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

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.

See Study Details

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.

See Study Details
See Total Back Pain Criteria
See Footnotes and Definitions

improvement  in
NOCTURNAL BACK PAIN1

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.

See Study Details
See Nocturnal Back Pain 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

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