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RINVOQ OFFERS RAPID AND LASTING

skin clearance1-3

Significant skin clearance at Week 16 vs placebo, consistent results through to Week 521-3

MONOTHERAPY:

*p<0.001 vs placebo, multiplicity-controlled analysis ITT (NRI-C) at Weeks 2 and 16

NRI-C, non-responder imputation incorporating MI to handle missing data due to COVID-19.

EASI 75 at Week 2 was a ranked secondary endpoint.2,3

Study design: Phase 3, randomized, placebo-controlled study of 847 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 1:1:1 to RINVOQ 15 mg (n=281) or 30 mg (n=285) QD monotherapy, or placebo (n=281). The co-primary endpoints (EASI 75 & vIGA-AD 0/1 at Week 16, ITT [NRI-C]) were met with both doses (p<0.001 vs placebo, multiplicity-controlled analysis).2,3

* p<0.001 vs placebo, multiplicity-controlled analysis

ITT (NRI-C) at Week 16

EASI 90 at Week 16 was a ranked secondary endpoint.2,3

Study design: Phase 3, randomized, placebo-controlled study of 847 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 1:1:1 to RINVOQ 15 mg (n=281) or 30 mg (n=285) QD monotherapy, or placebo (n=281). The co-primary endpoints (EASI 75 & vIGA-AD 0/1 at Week 16, ITT [NRI-C]) were met with both doses (p<0.001 vs placebo, multiplicity-controlled analysis). 2,3

MONOTHERAPY:

*p<0.001 vs placebo, multiplicity-controlled analysis ITT (NRI-C) at Weeks 2 and 16

NRI-C, non-responder imputation incorporating MI to handle missing data due to COVID-19.

EASI 75 at Week 2 was a ranked secondary endpoint.2,3

Study design: Phase 3, randomized, placebo-controlled study of 836 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 1:1:1 to RINVOQ 15 mg (n=276) or 30 mg (n=282) QD monotherapy, or placebo (n=278). The co-primary endpoints (EASI 75 & vIGA-AD 0/1 at Week 16, ITT [NRI-C]) were met with both doses (p<0.001 vs placebo, multiplicity-controlled analysis).2,3

* p<0.001 vs placebo, multiplicity-controlled analysis 

ITT (NRI-C) at Week 16

EASI 90 at Week 16 was a ranked secondary endpoint.2,3

Study design: Phase 3, randomized, placebo-controlled study of 836 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 1:1:1 to RINVOQ 15 mg (n=276) or 30 mg (n=282) QD monotherapy, or placebo (n=278). The co-primary endpoints (EASI 75 & vIGA-AD 0/1 at Week 16, ITT [NRI-C]) were met with both doses (p<0.001 vs placebo, multiplicity-controlled analysis).2,3

MONOTHERAPY:

EASI, Eczema Area and Severity Index; EASI 75/90, ≥ 75/90% reduction in EASI; ITT, intention-to-treat; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; QD, once daily; RCT, randomised controlled trial; TCS, topical corticosteroids; vIGA-AD, validated Investigator's Global Assessment for atopic dermatitis. 

Study design: Integrated analysis of two Phase 3, randomized, placebo-controlled studies of 847 (MEASURE UP 1) and 836 (MEASURE UP 2) adult and adolescent (≥12 years of age) with moderate to severe AD. Patients were randomized 1:1:1 to RINVOQ 15 mg (n= 281 and 276) or 30 mg (n=285 and 282) QD monotherapy, or placebo (n=281 and 278). At Week 16, patients entered a blinded extension with no placebo control and patients were aware they were on treatment but blinded to dose. Co-primary endpoints were EASI 75 & vIGA-AD 0/1 at Week 16, ITT [NRI-C]. 
DATA LIMITATIONS: Data were prespecified nonranked endpoints not controlled for multiplicity. Observed cases (OC): o imputation of missing data; patients missing data at a visit were excluded from the observed analysis for that visit. There is a potential enrichment as patients who are unable to tolerate or do not respond to drug may drop out. Awareness of active treatment may cause bias related to overall treatment effect.

*TCS use was permitted during the blinded extension period (Week 16 to Week 52) and was not counted as rescue therapy.

OBJECTIVE: TO EVALUATE THE EFFICACY AND SAFETY OF RINVOQ MONOTHERAPY FOR THE TREATMENT OF ADOLESCENT
(12 years and older) AND ADULT SUBJECTS WITH MODERATE TO SEVERE AD WHO ARE CANDIDATES FOR SYSTEMIC THERAPY2,3

These studies were only vs placebo and were not designed to compare the RINVOQ 15 mg and 30 mg doses against each other

Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the co-primary and ranked secondary endpoints were handled using NRI-C (non-responder imputation incorporating MI to handle missing data due to COVID-19).

*TCS were permitted during the blinded extension period and were not counted as rescue therapy. 30-day follow up.

AD, atopic dermatitis; BID, twice daily; BL, baseline; EASI, Eczema Area and Severity Index; EASI 75, ≥ 75 reduction in EASI; QD,  once daily; RCT, randomised controlled trial; vIGA-AD, validated Investigator’s Global Assessment for atopic dermatitis.

*30 day follow-up.

12 to 75 yearsa with chronic ADb  AD symptoms ≥3 years

≥10% BSA, EASI ≥16, and IGA ≥3

BL weekly average of daily  worst pruritus NRS ≥4

Inadequate response to TCS or  TCIc within 6 months prior to BL

Topical treatments within  7 days prior to BLd

Systemic therapy for AD or  phototherapye or traditional Chinese  medicinef or any investigational  drugg within 4 weeks prior to BL

Prior exposure to dupilumab  or systemic JAK inhibitors

aBody weight ≥40 kg at BL for subjects ≥12 and <18 yrs; bDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features); cor for patients for whom topical treatments were  otherwise medically inadvisable; dexception of topical emollients; elaser therapy, tanning booth, or extended sun  exposure that could affect disease severity or interfere with disease assessments; fOral or parenteral; gwithin 4  weeks or five half-lives of the drug (whichever is longer) or is currently enrolled in another clinical study.

AD, atopic dermatitis; BL, baseline; BSA, body surface area; EASI, Eczema Activity and Severity Index; IGA, Investigator’s Global Assessment; JAK, Janus kinase; NRS, Numerical Rating Scale; TCI, topical calcineurin inhibitor; TCS, topical corticosteroids.

aNo patients were discontinued for COVID-19 infection or logistical restrictions.

bIncludes protocol-mandated discontinuation because of 25% worsening of EASI and other reasons.

AE: adverse event; COVID-19: coronavirus disease 2019; EASI: Eczema Area and Severity Index.

Based on ITT Population. Calculations are based on non-missing records.

aBased on weekly average.

AD: atopic dermatitis; BMI: body mass index; BSA: body surface area; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; ITT: intent-to-treat for the main study; NRS: Numerical Rating Scale; POEM: Patient-oriented Eczema Measure; vIGA-AD: validated Investigator’s Global Assessment for AD.

RAISE THE BAR IN AD WITH RINVOQ:

Superior efficacy in skin clearance vs dupilumab at Week 161

MONOTHERAPY | HEADS UP1

NRI-C, non-responder imputation incorporating MI to handle missing data due to COVID-19.

AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75/90, ≥ 75/90% reduction in EASI; Q2W, once every 2 weeks; QD, once daily.

Study design: Phase 3b, randomized, active-controlled, double-dummy trial of 692 adult patients with moderate to severe AD. Patients were randomized 1:1 to RINVOQ 30 mg QD + placebo SC Q2W for dupilumab (n=348) or dupilumab 300 mg SC Q2W + placebo QD for RINVOQ (n=344). Patients randomized to the dupilumab 300 mg SC Q2W group received the starting dose of 600 mg at the Baseline visit.

Primary endpoint was EASI 75 at Week 16 and EASI 75 at Week 2 and EASI 90 at Week 16 were ranked secondary endpoints.

Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the primary and ranked secondary endpoints were handled using NRI-C (non-responder imputation incorporating MI to handle missing data due to COVID-19).

*12-week follow up. †Patients randomized to the dupilumab 300 mg SC Q2W group received the starting dose of 600 mg at the Baseline visit.

18 to 75 years with chronic ADa  AD symptoms ≥3 years

≥10% BSA, EASI ≥16, and IGA ≥3

BL weekly average of daily  worst pruritus NRS ≥4

Inadequate response to TCS or  TCIb within 6 months prior to BL

Topical treatments within  7 days prior to BLc

Systemic therapy for AD or  phototherapyd or traditional Chinese  medicinee or any investigational  drugf within 4 weeks prior to BL

Prior exposure to dupilumab  or systemic JAK inhibitors

aDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features);  bor for patients for whom topical treatments were otherwise medically inadvisable; cexception of topical emollients;  dlaser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with  disease assessments; eOral or parenteral; fwithin 4 weeks or five half lives of the drug (whichever is longer) or is  currently enrolled in another clinical study.

AD: atopic dermatitis; BL: baseline; BSA: body surface area; EASI: eczema activity and severity index; IGA: investigator’s global assessment; JAK: Janus kinase; NRS: Numerical Rating Scale; TCI: topical calcineurin inhibitor; TCS: topical corticosteroids.

RINVOQ OFFERS SIGNIFICANT AND RAPID

itch reduction1

INTEGRATED ANALYSIS OF MEASURE UP 1 & 2:1,2

ITCH RELIEF (≥4 POINTS REDUCTION IN WORST PRURITUS NRS)  AS SOON AS DAY 1 & 2

after treatment initiation for RINVOQ 30 mg (8–12%) vs placebo (1–4%) and RINVOQ 15 mg (12–16%) vs placebo (3%), respectively.1-3


p<0.001 vs placebo, multiplicity-controlled analysis ITT (NRI-C)

Itch reduction (≥4 point improvement in Worst Pruritus NRS from baseline assessed in patients with Worst Pruritus NRS ≥4 at baseline)
at Day 1 & 2 for RINVOQ 30 mg and 15 mg, respectively, and at Week 16 for both doses were ranked secondary endpoints.2,3

TCS use was permitted during the blinded extension period (Week 16 to Week 52) and was not counted as rescue therapy.

Itch reduction (≥4 point improvement in Worst Pruritus NRS from baseline assessed in patients with Worst Pruritus NRS ≥4 at baseline) at Day 1 & 2 for RINVOQ 30 mg and 15 mg, respectively, and at Week 16 for both doses were ranked secondary endpoints.1-3

There is a potential enrichment as patients who are unable to tolerate or do not respond to drug may drop out. Awareness of active treatment may cause bias related to overall treatment effect.

DATA LIMITATIONS: Data were prespecified non-ranked endpoints not controlled for multiplicity.

Observed cases (OC): No imputation of missing data; patients missing data at a visit were excluded from the observed analysis for that visit.

OBJECTIVE: TO EVALUATE THE EFFICACY AND SAFETY OF RINVOQ MONOTHERAPY FOR THE TREATMENT OF ADOLESCENT (12 years and older) AND ADULT SUBJECTS WITH MODERATE TO SEVERE AD WHO ARE CANDIDATES FOR SYSTEMIC THERAPY2,3

These studies were only vs placebo and were not designed to compare the RINVOQ 15 mg and 30 mg doses against each other

Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the co-primary and ranked secondary endpoints were handled using NRI-C (non-responder imputation incorporating MI to handle missing data due to COVID-19).

*TCS were permitted during the blinded extension period and were not counted as rescue therapy. 30-day follow up.

AD, atopic dermatitis; BID, twice daily; BL, baseline; EASI, Eczema Area and Severity Index; EASI 75, ≥ 75 reduction in EASI; QD,  once daily; RCT, randomised controlled trial; vIGA-AD, validated Investigator’s Global Assessment for atopic dermatitis.

*30 day follow-up.

18 to 75 years with chronic ADa  AD symptoms ≥3 years

≥10% BSA, EASI ≥16, and IGA ≥3

BL weekly average of daily  worst pruritus NRS ≥4

Inadequate response to TCS or  TCIb within 6 months prior to BL

Topical treatments within  7 days prior to BLc

Systemic therapy for AD or  phototherapyd or traditional Chinese  medicinee or any investigational  drugf within 4 weeks prior to BL

Prior exposure to dupilumab  or systemic JAK inhibitors

aBody weight ≥40 kg at BL for subjects ≥12 and <18 yrs; bDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features); cor for patients for whom topical treatments were  otherwise medically inadvisable; dexception of topical emollients; elaser therapy, tanning booth, or extended sun  exposure that could affect disease severity or interfere with disease assessments; fOral or parenteral; gwithin 4  weeks or five half-lives of the drug (whichever is longer) or is currently enrolled in another clinical study.

AD, atopic dermatitis; BL, baseline; BSA, body surface area; EASI, Eczema Activity and Severity Index; IGA, Investigator’s Global Assessment; JAK, Janus kinase; NRS, Numerical Rating Scale; TCI, topical calcineurin inhibitor; TCS, topical corticosteroids.

aNo patients were discontinued for COVID-19 infection or logistical restrictions.

bIncludes protocol-mandated discontinuation because of 25% worsening of EASI and other reasons.

AE: adverse event; COVID-19: coronavirus disease 2019; EASI: Eczema Area and Severity Index.

Based on ITT Population. Calculations are based on non-missing records.

aBased on weekly average. 

AD: atopic dermatitis; BMI: body mass index; BSA: body surface area; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; ITT: intent-to-treat for the main study; NRS: Numerical Rating Scale; POEM: Patient-oriented Eczema Measure; vIGA-AD: validated Investigator’s Global Assessment for AD.

SUPERIOR AND MORE RAPID
ITCH REDUCTION vs dupilumab4

MONOTHERAPY | HEADS UP:4

Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the primary and ranked secondary endpoints were handled using NRI-C (non-responder imputation incorporating MI to handle missing data due to COVID-19).

*12-week follow up. †Patients randomized to the dupilumab 300 mg SC Q2W group received the starting dose of 600 mg at the Baseline visit.

18 to 75 years with chronic ADa  AD symptoms ≥3 years

≥10% BSA, EASI ≥16, and IGA ≥3

BL weekly average of daily  worst pruritus NRS ≥4

Inadequate response to TCS or  TCIb within 6 months prior to BL

Topical treatments within  7 days prior to BLc

Systemic therapy for AD or  phototherapyd or traditional Chinese  medicinee or any investigational  drugf within 4 weeks prior to BL

Prior exposure to dupilumab  or systemic JAK inhibitors

aDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features);  bor for patients for whom topical treatments were otherwise medically inadvisable; cexception of topical emollients;  dlaser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with  disease assessments; eOral or parenteral; fwithin 4 weeks or five half lives of the drug (whichever is longer) or is  currently enrolled in another clinical study.

AD: atopic dermatitis; BL: baseline; BSA: body surface area; EASI: eczema activity and severity index; IGA: investigator’s global assessment; JAK: Janus kinase; NRS: Numerical Rating Scale; TCI: topical calcineurin inhibitor; TCS: topical corticosteroids.

*p=0.001 vs dupilumab, ITT (MMRN)

Study design: Phase 3b, randomized, active-controlled, double-dummy trial of 692 adult patients with moderate to severe AD. Patients were randomized 1:1 to RINVOQ 30 mg QD + placebo SC Q2W for dupilumab (n=348) or dupilumab 300 mg SC Q2W + placebo QD for RINVOQ (n=344). Primary endpoint was EASI 75 at Week 16. Itch reduction (percent improvement in Worst Pruritus NRS from baseline) vs dupilumab at Weeks 1, 4, and 16 were ranked secondary endpoints.

QUALITY OF LIFE SIGNIFICANTLY IMPROVED
as early as Week 25

Proportion of patients who achieved DLQI improvement ≥4 (ITT population)5

* Nominal p<0.001 vs placebo.

† Multiplicity-controlled endpoint with p<0.001 vs placebo.

Offering 4 in 10 patients a quality of life unaffected by dermatological disease5

42% of patients receiving RINVOQ 30mg (n=261) achieved a DLQI score of 0 or 1 at Week 16, indicating that their lives are unaffected by dermatological disease (vs 4% placebo, n=252, p<0.001). 

Response rate was assessed among subjects with a baseline DLQI ≥4.

DLQI, Dermatology Life Quality Index; ITT, intent-to-treat of main study; MCID, minimal clinically important difference; TCS, topical corticosteroids.

Results from 2 Phase 3 randomised, double-blind, placebo-controlled studies to evaluate RINVOQ in adolescents and adults aged 12 - 75 yrs with moderate to severe  atopic dermatitis (MEASURE UP 1 and 2. Patients received oral study treatment (upadacitinib 30 mg, upadacitinib 15 mg, or placebo) once daily. Coprimary endpoints, EASI 75 and vIGA-AD 0/1 at Week 16 (ITT [NRI-C]), were met with both doses (p<0.001 vs placebo,  multiplicity-controlled analysis). TCS were not permitted up to Week 16. 

* Nominal P<0.001 vs placebo.

Multiplicity-controlled endpoint with P<0.001 vs placebo.* Nominal P<0.001 vs placebo.

Offering 4 in 10 patients a quality of life unaffected by dermatological disease5

40% of patients receiving RINVOQ 30mg (n=256) achieved a DLQI score of 0 or 1 at Week 16, indicating that their lives are unaffected by dermatological disease (vs 5% placebo, n=257, p<0.001). 

Response rate was assessed among subjects with a baseline DLQI ≥4.

DLQI, Dermatology Life Quality Index; ITT, intent-to-treat of main study; MCID, minimal clinically important difference; TCS, topical corticosteroids.

Results from 2 Phase 3 randomised, double-blind, placebo-controlled studies to evaluate RINVOQ in adolescents and adults aged 12 - 75 yrs with moderate to severe  atopic dermatitis (MEASURE UP 1 and 2. Patients received oral study treatment (upadacitinib 30 mg, upadacitinib 15 mg, or placebo) once daily. Coprimary endpoints, EASI 75 and vIGA-AD 0/1 at Week 16 (ITT [NRI-C]), were met with both doses (p<0.001 vs placebo,  multiplicity-controlled analysis). TCS were not permitted up to Week 16. 

OBJECTIVE: TO EVALUATE THE EFFICACY AND SAFETY OF RINVOQ MONOTHERAPY FOR THE TREATMENT OF ADOLESCENT (12 years and older) AND ADULT SUBJECTS WITH MODERATE TO SEVERE AD WHO ARE CANDIDATES FOR SYSTEMIC THERAPY2,3

These studies were only vs placebo and were not designed to compare the RINVOQ 15 mg and 30 mg doses against each other

Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the co-primary and ranked secondary endpoints were handled using NRI-C (non-responder imputation incorporating MI to handle missing data due to COVID-19).

*TCS were permitted during the blinded extension period and were not counted as rescue therapy. 30-day follow up.

AD, atopic dermatitis; BID, twice daily; BL, baseline; EASI, Eczema Area and Severity Index; EASI 75, ≥ 75 reduction in EASI; QD,  once daily; RCT, randomised controlled trial; vIGA-AD, validated Investigator’s Global Assessment for atopic dermatitis.

*30 day follow-up.

18 to 75 years with chronic ADa  AD symptoms ≥3 years

≥10% BSA, EASI ≥16, and IGA ≥3

BL weekly average of daily  worst pruritus NRS ≥4

Inadequate response to TCS or  TCIb within 6 months prior to BL

Topical treatments within  7 days prior to BLc

Systemic therapy for AD or  phototherapyd or traditional Chinese  medicinee or any investigational  drugf within 4 weeks prior to BL

Prior exposure to dupilumab  or systemic JAK inhibitors

aBody weight ≥40 kg at BL for subjects ≥12 and <18 yrs; bDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features); cor for patients for whom topical treatments were  otherwise medically inadvisable; dexception of topical emollients; elaser therapy, tanning booth,
or extended sun  exposure that could affect disease severity or interfere with disease assessments; fOral or parenteral; gwithin 4  weeks or five half-lives of the drug (whichever is longer) or is currently enrolled in another clinical study.

AD, atopic dermatitis; BL, baseline; BSA, body surface area; EASI, Eczema Activity and Severity Index; IGA, Investigator’s Global Assessment; JAK, Janus kinase; NRS, Numerical Rating Scale; TCI, topical calcineurin inhibitor; TCS, topical corticosteroids.

aNo patients were discontinued for COVID-19 infection or logistical restrictions.

bIncludes protocol-mandated discontinuation because of 25% worsening of EASI and other reasons.

AE: adverse event; COVID-19: coronavirus disease 2019; EASI: Eczema Area and Severity Index.

Based on ITT Population. Calculations are based on non-missing records.

aBased on weekly average.

AD: atopic dermatitis; BMI: body mass index; BSA: body surface area; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; ITT: intent-to-treat for the main study; NRS: Numerical Rating Scale; POEM: Patient-oriented Eczema Measure; vIGA-AD: validated Investigator’s Global Assessment for AD.

 

References

  1. AbbVie Data on File. ABVRRTI72028
  2. Guttman-Yassky E, Teixeira H, Simpson E, et al. Safety and efficacy of  upadacitinib monotherapy in adolescents and adults with moderate-to-severe  atopic dermatitis: Results from 2 pivotal, Phase 3, randomised, double-blinded,  placebo-controlled studies (Measure Up 1 and Measure Up 2). Presentation for  the 29th European Academy of Dermatology and Venereology Congress, 31st  October 2020 (virtual).
  3. RINVOQ Summary of Product Characteristics. 2021.
  4. Blauvelt A, Teixeira H, Simpson E, et al. Upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: analysis of the Heads Up Phase 3 trial. Presentation for the 11th Georg Rajka International Symposium on Atopic Dermatitis (ISAD 2021, Hybrid Meeting), April 19–20, 2021.
  5. Eyerich K, Lynde CW, Calimlim BM, et al. Rapid Quality-of-Life Improvement with Upadacitinib with or without Topical Corticosteroids (TCS) in Moderate-to-Severe Atopic Dermatitis: Results from 3 Phase 3 Studies (Measure Up 1, Measure Up 2, and AD Up). Presented at ISAD 2021.

UK-RNQD-210056. Date of preparation: May 2021

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com