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
US-MULT-230356
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
RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 2, up to 1 year1,3,5
RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo, and responses observed at Week 2, up to 1 year1,3,5
ASAS=Assessment of SpondyloArthritis international Society; 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; ASDAS=Ankylosing Spondylitis Disease Activity Score; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASDAI50=a 50% improvement of the initial Bath Ankylosing Spondylitis Disease Activity Index score; BASFI=Bath Ankylosing Spondylitis Functional Index; CRP=C-reactive protein; nr-axSpA=non-radiographic axial spondyloarthritis; TNFi=tumor necrosis factor inhibitor
*Mixed=67% bDMARD-naïve & 33 % bDMARD-IR3
†P<0.00015
SELECT-AXIS 2 Study 2: nr-axSpA Design Intro:2,3
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
RAPID Improvement in ASAS401,3-5
SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response (NRI-MI)1,3-5
A study in mixed* biologic patients
SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response (NRI-MI)1,3-5
A study in mixed* biologic patients
Nearly half (44.9%) of nr-axSpA mixed* biologic patients achieved ASAS40 primary endpoint at Week 14 (vs placebo 22.3%,P<0.0001)
Responses observed as early as
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P<0.00015
‡P<0.05; P-value obtained through nominal statistical testing.5
ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain:3
ASAS Domains
§Total back pain defined on an NRS (0-10) based on the following question: "What is the amount of back pain that you experienced at any time during the last week?"
||Mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness.
Nearly half (44.9%) of nr-axSpA mixed* biologic patients achieved ASAS40 primary endpoint at Week 14 (vs placebo 22.3%,P<0.0001)
Responses observed as early as
Data LIMITATIONS:3 Data labeled as a primary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
DURABLE ASAS40 Rates1,3,4
SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 521,3,4
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients
SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 521,3,4
ALL DATA ARE OBSERVED CASES (AO)
A study in mixed* biologic patients
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain:3
ASAS Domains
§ Total back pain defined on an NRS (0-10) based on the following question: "What is the amount of back pain that you experienced at any time during the last week?"
|| Mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness.
of RINVOQ nr-axSpA patients achieved ASAS40 at 1 year4
In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.
SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 52
(NRI-MI)1,3-5
A study in mixed* biologic patients
SELECT-AXIS 2 Study 2: nr-axSpA ASAS40 Response up to Week 52 (NRI-MI)1,3-5
A study in mixed* biologic patients
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain:3
ASAS Domains
†P <0.00015
‡P <0.05; P-value obtained through nominal statistical testing5
§ Total back pain defined on an NRS (0-10) based on the following question: "What is the amount of back pain that you experienced at any time during the last week?"
|| Mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness.
Data LIMITATIONS: Data labeled as a primary endpoint at Week 14 were multiplicity controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P<0.00013
ASDAS-CRP measures:3
ASDAS Disease Activity States4
Change from baseline (MMRM) ASDAS-CRP score at Week 14
RINVOQ patients:
-1.36 (n=154)
Placebo patients: -0.71 (n=156)
Mean baseline
ASDAS-CRP
score
RINVOQ patients:
3.6
Placebo patients:
3.7
ASDAS-CRP measures:3
ASDAS Disease Activity States4
Change from baseline (MMRM)
ASDAS-CRP score at Week 14
RINVOQ patients: -1.36 (n=154)
Placebo patients: -0.71 (n=156)
Mean baseline ASDAS-CRP score
RINVOQ patients: 3.6
Placebo patients: 3.7
DATA LIMITATIONS:3 Data labeled as a ranked secondary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
DURABLE
ASDAS-CRP Low Disease Activity Rates4
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
ASDAS-CRP measures:6
ASDAS Disease Activity States7
ASDAS-CRP measures:6
ASDAS Disease Activity States7
of RINVOQ nr-axSpA patients achieved Low Disease Activity at
1 year4
In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P <0.00013
§RINVOQ (n=156); Placebo (n=154)3
ASDAS-CRP measures:6
ASDAS Disease Activity States7
Change from baseline (MMRM) ASDAS-CRP score at Week 52
RINVOQ patients:
-1.80 (n=154)
Placebo patients: -1.23 (n=156)9
Mean baseline
ASDAS-CRP
score
RINVOQ patients:
3.6
Placebo patients:
3.7
ASDAS-CRP measures:6
ASDAS Disease Activity States7
Change from baseline (MMRM)
ASDAS-CRP score at Week 52
RINVOQ patients: -1.80 (n=154)
Placebo patients: -1.23 (n=156)9
Mean baseline ASDAS-CRP score
RINVOQ patients: 3.6
Placebo patients: 3.7
DATA LIMITATIONS: Data labeled as a primary endpoint at Week 14 were multiplicity controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
†P≤0.0014
BASDAI50 reflects a ≥50% improvement in BASDAI from baseline5
BASDAI Components
DATA LIMITATIONS:3 Data labeled as a primary or ranked secondary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
DURABLE BASDAI50 Rates 4
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
BASDAI50 reflects a ≥50% improvement in BASDAI from baseline5
BASDAI Components
of RINVOQ nr-axSpA patients achieved BASDAI50 at 1 year4
In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
‡P≤0.0013
‖RINVOQ (n=156); Placebo (n=157)3
BASDAI50 reflects a ≥50% improvement in BASDAI from baseline5
BASDAI Components
DATA LIMITATIONS: Data labeled as a primary endpoint at Week 14 were multiplicity controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
Review the safety profile of RINVOQ,
including both short- and long-term analyses
RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy.
Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
REFERENCES
US-MULT-221344
REFERENCES
US-MULT-221344
ASDAS=Ankylosing Spondylitis Disease Activity Score; CRP=C‑reactive protein; LDA=low disease activity
REFERENCE
US-MULT-221344
REFERENCES
US-MULT-221344