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 AS

Treatment with RINVOQ results in improvement from baseline
in Total & Nocturnal back pain at Week 14 with response up to 2 years1-3

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor


Treatment with RINVOQ results in
improvement from baseline in
Total & Nocturnal back pain at Week 14 with response up to 2 years1-3

IR=intolerance or inadequate response; MRI=magnetic resonance imaging; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor

Clinical Trial Overview

Clinical Trial Overview

 

SELECT-AXIS 2: Clinical Trial Overview

*P<0.00013

 

SELECT-AXIS 2 Study 1: AS Design Intro:1,3
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.

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; BASDI=Bath Ankylosing Spondylitis Disease Activity Index; 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 2 years2-4

SELECT-AXIS 2 Study 1: AS
ΔTotal Back Pain from baseline up to 2 years (MMRM)2-4,*

A study in biologic DMARD-IR patients

SELECT-AXIS 2 Study 1: AS ΔTotal Back Pain from baseline up to 2 years (MMRM)2-4,*

A study in biologic DMARD-IR patients

39 Percent
improvement
(n=206) vs 19% (n=203) with placebo at Week 14 as
observed and
 68% improvement
(n=168) at 2 Years as observed2,3

SELECT-AXIS 2: Total Back Pain over time through week 104.

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

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

39 Percent
improvement
(n=206) vs 19% (n=203) with placebo at Week 14 as
observed and
68% improvement
(n=168) at 2 years as observed2,3

DATA LIMITATIONS: 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.3

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

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 years2-4

Improvement in Nocturnal Back Pain1

Nocturnal Back Pain ranked secondary endpoint at Week 14 with response rates up to 2 years2-4

SELECT-AXIS 2 Study 1: AS
ΔNocturnal Back Pain from baseline up to 2 years (MMRM)2-4,*

SELECT-AXIS 2 Study 1 AS: ΔNocturnal Back Pain from baseline up to 2 years (MMRM)2-4,*

A study in biologic DMARD-IR patients

44 Percent
improvement
(n=205) vs 21% (n=202) with placebo at Week 14 as
observed3

SELECT-AXIS 2: Nocturnal Back Pain over time through week 104.

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

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

44 Percent
improvement
(n=205) vs 21% (n=202) with placebo at Week 14 as
observed3

DATA LIMITATIONS: 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.3

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

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

SEE SAFETY PROFILE