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

RAPID & DURABLE
DISEASE CONTROL

in NR-AxSpA1-3

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 2, up to 1 year1-3

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 2, up to 1 year1-3

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-IR2
†P<0.00013

SELECT-AXIS 2 Study 2: nr-axSpA Design Intro:1,2
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

ASAS40 RATES1-4

Week 14
Week 52

RAPID Improvement in ASAS401-4

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response (NRI-MI)1-4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response (NRI-MI)1-4
A study in mixed* biologic 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)

Responses observed as early as week 2

SELECT-AXIS 2: ASAS40 Response through week 14

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00013
‡P<0.05; P-value obtained through nominal statistical testing.3

ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain:2

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)

Responses observed as early asweek 2

Data LIMITATIONS:2 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

DURABLE ASAS40 Rates1,2,4

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 521,2,4
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 521,2,4
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients

77.3 Percentof RINVOQ nr-axSpA patients achieved ASAS40 at 1 year4

SELECT-AXIS 2: ASAS40 Response as observed through week 52

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2

ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain:2

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.

77.3 Percent

of RINVOQ nr-axSpA patients achieved ASAS40 at 1 year4

In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

See ASAS40 Criteria
See Study Details
See Footnotes and Definitions
AS OBSERVED
NRI-MI

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 52
(NRI-MI)1-4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 52 (NRI-MI)1-4
A study in mixed* biologic patients

SELECT-AXIS 2: ASAS40 Response NRI-MI through week 52

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2

ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain:2

ASAS Domains

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

†P <0.00013
‡P <0.05; P-value obtained through nominal statistical testing3
§ 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.

Data LIMITATIONS: 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

ASDAS-LOW DISEASE ACTIVITYRATES2,4

ASDAS-LDA is a composite measure of disease activity in nr-axSpA that assess common patient symptoms and an objective sign of inflammation.

ASDAS-CRP disease activity state components:5

A patient's ASDAS-CRP score is calculated by assessing the following components on a numerical rating scale (from 0 to 10):

  • Back Pain
  • Duration of Morning Stiffness
  • Patient Global Assessment
  • Peripheral Joint Pain/Swelling
  • Inflammation (CRP)

ASDAS Disease Activity States6

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

ASDAS low disease activity (LDA) is one of 4 disease activity states defined by the above cutoffs in the ASDAS score.

Achieving ASDAS-LDA may indicate disease control—making it a measure to strive for in patients with AS or nr-axSpA

Week 14
Week 52

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA) (NRI-MI)2,4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA) (NRI-MI)2,4
A study in mixed* biologic patients

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

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012

  nr-axSpA Patients
ASDAS-CRP Score Placebo
(n=156)		 RINVOQ
(n=154)
Mean baseline 3.7 3.6
Change in baseline at
Week 14 (MMRM)
(Ranked Secondary Endpoint)		 -0.71 -1.36

DATA LIMITATIONS:2 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

DURABLE
ASDAS-CRP Low Disease Activity Rates4

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA) up to Week 524
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA) up to Week 524
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients

~99 Percent

of nr-axSpA patients started in high (44.9%) or very high (54.5%) disease activity at baseline7

70.3 Percentof RINVOQ nr-axSpA patients achieved Low Disease Activity at 1 year4

SELECT-AXIS 2 Study 2: ASDAS-CRP Low Disease Activity (LDA) as observed through week 52

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2

In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

 

70.3 Percent

of RINVOQ nr-axSpA patients achieved Low Disease Activity at
1 year4

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

Disease Activity Brochure
See ASDAS-CRP Criteria
See Study Details
See Footnotes and Definitions
AS OBSERVED
NRI-MI

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA) up to Week 52 (NRI-MI)4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA) up to Week 52 (NRI-MI)4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: ASDAS-CRP Low Disease Activity (LDA) NRI-MI through week 52

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P <0.00012
§RINVOQ (n=156); Placebo (n=154)2

DATA LIMITATIONS: 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 ASDAS-CRP Criteria
See Study Details
See Footnotes and Definitions

BASDAI50 RATES2,4

Week 14
Week 52

SELECT-AXIS 2 Study 2: nr-axSpA BASDAI50 response rates (NRI-MI)4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA BASDAI50 response rates (NRI-MI)4
A study in mixed* biologic patients

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

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P≤0.0014

BASDAI50 reflects a ≥50% improvement in BASDAI from baseline8

BASDAI Components

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

DATA LIMITATIONS:2 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

DURABLE BASDAI50 Rates4

SELECT-AXIS 2 Study 2: nr-axSpA BASDAI50 response rates up to Week 524
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA BASDAI50 response rates up to Week 524
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients

68.2 Percentof RINVOQ nr-axSpA patients achieved BASDAI50 at 1 year4

SELECT-AXIS 2 Study 2: BASDAI50 Response Rates as observed through week 52

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2

BASDAI50 reflects a ≥50% improvement in BASDAI from baseline8

BASDAI Components

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

68.2 Percent

of RINVOQ nr-axSpA patients achieved BASDAI50 at 1 year4

In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

See BASDAI50 Criteria
See Study Details
See Footnotes and Definitions
AS OBSERVED
NRI-MI

SELECT-AXIS 2 Study 2: nr-axSpA BASDAI50 response rates up to Week 52 (NRI-MI)4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA BASDAI50 response rates up to Week 52 (NRI-MI)4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: BASDAI50 Response Rates NRI-MI through week 52

RINVOQ is indicated for
TNFi-IR patients

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
‡P≤0.0012
‖RINVOQ (n=156); Placebo (n=157)2

BASDAI50 reflects a ≥50% improvement in BASDAI from baseline8

BASDAI Components

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

DATA LIMITATIONS: 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 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