For active psoriatic arthritis (PsA) in adult TNFi‑IR patients1
US-MULT-230356
US-MULT-230356
For active psoriatic arthritis (PsA) in adult TNFi‑IR patients1
As measured by PASI 75 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; PASI 75=at least 75% reduction in PASI score from baseline; TNFi=tumor necrosis factor inhibitor
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.
RINVOQ has not been studied in and is not indicated for the treatment of plaque psoriasis.1
*P<0.0012
†PASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.2,4
DATA LIMITATIONS:2 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 patients3
ALL DATA ARE OBSERVED CASES
aPASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.2,4
bAfter Week 16, the use of concomitant treatments for psoriasis was permitted.2,4
RINVOQ is not indicated for the treatment of plaque psoriasis.1
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.
Review the safety profile of RINVOQ,
including both short- and long-term analyses
RINVOQ is indicated for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
REFERENCES
Adults with active PsA who had an inadequate response or intolerance to ≥1 biologic DMARD.1
RINVOQ is indicated for TNFi-IR patients
Upadacitinib 30 mg is not an approved dose for PsA.
aStarting at Week 16, patients who did not achieve ≥20% improvement in tender and/or swollen joint counts (TJC68/SJC66) compared to baseline at Weeks 12 and 16 had background medications adjusted or initiated.3
bAfter Week 16, the use of concomitant treatments for psoriasis was permitted.2
cAt Week 24, all remaining placebo patients were switched to RINVOQ 15 mg QD or upadacitinib 30 mg QD.3
dStarting at Week 36, patients who did not achieve ≥20% improvement in TJC68 and SJC66 compared to baseline at 2 consecutive visits were discontinued from the study.3
Primary Endpoint1
Select Ranked Key Secondary Endpoints3
Additional Key Secondary Endpoints3
Select Prespecified Nonranked Endpoints3
Data Limitations
Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
BASELINE CHARACTERISTICS3,4
*Patients with intolerance but not inadequate response to a biologic DMARD.
†ULN=2.87 mg/L
ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; BSA=body surface area; CCP=cyclic citrullinated peptide; DMARD=disease‑modifying antirheumatic drug; HAQ-DI=health assessment questionnaire disability index; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; LDI=Leeds dactylitis index; LEI=Leeds enthesitis index; MDA=minimal disease activity; MTX=methotrexate; NRS=numeric rating scale; NSAID=nonsteroidal anti-inflammatory drug; PASI=psoriasis area severity index; PASI 75/90/100=at least 75%/90%/100% reduction in psoriasis area severity score from baseline; PsA=psoriatic arthritis; QD=once per day; RF=rheumatoid factor; SD=standard deviation; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; TNFi=tumor necrosis factor inhibitor; ULN=upper limit of normal
REFERENCES
US-MULT-221361
