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-AxSpA1,3,5

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 2, up to 1 year1,3,5

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 2, up to 1 year1,3,5

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

 

SELECT-AXIS 2: Clinical Trial Overview

*Mixed=67% bDMARD-naïve & 33 % bDMARD-IR3
P<0.00015

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.

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 RATES1,3-5

RAPID Improvement in ASAS401,3-5

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response (NRI-MI)1,3-5
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response (NRI-MI)1,3-5
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-IR3
P<0.00015
P<0.05; P-value obtained through nominal statistical testing.5

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)

Responses observed as early asweek 2

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.

DURABLE ASAS40 Rates1,3,4

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 521,3,4
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 521,3,4
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-IR3

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.

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.

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 52
(NRI-MI)1,3-5
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 52 (NRI-MI)1,3-5
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-IR3

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

P <0.00015
P <0.05; P-value obtained through nominal statistical testing5
§ 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.

ASDAS-LOW DISEASE ACTIVITYRATES3,4

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA)(NRI-MI)3,4
A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA)(NRI-MI)3,4
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-IR3
P<0.00013

ASDAS-CRP measures:3

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

ASDAS Disease Activity States4

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

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:3

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

ASDAS Disease Activity States4

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

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

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.

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

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-IR3

ASDAS-CRP measures:6

  • 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

ASDAS-CRP measures:6

  • 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

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

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.

SELECT-AXIS 2 Study 2: nr-axSpA ASDAS-CRP Low Disease Activity (LDA) up to Week 52 (NRI-MI)6
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)6
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-IR3
P <0.00013
§RINVOQ (n=156); Placebo (n=154)3

ASDAS-CRP measures:6

  • 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 52

RINVOQ patients:
-1.80 (n=154)

Placebo patients: -1.23 (n=156)9

Mean baseline
ASDAS-CRP
score

RINVOQ patients:
3.6

Placebo patients:
3.7

ASDAS-CRP measures:6

  • 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 52

RINVOQ patients: -1.80 (n=154)

Placebo patients: -1.23 (n=156)9

Mean baseline ASDAS-CRP score

RINVOQ patients: 3.6

Placebo patients: 3.7

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.

BASDAI50 RATES3,4

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-IR3
P≤0.0014

BASDAI50 reflects a ≥50% improvement in BASDAI from baseline5

BASDAI Components

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

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.

DURABLE BASDAI50 Rates 4

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-IR3

BASDAI50 reflects a ≥50% improvement in BASDAI from baseline5

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.

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-IR3
P≤0.0013
RINVOQ (n=156); Placebo (n=157)3

BASDAI50 reflects a ≥50% improvement in BASDAI from baseline5

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.

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RINVOQ SAFETY DATA

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