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 PAIN, INFLAMMATION, PHYSICAL FUNCTION IN NR-AxSpA1,2
Treatment with RINVOQ results in improvement from baseline
in Total & Nocturnal back pain, Inflammation (Morning Stiffness),
hs-CRP , SPARCC-MRI, and Physical Function (BASFI) at Week 141,2
BASFI=Bath Ankylosing Spondylitis Functional Index; hs-CRP=high-sensitivity C-reactive protein; 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
Treatment with RINVOQ results in
improvement from baseline in
Total & Nocturnal back pain,
Inflammation (Morning Stiffness),
hs-CRP, SPARCC-MRI, and
Physical Function (BASFI) at Week 141,2
BASFI=Bath Ankylosing Spondylitis Functional Index; hs-CRP=high-sensitivity C-reactive protein; 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
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00017
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 1 year2,3
SELECT-AXIS 2
Study 2: nr-axSpA
ΔTotal Back Pain from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed† biologic patients
SELECT-AXIS 2 Study 2: nr-axSpA ΔTotal Back Pain from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed† biologic patients
improvement
(n=143) vs 28% (n=148) with placebo at Week 14 as
observed and
59% improvement
(n=132) vs 47% (n=134) with placebo at 1 year as observed4
RINVOQ is indicated for
TNFi-IR patients
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
improvement
(n=143) vs 28% (n=148) with placebo at Week 14 as
observed and
59% improvement
(n=132) vs 47% (n=134) with placebo at 1 year as observed4
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.
improvement in
NOCTURNAL BACK PAIN1
ΔNocturnal Back Pain ranked secondary endpoint at Week 14 with response rates
up to 1 year2,3
SELECT-AXIS 2
Study 2: nr-axSpA
ΔNocturnal Back Pain from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed† biologic patients
SELECT-AXIS 2 Study 2: nr-axSpA ΔNocturnal Back Pain from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed† biologic patients
improvement
(n=138) vs 26% (n=146) with placebo at Week 14 as
observed and
62% improvement
(n=130) vs 50% (n=132) with placebo at 1 year as observed4
RINVOQ is indicated for
TNFi-IR patients
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?”6
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
‡P<0.0012
improvement
(n=138) vs 26% (n=146) with placebo at Week 14 as
observed and
62% improvement
(n=130) vs 50% (n=132) with placebo at 1 year as observed4
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.
improvement IN Patient-Reported and Objective MEASURES
OF INFLAMMATION1
ΔInflammation (Morning Stiffness) and Δhs-CRP at Week 14 with response rates
up to 1 year2,5
Patient-Reported
Outcome
Patient-Reported Outcome
SELECT-AXIS 2 Study 2: nr-axSpA ΔInflammation (Morning Stiffness) from Baseline up to Week 52 (MMRM)2,5,*
A study in mixed† biologic patients
SELECT-AXIS 2 Study 2:
nr-axSpA ΔInflammation (Morning Stiffness) from Baseline up to Week 52 (MMRM)2,5,*
A study in mixed† biologic patients
improvement
(n=143) vs 29% (n=148) with placebo at Week 14 as
observed and
61% improvement
(n=132) vs 49% (n=134) with placebo at 1 year as observed4
RINVOQ is indicated for TNFi-IR patients
RINVOQ is indicated for
TNFi-IR patients
*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
*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
improvement
(n=143) vs 29% (n=148) with placebo at Week 14 as
observed and
61% improvement
(n=132) vs 49% (n=134) with placebo at 1 year as observed4
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.
Objective Measure
SELECT-AXIS 2 Study 2: nr-axSpA Δhs-CRP from Baseline at Week 14 (MMRM)2
A study in mixed* biologic patients
SELECT-AXIS 2 Study 2:
nr-axSpA Δhs-CRP from Baseline at Week 14 (MMRM)2
A study in mixed* biologic patients
Mean change from baseline was -6.91 vs -2.62 with placebo at Week 523
RINVOQ is indicated for
TNFi-IR patients
RINVOQ is indicated for TNFi-IR patients
*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
†RINVOQ (n=144); Placebo (n=136)2
‡P<0.0001; P-value obtained through nominal statistical testing.2
Mean change from baseline was -6.91 vs -2.62 with placebo at Week 523
DATA LIMITATIONS:2 Data labeled as primary endpoint at Week 14 were multiplicity-controlled. Prespecified nonranked endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established.
SELECT-AXIS 2 Study 2: nr-axSpA ΔMRI SI Joint Score (SPARCC) from Baseline at Week 14 (MMRM)2,*
A study in mixed* biologic DMARD-IR patients
The clinical relevance of SPARCC MRI as a surrogate endpoint has not been established
SELECT-AXIS 2 Study 2: nr-axSpA ΔMRI SI Joint Score (SPARCC) from Baseline at Week 14 (MMRM)2,*
A study in mixed* biologic DMARD-IR patients
The clinical relevance of SPARCC MRI as a surrogate endpoint has not been established
RINVOQ is indicated for
TNFi-IR patients
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
RINVOQ is indicated for TNFi-IR patients
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
improvement in Physical FUNCTION1
ΔBASFI ranked secondary endpoint at Week 14 with response rates up to 1 year2,3
SELECT-AXIS 2 Study 2: nr-axSpA ΔBASFI from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed* biologic patients
SELECT-AXIS 2 Study 2:
nr-axSpA ΔBASFI from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed* biologic patients
improvement
(n=143) vs 23% (n=148) with placebo at Week 14 as
observed and
64% improvement
(n=132) vs 46% (n=134) with placebo at 1 year as observed4
RINVOQ is indicated for
TNFi-IR patients
RINVOQ is indicated for TNFi-IR patients
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
improvement
(n=143) vs 23% (n=148) with placebo at Week 14 as
observed and
64% improvement
(n=132) vs 46% (n=134) with placebo at 1 year as observed4
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.
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
RINVOQ SAFETY DATA
Review the safety profile of RINVOQ,
including both short- and long-term analyses
