Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Refractory, Moderate to Severe

Atopic Dermatitis

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

Learn more about AbbVie's response to COVID-19

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

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

RINVOQ is indicated for the treatment of:

  • Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.
  • Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

REFERENCES

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. McInnes IB, Anderson JK, Magrey M, et al. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. NEJM. 2021;384(13):1227-1239. doi:10.1056/nejmoa2022516.
  3. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320.
  4. Data on File. ABVRRTI71685.
  5. Mease PJ, Lertratanakul A, Anderson JK, et al. Supplement - Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320.
  6. McInnes IB, Anderson JK, Magrey M, et al. Supplement - Trial of upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med. 2021;384(13):1227-1239. doi:10.1056/NEJMoa2022516.
  7. Cohen SB, Van Vollenhoven R, Curtis JR, et al. Integrated safety profile of upadacitinib with up to 4.5 years of exposure in patients with rheumatoid arthritis. Poster presented at: The European Congress of Rheumatology, 2-5 June 2021, E‑Congress.
  8. Burmester GR, Winthrop K, Blanco R, et al. Safety Profile of Upadacitinib Up to 3 Years in Patients with Psoriatic Arthritis: An Integrated Analysis from the Phase 3 Program. Presented at: The European Congress of Rheumatology, 2-5 June 2021, E‑Congress. Data on File. ABVRRTI71686.
  9. Data on File, AbbVie Inc. Payer reported lives. December 2021.
  10. Data on File. ABVRRTI71618. 

INDICATIONS & LIMITATION OF USE1

RINVOQ is indicated for the treatment of:

  • Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more
    TNF blockers.
  • Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

INDICATIONS & LIMITATION OF USE1

RINVOQ is indicated for the treatment of:

  • Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more
    TNF blockers.
  • Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

RINVOQ is indicated for the treatment of:

  • Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.
  • Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS