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

Durable joint
efficacy2,3

RINVOQ met its primary endpoint (ACR20 at Week 12) and several secondary endpoints at Week 12 or 24, with response rates up to Week 56.1-6

Primary Endpoint

Secondary Endpoints

ACR20

ACR50/70    ΔmTSS    ΔHAQ-DI

Select Pre-specified
Non-ranked Endpoints
Complete resolution of enthesitis (LEI=0)
Complete resolution of dactylitis (LDI=0)

Primary Endpoint
ACR20

Secondary Endpoints
ACR50/70    ΔmTSS    ΔHAQ-DI

Select Pre-specified
Non-ranked Endpoints
Complete resolution of enthesitis (LEI=0)
Complete resolution of dactylitis (LDI=0)

ACR=American College of Rheumatology; ACR20/50/70=improvement of at least 20%/50%/70% 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); HAQ-DI=health assessment questionnaire disability index; IR=intolerance or inadequate response; LDI=Leeds dactylitis index; LEI=Leeds enthesitis index; mTSS=modified total Sharp/van der Heijde score; TNFi=tumor necrosis factor inhibitor

Clinical Trial Overview

SELECT-PsA 1 Clinical Trial Overview

*P<0.001 for RINVOQ vs placebo2,4

SELECT-PsA 2 Clinical Trial Overview

*P<0.001 for RINVOQ vs placebo2,4

SELECT-PsA 1 Study Design Intro:1

24-week, double-blind, multicenter, placebo and active comparator-controlled study of 1705 adult patients with moderately to severely active PsA who had an inadequate response or intolerance to at least one non-biologic DMARD. Patients were randomized to receive either upadacitinib, active comparator, or placebo. The primary endpoint was proportion of patients achieving ACR20 response at Week 12 vs placebo.

 

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 (hsCRP); 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

Rapid and Durable
ACR20 Response Rates3

SELECT-PsA 2 (biologic DMARD‑IR): ACR20 over time3,4

RINVOQ is indicated for TNFi-IR patients

 

SELECT-PsA 2 (biologic DMARD‑IR): ACR20 over time3,4

RINVOQ is indicated for
TNFi-IR patients

 

SELECT-PsA 1: ACR20 over time

*P<0.0014

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

Durable ACR50/70 Response Rates
up to ~1 year3

SELECT-PsA 2 (biologic DMARD‑IR): ACR50/70 over time3,4

RINVOQ is indicated for TNFi-IR patients

 

SELECT-PsA 2 (biologic DMARD‑IR): ACR50/70 over time3,4

RINVOQ is indicated for
TNFi-IR patients

ACR50

SELECT-PsA 1: ACR50 over time

*P<0.001; analyses were not controlled for multiplicity; P‑values obtained through nominal statistical testing4

At ~1 year, 4 out of 10 RINVOQ patients saw a ≥50% improvement in ACR score3

At ~1 year, 4 out of 10 RINVOQ patients saw a ≥50% improvement in ACR score3

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

 

ACR70

SELECT-PsA 1: ACR70 over time

*P<0.001; analyses were not controlled for multiplicity; P‑values obtained through nominal statistical testing4

 

At ~1 year, ~1 in 4 RINVOQ patients saw a ≥70% improvement in ACR score3 

At ~1 year, ~1 in 4 RINVOQ patients saw a ≥70% improvement in ACR score3 

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

Power to help stop further joint damage1
RINVOQ vs placebo in
∆mTSS at Week 24

SELECT-PsA 1 (non‑biologic DMARD‑IR): Radiographic Inhibition at Week 241,5

RINVOQ is indicated for TNFi-IR patients

 

SELECT-PsA 1 (non‑biologic DMARD‑IR): Radiographic Inhibition at Week 241,5

RINVOQ is indicated for
TNFi-IR patients

 

SELECT-PsA 1: Radiographic Inhibition at Week 24

*P=0.00215

P=0.0003

P=0.0386; analyses were not controlled for multiplicity, p‑values obtained through nominal statistical testing.5

At Week 24 the mean change from baseline in mTSS was -0.02 for RINVOQ (random coefficient model)5

At Week 56 the mean change from baseline in mTSS was -0.04 for RINVOQ (random coefficient model)8

93% of RINVOQ patients showed no radiographic progression (∆mTSS≤0) at 24 weeks vs 89% on placebo (LE)1

95% of RINVOQ patients showed no radiographic progression (∆mTSS≤0) at 56 weeks (LE)6,a

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. 

Improvement In physical function
LS mean ∆HAQ‑DI from baseline at Week 12 was -0.30* for RINVOQ (n=199) vs -0.10 for placebo (n=180) (MMRM) (ranked secondary endpoint)4

SELECT-PsA 2 (biologic DMARD‑IR): Mean change from baseline in HAQ‑DI9,10

RINVOQ is indicated for TNFi-IR patients

 

SELECT-PsA 2 (biologic DMARD‑IR): Mean change from baseline in HAQ‑DI9,10

RINVOQ is indicated for
TNFi-IR patients

 

SELECT-PsA 1: Mean change from baseline in HAQ-DI

*P<0.0014

 

Durable HAQ-DI responses for RINVOQ up to ~1 year9,10

DATA LIMITATION: 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. 

Complete Resolution of Enthesitis1
LEI=0 at Week 24 vs placebo with response rates at ~1 year

SELECT-PsA 2 (biologic DMARD‑IR): Complete Resolution of Enthesitis (LEI=0)1,4,9,10

RINVOQ is indicated for TNFi-IR patients

 

SELECT-PsA 2 (biologic DMARD‑IR): Complete
Resolution of Enthesitis (LEI=0)1,4,9,10

RINVOQ is indicated for
TNFi-IR patients

 

43% of RINVOQ patients achieved complete resolution of enthesitis at Week 241,4,10

43% of RINVOQ patients achieved complete resolution of enthesitis at Week 241,4,10

SELECT-PsA 1: Complete Resolution of Enthesitis

For subjects with baseline presence of enthesitis (LEI>0).

*P<0.001; analysis was not controlled for multiplicity, P-value obtained through nominal statistical testing.4

43% of RINVOQ patients achieved complete resolution of enthesitis at Week 241,4,10

43% of RINVOQ patients achieved complete resolution of enthesitis at Week 241,4,10

 

DATA LIMITATION: Enthesitis data and dactylitis data for all comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established. Complete resolution of dactylitis (LDI=0) and Complete resolution of enthesitis (LEI=0) were both exploratory endpoints. 

Complete Resolution of Dactylitis1
LDI=0 at Week 24 vs placebo with response rates at ~1 year

SELECT-PsA 2 (biologic DMARD‑IR): Complete Resolution of Dactylitis ⁠(LDI=0)1,4,9,10

RINVOQ is indicated for TNFi-IR patients

 

SELECT-PsA 2 (biologic DMARD‑IR): Complete Resolution of Dactylitis ⁠(LDI=0)1,4,9,10

RINVOQ is indicated for
TNFi-IR patients

 

58% of RINVOQ patients achieved complete resolution of dactylitis at Week 241,4,10

58% of RINVOQ patients achieved complete resolution of dactylitis at Week 241,4,10

SELECT-PsA 1: Complete Resolution of Dactylitis ⁠

For subjects with baseline presence of dactylitis (LDI>0).

*P<0.001; analysis was not controlled for multiplicity, P-value obtained through nominal statistical testing.4

58% of RINVOQ patients achieved complete resolution of dactylitis at Week 241,4,10

 

DATA LIMITATION: Enthesitis data and dactylitis data for all comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established. Complete resolution of dactylitis (LDI=0) and Complete resolution of enthesitis (LEI=0) were both exploratory endpoints. 

RINVOQ SAFETY DATA

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