achieving clinical remission on RINVOQ 30 mg at Week 100. It also shows 78% of patients achieving clinical remission on RINVOQ 15 mg and 79% of patients achieving clinical remission on RINVOQ 30 mg at Week 148.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Additional Information: U‑ACTIVATE Open‑Label Extension
See Definition of Clinical Remission
Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 42% of patients achieved the primary endpoint of clinical remission on RINVOQ 15 mg vs 12% on placebo at Week 52. The bar chart also provides Bio-IR subgroup analysis data that shows that 41% of patients achieved clinical remission on RINVOQ 15 mg vs 7% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 78% of patients achieving clinical remission on RINVOQ 15 mg at Week 100, with a Bio-IR subgroup analysis showing 76% of patients achieving clinical remission on RINVOQ 15 mg at Week 100. It also shows 78% of patients achieving clinical remission on RINVOQ 15 mg at Week 148, with a Bio-IR subgroup analysis showing 72% of patients achieving clinical remission on RINVOQ 15 mg at Week 148. There is also a callout that approximately 95% of Bio-IR patients had TNFi exposure.

†Bio-IR is defined as patients who have an inadequate response to, lose response to, or are intolerant to biologic therapy.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Additional Information: U‑ACTIVATE Open‑Label Extension
See Definition of Clinical Remission
Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 52% of patients achieved the primary endpoint of clinical remission on RINVOQ 30 mg vs 12% on placebo at Week 52. The bar chart also provides Bio-IR subgroup analysis data that shows that 49% of patients achieved clinical remission on RINVOQ 30 mg vs 7% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 77% of patients achieving clinical remission on RINVOQ 30 mg at Week 100, with a Bio-IR subgroup analysis showing 79% of patients achieving clinical remission on RINVOQ 30 mg at Week 100. It also shows 79% of patients achieving clinical remission on RINVOQ 30 mg at Week 148, with a Bio-IR subgroup analysis showing 85% of patients achieving clinical remission on RINVOQ 30 mg at Week 148. There is also a callout that approximately 95% of Bio-IR patients had TNFi exposure.

†Bio-IR is defined as patients who have an inadequate response to, lose response to, or are intolerant to biologic therapy.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Additional Information: U‑ACTIVATE Open‑Label Extension
See Definition of Clinical Remission

Corticosteroid-Free Clinical Remission at Week 521*

*Among patients who achieved remission at Week 8.

Bar chart reflecting data from the U-ACHIEVE Maintenance clinical trial, showing ranked secondary endpoint of steroid-free clinical remission was achieved by 57% of patients on RINVOQ 15 mg and 68% of patients on RINVOQ 30 mg vs 22% on placebo at Week 52, with the observation that patients were steroid-free for at least 90 days prior to the Week 52 visit.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

 

See Study Details
See Definition of Corticosteroid-Free Remission

Clinical Remission at Week 81

U-ACHIEVE
U-ACCOMPLISH
Bar chart reflects data from the U-ACHIEVE clinical trial that displays overall population, reflecting that five times as many patients achieved the primary endpoint of clinical remission on RINVOQ 45 mg over placebo at Week 8.
Bar chart reflects data from the U-ACHIEVE clinical trial, showing subgroup analysis, with 35% of Bio-naïve patients achieving clinical remission on RINVOQ 45 mg vs 9% on placebo at Week 8. The bar chart also reflects 18% of Bio-IR patients achieving clinical remission on RINVOQ 45 mg vs less than 1% on placebo at Week 8.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg may be considered for patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.

 

See Study Details
See Definition of Clinical Remission
Bar chart reflects data from the U-ACCOMPLISH clinical trial that displays overall population, reflecting that eight times as many patients achieved the primary endpoint of clinical remission on RINVOQ 45 mg over placebo at Week 8.
Bar chart reflects data from the U-ACCOMPLISH clinical trial showing subgroup analysis, with 38% of Bio-naïve patients achieving clinical remission on RINVOQ 45 mg vs 6% on placebo at Week 8. The bar chart also reflects 30% of Bio-IR patients achieving clinical remission on RINVOQ 45 mg vs 2% on placebo at Week 8.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg may be considered for patients with refractory, severe or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.

 

See Study Details
See Definition of Clinical Remission

Powerful Healing

at Weeks 8 and 52

Endoscopic & Histo‑endoscopic Mucosal Improvement Data

Endoscopic Improvement
Endoscopic Remission
Histo-endoscopic Mucosal Improvement
Induction

Endoscopic Improvement at Week 52 and Up to Week 1481,2
(Endoscopy subscore of 0 or 1, without friability)

WEEK 52 & OLE
BIO-IR† 15 MG
BIO-IR† 30 MG
Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 49% of patients achieved the ranked secondary endpoint of endoscopic improvement (among those who achieved clinical response at Week 8) on RINVOQ 15 mg and 62% of patients achieved the ranked secondary endpoint of endoscopic improvement (among those who achieved clinical response at Week 8) on RINVOQ 30 mg vs 14% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 82% of patients achieving endoscopic improvement on RINVOQ 15 mg and 82% of patients achieving endoscopic improvement on RINVOQ 30 mg at Week 100. The chart also shows 82% of patients achieving endoscopic improvement on RINVOQ 15 mg and 87% of patients achieving endoscopic improvement on RINVOQ 30 mg at Week 148.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Additional Information: U‑ACTIVATE Open‑Label Extension
See Definition of Endoscopic Improvement
Four endoscopic images show changes in mucosal appearance, ranging from Mayo endoscopy subscore of 0, which is normal; 1, which is mild; 2, which is moderate; and 3, which is severe.
Endoscopy Subscores3

Patient baseline characteristics at induction include4:

70% Endoscopic Subscore 3

30% Endoscopic Subscore 2

Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 49% of patients achieved the ranked secondary endpoint of endoscopic improvement (among those who achieved clinical response at Week 8) on RINVOQ 15 mg vs 14% on placebo at Week 52. The bar chart also provides Bio-IR subgroup analysis data that shows that 43% of patients achieved endoscopic improvement on RINVOQ 15 mg vs 8% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 82% of patients achieving endoscopic improvement on RINVOQ 15 mg at Week 100, with a Bio-IR subgroup analysis showing 76% of patients achieving endoscopic improvement on RINVOQ 15 mg at Week 100. It also shows 82% of patients achieving endoscopic improvement on RINVOQ 15 mg at Week 148, with a Bio-IR subgroup analysis showing 76% of patients achieving endoscopic improvement on RINVOQ 15 mg at Week 148. There is also a callout that approximately 95% of Bio-IR patients had TNFi exposure.

†Bio-IR is defined as patients who have an inadequate response to, lose response to, or are intolerant to biologic therapy.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Additional Information: U‑ACTIVATE Open‑Label Extension
See Definition of Endoscopic Improvement
Endoscopy Subscores3

Patient baseline characteristics at induction include4:

70% Endoscopic Subscore 3

30% Endoscopic Subscore 2

Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 62% of patients achieved the ranked secondary endpoint of endoscopic improvement (among those who achieved clinical response at Week 8) on RINVOQ 30 mg vs 14% on placebo at Week 52. The bar chart also provides Bio-IR subgroup analysis data that shows that 56% of patients achieved endoscopic improvement on RINVOQ 30 mg vs 8% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 82% of patients achieving endoscopic improvement on RINVOQ 30 mg at Week 100, with a Bio-IR subgroup analysis showing 79% of patients achieving endoscopic improvement on RINVOQ 30 mg at Week 100. It also shows 87% of patients achieving endoscopic improvement on RINVOQ 30 mg at Week 148, with a Bio-IR subgroup analysis showing 86% of patients achieving endoscopic improvement on RINVOQ 30 mg at Week 148. There is also a callout that approximately 95% of Bio-IR patients had TNFi exposure.

†Bio-IR is defined as patients who have an inadequate response to, lose response to, or are intolerant to biologic therapy.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Additional Information: U‑ACTIVATE Open‑Label Extension
See Definition of Endoscopic Improvement
Four endoscopic images show changes in mucosal appearance, ranging from Mayo endoscopy subscore of 0, which is normal; 1, which is mild; 2, which is moderate; and 3, which is severe.
Endoscopy Subscores3

Patient baseline characteristics at induction include4:

70% Endoscopic Subscore 3

30% Endoscopic Subscore 2

Endoscopic Remission at Week 52 and Up to Week 1481,2
(Endoscopy subscore of 0)

WEEK 52 & OLE
BIO-IR† 15 MG
BIO-IR† 30 MG
Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 24% of patients achieved the ranked secondary endpoint of endoscopic remission (among those who achieved clinical response at Week 8) on RINVOQ 15 mg and 26% of patients achieved the ranked secondary endpoint of endoscopic remission (among those who achieved clinical response at Week 8) on RINVOQ 30 mg vs 6% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 55% of patients achieving endoscopic remission on RINVOQ 15 mg and 56% of patients achieving endoscopic remission on RINVOQ 30 mg at Week 100. It also shows 49% of patients achieving endoscopic remission on RINVOQ 15 mg and 49% of patients achieving endoscopic remission on RINVOQ 30 mg at Week 148.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Definition of Endoscopic Remission
See Additional Information: U‑ACTIVATE Open‑Label Extension
Endoscopic image shows a Mayo endoscopy subscore of 0, which is normal.

Endoscopy Subscore=0

See More Subscores
Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 24% of patients achieved the ranked secondary endpoint of endoscopic remission (among those who achieved clinical response at Week 8) on RINVOQ 15 mg vs 6% on placebo at Week 52. The bar chart also provides Bio-IR subgroup analysis data that shows that 22% of patients achieved endoscopic remission on RINVOQ 15 mg vs 3% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 55% of patients achieving endoscopic remission on RINVOQ 15 mg at Week 100, with a Bio-IR subgroup analysis showing 50% of patients achieving endoscopic remission on RINVOQ 15 mg at Week 100. It also shows 49% of patients achieving endoscopic remission on RINVOQ 15 mg at Week 148, with a Bio-IR subgroup analysis showing 42% of patients achieving endoscopic remission on RINVOQ 15 mg at Week 148. There is also a callout that approximately 95% of Bio-IR patients had TNFi exposure.

†Bio-IR is defined as patients who have an inadequate response to, lose response to, or are intolerant to biologic therapy.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Definition of Endoscopic Remission
See Additional Information: U‑ACTIVATE Open‑Label Extension
Endoscopic image shows a Mayo endoscopy subscore of 0, which is normal.

Endoscopy Subscore=0

See More Subscores
Bar chart shows data from the U-ACHIEVE Maintenance double-blind random controlled trial, reflecting that 26% of patients achieved the ranked secondary endpoint of endoscopic remission (among those who achieved clinical response at Week 8) on RINVOQ 30 mg vs 6% on placebo at Week 52. The bar chart also provides Bio-IR subgroup analysis data that shows that 20% of patients achieved endoscopic remission on RINVOQ 30 mg vs 3% on placebo at Week 52.
Bar chart shows data from the U-ACTIVATE open-label extension clinical trial, showing as-observed data, with 56% of patients achieving endoscopic remission on RINVOQ 30 mg at Week 100, with a Bio-IR subgroup analysis showing 52% of patients achieving endoscopic remission on RINVOQ 30 mg at Week 100. It also shows 49% of patients achieving endoscopic remission on RINVOQ 30 mg at Week 148, with a Bio-IR subgroup analysis showing 41% of patients achieving endoscopic remission on RINVOQ 30 mg at Week 148. There is also a callout that approximately 95% of Bio-IR patients had TNFi exposure.

†Bio-IR is defined as patients who have an inadequate response to, lose response to, or are intolerant to biologic therapy.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO DISCLOSURE: In an as-observed (AO) analysis, missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug or initiation of concomitant medications. The same patient may not have a response at each timepoint.

See Study Details
See Definition of Endoscopic Remission
See Additional Information: U‑ACTIVATE Open‑Label Extension
Endoscopic image shows a Mayo endoscopy subscore of 0, which is normal.

Endoscopy Subscore=0

See More Subscores

Histo-endoscopic Mucosal Improvement1
(Endoscopic subscore of 0 or 1, without friability and histologic improvement with Geboes score ≤3.1)

*Among patients who achieved clinical response per modified Mayo Score with RINVOQ at Week 8.

WEEK 8
WEEK 52
Bar chart shows data from the U-ACHIEVE Induction clinical trial, showing ranked secondary endpoint of Histo-endoscopic Mucosal Improvement was achieved by 30% of patients on RINVOQ 45 mg, vs 7% on placebo at Week 8, equating to four times as many patients achieving histo-endoscopic mucosal improvement on RINVOQ vs placebo. Bar chart shows data from the U-ACCOMPLISH Induction clinical trial, showing ranked secondary endpoint of Histo-endoscopic Mucosal Improvement was achieved by 37% of patients on RINVOQ 45 mg, vs 6% on placebo at Week 8, equating to six times as many patients achieving histo-endoscopic mucosal improvement on RINVOQ vs placebo.

The relationship between this endpoint to disease progression and long-term outcomes was not evaluated.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

 

See Study Details
See Definition of Histo-endoscopic

Mucosal Improvement
Bar chart reflects data from the U-ACHIEVE Maintenance clinical trial, showing ranked secondary endpoint of Histo-endoscopic Mucosal Improvement was achieved by 35% of patients on RINVOQ 15 mg and 50% of patients on RINVOQ 30 mg vs 12% on placebo at Week 52.

The relationship between this endpoint to disease progression and long-term outcomes was not evaluated.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

 

See Study Details
See Definition of Histo-endoscopic

Mucosal Improvement

Endoscopic Outcomes at Week 81

ENDOSCOPIC IMPROVEMENT
ENDOSCOPIC REMISSION
Bar chart shows data from the U-ACHIEVE Induction clinical trial, showing ranked secondary endpoint of Endoscopic Improvement was achieved by 36% of patients on RINVOQ 45 mg, vs 7% on placebo at Week 8. Bar chart shows data from the U-ACCOMPLISH Induction clinical trial, showing ranked secondary endpoint of Endoscopic Improvement was achieved by 44% of patients on RINVOQ 45 mg, vs 8% on placebo at Week 8.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

 

See Study Details
See Definition of Endoscopic Improvement
Four endoscopic images show changes in mucosal appearance, ranging from Mayo endoscopy subscore of 0, which is normal; 1, which is mild; 2, which is moderate; and 3, which is severe.
Endoscopy Subscores3

Patient baseline characteristics at induction include4:

70% Endoscopic Subscore 3

30% Endoscopic Subscore 2

Bar chart shows data from the U-ACHIEVE Induction clinical trial, showing ranked secondary endpoint of Endoscopic Remission was achieved by 14% of patients on RINVOQ 45 mg, vs 1% on placebo at Week 8. Bar chart shows data from the U-ACCOMPLISH Induction clinical trial, showing ranked secondary endpoint of Endoscopic Remission was achieved by 18% of patients on RINVOQ 45 mg, vs 2% on placebo at Week 8.

RECOMMENDED MAINTENANCE DOSING

The recommended maintenance dosage of RINVOQ is 15 mg once daily. A dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.

 

See Study Details
See Definition of Endoscopic Remission
Four endoscopic images show changes in mucosal appearance, ranging from Mayo endoscopy subscore of 0, which is normal; 1, which is mild; 2, which is moderate; and 3, which is severe.
Endoscopy Subscores3

Patient baseline characteristics at induction include4:

70% Endoscopic Subscore 3

30% Endoscopic Subscore 2

Safety Considerations

Serious Infections: RINVOQ-treated patients are at increased risk of serious bacterial (including tuberculosis [TB]), fungal, viral, and opportunistic infections leading to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.

Mortality: A higher rate of all-cause mortality, including sudden cardiovascular (CV) death, was observed with a Janus kinase inhibitor (JAKi) in a study comparing another JAKi with tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years with ≥1 CV risk factor.

Malignancies: Malignancies have occurred in RINVOQ-treated patients. A higher rate of lymphomas and lung cancer (in current or past smokers) was observed with another JAKi when compared with TNF blockers in RA patients.

Major Adverse Cardiovascular Events: A higher rate of CV death, myocardial infarction, and stroke was observed with a JAKi in a study comparing another JAKi with TNF blockers in RA patients ≥50 years with ≥1 CV risk factor. History of smoking increases risk.

Thrombosis: Deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. A higher rate of thrombosis was observed with another JAKi when compared with TNF blockers in RA patients.

Hypersensitivity: RINVOQ is contraindicated in patients with hypersensitivity to RINVOQ or its excipients.

Other Serious Adverse Reactions: Hypersensitivity Reactions, Gastrointestinal Perforations, Laboratory Abnormalities, and Embryo-Fetal Toxicity.

Learn more about these and the full Important Safety Information below 

Rapid Relief

of Rectal Bleeding and Stool Frequency at Week 2

Clinical Response at Weeks 2, 4, 6, and 85

Composite of Rectal Bleeding and Stool Frequency Subscores

Line graph representing Overall population, pooled induction analysis of data reflecting clinical response at Weeks 2, 4, 6, and 8. A yellow line depicts RINVOQ 45 mg and a grey line represents placebo. Clinical response was achieved by 62% of patients on RINVOQ 45 mg vs 27% on placebo at Week 2. At Week 8, clinical response was achieved by 78% of patients on RINVOQ 45 mg vs 38% of patients on placebo.

CLINICAL RESPONSE AT WEEK 2:

  • U-ACHIEVE Induction: 60% on RINVOQ 45 mg vs 27% on placebo (P<0.001)4 
  • U-ACCOMPLISH Induction: 63% on RINVOQ 45 mg vs 26% on placebo (P<0.001)4

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.

See Study Details
See Definition of Clinical Response

Patient Symptoms Data by Day

RBS
SFS
Urgency

Rectal Bleeding Subscore (RBS) Data by Day6
(Daily Patient Diary Data)

Line graph representing Daily Patient Diary data of patients with rectal bleeding subscore=0. A yellow line depicts RINVOQ 45 mg, and a grey line represents placebo. At Day 1, 22% of patients on RINVOQ 45 mg reported no rectal bleeding vs 15% on placebo. At Day 7, 54% of patients on RINVOQ 45 mg reported no rectal bleeding vs 22% on placebo. At Day 14, 64% of patients on RINVOQ 45 mg reported no rectal bleeding vs 25% on placebo.

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.

  • At Day 1, 22% of patients on RINVOQ 45 mg reported no rectal bleeding vs 15% on placebo6
  • At Week 1, 54% of patients on RINVOQ 45 mg reported no rectal bleeding vs 22% on placebo6

Stool Frequency Subscore (SFS) Data by Day6
(Daily Patient Diary Data)

Patients with a reduction in stool frequency subscore ≤1 point
Post Hoc Analysis: Pooled Induction Data

Line graph representing Daily Patient Diary data of patients with stool frequency subscores day by day. A yellow line depicts RINVOQ 45 mg, and a grey line represents placebo. At Day 1, 21% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 12% on placebo. At Day 7, 43% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 16% on placebo. At Day 14, 53% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 23% on placebo.

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.

  • At Day 1, 21% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 12% on placebo6
  • At Week 1, 43% of patients on RINVOQ 45 mg reported a reduction in stool frequency vs 16% on placebo6

No Bowel Urgency Data by Day6
(Daily Patient Diary Data)

Line graph representing Daily Patient Diary data of patients with no bowel urgency subscores day by day. A yellow line depicts RINVOQ 45 mg, and a grey line represents placebo. At Day 1, 17% of patients on RINVOQ 45 mg reported no bowel urgency vs 13% on placebo. At Day 7, 38% of patients on RINVOQ 45 mg reported no bowel urgency vs 17% on placebo. At Day 14, 47% of patients on RINVOQ 45 mg reported no bowel urgency vs 22% on placebo.

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.

  • At Day 1, 17% of patients on RINVOQ 45 mg reported no bowel urgency vs 13% on placebo6
  • At Week 1, 38% of patients on RINVOQ 45 mg reported no bowel urgency vs 17% on placebo6

Fecal Calprotectin Reduction at Weeks 2 and 87

Line graph representing Median Fecal Calprotectin pooled induction analysis. A yellow line depicts RINVOQ 45 mg, and a grey line represents placebo. At baseline, 573 patients on RINVOQ 45 mg had median fecal calprotectin levels of 1734 mg/kg vs 289 patients on placebo with median fecal calprotectin levels of 1771 mg/kg. At Week 2, 512 patients on RINVOQ 45 mg had median FC levels of 420 mg/kg vs 256 patients on placebo with median fecal calprotectin levels of 1681 mg/kg. At Week 8, 489 patients on RINVOQ 45 mg had median fecal calprotectin levels of 116 mg/kg vs 232 patients on placebo with median fecal calprotectin levels of 1429 mg/kg.

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.

FECAL CALPROTECTIN <150 MG/KG

  • At Week 2, 30% of patients on RINVOQ 45 mg had FC <150 mg/kg compared to 5% on placebo8
  • At Week 8, 46% of patients on RINVOQ 45 mg had FC <150 mg/kg compared to 8% on placebo8
See Study Details

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