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

Powerful
disease
control
in NR-AxSpA1

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 21-3

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 21-3

Primary endpoint
ASAS40
Key secondary endpoints
ASDAS-CRP Low Disease Activity (LDA)
BASDAI50

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; BASDAI50=a 50% improvement of the initial Bath Ankylosing Spondylitis Disease Activity Index score; BASFI=Bath Ankylosing Spondylitis Functional Index; CRP=C-reactive protein; nr-axSpA=non-radiographic axial spondyloarthritis; TNFi=tumor necrosis factor inhibitor

Clinical Trial Overview

Clinical Trial Overview

 

SELECT-AXIS 2: Clinical Trial Overview

*Mixed=67% bDMARD-naïve & 33 % bDMARD-IR3
†P<0.00018

SELECT-AXIS 2 Study 2: nr-axSpA Design Intro:2,3
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 Study Details

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; DMARD=disease-modifying antirheumatic drug; IR=intolerance or inadequate response; nr-axSpA=non-radiographic axial spondyloarthritis; NRI-MI=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; NSAID=nonsteroidal anti-inflammatory drug; QD=once per day; TNFi=tumor necrosis factor inhibitor

powerful
DISEASE CONTROL
ACHIEVED

ASAS40 response rates at Week 141

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response1,3
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 2:
nr-axSpA ASAS40 Response1,3
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

Nearly half (44.9%) of nr-axSpA mixed* biologic patients achieved ASAS40 primary endpoint at Week 14 (vs placebo 22.3%, p<0.0001)1,8

SELECT-AXIS 2 Study 2: ASAS40 Response

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P<0.00018
‡P<0.05; P-value obtained through nominal statistical testing.8

ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain:3

ASAS Domains

  • Total back pain§
  • Inflammation (Morning Stiffness)||
  • Physical function (BASFI)
  • Patient Global Assessment of disease activity

§Total back pain defined on an NRS (0-10) based on the following question: "What is the amount of back pain that you experienced at any time during the last week?"
||Mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness.

Nearly half (44.9%) of nr-axSpA mixed* biologic patients achieved ASAS40 primary endpoint at Week 14 (vs placebo 22.3%, p<0.0001)1,8

Data LIMITATIONS: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 ASAS40 Criteria
See Study Details
See Footnotes and Definitions

DEMONSTRATED
improvement
Across ASAS DOMAINS
VS PLACEBO AT WEEK 14

ASAS Individual Domains1-3

SELECT-AXIS 2 Study 2: nr-axSpA ASAS Domains1-3
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 2:
nr-axSpA ASAS Domains1-3
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

Greater improvements across ASAS domains with RINVOQ vs placebo at Week 142

SELECT-AXIS 2 Study 2: ASAS40 Domains SELECT-AXIS 2 Study 2: ASAS40 Domains SELECT-AXIS 2 Study 2: ASAS40 Domains

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P<0.0013
‡P<0.0001; P-value obtained through nominal statistical testing.3
§P<0.00013
P<0.001; P-value obtained through nominal statistical testing.3
aTotal back pain defined on a numeric rating scale (0–10) based on the following question: “What is the amount of back pain that you experienced at any time during the last week?”3
bInflammation (Morning Stiffness) defined as the mean of BASDAI questions 5 and 6 on severity and duration of morning stiffness.3

Greater improvements across ASAS domains with RINVOQ vs placebo at Week 142

DATA LIMITATIONS3: Data labeled as a primary or ranked secondary endpoint at Week 14 were multiplicity-controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

See ASAS40 Criteria
See Study Details
See Footnotes and Definitions

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P<0.0013
‡P<0.0001; P-value obtained through nominal statistical testing.3
§P<0.00013
P<0.001; P-value obtained through nominal statistical testing.3
aTotal back pain defined on a numeric rating scale (0–10) based on the following question: “What is the amount of back pain that you experienced at any time during the last week?”3
bInflammation (Morning Stiffness) defined as the mean of BASDAI questions 5 and 6 on severity and duration of morning stiffness.3

low disease activity achieved at week 14

42% of nr-axSpA mixed* biologic patients achieved ASDAS-CRP LDA at Week 141,3

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA)3
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 2:
nr-axSpA ASDAS-CRP
Low Disease Activity (LDA)3
A study in mixed* biologic patients

RINVOQ is indicated for
TNFi-IR patients

Greater than 2x of
RINVOQ patients met
LDA at Week 14 vs placebo3

SELECT-AXIS 2 Study 2: ASDAS-CRP Low Disease Activity (LDA) through Week 14

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P<0.00013

ASDAS-CRP measures:4

  • Spinal pain (back, neck, hips)
  • Duration of morning stiffness
  • Peripheral joint pain/swelling
  • Patient Global Assessment of disease activity
  • CRP

ASDAS Disease Activity States5

ASDAS Disease Activity States: Inactive Disease; Low Disease Activity; High Disease Activity; Very High Disease Activity

Change from baseline (MMRM) ASDAS-CRP score at Week 14
(Ranked Secondary Endpoint)

RINVOQ patients: -1.36 (n=154)

Placebo patients: -0.71 (n=156)


Mean baseline
ASDAS-CRP
score

RINVOQ patients:
3.6

Placebo patients:
3.7

ASDAS-CRP measures:4

  • Spinal pain (back, neck, hips)
  • Duration of morning stiffness
  • Peripheral joint pain/swelling
  • Patient Global Assessment of disease activity
  • CRP

ASDAS Disease Activity States7

ASDAS Disease Activity States: Inactive Disease; Low Disease Activity; High Disease Activity; Very High Disease Activity

Change from baseline (MMRM)
ASDAS-CRP score at Week 14
(Ranked Secondary Endpoint)

RINVOQ patients: -1.36 (n=154)

Placebo patients: -0.71 (n=156)

Mean baseline ASDAS-CRP score

RINVOQ patients: 3.6

Placebo patients: 3.7

Get A Summary
Of The Low Disease
Activity (LDA) Data

Disease Activity Brochure

Greater than 2x of RINVOQ patients met LDA at Week 14 vs placebo3

DATA LIMITATIONS:3 Data labeled as a ranked secondary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

See ASDAS-CRP Criteria
See Study Details
See Footnotes and Definitions

SIGNIFICANTLY
GREATER
BASDAI50 RESPONSE
RATE ACHIEVED

RINVOQ vs placebo at Week 146

SELECT-AXIS 2 Study 2: nr-axSpA BASDAI50 response rates6
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 2:
nr-axSpA BASDAI50 response rates6
A study in mixed* biologic patients

RINVOQ is indicated for
TNFi-IR patients

42% of RINVOQ patients achieved BASDAI50 at
Week 146

SELECT-AXIS 2 Study 2: BASDAI50 Response Rates at Week 14

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P<0.00016

BASDAI50 reflects a ≥50% improvement in BASDAI from baseline7

BASDAI Components

  • Fatigue
  • Spinal pain
  • Peripheral joint pain and swelling
  • Enthesitis
  • Severity of morning stiffness
  • Duration of morning stiffness

42% of RINVOQ
patients achieved
BASDAI50 at Week 146

DATA LIMITATIONS:3 Data labeled as a primary or ranked secondary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

See BASDAI50 Criteria
See Study Details
See Footnotes and Definitions
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RINVOQ SAFETY DATA

Review the safety profile of RINVOQ,
including both short- and long-term analyses

SEE SAFETY PROFILE