For active psoriatic arthritis (PsA) in adult TNFi-IR patients1

Noticeably
clearer skin

As measured by PASI75 for RINVOQ vs placebo at Week 16a,b

RINVOQ is not indicated for the treatment of plaque psoriasis1

IR=intolerance or inadequate response; PASI=psoriasis area and severity index; PASI75=at least 75% improvement in PASI score from baseline; TNFi=tumor necrosis factor inhibitor

Clinical Trial Overview

Clinical Trial Overview

Clinical Trial Overview

SELECT-PsA 2 Clinical Trial Overview

*P<0.001 for RINVOQ vs placebo3

SELECT-PsA 2 Study Design Intro:1

24-week, double-blind, placebo-controlled study of 642 adult patients with moderately to severely active PsA who had an inadequate response or intolerance to at least one biologic DMARD. Patients were randomized to receive upadacitinib or placebo. The primary endpoint was proportion of patients achieving ACR20 response at Week 12 vs placebo.

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 of the 5 other core criteria, including patient and physician global assessments, health assessment questionnaire — disability index (HAQ-DI), pain assessment, and high‑sensitivity C‑reactive protein (hs‑CRP); bDMARD=biologic disease-modifying antirheumatic drug; DMARD=disease‑modifying antirheumatic drug; IR=intolerance or inadequate response; NRI=non-responder imputation; PsA=psoriatic arthritis; QD=once per day; TNFi=tumor necrosis factor inhibitor

Noticeably CLEARER SKIN
As measured by PASI75 RINVOQ vs placebo at Week 16a,b

SELECT-PsA 2 (biologic DMARD-IR): PASI752,3

RINVOQ is indicated for TNFi-IR patients

SELECT-PsA 2 (biologic DMARD-IR): PASI752,3

RINVOQ is indicated for
TNFi-IR patients

SELECT-PsA 1 (non‑bDMARD‑IR): PASI75

*P<0.001 for RINVOQ vs placebo3

aPASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.2,3
bAfter Week 16, the use of concomitant treatments for psoriasis was permitted.2,3

Durable PASI75
response rates observed at Week 56

RINVOQ is not indicated for the treatment of plaque psoriasis.1

DATA LIMITATIONS: Data labeled as a ranked secondary endpoint were multiplicity controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

PASI90 Response Rates
With data up to ~1 yeara,b

SELECT-PsA 2 (biologic DMARD-IR): PASI902,3

RINVOQ is indicated for TNFi-IR patients

SELECT-PsA 2 (biologic DMARD-IR): PASI902,3

RINVOQ is indicated for
TNFi-IR patients

SELECT-PsA 1 (non‑bDMARD‑IR): PASI90

aPASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.2,3
bAfter Week 16, the use of concomitant treatments for psoriasis was permitted.2,3

 

RINVOQ is not indicated for the treatment of plaque psoriasis.1

DATA LIMITATIONS: PASI90 data for all comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

PASI100 Response Rates
With data up to ~1 yeara,b

SELECT-PsA 2 (biologic DMARD-IR): PASI1002,3

RINVOQ is indicated for TNFi-IR patients

SELECT-PsA 2 (biologic DMARD-IR): PASI1002,3

RINVOQ is indicated for
TNFi-IR patients

SELECT-PsA 1 (non‑bDMARD‑IR): PASI100

aPASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.2,3
bAfter Week 16, the use of concomitant treatments for psoriasis was permitted.2,3

RINVOQ is not indicated for the treatment of plaque psoriasis.1

DATA LIMITATIONS: PASI100 data for all comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

RINVOQ SAFETY DATA

Review the well-studied safety profile
of RINVOQ,
including
both short- and
long-term analyses