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
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;
nr-axSpA=non-radiographic axial spondyloarthritis; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor
*P-value obtained through nominal statistical testing.2
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; nr-axSpA=non-radiographic axial spondyloarthritis; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor
*P-value obtained through nominal statistical testing.2
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00019
SELECT-AXIS 2 STUDY 2: nr-axSpA Design Intro:1,2
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
ΔTotal Back Pain ranked secondary endpoint at Week 14 with response rates up to 1 year2,3
SELECT-AXIS 2
Study 2: nr-axSpA
ΔTotal Back Pain from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed† biologic patients
improvement
(n=143) vs 28% (n=148) with placebo at Week 14 as
observed and
59% improvement
(n=132) vs 47% (n=134) with placebo 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
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
§P=0.00042
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.
ΔNocturnal Back Pain ranked secondary endpoint at Week 14 with response rates
up to 1 year2,3
SELECT-AXIS 2
Study 2: nr-axSpA
ΔNocturnal Back Pain from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed† biologic patients
improvement
(n=138) vs 26% (n=146) with placebo at Week 14 as
observed and
62% improvement
(n=130) vs 50% (n=132) with placebo 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 the amount of back pain at night that you experienced during the last week?”6
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
‡P<0.0012
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.
ΔInflammation (Morning Stiffness) and Δhs-CRP at Week 14 with response rates
up to 1 year2,5
SELECT-AXIS 2 Study 2:
nr-axSpA ΔInflammation (Morning Stiffness) from Baseline up to Week 52 (MMRM)2,5,*
A study in mixed† biologic patients
improvement
(n=143) vs 29% (n=148) with placebo at Week 14 as
observed and
61% improvement
(n=132) vs 49% (n=134) with placebo at 1 year as observed4
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
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
‡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
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
‡P<0.0001; P-value obtained through nominal statistical testing.2
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.
SELECT-AXIS 2 Study 2:
nr-axSpA Δhs-CRP from Baseline at Week 14 (MMRM)2
A study in mixed* biologic patients
Mean change from baseline was -6.91 vs -2.62 with placebo at Week 523
RINVOQ is indicated for
TNFi-IR patients
Mean change from baseline was -6.91 vs -2.62 with placebo at Week 523
DATA LIMITATIONS:2 Data labeled as primary endpoint at Week 14 were multiplicity-controlled. Prespecified nonranked endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established.
The clinical relevance of SPARCC MRI as a surrogate endpoint has not been established
SELECT-AXIS 2 Study 2: nr-axSpA ΔMRI SI Joint Score (SPARCC) from Baseline at Week 14 (MMRM)2,*
A study in mixed* 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
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
ΔBASFI ranked secondary endpoint at Week 14 with response rates up to 1 year2,3
SELECT-AXIS 2 Study 2:
nr-axSpA ΔBASFI from Baseline up to Week 52 (MMRM)2,3,*
A study in mixed* biologic patients
improvement
(n=143) vs 23% (n=148) with placebo at Week 14 as
observed and
64% improvement
(n=132) vs 46% (n=134) with placebo at 1 year as observed4
RINVOQ is indicated for
TNFi-IR patients
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
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.
*Mixed=67% bDMARD-naïve & 33% bDMARD-IR2
†P<0.00012
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
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US-MULT-221344
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US-MULT-221344
REFERENCES
US-MULT-221344
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US-MULT-221344
REFERENCES
US-MULT-221344
REFERENCE
US-MULT-221344
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
