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 2 years1-3

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 with responses observed at Week 4, up to 2 years1-3

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

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 and Patient Global Assessment of disease activity; ASDAS=Ankylosing Spondylitis Disease Activity Score; 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 RATES1-4

Week 14
Week 104

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 Study Details
See ASAS40 Criteria
See Footnotes and Definitions

SELECT-AXIS 2 Study 1: AS ASAS40 Response up to 2 Years1-3
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD-IR patients
82% of RINVOQ AS patients achieved ASAS40 at 2 Years3

SELECT-AXIS 2 Study 1: AS ASAS40 Response up to 2 Years1-3
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD-IR patients
82% of RINVOQ AS patients achieved ASAS40 at 2 Years3

SELECT-AXIS 2: ASAS40 Response as observed through week 104.

RINVOQ is indicated for TNFi-IR patients

‡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 domain2:

ASAS Domains

  • Total back pain‡
  • Inflammation (morning stiffness)§
  • Physical function (BASFI)
  • Patient global assessment of disease activity

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.3

In an 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.

‡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.

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

ASDAS-LOW DISEASE ACTIVITYRATES2-4

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: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 104

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 Study Details
See ASDAS-CRP Criteria
See Footnotes and Definitions

SELECT-AXIS 2 Study 1: AS ASDAS-CRP LDA and rates up to 2 years1-3
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD-IR patients
71% of RINVOQ AS patients achieved Low Disease Activity at 2 Years3

SELECT-AXIS 2 Study 1: AS ASDAS-CRP LDA and rates up to 2 years1-3
ALL DATA ARE OBSERVED CASES (AO)
A study in biologic DMARD-IR patients
71% of RINVOQ AS patients achieved Low Disease Activity at 2 Years3

SELECT-AXIS 2: ASDAS-CRP Low Disease Activity (LDA) as observed through week 104.

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.

See Study Details
See ASDAS-CRP Criteria
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 Study Details
See ASDAS-CRP Criteria
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