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 IMPROVEMENT
IN ASAS40 FOR NR-AxSpA1,2

  • ASAS40 Primary Endpoint at Week 14
    (44.9% vs 22.3% placebo, p<0.0001)1,2,5
  • ASAS40 Responses observed as early as Week 2
    (12% vs 6% placebo, p≤0.05*)1,2,5

Treatment with RINVOQ results in improvement from baseline
in Total & Nocturnal back pain, Inflammation (Morning Stiffness),
hs-CRP, and Physical Function (BASFI) at Week 141,2

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; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; nr-axSpA=non-radiographic axial spondyloarthritis; TNFi=tumor necrosis factor inhibitor

*P-value obtained through nominal statistical testing.2

Treatment with RINVOQ results in
improvement from baseline in
Total & Nocturnal back pain
,
Inflammation (Morning Stiffness),
hs-CRP, and
Physical Function (BASFI) at Week 141,2


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; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; nr-axSpA=non-radiographic axial spondyloarthritis; TNFi=tumor necrosis factor inhibitor

*P-value obtained through nominal statistical testing.2

Clinical Trial Overview

 

SELECT-AXIS 2 Study 2: Clinical Trial Overview

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.00015

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.

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

improvement in total back pain1
As measured by ΔTotal Back Pain from baseline at Week 14 vs placebo2

SELECT-AXIS 2
Study 2: nr-axSpA
Total Back Pain2,*
A study in mixed biologic patients

RINVOQ is indicated
for TNFi-IR patients

SELECT-AXIS 2 Study 2: nr-axSpA Total Back Pain2,*
A study in mixed biologic patients

RINVOQ is indicated for TNFi-IR patients


(n=143)
improvement
vs. 28% (n=148) with
placebo at Week 14
(as observed)
3

SELECT-AXIS 2 Study 2: Total Back Pain over time

*Total 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

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

P<0.0012

§RINVOQ (n=143); Placebo (n=148)2

41
(n=143)
improvement
vs. 28% (n=148) with
placebo at Week 14
(as observed)
3

DATA LIMITATIONS:2 Data labeled as a primary and 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.

improvement in NOCTURNAL BACK PAIN2
As measured by ΔNocturnal Back Pain from baseline up to Week 14 vs placebo

SELECT-AXIS 2
Study 2: nr-axSpA
Nocturnal Back Pain2,*
A study in mixed biologic patients

RINVOQ is indicated
for TNFi-IR patients

SELECT-AXIS 2 Study 2: nr-axSpA Nocturnal Back Pain2,*
A study in mixed biologic patients

RINVOQ is indicated for TNFi-IR patients


(n=138)
improvement
vs. 26% (n=146) with
placebo at Week 14
(as observed)
3

SELECT‑AXIS 2 Study 2: Nocturnal Back Pain over time

*Nocturnal back pain defined on a numeric rating scale (0–10) based on the following question: “What is the amount of back pain at night that you experienced during the last week?”4
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.0012
§RINVOQ (n=140); Placebo (n=146)2

44
(n=138)
improvement
vs. 26% (n=146) with
placebo at Week 14
(as observed)
3

DATA LIMITATIONS:2 Data labeled as a primary and 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.

improvement IN Objective and Patient-Reported MEASURES OF INFLAMMATION1
As measured by Δhs-CRP and ΔInflammation (Morning Stiffness)
from baseline up to Week 14 vs placebo2

Objective Measure

SELECT-AXIS 2 Study 2: nr-axSpA hs-CRP2
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 2:
nr-axSpA hs-CRP2
A study in mixed* biologic patients

RINVOQ is indicated for
TNFi-IR patients

SELECT-AXIS 2 Study 2: hs-CRP at Week 14
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†RINVOQ (n=144); Placebo (n=136)2
P<0.0001; P-value obtained through nominal statistical testing.2

DATA LIMITATIONS:2 Data labeled as a primary endpoint at Week 14 were multiplicity-controlled. Prespecified nonranked endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established.

Patient-Reported
Outcome

Patient-Reported Outcome

SELECT-AXIS 2 Study 2:
nr-axSpA Inflammation (Morning Stiffness)2,*
A study in mixed biologic patients

RINVOQ is indicated for
TNFi-IR patients


(n=143)
improvement
vs. 29% (n=148) with
placebo at Week 14
(as observed)
3

SELECT-AXIS 2 Study 2: nr-axSpA Inflammation (Morning Stiffness)2,*
A study in mixed biologic patients

RINVOQ is indicated for TNFi-IR patients

SELECT‑AXIS 2 Study 2: Inflammation over time

*Inflammation defined as the mean of BASDAI questions 5 and 6 on severity and duration of morning stiffness.2
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.0001; P-value obtained through nominal statistical testing.2
§RINVOQ (n=143); Placebo (n=148)2

46
(n=143)
improvement
vs. 29% (n=148) with
placebo at Week 14
(as observed)
3

*Inflammation defined as the mean of BASDAI questions 5 and 6 on severity and duration of morning stiffness.2
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.0001; P-value obtained through nominal statistical testing.2
§RINVOQ (n=143); Placebo (n=148)2

improvementIN Physical FUNCTION
FOR PATIENTS

As measured by ΔBASFI from baseline up to Week 14 vs placebo2

SELECT-AXIS 2 Study 2: nr-axSpA BASFI1,2
A study in mixed* biologic patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 2:
nr-axSpA BASFI1,2
A study in mixed* biologic patients

RINVOQ is indicated for
TNFi-IR patients


(n=143)
improvement
vs. 23% (n=148) with
placebo at Week 14
(as observed)
3

SELECT-AXIS 2 Study 2: BASFI

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.00012
‡RINVOQ (n=143); Placebo (n=148)2

44
(n=143)
improvement
vs. 23% (n=148) with
placebo at Week 14
(as observed)
3

DATA LIMITATIONS:2 Data labeled as a primary and 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.

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.00012
‡RINVOQ (n=143); Placebo (n=148)2

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RINVOQ SAFETY DATA

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