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 AS

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; 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; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor

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 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.

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; BASFI=Bath Ankylosing Spondylitis Functional Index; bDMARD=biologic disease-modifying antirheumatic drug; IR=intolerance or inadequate response; NRI=nonresponder imputation; 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 1: AS
ΔTotal Back Pain from baseline up to Week 52 (MMRM)2,3,*
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ΔTotal Back Pain from baseline up to Week 52 (MMRM)2,3,*
A study in biologic DMARD‑IR patients

39 Percent
improvement
(n=206) vs 19% (n=203) with placebo at Week 14 as
observed and
61% improvement
(n=194) at 1 Year as observed4

SELECT-AXIS 2: Total Back Pain over time

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

P<0.00012

*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

P<0.00012

39 Percent
improvement
(n=206) vs 19% (n=203) with placebo at Week 14 as
observed and
61% improvement
(n=194) at 1 Year as observed4

DATA LIMITATIONS:2 Data labeled as ranked secondary endpoints at Week 14 were multiplicity-controlled for comparisons. 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.

improvement  in
NOCTURNAL BACK PAIN
1

ΔNocturnal Back Pain ranked secondary endpoint at Week 14 with response rates
up to 1 year2,3

SELECT-AXIS 2 Study 1: AS
ΔNocturnal Back Pain from baseline up to Week 52 (MMRM)2,3,*
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ΔNocturnal Back Pain from baseline up to Week 52 (MMRM)2,3,*
A study in biologic DMARD‑IR patients

44 Percent
improvement
(n=205) vs 21% (n=202) with placebo at Week 14 as
observed and
64% improvement
(n=193) at 1 Year as observed4

SELECT‑AXIS 2: Nocturnal Back Pain over time

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 amount of back pain at night that you experienced during the last week?”4
P<0.0012

*Nocturnal back pain defined on a numeric rating scale (0–10) based on the following question, “What is amount of back pain at night that you experienced during the last week?”4
P<0.0012

44 Percent
improvement
(n=205) vs 21% (n=202) with placebo at Week 14 as
observed and
64% improvement
(n=193) at 1 Year as observed4

DATA LIMITATIONS:2 Data labeled as ranked secondary endpoints at Week 14 were multiplicity-controlled for comparisons. 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.

Improvement in Patient-Reported and Objective MEASURES OF INFLAMMATION1,2,7

ΔInflammation (Morning Stiffness) and Δhs-CRP at Week 14 with response rates
up to 1 year2,7

Patient-Reported
Outcome

Patient-Reported Outcome

SELECT-AXIS 2 Study 1: AS
ΔInflammation
(Morning Stiffness) from Baseline up to Week 52 (MMRM)2,7,*
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ΔInflammation (Morning Stiffness) from Baseline up to Week 52 (MMRM)2,7,*
A study in biologic DMARD‑IR patients

43 Percent
improvement
(n=206) vs 24% (n=203) with placebo at Week 14 as
observed and
61% improvement
(n=194) at 1 year as observed4

SELECT‑AXIS 2: Inflammation (morning stiffness) over time

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
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
P<0.0001; P-value obtained through nominal statistical testing.2

43 Percent
improvement
(n=206) vs 24% (n=203) with placebo at Week 14 as observed and
61% improvement
(n=194) at 1 year as observed4

DATA LIMITATIONS:2 Data labeled as ranked secondary endpoints at Week 14 were multiplicity-controlled for comparisons. 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.

Objective Measure

SELECT-AXIS 2 Study 1: AS Δhs-CRP from Baseline at Week 14 (MMRM)1,2,6
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS Δhs-CRP from Baseline at Week 14 (MMRM)1,2,6
A study in biologic DMARD‑IR patients

 

Mean change from baseline was -9.95 at Week 52 with RINVOQ (OLE)3

SELECT-AXIS 2: hs-CRP at Week 14

RINVOQ is indicated
for TNFi-IR patients

*P<0.0001; P-value obtained through nominal statistical testing.2

Mean change from baseline was -9.95 at Week 52 with RINVOQ (OLE)3

DATA LIMITATIONS:2 Prespecified additional endpoints 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.

improvement in SPARCC MRI

ΔSPARCC MRI at Week 14

SELECT-AXIS 2 Study 1: AS ΔMRI Spine Score (SPARCC) from Baseline at Week 14 (MMRM)2
A study in biologic DMARD‑IR patients

The clinical relevance of SPARCC MRI as a surrogate endpoint has not been established

SELECT-AXIS 2 Study 1: AS ΔMRI Spine Score (SPARCC) from Baseline at Week 14 (MMRM)2
A study in biologic DMARD-IR patients

The clinical relevance of SPARCC MRI as a surrogate endpoint has not been established

SELECT-AXIS 2: Change in MRI Spine Score from Baseline at Week 14

RINVOQ is indicated
for TNFi-IR patients

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 1: AS ΔBASFI from baseline up to Week 52 (MMRM)2,3
A study in biologic DMARD‑IR patients

SELECT-AXIS 2 Study 1: AS ΔBASFI from baseline up to Week 52 (MMRM)2,7
A study in biologic DMARD‑IR patients

35 Percent
improvement
(n=206) vs 18% (n=203) with placebo at Week 14 as
observed and
58% improvement
(n=193) at 1 year as observed4

SELECT-AXIS 2: BASFI over time

RINVOQ is indicated
for TNFi-IR patients

P<0.00012

35 Percent
improvement
(n=206) vs 18% (n=203) with placebo at Week 14 as observed and
58% improvement
(n=193) 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.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

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RINVOQ SAFETY DATA

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