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; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor
*P-value obtained through nominal statistical testing.
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
*P-value obtained through nominal statistical testing.
*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
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
improvement
(n=206) vs 19% (n=203) with placebo at Week 14 as
observed and
61% improvement
(n=194) at 1 Year as observed4
*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
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.
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
improvement
(n=205) vs 21% (n=202) with placebo at Week 14 as
observed and
64% improvement
(n=193) at 1 Year as observed4
*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
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.
ΔInflammation (Morning Stiffness) and Δhs-CRP at Week 14 with response rates
up to 1 year2,7
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
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.
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
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.
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
ΔBASFI ranked secondary endpoint at Week 14 with response rates up to 1 year2,7
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
†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.
OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.
Review the safety profile of RINVOQ,
including both short- and long-term analyses
RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
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 AS who had an inadequate response or intolerance to at least two NSAIDs and inadequate response to bDMARD therapy1,2
RINVOQ is indicated for TNFi-IR patients
Primary Endpoint1,3
SELECT MULTIPLICITY-CONTROLLED KEY SECONDARY ENDPOINTS (RINVOQ vs Placebo at Week 14)3
PRESPECIFIED ADDITIONAL ENDPOINTS (RINVOQ vs Placebo at Week 14)3
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.
†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, Taiwan, South Korea, and Japan.
†Australia, Israel, and New Zealand.
‡Assessed in 208 participants in the placebo group and 211 participants in the upadacitinib group.
§Assessed in 202 participants in the placebo group and 199 participants in the upadacitinib group with available baseline MRI data up to 3 days after first dose of study drug.
AS=ankylosing spondylitis; 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 in BASDAI score from baseline; BASFI=Bath Ankylosing Spondylitis Functional Index; bDMARD=biologic disease-modifying antirheumatic drug; COVID-19=coronavirus disease-2019; CRP=C-reactive protein; DMARD=disease-modifying antirheumatic drug; HLA=human leukocyte antigen; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; NRS=numeric rating scale; NSAID=nonsteroidal anti-inflammatory drug; QD=once per day; SD=standard deviation; 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
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US-MULT-221344
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US-MULT-221344
REFERENCES
US-MULT-221344
REFERENCE
US-MULT-221344
Adults with active AS who had an inadequate response or intolerance to at least two NSAIDs and inadequate response to bDMARD therapy1,2
RINVOQ is indicated for TNFi-IR patients
Primary Endpoint1,3
SELECT MULTIPLICITY-CONTROLLED KEY SECONDARY ENDPOINTS (RINVOQ vs Placebo at Week 14)3
PRESPECIFIED ADDITIONAL ENDPOINTS (RINVOQ vs Placebo at Week 14)3
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.
†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, Taiwan, South Korea, and Japan.
†Australia, Israel, and New Zealand.
‡Assessed in 208 participants in the placebo group and 211 participants in the upadacitinib group.
§Assessed in 202 participants in the placebo group and 199 participants in the upadacitinib group with available baseline MRI data up to 3 days after first dose of study drug.
AS=ankylosing spondylitis; 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 in BASDAI score from baseline; BASFI=Bath Ankylosing Spondylitis Functional Index; bDMARD=biologic disease-modifying antirheumatic drug; COVID-19=coronavirus disease-2019; CRP=C-reactive protein; DMARD=disease-modifying antirheumatic drug; HLA=human leukocyte antigen; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; NRS=numeric rating scale; NSAID=nonsteroidal anti-inflammatory drug; QD=once per day; SD=standard deviation; SPARCC=Spondyloarthritis Research Consortium of Canada; TNFi=tumor necrosis factor inhibitor; ULN=upper limit of normal
REFERENCES
US-MULT-221344
