For moderate to severe rheumatoid arthritis (RA) in adult TNFi‑IR patients1
For active psoriatic arthritis (PsA) in adult TNFi‑IR patients1
For active ankylosing spondylitis (AS)
in adult TNFi‑IR patients1

Defy Expectations

Challenge treatment goals in AS

RINVOQ met its primary endpoint (ASAS40 at Week 14)
in ankylosing spondylitis in SELECT-AXIS 21,2

RINVOQ met its
primary endpoint
(ASAS40 at Week 14) in ankylosing spondylitis in SELECT-AXIS 21,2

AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; ASAS40=≥40% improvement and an absolute improvement from baseline of ≥2 units on a scale of 0 to 10 in at least 3 of the 4 domains, with no worsening in the fourth domain: total back pain, inflammation (mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness), physical function (BASFI), and Patient Global Assessment of disease activity; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; NRS=numeric rating scale; TNFi=tumor necrosis factor inhibitor

AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; ASAS40=≥40% improvement and an absolute improvement from baseline of ≥2 units on a scale of 0 to 10 in at least 3 of the 4 domains, with no worsening in the fourth domain: total back pain, inflammation (mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness), physical function (BASFI), and Patient Global Assessment of disease activity; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; NRS=numeric rating scale; TNFi=tumor necrosis factor inhibitor

Powerful Disease Control achieved with ASAS40 at Week 141,2

Significant ASAS40 Response at Week 14 vs placebo1,2

Significant ASAS40 Response
at Week 14 vs placebo1,2

Nearly half (44.5%) of AS
bDMARD-IR patients achieved ASAS40 primary endpoint at Week 14 (vs placebo 18.2%, p<0.0001)1,2

 

SELECT-AXIS 2: ASAS40 Response at Week 14

*P<0.00012

Nearly half (44.5%) of AS bDMARD-IR patients achieved ASAS40 primary endpoint at Week 14 (vs placebo 18.2%, p<0.0001)1,2

Improvement in ASAS40 responses observed atWEEK 42

21.8% RINVOQ 15 mg vs 12.4% placebo;
(p<0.05; p-value obtained through nominal statistical testing)

SELECT-AXIS 2 Study Design Intro:1,2
14-week, double-blind, parallel-group, placebo-controlled Phase 3 study of 420 patients with active AS who had an intolerance or inadequate response to at least two NSAIDs and 1 or 2 bDMARDs. Patients were randomized to receive RINVOQ 15 mg once daily or placebo. Patients could continue background NSAIDs. The primary endpoint was proportion of patients achieving ASAS40 response at Week 14 vs placebo.

Data Limitations:2 Data labeled as a primary endpoint at Week 14 was multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

 

Improvement in ASAS40 responses observed atWEEK 42

21.8% RINVOQ 15 mg vs 12.4% placebo; (p<0.05; p-value obtained through nominal statistical testing)

AS=ankylosing spondylitis; ASAS40=≥40% improvement and an absolute improvement from baseline of ≥2 units on a scale of 0 to 10 in at least 3 of the 4 domains, with no worsening in the fourth domain: total back pain, inflammation (mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness), physical function (BASFI), and Patient Global Assessment of disease activity; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; bDMARD=biologic disease-modifying antirheumatic drug; IR=intolerance or inadequate response; JAKi=Janus kinase inhibitor; NRI-MI=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; NRS=numeric rating scale; NSAID=nonsteroidal anti-inflammatory drug; QD=once daily; TNFi=tumor necrosis factor inhibitor

RINVOQ is a once-daily
oral therapy1

Powerful Disease Control1,2

  • ASAS40 at Week 14 (Primary Endpoint) and responses observed at Week 4
  • ASDAS-LDA (Low Disease Activity) at Week 14

Rapid Improvement1,2

  • ASAS40 at Week 14 and at Week 4
  • Total and nocturnal back pain, Inflammation (Morning Stiffness)*, hs-CRPPhysical Function at Week 14

Safety Data from 10 Trials Across RA, PsA and AS1,3-6

  • 10 clinical trials
  • >6,800 patients evaluated on upadacitnib
  • >8,800 patient-years of exposure to RINVOQ 15 mg §
  • Up to ~4.5 years maximum exposure in RA (~2.6 yrs median), ~3 years max. exposure in PsA (~1.3 yrs median) and ~2.3 years max. exposure in AS
    (~1.7 yrs median)||
(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, PsA and AS. Access is as of April 2022 and available through commercial insurance, or through RINVOQ Complete if coverage is denied.7,¶
  • 1:1 support to help patients start and stay on track with prescribed treatment plan

*Mean of BASDAI questions 5 and 6 assessing morning stiffness severity and duration.
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). Includes 2 AS Phase 2/3 studies (SELECT-AXIS 1 and SELECT-AXIS 2).
RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: RINVOQ 15 mg, upadacitinib 30 mg; AS: RINVOQ 15 mg. Data cutoff date for SELECT-AXIS 1 was Nov 26, 2020 and SELECT-AXIS 2 study 1 was Aug 26, 2021. RINVOQ 15 mg is the approved dose in RA, PsA and AS.
§Includes 7023.8 patient-years in RA trials, 1247.2 patient-years in PsA trials, and 577.3 patient-years in AS trials. Data cutoff date for SELECT-AXIS 1 was Nov 26, 2020 and SELECT-AXIS 2 study 1 was Aug 26, 2021.
||AS exposure data is from SELECT-AXIS 1.
Commercial insurance coverage varies by type and plan. Eligibility criteria: Available to patients aged 63 or younger with commercial insurance coverage. Patients must have a valid prescription for RINVOQ® (upadacitinib) for an FDA approved indication and a denial of insurance coverage based on a prior authorization request on file along with a confirmation of appeal. Continued eligibility for the program requires the submission of an appeal of the coverage denial every 180 days. Program provides for RINVOQ® (upadacitinib) at no charge to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier, and is not contingent on purchase requirements of any kind. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage. No claims for payment may be submitted to any third party for product dispensed by program. Limitations may apply.

AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; ASAS40=≥40% improvement and an absolute improvement from baseline of ≥2 units on a scale of 0 to 10 in at least 3 of the 4 domains, with no worsening in the fourth domain: total back pain, inflammation (mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness), physical function (BASFI), and Patient Global Assessment of disease activity; ASDAS=Ankylosing Spondylitis Disease Activity Score; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; NRS=numeric rating scale; NSAID=nonsteroidal anti-inflammatory drug; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor