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 AS1-3

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 with responses observed at Week 4, up to 1 year1-3

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 with responses observed at Week 4, up to 1 year1-3

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

ASAS40 RATES1-3

Week 14
Week 52

RAPID Improvement in ASAS401,2

SELECT-AXIS 2 Study 1: AS ASAS40 Response 
(NRI-MI)1,2
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ASAS40 Response (NRI-MI)1,2
A study in biologic DMARD‑IR patients

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

Responses observed as early as Week 4

SELECT-AXIS 2: ASAS40 Response through week 14

RINVOQ is indicated for
TNFi-IR patients

*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)

Responses observed as early asWeek 4

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

DURABLE ASAS40 Rates1-3

SELECT-AXIS 2 Study 1: AS ASAS40 Response up to Week 521-3
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ASAS40 Response up to Week 521-3
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD‑IR patients

74 Percentof RINVOQ AS patients achieved ASAS40 at 1 year3

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

RINVOQ is indicated for
TNFi-IR patients

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.

74 Percent

of RINVOQ AS patients achieved ASAS40 at 1 year3

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.

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.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

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

SELECT-AXIS 2 Study 1: AS ASAS40 Response up to Week 52 (NRI-MI)1-3
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ASAS40 Response up to Week 52 (NRI-MI)1-3
A study in biologic DMARD‑IR patients

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

RINVOQ is indicated for
TNFi-IR patients

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<0.00012,3
‡P<0.05;P-value obtained through nominal statistical testing2,3
§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.

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<0.00012,3
‡P<0.05; P-value obtained through nominal statistical testing2,3
§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: 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.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

See ASAS40 Criteria
See Study Details
See Footnotes and Definitions

ASDAS-LOW DISEASE ACTIVITYRATES2,3

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

ASDAS-CRP disease activity state components:4

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 States5

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 1: AS ASDAS-CRP Low Disease Activity (LDA)
(NRI-MI)2
A study in biologic DMARD‑IR patients

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

Change from baseline (MMRM) ASDAS-CRP score:

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

RINVOQ is indicated for
TNFi-IR patients

*P<0.00012

  AS Patients
ASDAS-CRP Score Placebo
(n=209)		 RINVOQ
(n=211)
Mean baseline 3.9 3.9
Change in baseline at
Week 14 (MMRM)
(Ranked Secondary Endpoint)		 -0.49 -1.52

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 Rates3

SELECT-AXIS 2 Study 1: AS ASDAS-CRP Low Disease Activity (LDA) up to Week 523
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ASDAS-CRP Low Disease Activity (LDA) up to Week 523
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD‑IR patients

~99 percent

of AS patients started in high (30.8%) or very high (68.7%) disease activity at baseline6

66 Percentof RINVOQ AS patients achieved Low Disease Activity at 1 year3

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

RINVOQ is indicated for
TNFi-IR patients

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.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

66 Percent

of RINVOQ AS patients achieved Low Disease Activity at
1 year3

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

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

DURABLE ASDAS-CRP Low Disease Activity Rates3

SELECT-AXIS 2 Study 1: AS ASDAS-CRP Low Disease Activity (LDA) up to Week 52 (NRI-MI)3
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ASDAS-CRP Low Disease Activity (LDA) up to Week 52 (NRI-MI)3
A study in biologic DMARD‑IR patients

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

RINVOQ is indicated for
TNFi-IR patients

†P<0.00012

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.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

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

BASDAI50 RATES2,3

Week 14
Week 52

SELECT-AXIS 2 Study 1: AS BASDAI50 Response Rates (NRI-MI)2,3
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS BASDAI50 Response Rates (NRI-MI)2,3
A study in biologic DMARD‑IR patients

SELECT-AXIS 2: BASDAI50 Response Rates through Week 14

RINVOQ is indicated for
TNFi-IR patients

*P<0.00012

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

*P<0.00012

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

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

DURABLE BASDAI50 Rates2,3

SELECT-AXIS 2 Study 1: AS BASDAI50 Response Rates up to Week 523
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS BASDAI50 Response Rates up to Week 523
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD‑IR patients

65 Percentof RINVOQ AS patients achieved BASDAI50 at
1 year3

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

RINVOQ is indicated for
TNFi-IR patients

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

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

65 Percent

of RINVOQ AS patients achieved BASDAI50 at 1 year3

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.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

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

DURABLE BASDAI50 Rates2,3

SELECT-AXIS 2 Study 1: AS BASDAI50 Response Rates up to Week 52
(NRI-MI)2,3
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS BASDAI50 Response Rates up to Week 52 (NRI-MI)2,3
A study in biologic DMARD‑IR patients

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

RINVOQ is indicated for
TNFi-IR patients

†P<0.00012

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

†P<0.00014

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

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.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

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