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SKIN CLEARANCE DATA
RAPID SKIN CLEARANCE RATES* for RINVOQ 15mg vs placebo as early as Week 21,2
*EASI 75
MEASURE UP 1 MONOTHERAPY STUDY (WEEKS 0-16) - EASI 75
MEASURE UP 2 MONOTHERAPY STUDY (WEEKS 0-16) - EASI 75
The PI recommends initiation of RINVOQ at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI). These data include patients initiated on 30mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
Study design: Phase 3, randomised, placebo-controlled study of 847 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomised 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).1
† p<0.0001 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.
AD: atopic dermatitis; COVID-19: coronavirus disease 2019; EASI 75: ≥75% reduction in Eczema Area and Severity Index; ITT: intention-to-treat; MI: multiple imputation; NRI-C: non-responder imputation incorporating MI to handle missing data due to COVID-19; QD: once daily.
SKIN CLEARANCE RATES* LASTING through week 52 for RINVOQ 15mg1-3
*EASI75
MONOTHERAPY: INTEGRATED ANALYSIS OF MEASURE UP 1 & 2 - EASI 753
Data are as observed. DATA LIMITATIONS: Data were prespecified nonranked endpoints not controlled for multiplicity during the blinded extension period, only. Observed cases (OC): No 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.
The PI recommends initiation of RINVOQ at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI). These data include patients initiated on 30mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
EASI 75: ≥75% reduction in Eczema Area and Severity Index; QD: once daily; RCT: randomised controlled trial; TCS: topical corticosteroid.
SUPERIOR SKIN CLEARANCE* RATES for RINVOQ 15mg vs placebo at Week 16
*EASI 901,2
MEASURE UP 1 MONOTHERAPY STUDY (WEEKS 0-16) - EASI 90
MEASURE UP 2 MONOTHERAPY STUDY (WEEKS 0-16) - EASI 90
SUPERIOR SKIN CLEARANCE* RATES for RINVOQ 15mg vs placebo at Week 161-2
*vIGA-AD 0/1
MEASURE UP 1 MONOTHERAPY STUDY (WEEKS 0-16) - vIGA-AD 0/1
MEASURE UP 2 MONOTHERAPY STUDY (WEEKS 0-16) - vIGA-AD 0/1
The PI recommends initiation of RINVOQ at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI). These data include patients initiated on 30mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
†p<0.0001 vs placebo, multiplicity-controlled analysis ITT (NRI-C); all timepoints.
EASI 90 at Week 16 was a ranked secondary endpoint.
vIGA-AD 0/1 at Week 16 was a co-primary endpoint.
NRI-C, nonresponder imputation incorporating MI to handle missing data due to COVID-19.
EASI 90/100 (90/100% reduction in EASI) are stringent assessment criteria, where EASI 100 is complete skin clearance (EASI score of 0).
vIGA-AD 0/1 responders defined as patients with vIGA-AD 0 or 1 (“clear” or “almost clear”) with a reduction of ≥2 points on a 0–4 ordinal scale.1,2
COVID-19: coronavirus disease 2019; EASI 90: ≥90% reduction in Eczema Area and Severity Index; ITT: intent-to-treat; MI: multiple imputation; NRI-C: non-responder imputation incorporating MI to handle missing data due to COVID-19; QD: once daily; Q2W: every 2 weeks; SC: subcutaneous..
MONOTHERAPY: INTEGRATED ANALYSIS OF MEASURE UP 1 & 2 - EASI 903
Data are as observed. DATA LIMITATIONS: Data were prespecified nonranked endpoints not controlled for multiplicity during the blinded extension period, only. Observed cases (OC): No 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.
The PI recommends initiation of upadacitinib at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI).
These data include patients initiated on 30 mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
AD: atopic dermatitis; COVID-19: coronavirus disease 2019; EASI 90: ≥90% reduction in Eczema Area and Severity Index; ITT: intent-to-treat; MI: multiple imputation; NRI-C: non-responder imputation incorporating MI to handle missing data due to COVID-19; QD: once daily.
ITCH REDUCTION DATA
RAPID* AND LASTING ITCH REDUCTION† RATES for RINVOQ 15mg through Week 52 2,3
*As soon as 2 days after initiation for RINVOQ 15 mg.
†Patients with an improvement in Worst Pruritus NRS ≥4 from baseline
Data are as observed 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.
The PI recommends initiation of RINVOQ at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI). These data include patients initiated on 30mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
§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.1,2 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.
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REFERENCES
- Guttman-Yassky E et al. Lancet 2021;397(10290):2151–2168.
- RINVOQ Approved Product Information.
- Simpson EL et al. Efficacy and Safety of Upadacitinib in Patients With Atopic Dermatitis: Results Through Week 52 From Replicate, Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies: Measure Up 1 and Measure Up 2. Poster presented at the 2021 Dermatology Education Foundation (DEF) Essential Resource Meeting (DERM2021), August 5–8, 2021, Las Vegas NV, USA.
PBS Information
RINVOQ: Authority required. Refer to PBS Schedule for full authority information. This product is not listed on the PBS for the treatment of Crohn’s disease.
Please review the full Product Information (PI) before prescribing, available below.
AU-ABBV-210077. August 2023