A ONCE-DAILY ORAL JAK inhibitor indicated for the treatment of adults and pediatric patients 12+ years of age with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.1

SKIN CLEARANCE AND ITCH REDUCTION TO

DISRUPT

THE ITCH AND RASH OF ATOPIC DERMATITIS

Man with atopic dermatitis.
Skin Clearance Data

SKIN CLEARANCE DATA

Proportion of patients achieving EASI 75 skin clearance

Week 16
52-week extension

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)

*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.

MEASURE UP 1
MEASURE UP 2

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

Study details
Footnotes & definitions

Durable skin clearance rates at Week 52 in a blinded extension study5,6*

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.

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; 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.

Study details
Footnotes & definitions

Proportion of patients achieving EASI 90 skin clearance

Week 16
52-week extension

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

Chart showing EASI 90 at Week 16 in the Measure Up 1 trial.
Chart showing EASI 90 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.

MEASURE UP 1
MEASURE UP 2

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

RANKED SECONDARY ENDPOINT1

included percentage of patients achieving EASI 90 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

RANKED SECONDARY ENDPOINT1

included percentage of patients achieving EASI 90 at Week 16

vIGA 0/1 AT WEEK 161,2:

5%Placebo

39%†RINVOQ 15 mg

52%†RINVOQ 30 mg

Study details
Footnotes & definitions

Durable skin clearance rates at Week 52 in a blinded extension study5,6*

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.

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.

Study details
Footnotes & definitions

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 clinical trials. 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.

Study details

ITCH RELIEF DATA

Proportion of patients with improvement in worst pruritus NRS ≥4

Week 16
52-week extension

Rapid, controlled itch relief 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 1 trial. 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. Chart showing itch relief at Week 16 in the Measure Up 2 trial. Chart showing itch relief at Week 16 in the Measure Up 2 trial.
  Placebo (n=272)
  RINVOQ 15 mg (n=274)
  RINVOQ 30 mg (n=280)

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

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

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

MEASURE UP 1
MEASURE UP 2

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

RANKED SECONDARY ENDPOINT2

RESPONSES OBSERVED AS EARLY AS

2 DAYSafter 1st dose:

16%†RINVOQ 15 mg (n=275)

3%Placebo (n=270)

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

RANKED SECONDARY ENDPOINT2

RESPONSES OBSERVED AS EARLY AS

2 DAYSafter 1st dose:

12%†RINVOQ 15 mg (n=269)

3%Placebo (n=267)

Study details
Footnotes & definitions

Durable rates of itch relief at Week 52 in a blinded extension study5,6*

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.

Study details
Footnotes & definitions

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

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SAFETY RATES

UP TO 3 YEARS7,8

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