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

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Defy expectations – Challenge treatment goals in AS and nr-axSpA

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

See latest 1-year data
EXPLORE AS DATA
EXPLORE nr-axSpA DATA

*P<0.00012 , 5
†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

Axial Spondyloarthritis includes both AS and nr-axSpA

Ankylosing Spondylitis requires radiographic evidence of sacroiliitis4

RAPID IMPROVEMENT IN ASAS40 AT WEEK 141-3

Responses observed as early as Week 4 (AS) and Week 2 (nr-axSpA)1-3,5

Significant ASAS40 Response vs placebo at Week 141-3

 

SELECT-AXIS 2 STUDY 1
AS (bDMARD-IR)

SELECT-AXIS 2 Study 1: ASAS40 Response at Week 14

SELECT-AXIS 2 STUDY 2
nr-axSpA mixed†

SELECT-AXIS 2 Study 2: ASAS40 Response at Week 14
RINVOQ is indicated for TNFi-IR patients

 

Improvement in ASAS40 responses observed at WEEK 4 (AS) and WEEK 2 (nr-axSpA):1-3,5
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.

See details

 

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.

See details

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.

See Study Details
See ASAS40 Response Criteria

*P<0.00012,5
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
‡P<0.00012,5
§P<0.05; P-value obtained through nominal statistical testing.2,5

 

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

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RINVOQ, a once-daily pill: 1st & only JAKi approved for both AS and nr-axSpA1-3

RAPID & DURABLE
Disease Control1-3,6-9

  • ASAS40 Primary Endpoint at Week 14, with responses observed at Week 4 (AS) and Week 2 (nr-axSpA), and up to 1 year
  • ASDAS Low Disease Activity at Week 14 with responses observed at 1 year
  • Total and nocturnal back pain, Inflammation (morning stiffness)*, hs-CRP, Physical Function at Week 14 with responses observed at 1 year

Safety Data from
21 Clinical Trials
Across 6 Indications1,10,†

  • >11,300 patients in global clinical trials across US-approved indications, including pediatrics 12+ years in AD10,†
  • >31,200 patient-years of exposure to RINVOQ 15, 30 or 45 mg10,†
  • >6.5 years max. exposure beginning in RA (~4 yrs median) to RINVOQ 15 mg as of 8/15/2210,‡

AbbVie's Commitment to Exceptional Access and Patient Support

  • >95% preferred national commercial and Medicare Part D formulary coverage under the pharmacy benefit as of June 202311,§,**
  • Payers cover RINVOQ after the trial of 1 TNFi with >95% preferred coverage11,§,**
  • 1:1 support to help AS and nr-axSpA patients start and stay on track with their 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 and 1 phase 3 AS trials, 1 phase 3 nr-axSpA trials, 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.1,10

‡In PsA: ~5.0 years maximum exposure (~2.9 years median) to RINVOQ 15 mg as of 08/2022. In AS: ~3.8 years maximum exposure (~1.7 years median) to RINVOQ 15 mg as of 08/2022. In nr-axSpA: ~2.4 years maximum exposure (~1.0 years median) to RINVOQ 15 mg as of 08/2022.10

§RINVOQ is on a preferred tier or otherwise has preferred status on the plan's 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.

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