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

SKIN CLEARANCE AND ITCH REDUCTION TO

DISRUPT

THE ITCH AND RASH OF ATOPIC DERMATITIS

Man with atopic dermatitis.

SKIN CLEARANCE DATA

Proportion of patients achieving EASI 75 skin clearance

Rapid, controlled skin clearance at Week 161,2*

Chart showing EASI 75 at Week 16 in the Measure Up 1 trial.
Chart showing EASI 75 at Week 16 in the Measure Up 2 trial.
  Placebo (n=281)
  RINVOQ 15 mg (n=281)
  RINVOQ 30 mg (n=285)

Response observed as early as 2 WEEKS2

Ranked secondary endpoint

MEASURE UP 1

38%RINVOQ 15 mg

47%RINVOQ 30 mg

4%Placebo

*Monotherapy results. †p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

  Placebo (n=278)
  RINVOQ 15 mg (n=276)
  RINVOQ 30 mg (n=282)

Response observed as early as 2 WEEKS2

Ranked secondary endpoint

MEASURE UP 2

33%RINVOQ 15 mg

44%RINVOQ 30 mg

4%Placebo

*Monotherapy results. †p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

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

vIGA 0/1 at Week 161,2:

8%Placebo

48%RINVOQ 15 mg

62%RINVOQ 30 mg

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

vIGA 0/1 at Week 161,2:

5%Placebo

39%RINVOQ 15 mg

52%RINVOQ 30 mg

Response observed as early as 2 WEEKS2

Ranked secondary endpoint

MEASURE UP 1

38%RINVOQ 15 mg

47%RINVOQ 30 mg

4%Placebo

*Monotherapy results. †p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

Response observed as early as 2 WEEKS2

Ranked secondary endpoint

MEASURE UP 2

33%RINVOQ 15 mg

44%RINVOQ 30 mg

4%Placebo

*Monotherapy results. †p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

Durable skin clearance rates at Week 52 in a blinded extension study7,9,10*

INTEGRATED RESULTS FROM MEASURE UP 1 AND 2;
ALL DATA ARE OBSERVED CASES

Chart showing EASI 75 skin clearance at Week 52 with RINVOQ® in a blinded to dose extension study.
  Placebo
  RINVOQ 15 mg
  RINVOQ 30 mg

*Monotherapy results. 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 Week 52 were prespecified, non-ranked endpoints, not controlled for multiplicity; results cannot be considered statistically significant.

OLE LIMITATIONS: There is potential for enrichment of OLE data, as those who remain in the study are aware of their treatment and generally fare better than those who discontinue. Patients may have used topical medications.

Proportion of patients achieving EASI 90 skin clearance

Robust EASI 90 skin clearance measured at Week 161,2*

Chart showing itch relief at Week 16 in the Measure Up 1 trial.
Chart showing itch relief at Week 16 in the Measure Up 2 trial.
  Placebo (n=281)
  RINVOQ 15 mg (n=281)
  RINVOQ 30 mg (n=285)

*Monotherapy results. p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

  Placebo (n=278)
  RINVOQ 15 mg (n=276)
  RINVOQ 30 mg (n=282)

*Monotherapy results. p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

RANKED SECONDARY ENDPOINT1

Percentage of patients achieving EASI 90 at Week 16

RANKED SECONDARY ENDPOINT1

percentage of patients achieving EASI 90 at Week 16

Durable skin clearance rates at Week 52 in a blinded extension study7,9,10*

INTEGRATED RESULTS FROM MEASURE UP 1 AND 2;
ALL DATA ARE OBSERVED CASES

Chart showing EASI 90 skin clearance at Week 52 with RINVOQ® in a blinded to dose extension study.
  Placebo
  RINVOQ 15 mg
  RINVOQ 30 mg

*Monotherapy results. 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 Week 52 were prespecified, non-ranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant.

OLE LIMITATIONS: There is potential for enrichment of OLE data, as those who remain in the study are aware of their treatment and generally fare better than those who discontinue. Patients may have used topical medications.

Visible results at Week 16 with RINVOQ3

EASI 75
(Co-primary endpoint)1

Patient 1: Legs

Legs after the treatment at 16 weeks.
Legs before the treatment.

BASELINE

EASI: 42

WEEK 16

EASI: 8.4

Patient 2: Right arm

Arms after the treatment at 16 weeks.
Arms before the treatment.

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)2

Patient 3: Back

Back after the treatment at 16 weeks.
Back before the treatment.

BASELINE

EASI: 43.7

WEEK 16

EASI: 1.6

Patient 3: Left arm

Arms after the treatment at 16 weeks.
Arms before the treatment.

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.

Itch Relief Data

Proportion of patients with improvement in worst pruritus NRS ≥4

Rapid, controlled itch relief at
Week 161,2*

Chart showing itch improvement in worst pruiritus NRS ≥4 at Week 16 in the Measure Up 1 trial. Chart showing itch improvement in worst pruiritus NRS ≥4 at Week 16 in the Measure Up 1 trial. Chart showing itch improvement in worst pruiritus NRS ≥4 at Week 16 in the Measure Up 1 trial.
Chart showing itch improvement in worst pruiritus NRS ≥4 at Week 16 in the Measure Up 2 trial. Chart showing itch improvement in worst pruiritus NRS ≥4 at Week 16 in the Measure Up 2 trial. Chart showing itch improvement in worst pruiritus NRS ≥4 at Week 16 in the Measure Up 2 trial.
  Placebo (n=272)
  RINVOQ 15 mg (n=274)
  RINVOQ 30 mg (n=280)

Response as early as 2 DAYS after 1st dose2

Ranked secondary endpoint

MEASURE UP 1

16%RINVOQ 15 mg (n=275)

3%Placebo (n=270)

*Monotherapy results. p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

  Placebo (n=274)
  RINVOQ 15 mg (n=270)
  RINVOQ 30 mg (n=280)

Response observed as early as 2 DAYS after 1st dose2

Ranked secondary endpoint

MEASURE UP 2

12%RINVOQ 15 mg (n=269)

3%Placebo (n=267)

*Monotherapy results. p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

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

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

Response as early as 2 DAYS after 1st dose2

Ranked secondary endpoint

MEASURE UP 1

16%RINVOQ 15 mg (n=275)

3%Placebo (n=270)

*Monotherapy results. p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

Response observed as early as 2 DAYS after 1st dose2

Ranked secondary endpoint

MEASURE UP 2

12%RINVOQ 15 mg (n=269)

3%Placebo (n=267)

*Monotherapy results. p≤0.001; RINVOQ vs placebo. NRI-C; ITT.

Durable rates of itch relief at Week 52 in a blinded extension study7,9,10*

INTEGRATED RESULTS FROM MEASURE UP 1 AND 2;
ALL DATA ARE OBSERVED CASES

Chart showing itch relief at Week 52 in a blinded to dose extension study. Chart showing itch relief at Week 52 in a blinded to dose extension study. Chart showing itch relief at Week 52 in a blinded to dose extension study.
  Placebo
  RINVOQ 15 mg
  RINVOQ 30 mg

*Monotherapy results. 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 Week 52 were prespecified, non-ranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant.

OLE LIMITATIONS: There is potential for enrichment of OLE data, as those who remain in the study are aware of their treatment and generally fare better than those who discontinue. Patients may have used topical medications.

Proportion of patients achieving no-to-little itch worst pruritus NRS 0/1

Rates of worst pruritus NRS 0/1 at Week 164*

Chart showing the proportion of patients in MEASURE UP 1 achieving worst pruritus NRS 0/1 at Week 16.
Chart showing the proportion of patients in MEASURE UP 2 achieving worst pruritus NRS 0/1 at Week 16.
  Placebo (n=275)
  RINVOQ 15 mg (n=279)
  RINVOQ 30 mg (n=282)

*Monotherapy results. NRI-C; ITT.

n=number of patients whose baseline WP-NRS is >1.

  Placebo (n=277)
  RINVOQ 15 mg (n=275)
  RINVOQ 30 mg (n=281)

*Monotherapy results. NRI-C; ITT.

n=number of patients whose baseline WP-NRS is >1.

DATA LIMITATIONS4: Worst pruritus NRS 0/1 was a prespecified, non-ranked additional endpoint and was not controlled for multiplicity; thus, observed differences cannot be regarded as statistically significant.

Worst pruritus NRS 0/1 captured daily through Week 16 and averaged for prior week.

DATA LIMITATIONS4: Worst pruritus NRS 0/1 was a prespecified, non-ranked additional endpoint and was not controlled for multiplicity; thus, observed differences cannot be regarded as statistically significant.

Worst pruritus NRS 0/1 captured daily through Week 16 and averaged for prior week.

*Monotherapy results. NRI-C; ITT.

n=number of patients whose baseline WP-NRS is >1.

Rates of worst pruritus NRS 0/1 observed at Week 52*

INTEGRATED RESULTS FROM MEASURE UP 1 AND 29,11
ALL DATA ARE OBSERVED CASES

INTEGRATED RESULTS FROM MEASURE UP 1 AND 29,11

ALL DATA ARE OBSERVED CASES

Chart showing the rates of worst pruritus NRS 0/1 observed at Week 52.
  Placebo
  RINVOQ 15 mg
  RINVOQ 30 mg

*Monotherapy results. 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.

DATA LIMITATIONS: Worst pruritus NRS 0/1 data at Week 16 and through Week 52 were prespecified, non-ranked endpoints and not controlled for multiplicity; thus, results cannot be considered statistically significant.

OLE LIMITATIONS: There is potential for enrichment of OLE data, as those who remain in the study are aware of their treatment and generally fare better than those who discontinue. Patients may have used topical medications.

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
INTEGRATED ANALYSIS OF MEASURE UP 1 AND 2

Chart showing a scale from severe itch (6.5‐ 10) to absent (0). The baseline mean WPNRS 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).

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.


ITCH RELIEF AT WEEK 16 IN A MEASURE UP PATIENT3

BASELINE

Image showing baseline atopic dermatitis on a patient's back. EASI: 43.7. WP‐NRS 8.7.

WEEK 16

Image showing Week 16 skin clearance and itch relief on a patient's back. EASI: 1.6. WP‐ NRS 1.0.

Actual MEASURE UP patient treated with RINVOQ 15 mg in a clinical trial. Individual results may vary.

Rates of worst pruritus NRS 0/1 observed at Week 164

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