For moderate to severe patients 12+ years not adequately controlled with other systemic drugs, including biologics.1

ITCH RELIEF

AND SKIN CLEARANCE RESULTS

HELP YOUR PATIENTS
QUIET THE ITCH AND RASH OF AD

AD=atopic dermatitis.

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

Graph showing patient improvement in WP-NRS ≥ 4 at Week 16. Graph showing patient improvement in WP-NRS ≥ 4 at Week 16. Graph showing patient improvement in WP-NRS ≥ 4 at Week 16.

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

MEASURE UP 1

16%*RINVOQ
15 mg

3% Placebo

MEASURE UP 2

12%*RINVOQ
15 mg

3%Placebo

Week 1

Ranked secondary endpoint

MEASURE UP 1

15%*RINVOQ
15 mg

20%*RINVOQ
30 mg

0%Placebo

MEASURE UP 2

7%*RINVOQ
15 mg

16%*RINVOQ
30 mg

1%Placebo

*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*

Graph showing rates of proportion of patients with improvement in WP-NRS ≥4 at 3 years. Graph showing rates of proportion of patients with improvement in WP-NRS ≥4 at 3 years. Graph showing rates of proportion of patients with improvement in WP-NRS ≥4 at 3 years.

*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*

Graph showing rates of patients achieving WP-NRS 0/1 at Week 16 and 3 years.

*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
Help quiet the itch of AD.

“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

Itch scale.
The baseline mean WP-NRS in clinical trials is 7.3 (moderate–severe). The Week 16 mean WP–NRS is 2.8 for RINVOQ 15 mg and 2.0 for RINVOQ 30 mg (minimal–mild). Week 16 WP­-NRS is 1.0 and the baseline WP-NRS is 8.7.
Hear the itch. Press play to hear the difference in itch scores.

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

Graph showing the proportion of patients achieving EASI 75 and vIGA 0/1 skin clearance at Week 16.

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*

Graph showing rates of proportion of patients achieving EASI 75 at 3 years.

*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

Chart showing itch improvement in worst pruritus NRS ≥4 at Week 16 in the Measure Up 1 and 2 trials.

*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*

Graph showing rates of proportion of patients achieving EASI 90 at 3 years.

*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.

Graph showing difference between baseline, EASI 75, and EASI 90.

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

EASI 75
(Co-primary endpoint)7

PATIENT 1 - PEDIATRIC: LEGS

Pediatric legs before and after.
Pediatric legs before and after.

BASELINE

EASI: 17.2

WEEK 16

EASI: 2.1

PATIENT 2 - ADULT: LEGS

Adult legs before and after.
Adult legs before and after.

BASELINE

EASI: 42

WEEK 16

EASI: 8.4

PATIENT 3 - ADULT: ARM

Adult arm before and after.
Adult arm before and after.

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.

EASI 90
(Ranked secondary endpoint)7

PATIENT 4: BACK

Patient back before and after.
Patient back before and after.

BASELINE

EASI: 43.7

WEEK 16

EASI: 1.6

PATIENT 5: LEFT ARM

Patient left arm before and after.
Patient left arm before and after.

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.

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Interested in what patients experienced with RINVOQ in clinical trials?

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SAFETY RATES

UP TO 5 YEARS9