HELP YOUR PATIENTS
QUIET THE ITCH AND RASH OF AD
RINVOQ vs
DUPIXENT® (dupilumab)
HEAD-TO-HEAD
Explore head-to-head data of RINVOQ vs DUPIXENT
For moderate to severe patients 12+ years not adequately controlled with other systemic drugs, including biologics.1
ITCH RELIEF
AND SKIN CLEARANCE RESULTS
RAPID & DURABLE RATES OF ITCH RELIEF
Rapid itch relief in 4x more patients vs placebo at Week 16
Proportion of patients with improvement in WP-NRS ≥4 at Week 161,2
MONOTHERAPY RESULTS; RANKED SECONDARY ENDPOINT
RECOMMENDED DOSAGE IN AD1:
- 30 mg is not an approved starting dose
- For 12 to <65 years: Initiate with 15 mg once daily. If an adequate response is not achieved, consider increasing dosage to 30 mg once daily. Discontinue if an adequate response is not achieved with 30 mg dose. Use the lowest effective dose needed to maintain response
- For 65+ years: Recommended dosage is 15 mg once daily
THE CO-PRIMARY ENDPOINTS1
were the percentage of patients achieving EASI 75 and a vIGA score of 0/1 at Week 16
Response as early as 2 DAYS after 1st dose2
Ranked secondary endpoint
Week 1
Ranked secondary endpoint
*p≤0.001; RINVOQ vs placebo. NRI-C; ITT.
Durable itch relief rates at ~3 years in a blinded extension study
Proportion of patients with improvement in WP-NRS ≥4 at ~3 years3,5,6
INTEGRATED MONOTHERAPY RESULTS FROM MEASURE UP 1 AND 2; ALL DATA ARE OBSERVED CASES*
*OC; ITT. Data are a sub-analysis of the MEASURE UP blinded extension data including only patients who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.
RECOMMENDED DOSAGE IN AD1:
- 30 mg is not an approved starting dose
- For 12 to <65 years: Initiate with 15 mg once daily. If an adequate response is not achieved, consider increasing dosage to 30 mg once daily. Discontinue if an adequate response is not achieved with 30 mg dose. Use the lowest effective dose needed to maintain response
- For 65+ years: Recommended dosage is 15 mg once daily
DATA LIMITATIONS: Data through ~3 years were prespecified, non-ranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant.
BE LIMITATIONS: There is potential for enrichment of BE data; awareness of active treatment may cause bias related to overall treatment effect. Topicals, if used, were no longer considered rescue.
No to little itch (WP-NRS 0/1) rates observed up to ~3 years
Proportion of patients achieving WP-NRS 0/1 at Week 16 and ~3 years3,4
INTEGRATED MONOTHERAPY RESULTS FROM MEASURE UP 1 AND 2; ALL DATA ARE OBSERVED CASES*
*OC. A sub-analysis of the MEASURE UP blinded extension data including only patients who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.
†n=number of patients whose baseline WP-NRS is >1.
RECOMMENDED DOSAGE IN AD1:
- 30 mg is not an approved starting dose
- For 12 to <65 years: Initiate with 15 mg once daily. If an adequate response is not achieved, consider increasing dosage to 30 mg once daily. Discontinue if an adequate response is not achieved with 30 mg dose. Use the lowest effective dose needed to maintain response
- For 65+ years: Recommended dosage is 15 mg once daily
DATA LIMITATIONS: Data through ~3 years were prespecified, non-ranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant.
WP-NRS 0/1 captured daily through Week 16 and averaged for prior week.4
BE LIMITATIONS: There is potential for enrichment of BE data; awareness of active treatment may cause bias related to overall treatment effect. Topicals, if used, were no longer considered rescue.
RECOMMENDED DOSAGE IN AD1:
- 30 mg is not an approved starting dose
- For 12 to <65 years: Initiate with 15 mg once daily. If an adequate response is not achieved, consider increasing dosage to 30 mg once daily. Discontinue if an adequate response is not achieved with 30 mg dose. Use the lowest effective dose needed to maintain response
- For 65+ years: Recommended dosage is 15 mg once daily
“Imagine the itching feeling of having mosquito bites scattered across your body, sometimes itching for hours a day, for years. All of a sudden, we can appreciate how unrelenting moderate to severe AD can be.”
Dr. Silverberg, MD, PhD, MPH
MEASURING ITCH IMPROVEMENT1,2,5-7
PATIENTS ON RINVOQ ACHIEVED AN IMPROVEMENT IN ITCH AS MEASURED BY A ≥4-POINT REDUCTION IN WP-NRS AT WEEK 16 IN MEASURE UP 1 AND 2
Play sound for itch score of 1
Play sound for itch score of 3
Play sound for itch score of 7
Play sound for itch score of 9
Actual MEASURE UP patient treated with RINVOQ in a clinical trial. The typical RINVOQ patient achieved a 4-point improvement in WP-NRS score from baseline. Individual results may vary. The Worst Pruritus Numerical Rating Scale (WP-NRS) is a validated tool for measurement of itch intensity.
Inclusion criteria for RINVOQ phase 3 clinical trials included moderate to severe atopic dermatitis, defined by EASI ≥16, vIGA ≥3, BSA ≥10%, and WP-NRS ≥4.2
A patient with baseline score of 7 would need a score of 3 or lower to achieve improvement in WP-NRS ≥4.
RAPID & DURABLE RATES OF SKIN CLEARANCE
Rapid skin clearance in 4-7x more patients vs placebo at Week 16
Proportion of patients achieving EASI 75 and vIGA 0/1 at Week 161,2
MONOTHERAPY RESULTS; CO-PRIMARY ENDPOINTS
RECOMMENDED DOSAGE IN AD1:
- 30 mg is not an approved starting dose
- For 12 to <65 years: Initiate with 15 mg once daily. If an adequate response is not achieved, consider increasing dosage to 30 mg once daily. Discontinue if an adequate response is not achieved with 30 mg dose. Use the lowest effective dose needed to maintain response
- For 65+ years: Recommended dosage is 15 mg once daily
EASI 75 response observed as early as 2 WEEKS2
Ranked secondary endpoint
MEASURE UP 1
38%*RINVOQ 15 mg
47%*RINVOQ 30 mg
4%Placebo
MEASURE UP 2
33%*RINVOQ 15 mg
44%*RINVOQ 30 mg
4%Placebo
*p≤0.001; RINVOQ vs placebo. NRI-C; ITT.
THE CO-PRIMARY ENDPOINTS1
were the percentage of patients achieving EASI 75 and a vIGA score of 0/1 at Week 16
Durable skin clearance rates at ~3 years in a blinded extension study
Proportion of patients achieving EASI 75 at ~3 years3,5
INTEGRATED MONOTHERAPY RESULTS FROM MEASURE UP 1 AND 2; ALL DATA ARE OBSERVED CASES*
*OC; ITT. Data are a sub-analysis of the MEASURE UP blinded extension data including only patients who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.
RECOMMENDED DOSAGE IN AD1:
- 30 mg is not an approved starting dose
- For 12 to <65 years: Initiate with 15 mg once daily. If an adequate response is not achieved, consider increasing dosage to 30 mg once daily. Discontinue if an adequate response is not achieved with 30 mg dose. Use the lowest effective dose needed to maintain response
- For 65+ years: Recommended dosage is 15 mg once daily
DATA LIMITATIONS: Data through ~3 years were prespecified, non-ranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant.
BE LIMITATIONS: There is potential for enrichment of BE data; awareness of active treatment may cause bias related to overall treatment effect. Topicals, if used, were no longer considered rescue.
Robust 90% skin clearance
Proportion of patients achieving robust EASI 90 skin clearance at Week 161,2*
MONOTHERAPY RESULTS; RANKED SECONDARY ENDPOINT
*p≤0.001; RINVOQ vs placebo. NRI-C; ITT.
RANKED SECONDARY ENDPOINT1:
Percentage of patients achieving EASI 90 at Week 16
Robust 90% skin clearance rates at ~3 years in a blinded extension study
Proportion of patients achieving EASI 90 at ~3 years3,5
INTEGRATED MONOTHERAPY RESULTS FROM MEASURE UP 1 AND 2;
ALL DATA ARE OBSERVED CASES*
*OC; ITT. Data are a sub-analysis of the MEASURE UP blinded extension data including only patients who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.
DATA LIMITATIONS: Data through ~3 years were prespecified, non-ranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant.
BE LIMITATIONS: There is potential for enrichment of BE data; awareness of active treatment may cause bias related to overall treatment effect. Topicals, if used, were no longer considered rescue.
What might 90% skin clearance look like for your patients?2,8
For illustrative purposes only (computer-generated image). EASI improvements shown here are a representation of a hypothetical patient.
Inclusion criteria for RINVOQ® (upadacitinib) phase 3 clinical trials included active moderate to severe AD, defined by EASI ≥16, vIGA ≥3, BSA ≥10% and WP-NRS ≥4.
SKIN CLEARANCE RESULTS IN REAL PATIENTS
Visible skin clearance on legs, arms, and back at Week 167
PATIENT 1 - PEDIATRIC: LEGS
BASELINE
EASI: 17.2
WEEK 16
EASI: 2.1
PATIENT 2 - ADULT: LEGS
BASELINE
EASI: 42
WEEK 16
EASI: 8.4
PATIENT 3 - ADULT: ARM
BASELINE
EASI: 21.4
WEEK 16
EASI: 4.4
Actual MEASURE UP patients treated with RINVOQ (15 mg) in a clinical trial. Individual results may vary.
PATIENT 4: BACK
BASELINE
EASI: 43.7
WEEK 16
EASI: 1.6
PATIENT 5: LEFT ARM
BASELINE
EASI: 43.7
WEEK 16
EASI: 1.6
Actual MEASURE UP patient treated with RINVOQ (15 mg) in a clinical trial. Individual results may vary.
EASI=Eczema Area and Severity Index.
EASI 75=improvement of at least 75% in lesion extent and severity.
EASI 90=improvement of at least 90% in lesion extent and severity.
When I had uncontrolled AD, I was disrupted by the itch. I wasn't fully present in my workouts.
HELEN
—Real RINVOQ patient
Many patients achieved an improvement in worst pruritus NRS ≥4 at Week 16.
