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
*RINVOQ is on a preferred tier or otherwise has preferred status on the plan's formulary.
†Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
Efficacy Results with RINVOQ
Hear from Dr. Evan Siegel, MD, FACP, FACR and Dr. Rachel Tate, DO, FACR about skin and joint efficacy data, safety data, and RINVOQ as an option for adult patients with active PsA who have not achieved their treatment goals on a TNF inhibitor.
Well-Studied Safety Profile
Watch Dr. Evan Siegel, MD, FACP, FACR and Dr. Rachel Tate, DO, FACR discuss the long-term safety profile of RINVOQ across indications—an important consideration prior to prescribing RINVOQ for patients who continue to have symptoms despite previous treatment with a TNF inhibitor.
MEET THE FEATURED PHYSICIANS
Significant ACR20 Response at Week 12 (primary endpoint) vs placebo3,4
Significant ACR20 Response at Week 12 (primary endpoint) vs placebo3,4
Rapid ACR20 response seen as early as WEEK 2 3
Rapid ACR20 response seen as early as WEEK 2 3
SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo (NRI)3
SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo (NRI)3
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.
SELECT-PsA 1 Study Design Intro:1
24-week, double‑blind, 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.
Data Limitations: Week 2 data for all comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
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; DMARD=disease‑modifying antirheumatic drug; IR=intolerance or inadequate response; NRI=nonresponder imputation; QD=once per day; TNFi=tumor necrosis factor inhibitor
*∆mTSS was evaluated in non-bDMARD-IR patients. RINVOQ is indicated for TNFi-IR patients.6
RINVOQ is not indicated for the treatment of plaque psoriasis
†Includes 2 phase 3 PsA trials, 3 phase 2 trials and 6 phase 3 RA trials, 1 phase 2/3 and 1 phase 3 AS trials, 1 phase 3 nr-axSpA trial, 1 phase 2 and 3 phase 3 AD trials, and 3 phase 3 UC trials. PsA: RINVOQ 15 mg, upadacitinib 30 mg; RA: RINVOQ 15 mg, upadacitinib 30 mg; AS: RINVOQ 15 mg; nr-axSpA: RINVOQ 15 mg; AD: RINVOQ 15 mg and 30 mg; UC: RINVOQ 15 mg, 30 mg, and 45 mg. RINVOQ 15 mg is the approved dose in PsA, RA, AS, and nr-axSpA; RINVOQ 15 mg and 30 mg are the approved doses in AD; RINVOQ 15 mg, 30 mg and 45 mg are the approved doses in UC.1,7
‡In PsA: ~5.0 years maximum exposure (~2.9 years median) to RINVOQ 15 mg as of 08/2022; In AS: ~3.8 years maximum exposure (~1.7 years median) to RINVOQ 15 mg as of 08/2022. In nr-axSpA: ~2.4 years maximum exposure (~1.0 years median) to RINVOQ 15 mg as of 08/2022.7
§RINVOQ is on a preferred tier or otherwise has preferred status on the plan's formulary.
||Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
ACR20/50/70=improvement of at least 20%/50%/70% in tender joint count, swollen joint count, and at least 3 other core criteria; AD=atopic dermatitis; AS=ankylosing spondylitis; DMARD=disease-modifying antirheumatic drug; IR=intolerance or inadequate response; LDI=Leeds dactylitis index; LEI=Leeds enthesitis index; max.=maximum; mTSS=modified total Sharp score; nr-axSpA=non-radiographic axial spondyloarthritis; PASI 75=at least 75% reduction in psoriasis area severity score from baseline; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis
RINVOQ is indicated for the treatment of:
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.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or other potent immunosuppressants such as azathioprine and cyclosporine.
REFERENCES
To achieve an ACR20, 50, or 70 response, a patient must have at least a 20%, 50%, or 70%, respectively, improvement in tender and swollen joint counts and three of five scores of individual elements:
IMPROVEMENTS IN ACR COMPONENTS OF DISEASE ACTIVITY IN SELECT-PsA 22
IMPROVEMENTS IN ACR
COMPONENTS OF DISEASE
ACTIVITY IN SELECT-PsA 22
aNumeric rating scale (NRS) from 0=best, to 10=worst
bHealth Assessment Questionnaire Disability Index ranked from 0=best, to 3=worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities
ACR=American College of Rheumatology; HAQ‑DI=health assessment questionnaire disability index; hs‑CRP=high‑sensitivity C‑reactive protein; NRS=numeric rating scale; QD=once per day; SD=standard deviation; ULN=upper limit of normal
US-MULT-221361
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
Adults with active PsA who had an inadequate response or intolerance to ≥1 non-biologic DMARD.1
RINVOQ is indicated for TNFi-IR patients
Upadacitinib 30 mg is not an approved dose for PsA.
aAll patients receive X-rays of hands and feet.2
bStarting 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 DMARDs, NSAIDs, acetaminophen, low potency opioids, or corticosteroids adjusted or initiated.3
cAfter Week 16, the use of concomitant treatments for psoriasis was permitted.2
dAt Week 24, all remaining placebo patients were switched to RINVOQ 15 mg QD or upadacitinib 30 mg QD (1:1 ratio) regardless of response.1
eStarting 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.4
Primary Endpoint1
Select Ranked Key Secondary Endpoints2
Upadacitinib vs placebo if not otherwise specified
Additional Key Secondary Endpoints2
Upadacitinib vs placebo if not otherwise specified
Select Prespecified Nonranked Endpoints2
Additional efficacy analyses include the following endpoints at the scheduled time points other than those specified for the primary and key secondary variables:
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 CHARACTERISTICS3,5
*ULN=2.87 mg/L
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; 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; BMI=body mass index; BSA=body surface area; 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; mTSS=modified total Sharp score; 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; PtGA=Patient Global Assessment; QD=once per day; 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
Adults with active PsA who had an inadequate response or intolerance to ≥1 non-biologic DMARD.1
RINVOQ is indicated for TNFi-IR patients
Upadacitinib 30 mg is not an approved dose for PsA.
aAll patients receive X-rays of hands and feet.2
bStarting 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 DMARDs, NSAIDs, acetaminophen, low potency opioids, or corticosteroids adjusted or initiated.3
cAfter Week 16, the use of concomitant treatments for psoriasis was permitted.2
dAt Week 24, all remaining placebo patients were switched to RINVOQ 15 mg QD or upadacitinib 30 mg QD (1:1 ratio) regardless of response.1
eStarting 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.4
Primary Endpoint1
Select Ranked Key Secondary Endpoints2
Upadacitinib vs placebo if not otherwise specified
Additional Key Secondary Endpoints2
Upadacitinib vs placebo if not otherwise specified
Select Prespecified Nonranked Endpoints2
Additional efficacy analyses include the following endpoints at the scheduled time points other than those specified for the primary and key secondary variables:
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 CHARACTERISTICS3,5
*ULN=2.87 mg/L
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; 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; BMI=body mass index; BSA=body surface area; 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; mTSS=modified total Sharp score; 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; PtGA=Patient Global Assessment; QD=once per day; 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
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
