For moderate to severe rheumatoid arthritis (RA) in adult TNFi-IR patients1
For active psoriatic arthritis (PsA) in adult TNFi-IR patients1

Defy Expectations - Challenge treatment goals in PsA

Challenge treatment goals in PSA

RINVOQ met its primary endpoint (ACR20 at Week 12) in two clinical trials1

RINVOQ met its primary endpoint (ACR20 at Week 12) in two clinical trials1

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; PsA=psoriatic arthritis; TNFi=tumor necrosis factor inhibitor

RINVOQ® (upadacitinib) met its primary endpoint in two clinical studies1

Significant ACR20 Response
at Week 12 vs placebo2,3

SELECT-PsA 2 ACR20 response at Week 12 SELECT-PsA 2 ACR20 response at Week 12 SELECT-PsA 2 ACR20 response at Week 12
SELECT-PsA 1 ACR20 response at Week 12 SELECT-PsA 1 ACR20 response at Week 12 SELECT-PsA 1 ACR20 response at Week 12

Rapid ACR20 response seen as early asWEEK 21,3,4

Rapid ACR20 response seen as early asWEEK 21,3,4

SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo (P≤0.05)3
SELECT-PsA 1: 28% RINVOQ 15 mg vs 12% placebo (P<0.001)4

SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo (P≤0.05)3
SELECT-PsA 1: 28% RINVOQ 15 mg vs 12% placebo (P<0.001);4

SELECT-PsA 2 Study Design Intro:1
24‑week, double‑blind, placebo‑controlled study of 642 adult patients with moderate to severe 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 moderate to severe PsA who had an inadequate response or intolerance to at least one non‑biologic DMARD. Patients were randomized to either receive upadacitinib, active comparator, or placebo. The primary endpoint was proportion of patients achieving ACR20 response at Week 12 vs placebo.

Data Limitations:5 Week 2 data for all comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established. P‑value obtained through nominal statistical testing.

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 Control3,5

  • Minimal Disease Activity (MDA) at Week 24 with results up to ~1 year

Durable Joint Efficacy1,3,5

  • ACR20/50/70 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.6 RINVOQ is indicated for TNFi-IR patients.

Skin Efficacy3,5

  • PASI75 at Week 16 with results up to ~1 year
  • Results in additional skin measures

RINVOQ is not indicated for the treatment of plaque psoriasis

Safety Data from 8 trials across 2 Rheumatology Indications7,8,†

  • >6200 patients evaluated on upadacitinib
  • >8200 patient-years of exposure to RINVOQ 15 mg as of 6/30/20§
  • Up to ~4.5 years maximum exposure in RA (~2.6 years median), ~3 years maximum exposure in PsA (~1.3 years median) to RINVOQ 15 mg as of 6/30/2020

Abbvie's Commitment to exceptional access and patient support

  • >9 out of 10 commercial patients have access to RINVOQ in RA and PsA through national commercial insurance or through RINVOQ Complete9,II
  • 1:1 support to help patients start and stay on track with their prescribed treatment plan

 

RINVOQ 15 mg is the approved dose in RA and PsA. 

Includes 6 RA Phase 3 studies (SELECT‑EARLY, SELECT‑MONOTHERAPY, SELECT‑NEXT, SELECT‑COMPARE, SELECT‑BEYOND and SELECT‑CHOICE). Includes 2 PsA Phase 3 studies (SELECT‑PsA 1 and SELECT‑PsA 2).10 
RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: RINVOQ 15 mg, upadacitinib 30 mg.1,7,8
§Includes 7023.8 patient-years in RA trials, and 1247.2 patient-years in PsA trials

Program is not available to patients receiving prescription reimbursement under any federal, state, or government‑funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government‑funded healthcare program, patient will no longer be eligible to participate in program. Available to patients between the ages of 18‑63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with active psoriatic arthritis, have a valid prescription for RINVOQ and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.

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); 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