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 AS1

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 41,2

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 41,2

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

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

Clinical Trial Overview

Clinical Trial Overview

 

SELECT-AXIS 2: Clinical Trial Overview

*P<0.00012

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 two NSAIDs and 1 or 2 bDMARDs. Patients were randomized to receive RINVOQ 15 mg once daily or placebo. Patients could continue background NSAIDs. The primary endpoint was proportion of patients achieving ASAS40 response at Week 14 vs placebo.

See Study Details

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; DMARD=disease-modifying antirheumatic drug; 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 1: AS ASAS40 Response1,2
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 1: AS
ASAS40 Response1,2
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

Nearly half (44.5%) of AS bDMARD-IR patients achieved ASAS40 primary endpoint at Week 141,2

SELECT-AXIS 2: ASAS40 Response

*P<0.00012
†P≤0.05; P-value obtained through nominal statistical testing.2

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?"2
§Defined as mean of BASDAI questions 5 and 6.

Nearly half (44.5%) of AS bDMARD-IR patients achieved ASAS40 primary endpoint at Week 14 (vs placebo 18.2%, p<0.0001)1,2

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?"2
§Defined as mean of BASDAI questions 5 and 6.

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

DEMONSTRATED
improvement
Across ASAS DOMAINS
VS PLACEBO AT WEEK 14

ASAS Individual Domains2-4

SELECT-AXIS 2 Study 1: AS ASAS Domains2-4
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 1: AS
ASAS Domains2-4
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

Greater improvements across ASAS domains with RINVOQ vs placebo at Week 14

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

*P<0.0001; P-value obtained through nominal statistical testing.4
†P<0.0001; P-value obtained through nominal statistical testing.4
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?”.2
bInflammation (Morning Stiffness) defined as the mean of BASDAI questions 5 and 6 on severity and duration of morning stiffness.2

Greater improvements across ASAS domains with RINVOQ vs placebo at Week 14

DATA LIMITATIONS:2 Data labeled as a 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

*P<0.0001; P-value obtained through nominal statistical testing.4
†P<0.0001; P-value obtained through nominal statistical testing.4
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?”.2
bInflammation (Morning Stiffness) defined as the mean of BASDAI questions 5 and 6 on severity and duration of morning stiffness.2

low disease activity achieved at week 142,5

44% of biologic DMARD-IR
patients achieved
ASDAS-CRP LDA at Week 14

SELECT-AXIS 2 Study 1: AS ASDAS-CRP Low Disease Activity (LDA)2,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 1: AS
ASDAS-CRP Low Disease
Activity (LDA)2,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for
TNFi-IR patients

4x of RINVOQ patients
met ASDAS-CRP LDA at Week 14 vs placebo2

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

*P<0.00015

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 144
(Ranked Secondary Endpoint)

RINVOQ patients: -1.52

Placebo patients: -0.49


Mean baseline
ASDAS-CRP
score2

RINVOQ patients: 3.9

Placebo patients: 3.9

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 144
(Ranked Secondary Endpoint)

RINVOQ patients: -1.52

Placebo patients: -0.49

Mean baseline ASDAS-CRP score2

RINVOQ patients: 3.9

Placebo patients: 3.9

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

AS Disease Activity Brochure

4x of RINVOQ patients met ASDAS-CRP LDA at Week 14 vs placebo2

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

SIGNIFICANTLY
GREATER
BASDAI50 RESPONSE
RATE ACHIEVED

RINVOQ vs placebo at Week 142,5

SELECT-AXIS 2 Study 1: AS BASDAI50 Response Rates1,2,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 1: AS
BASDAI50 Response Rates1,2,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for
TNFi-IR patients

43% of RINVOQ patients achieved BASDAI50 at
Week 142,5

SELECT-AXIS 2: BASDAI50 Response Rates at Week 14

*P<0.00015

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

*P<0.00015

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

43% of RINVOQ
patients achieved
BASDAI50 at Week 142,5

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 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