For active ankylosing spondylitis (AS) in adult TNFi-IR patients1
For active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation in adult TNFi-IR patients1
Challenge treatment goals in TNFi-IR
AS and NR-AXSPA patients
Nearly Half of AS (44.5%, n=211, bDMARD-IR vs placebo, n=209, 18.2%*) and nr-axSpA (44.9%, n=156, mixed† vs placebo, n=157, 22.3%*) Patients Achieved ASAS40 Primary Endpoint at Week 141-3
*P<0.00012,10
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
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; nr-axSpA=non-radiographic axial spondyloarthritis; TNFi=tumor necrosis factor inhibitor
Axial Spondyloarthritis includes both AS and nr-axSpA
Axial Spondyloarthritis
includes both
AS and nr-axSpA
10–40% of people with nr-axSpA may progress to develop ankylosing spondylitis (AS) over a period of 2 to 10 years.4
Ankylosing Spondylitis requires radiographic evidence of sacroiliitis4
POWERFUL
DISEASE CONTROL
ACHIEVED
Significant ASAS40 Response vs placebo at Week 141-3
Nearly Half of AS (44.5%, bDMARD-IR vs placebo, 18.2%*)
and nr-axSpA (44.9%, mixed† vs placebo, 22.3%*)
Patients Achieved ASAS40 Primary Endpoint at Week 141-3
SELECT-AXIS 2 STUDY 1
AS (bDMARD-IR)
SELECT-AXIS 2 STUDY 2
nr-axSpA mixed†
RINVOQ is indicated for TNFi-IR patients
Improvement in ASAS40 responses observed at WEEK 42 (AS) and WEEK 2 (nr-axSpA):1,3,10
SELECT-AXIS 2 Study 1: AS:
22% RINVOQ 15 mg
vs 12% placebo§
SELECT-AXIS 2 Study 2: nr-axSpA:
12% RINVOQ 15 mg
vs 6% placebo§
SELECT-AXIS 2 Study 1: AS 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 2 NSAIDs and 1 or 2 bDMARDs. Patients were randomized to receive RINVOQ 15 mg once daily or placebo. Patients could continue background NSAIDs.
SELECT-AXIS 2 Study 2: nr-axSpA Design Intro:1,3
52-week, double-blind, placebo-controlled phase 3 study of 313 patients with nr-axSpA and one objective sign of active inflammation based on MRI of the sacroiliac joints and/or hs-CRP greater than the upper limit of normal (ULN; 2.87 mg/L). Patients had an intolerance or inadequate response to at least 2 NSAIDs and, in 33%, to 1 bDMARD. Patients were randomized to receive RINVOQ 15 mg once daily or placebo. Patients could continue background NSAIDs.
DATA LIMITATIONS:2,3 Data labeled as a primary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
*P<0.00012,10
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
‡P<0.00012,10
§P<0.05; P-value obtained through nominal statistical testing.2,10
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; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; MRI=magnetic resonance imaging; NRI-MI=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; nr-axSpA=non-radiographic axial spondyloarthritis; NSAID=nonsteroidal anti-inflammatory drug; QD=once daily; TNFi=tumor necrosis factor inhibitor; ULN=upper limit of normal
RINVOQ, a once-daily pill: 1st & only JAKi approved for both AS and nr-axSpA1-3
Powerful
Disease Control1-3
- ASAS40 Primary Endpoint at Week 14, and responses observed at Week 4 (AS) and Week 2 (nr-axSpA)
- ASDAS-LDA (Low Disease Activity) at Week 14
Rapid
Improvement1-3
- ASAS40 at Week 14 and at Week 4 (AS) and Week 2 (nr-axSpA)
- Total and nocturnal back pain, Inflammation (Morning Stiffness)*, hs-CRP, Physical Function at Week 14
Safety Data from
21 Clinical Trials
Across 6 Indications1,5,†
- ~10,900 patients in global clinical trials across US-approved indications, including pediatrics 12+ years in AD1,5,6,†
- >23,900 patient-years of exposure to RINVOQ 15, 30 or 45 mg1,5,6,†
- ~5.5 years max. exposure beginning in RA (~3.5 yrs median) to RINVOQ 15 mg as of 6/30/215,7,‡
AbbVie's Commitment to Exceptional Access and Patient Support
- >9 out of 10 commercial patients have access to RINVOQ in RA, PsA, AS, and nr-axSpA. Access is available as of October 2022 and available through commercial insurance, or through RINVOQ Complete if coverage is denied.8,§
- 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 3 phase 2 and 6 phase 3 RA trials, 2 phase 3 PsA trials, 1 phase 2/3 AS trial, 1 phase 3 AS trial, 1 phase 3 nr-axSpA trial, 1 phase 2 and 3 phase 3 AD trials, and 3 phase 3 UC trials. RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: RINVOQ 15 mg, upadacitinib 30 mg; AS: RINVOQ 15 mg; nr-axSpA: 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 RA, PsA, 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.1,5
‡In PsA: ~3.9 years maximum exposure (~2.3 years median) to RINVOQ 15 mg as of 06/2021. In AS: ~3.3 years maximum exposure (~1.8 years median) to RINVOQ 15 mg as of 06/2021 (AS exposure data is from SELECT-AXIS 1). In AS: ~1.5 years maximum exposure (~0.6 years median) to RINVOQ 15 mg as of 08/2021 (AS exposure data is from SELECT-AXIS 2 study 1). In nr-axSpA: ~1.4 years maximum exposure (~0.6 years median) to RINVOQ 15 mg as of 08/2021.5,9
§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.
AD=atopic dermatitis; 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; bDMARD=biologic disease-modifying antirheumatic drug; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; LDA=low disease activity; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis
