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

IMPROVEMENT
IN BACK PAIN IN NR-AxSpA1

Treatment with RINVOQ results in improvement from baseline
in Total & Nocturnal back pain at Week 14 with responses observed up to 2 years2,3

IR=intolerance or inadequate response;
nr-axSpA=non-radiographic axial spondyloarthritis; TNFi=tumor necrosis factor inhibitor


Treatment with RINVOQ results in
improvement from baseline in
Total & Nocturnal back pain
, at week 14 with responses observed up to 2 years2,3


IR=intolerance or inadequate response; MRI=magnetic resonance imaging; nr-axSpA=non-radiographic axial spondyloarthritis; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor


Clinical Trial Overview

 

SELECT-AXIS 2 Study 2: Clinical Trial Overview

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.00014

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

ΔTotal Back Pain ranked secondary endpoint at Week 14 with response rates up to 2 years2,3

SELECT-AXIS 2
Study 2: nr-axSpA
ΔTotal Back Pain from Baseline up to 2 years (MMRM)2-6,*

SELECT-AXIS 2 Study 2: nr-axSpA ΔTotal Back Pain from Baseline up to 2 years (MMRM)2,3,*

A study in mixed* biologic patients

41 Percent
improvement
(n=143) vs 28% (n=148) with placebo at Week 14 as
observed and
64% improvement
(n=124) at 2 years as observed3

SELECT-AXIS 2 Study 2: Total Back Pain over time up to 104 weeks.

RINVOQ is indicated for TNFi-IR patients

*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=0.00042

RINVOQ is indicated for TNFi-IR patients

*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=0.00042

41 Percent
improvement
(n=143) vs 28% (n=148) with placebo at Week 14 as
observed and
64% improvement
(n=124) at 2 years as observed3

DATA LIMITATIONS:4 Data labeled as 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 PAIN
1

ΔNocturnal Back Pain ranked secondary endpoint at Week 14 with response rates up to 2 years2,3

SELECT-AXIS 2
Study 2: nr-axSpA
ΔNocturnal Back Pain from Baseline up to 2 years (MMRM)2,3,*

A study in mixed* biologic patients

SELECT-AXIS 2 Study 2: nr-axSpA ΔNocturnal Back Pain from Baseline up to 2 years (MMRM)2,3,*

A study in mixed* biologic patients

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

SELECT‑AXIS 2 Study 2: Nocturnal Back Pain over time up to 104 weeks.

RINVOQ is indicated for TNFi-IR patients

*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?”2
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
P<0.0013

RINVOQ is indicated for TNFi-IR patients

*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?”2
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
P<0.0012

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

DATA LIMITATIONS:2 Data labeled as 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.

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RINVOQ SAFETY DATA

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