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
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
of RINVOQ nr-axSpA patients achieved ASAS40 at 1 year4
*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
of RINVOQ nr-axSpA patients achieved Low Disease Activity at 1 year4
*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
of RINVOQ nr-axSpA patients achieved BASDAI50 at 1 year4
*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
Adults with active nr-axSpA who had an inadequate response or intolerance to at least two NSAIDs and to one bDMARD therapy in 33%.1,2
RINVOQ is indicated for TNFi-IR patients
Primary Endpoint1,2
SELECT MULTIPLICITY-CONTROLLED KEY SECONDARY ENDPOINTS (RINVOQ vs Placebo at Week 14)2
PRESPECIFIED ADDITIONAL ENDPOINTS (RINVOQ vs Placebo at Week 14)1,2
RESCUE CRITERIA3
After visit assessments were performed at Week 24 and through Week 52, patients who did not achieve an ASAS20 response at any 2 consecutively scheduled visits were rescued by adding or modifying background medications.
DATA LIMITATIONS2
Data labeled as a primary and ranked secondary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
*Patients randomized into the study and receiving concomitant oral corticosteroids or NSAIDs must have been on a stable dose for at least 14 days prior to the baseline visit, while those receiving concomitant conventional synthetic DMARDs were required to be on a stable dose for at least 28 days prior to the baseline visit.
†314 patients were enrolled and 313 patients received study drug.
‡At least 40% improvement and an absolute improvement of ≥2 units on a scale of 0 to 10 from baseline 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. NRI-MI means nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19.
§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?”
||Inflammation defined as the mean of the BASDAI questions 5 and 6 on severity and duration of morning stiffness.
BASELINE CHARACTERISTICS2,4
*China, Japan, South Korea, and Taiwan.
†Australia and Israel.
‡Three patients who had protocol deviations with both TNF inhibitor and IL-17 inhibitor exposure.
§Assessed in 155 participants in the placebo group and 154 participants in the upadacitinib group.
||Inflammation defined as the mean of the BASDAI questions 5 and 6 on severity and duration of morning stiffness.
¶Sacroiliac joint score assessed in 148 participants in the placebo group and 142 participants in the upadacitinib group; spine score assessed in 147 participants in the placebo group and 139 participants in the upadacitinib group; with available baseline MRI data up to 3 days after the first dose of study drug; MRI scored using the SPARCC 6-discovertebral unit method for the spine.
**MRI-positive defined as active sacroilitis according to the ASAS/Outcome Measures in Rheumatology Clinical Trials definition; hs-CRP-positive defined as C-reactive protein greater than the upper limit of normal (2.87 mg/L).
ASAS=Assessment of SpondyloArthritis international Society; ASDAS=Ankylosing Spondylitis Disease Activity Score; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; bDMARD=biologic disease-modifying antirheumatic drug; csDMARDs=conventional synthetic disease-modifying antirheumatic drugs; HLA-B27= human leukocyte antigen B27; hs-CRP=high-sensitivity C-reactive protein; IL-17i=interleukin-17 inhibitor; MRI=magnetic resonance imaging; nr-axSpA=non-radiographic axial spondyloarthritis; NRS=numerical rating scale; NSAID=nonsteroidal anti-inflammatory drug; QD=once daily; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor; ULN=upper limit of normal
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
