For moderate to severe Crohn's disease (CD) in adult TNFi-IR patients.1
For moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients.1
YOUR PATIENTS
CAN FEEL AND
YOU CAN SEE
RAPID
SYMPTOM
RELIEF1
Clinical response* achieved at Week 2.
DURABLE
CLINICAL
REMISSION1
Clinical remission† achieved at Weeks 12 and 52. Steroid-free clinical remission‡ achieved at Week 52.
SIGNIFICANT
ENDOSCOPIC
CONTROL1
Visible mucosal improvement with endoscopic response§ and endoscopic remission|| endpoints achieved at Weeks 12 and 52.
*Clinical response was defined as a reduction of CDAI ≥100 points from baseline.
†Clinical remission was defined as CDAI <150 points.
‡Steroid-free clinical remission at Week 52 was defined as no corticosteroid use for CD ≥90 days prior to Week 52 and achievement of CDAI clinical remission (among the subset of patients who were on steroids at induction baseline).
§Endoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
||Endoscopic remission was defined as SES-CD ≤4 and no subscore >1 in any individual variable, as scored by a central reviewer.
CD=Crohn's disease; CDAI=Crohn's disease activity index; IR=intolerance or inadequate response; SES-CD=simple endoscopic score for Crohn's disease; TNFi=tumor necrosis factor inhibitor
CO-PRIMARY ENDPOINTS
In Crohn's, RINVOQ achieved its co-primary endpoints of Clincal Remission & Endoscopic Response at Weeks 12 and 521
The STRIDE-II Recommendations include
Endoscopic Response as a short-term
goal
and Clinical Remission as an
intermediate-term goal in CD2
RINVOQ is indicated for TNFi-IR patients.
All P-values are RINVOQ treatment arms vs. placebo.
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg 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.
*Clinical remission was defined as CDAI <150 points.
†Endoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
‡The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
§Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
U-EXCEL Induction & U-EXCEED Induction Study Design Intro:1 12-week, double-blind, placebo-controlled Phase 3 induction studies that evaluated the efficacy and safety of RINVOQ in 857 adult patients (419 patients for U-EXCEED and 438 patients for U-EXCEL) with moderately to severely active Crohn's disease who demonstrated prior failure to biologic treatment (U-EXCEED) or prior failure to conventional and/or biologic treatment (U-EXCEL). Patients were randomized to receive RINVOQ 45 mg or placebo once daily for 12 weeks. The co-primary endpoints were the proportion of patients who achieved clinical remission (by CDAI) and endoscopic response (by SES-CD) at Week 12.
U-ENDURE Maintenance Study Design Intro:1 52-week, double-blind, placebo-controlled Phase 3 maintenance study of 343 adult patients with moderately to severely active Crohn’s disease who achieved clinical response (decrease in CDAI ≥100 points from baseline from RINVOQ induction) in the U-EXCEL and U-EXCEED studies. Patients were re-randomized to receive a maintenance regimen of either RINVOQ 15 mg, RINVOQ 30 mg or placebo once daily for 52 weeks. The co-primary endpoints were the proportion of patients who achieved clinical remission (by CDAI) and endoscopic response (by SES-CD) at Week 52.
CDAI=Crohn's disease activity index; SES-CD=simple endoscopic score for Crohn's disease
RAPID SYMPTOM RELIEF
AT WEEK 2
The STRIDE-II Recommendations include
Clinical Response as a short-term goal in CD2
Clinical Response (CDAI CR-100) at Weeks 2 and 123
RINVOQ is indicated for TNFi-IR patients
All P-values are RINVOQ treatment arms vs. placebo.
DATA LIMITATIONS: Data labeled as a ranked secondary endpoint were multiplicity controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
*The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
†Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
DURABLE CLINICAL REMISSION
The STRIDE-II Recommendations include
Clinical Remission as an intermediate-term
goal in CD2
Clinical Remission at Week 12 and at Week 521
WEEK 12
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg 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.
*Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
†The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
DURABLE STEROID-FREE CLINICAL REMISSION
Among patients who were on corticosteroids at induction baseline1
WEEK 12
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg 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.
SIGNIFICANT ENDOSCOPIC CONTROL
VISIBLE MUCOSAL IMPROVEMENT
The STRIDE-II Recommendations include
Endoscopic Response as a short-term
goal in CD2
Endoscopic Response at Weeks 12 and 521
WEEK 12
WEEK 12
RINVOQ is indicated for TNFi-IR patients
All P-values are RINVOQ treatment arms vs. placebo.
WEEK 12
RINVOQ is indicated for TNFi-IR patients
All P-values are RINVOQ treatment arms vs. placebo.
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg 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.
†Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
‡The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
REAL PATIENT CASE: CLINICAL TRIAL4
REAL PATIENT
CASE:
CLINICAL TRIAL4
Sex: Female | Age: 40s | Disease Duration: 2.9 Years |
Severe Crohn's, Prior TNFi-IR
Patient received RINVOQ 45 mg QD (induction) and RINVOQ 30 mg QD (maintenance)
All P-values are RINVOQ treatment arms vs. placebo.
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg 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.
IMAGES ARE FROM A CLINICAL TRIAL PATIENT TREATED WITH RINVOQ. INDIVIDUAL RESULTS MAY VARY.
CDAI clinical remission is defined as CDAI score <150.
Endoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
Endoscopic remission was defined as SES-CD ≤4 and no subscore >1 in any individual variable, as scored by a central reviewer.
*Patient did not meet endoscopic remission due to a subscore >1 in an individual variable of SES-CD measure
QD=once daily
Sex: Male | Age: 30s | Disease Duration: 28.8 Years |
Severe Crohn's, Prior TNFi-IR
Patient received RINVOQ 45 mg QD (induction) and RINVOQ 15 mg QD (maintenance)
In the U-EXCEED induction study, 19% (N=273) on RINVOQ 45 mg versus 3% (N=146) on placebo achieved endoscopic remission at Week 12 (P<0.001).1
In the U-ENDURE maintenance study, 16% (N=113) on RINVOQ 15 mg versus 4% (N=111) on placebo achieved clinical and endoscopic remission at Week 52 (P<0.001). Among bio-failure patients, 13% (N=85) on RINVOQ 15 mg versus 2% (N=87) on placebo had clinical and endoscopic remission at Week 52.1
All P-values are RINVOQ treatment arms vs. placebo.
IMAGES ARE FROM A CLINICAL TRIAL PATIENT TREATED WITH RINVOQ. INDIVIDUAL RESULTS MAY VARY.
CDAI clinical remission is defined as CDAI score <150.
Endoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
Endoscopic remission was defined as SES-CD ≤4 and no subscore >1 in any individual variable, as scored by a central reviewer.
QD=once daily
The STRIDE-II Recommendations include
Endoscopic Remission* as a long-term
goal in CD2
Endoscopic Remission at Weeks 12 and 52 (Ranked Secondary Endpoint)1
WEEK 12
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg 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.
*In the STRIDE-II guidelines, endoscopic remission was defined as SES-CD ≤2 points and a lack of ulcerations (e.g. SES-CD ulceration subscore = 0). In the RINVOQ CD clinical trials, endoscopic remission was defined as SES-CD ≤4 and no subscore >1 in any individual variable, as scored by a central reviewer.
†Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
‡The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
FECAL CALPROTECTIN POST-HOC
DATA AT WEEKS 12 AND 52
Median fecal calprotectin from baseline to Weeks 12 and 523
RINVOQ is indicated for TNFi-IR patients
DATA LIMITATIONS: Median fecal calprotectin at all time points presented were based on post-hoc analyses. These analyses were not adjusted for multiplicity thus no statistical inferences can be made.
Fecal calprotectin is not validated as a biomarker to monitor disease progression.
*The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
†Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
RINVOQ is indicated for TNFi-IR patients
DATA LIMITATIONS: Median fecal calprotectin at all time points presented were based on post-hoc analyses. These analyses were not adjusted for multiplicity thus no statistical inferences can be made.
Fecal calprotectin is not validated as a biomarker to monitor disease progression.
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg 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.
*The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
†Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
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ONE PILL. ONCE A DAY.
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