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
*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
improvement
(n=206) vs 19% (n=203) with placebo at Week 14 as
observed and
61% improvement
(n=194) at 1 Year as observed4
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
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 PAIN1
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
improvement
(n=205) vs 21% (n=202) with placebo at Week 14 as
observed and
64% improvement
(n=193) at 1 Year as observed4
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
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
improvement
(n=206) vs 24% (n=203) with placebo at Week 14 as
observed and
61% improvement
(n=194) at 1 year as observed4
RINVOQ is indicated
for TNFi-IR patients
‡P<0.0001; P-value obtained through nominal statistical testing.2
‡P<0.0001; P-value obtained through nominal statistical testing.2
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
RINVOQ is indicated
for TNFi-IR patients
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.
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
RINVOQ is indicated
for TNFi-IR patients
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
improvement
(n=206) vs 18% (n=203) with placebo at Week 14 as
observed and
58% improvement
(n=193) at 1 year as observed4
RINVOQ is indicated
for TNFi-IR patients
†P<0.00012
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.
RINVOQ SAFETY DATA
Review the safety profile of RINVOQ,
including both short- and long-term analyses