For active psoriatic arthritis (PsA) in adult TNFi-IR patients1
Challenge treatment goals in PSA
RINVOQ met its primary endpoint (ACR20 at Week 12) and several secondary endpoints at Week 12 or 24, with response rates up to Week 56.1,3-8
*Preferred coverage means the product is placed on the plan's preferred formulary requirement of a prior TIM (including a TNFi) failure before starting RINVOQ.
†Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies. Preferred means the product is placed on the plan's preferred formulary. Data on File, AbbVie Inc. July 2022.
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); IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
RINVOQ hits the mark on addressing many of the considerations for our patients with PsA
Dr. Rachel Tate, DO, RhMSUS, FACR
RINVOQ Reels:
Your peers discuss clinical data
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.
RINVOQ® (upadacitinib) met its primary endpoint in two clinical studies1
Significant ACR20 Response
at Week 12 vs placebo3,4
Rapid ACR20 response seen as early asWEEK 24,5
Rapid ACR20 response seen as early asWEEK 24,5
SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo4
SELECT-PsA 1: 28% RINVOQ 15 mg vs 12% placebo5
SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo (P≤0.05)4
SELECT-PsA 1: 28% RINVOQ 15 mg vs 12% placebo (P<0.001)5
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 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); 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
RINVOQ is a once-daily JAK inhibitor1
Powerful Disease Control4,6
- Minimal Disease Activity (MDA) at Week 24 with results up to ~1 year
Durable Joint Efficacy1,4,6
- ACR20/50/70 responses at Week 12 with results up to ~1 year
- ∆mTSS* and complete resolution of enthesitis (LEI=0) and dactylitis (LDI=0) evaluated at Week 24, with results up to ~1 year
*∆mTSS was evaluated in non-bDMARD-IR patients.9 RINVOQ is indicated for TNFi-IR patients.
Skin Efficacy4,6
- PASI75 at Week 16 with results up to ~1 year
- Results in additional skin measures up to ~1 year
RINVOQ is not indicated for the treatment of plaque psoriasis
Safety Data from
18 Clinical Trials Across 5 Indications1,10-14,†
- >10,500 patients in global clinical trials across US-approved indications, including pediatrics 12+ years in AD1,10‑12,14,‡
- >18,500 patient-years of exposure to RINVOQ 15 or 30 mg11,14-18,§
- ~5.5 years max. exposure beginning in RA (~3.5 yrs median) to RINVOQ 15 mg as of 6/30/2115,19,||
Exceptional Access and Patient Support
- >95% preferred Commercial and Medicare Part D coverage2,¶,#
- National commercial and Medicare Part D formulary coverage under the pharmacy benefit as of
July 2022.
- National commercial and Medicare Part D formulary coverage under the pharmacy benefit as of
- 1:1 support to help PsA patients start and stay on track with their prescribed treatment plan.
†Includes 2 PsA phase 3 studies (SELECT-PsA 1 and SELECT-PsA 2); 6 RA phase 3 studies (SELECT-EARLY, SELECT-MONOTHERAPY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND, and SELECT-CHOICE); 1 AS phase 2/3 study (SELECT-AXIS 1) and 1 AS phase 3 study (SELECT-AXIS 2); 4 AD phase 3 studies (MEASURE UP 1, MEASURE UP 2, AD UP, and HEADS UP); and 4 UC phase 3 studies (U‑ACHIEVE Induction, U-ACCOMPLISH Induction, U-ACHIEVE Maintenance, and the long-term extension study).1,10-14
‡PsA: RINVOQ 15 mg, upadacitinib 30 mg; RA: RINVOQ 15 mg, upadacitinib 30 mg; AS: RINVOQ 15 mg; AD: RINVOQ 15 mg and RINVOQ 30 mg; UC: RINVOQ 15 mg, 30 mg, and 45 mg. RINVOQ 15 mg is the approved dose in PsA, RA, and AS; 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.1,10-12,14,17
§Includes 2504.6 patient-years in PsA trials as of 06/2020, 12,259.5 patient-years in RA trials as of 06/2021, 577.3 patient-years in AS trials as of 11/2020 for SELECT-AXIS 1 and 08/2021 for SELECT-AXIS 2 study 1, 2787.6 patient-years in AD trials as of 11/2020, and 381.1 patient-years in UC trials as of 04/2021.11,14‑17,20‑21
||In PsA: ~3 years maximum exposure (~1.3 years median) to RINVOQ 15 mg as of 06/2020; In AS: ~2.3 years max. exposure (~1.7 yrs median).11,22
¶Formulary Definitions: Preferred means RINVOQ is placed on the plan's preferred 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 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); AD=atopic dermatitis; AS=ankylosing spondylitis; LDI=Leeds dactylitis index; LEI=Leeds enthesitis index; MDA=minimal disease activity; mTSS=modified total Sharp/van der Heijde score; PASI75=at least 75% improvement in psoriasis area severity from baseline; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis
