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

Control that’s fast and shown to last
RINVOQ has achieved >95% preferred national commercial coverage

AS & NR-AXSPA patients met ASAS40 at Week 14 (Primary Endpoint) and Disease Control through ASDAS Low Disease Activity at Week 14 (Ranked Secondary Endpoint) with responses observed at 2 years1,3-7

EXPLORE AS DATA
EXPLORE nr-axSpA DATA

*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.

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 and patient global assessment of disease activity; ASDAS=Ankylosing Spondylitis Disease Activity Score; 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.8

Axial Spondyloarthritis includes both AS and nr-axSpA

Ankylosing Spondylitis requires radiographic evidence of sacroiliitis8

RAPID IMPROVEMENT IN ASAS40 AT WEEK 141,5,6

Responses observed as early as Week 4 (AS) and Week 2 (nr-axSpA)1,5-7

Significant ASAS40 Response vs placebo at Week 141,5,6

 

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):1,5-7
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:1,5
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:1,6
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:5,6 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
Background Therapy

*P<0.00015,7
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR6
‡P<0.00015,7
§P<0.05; P-value obtained through nominal statistical testing.5,7

 

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

Yellow Stroke Image Bottom

CONTROL THAT'S FAST AND SHOWN TO LAST

AS & NR-AXSPA patients met ASAS40 at Week 14 (Primary Endpoint) and Disease Control
through ASDAS Low Disease Activity at Week 14 (Ranked Secondary Endpoint) with responses observed at 2 years1,3-6

RAPID & DURABLE CONTROL1,3-7

  • ASAS40 Primary Endpoint at Week 14, with responses observed at Week 4 (AS) and Week 2 (nr‑axSpA), and up to 2 years
  • ASDAS Low Disease Activity at Week 14 with responses observed at 2 years

WELL-STUDIED SAFETY1,9,†

  • Safety data from 25 clinical trials across 7 indications
  • >7.5 years max. exposure in RA (~4.2 years median) to RINVOQ 15 mg as of 8/15/23†

EXCEPTIONAL ACCESS AND PATIENT SUPPORT2

  • >95% preferred national commercial and Medicare Part D formulary coverage under the pharmacy benefit as of December 20232‡,§
  • 1:1 support to help AS and nr-axSpA patients start and stay on track with their prescribed treatment plan

*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 trial, 1 phase 2 and 3 phase 3 AD trials, 3 phase 3 UC trials, and 1 phase 2 and 3 phase 3 CD 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 30 mg; UC: RINVOQ 15 mg, 30 mg, and 45 mg; CD: 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 and CD.9

†In PsA: ~5.7 years maximum exposure (~3.7 years median) to RINVOQ 15 mg as of 08/2023. In AS: ~3.8 years maximum exposure (~1.7 years median) to RINVOQ 15 mg as of 08/2023. In nr‑axSpA: ~3.4 years maximum exposure (~1.1 years median) to RINVOQ 15 mg as of 08/2023.9

‡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; CD=Crohn's disease; 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