For active psoriatic arthritis (PsA) in adult TNFi‑IR patients1
Durable
JOINT EFFICACY IN PSA2,3
RINVOQ met its primary endpoint (ACR20 at Week 12) and several secondary
endpoints at Week 12 or 24.1,4
ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria (patient assessment of pain, patient global assessment, HAQ-DI, physician global assessment, and hs-CRP); IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

Durable JOINT RESPONSE RATES
OUT TO 3 YEARS5
SELECT-PsA 2 Study Design Intro:1 24-week, double-blind, placebo-controlled study of 642 adult patients with moderate to severe active PsA who had an inadequate response or intolerance to at least one biologic DMARD. Patients were randomized to receive upadacitinib or placebo.

*P<0.001; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing4
†P<0.0014
DATA LIMITATIONS:4 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.

SELECT-PsA 2: Biologic DMARD-IR patients5
ALL DATA ARE OBSERVED CASES

In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.
OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to the overall treatment effect.

*For subjects with baseline presence of enthesitis (LEI>0).
†For subjects with baseline presence of dactylitis (LDI>0).
‡P<0.001; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing4
DATA LIMITATIONS:4 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.
SELECT-PsA 2: Biologic DMARD-IR patients5
ALL DATA ARE OBSERVED CASES

Complete Resolution of Enthesitis (LEI=0)

For subjects with baseline presence of enthesitis (LEI>0).
In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.
OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to the overall treatment effect.

Complete Resolution of Dactylitis (LDI=0)

For subjects with baseline presence of dactylitis (LDI>0).
In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.
OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to the overall treatment effect.
SELECT-PsA 1 Study Design Intro:1 24-week, double-blind, placebo and active comparator-controlled study of 1705 adult patients with moderate to severe 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.
SELECT-PsA 1 in non-biologic DMARD-IR patients1,7
RINVOQ is indicated for TNFi-IR patients

*P=0.00217
†P=0.00037
‡P=0.0386; analyses were not controlled for multiplicity. P-values obtained through nominal statistical testing7
||P<0.0018
At Week 24 the mean change from baseline in mTSS was -0.02 for RINVOQ (random coefficient model)1
At Week 56 the mean change from baseline in mTSS was -0.04 for RINVOQ (random coefficient model)9
93% of RINVOQ patients showed no radiographic progression (ΔmTSS≤0) at 24 weeks vs 89% on placebo (LE)1
95% of RINVOQ patients showed no radiographic progression (ΔmTSS≤0) at 56 weeks (LE)10,a

DATA LIMITATIONS:11 Data labeled as a ranked secondary endpoint was multiplicity controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
Improvement in physical function4
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 patients12
Durable HAQ-DI responses for RINVOQ up to ~1 year12

*P<0.001 for RINVOQ vs placebo4
Durable HAQ-DI responses for RINVOQ up to ~1 year12
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.
RINVOQ SAFETY DATA
Review the safety profile of RINVOQ,
including both short- and long-term analyses