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
Nearly Half of AS (44.5%, n=211, bDMARD-IR vs placebo, n=209, 18.2%*) and nr-axSpA (44.9%, n=156, mixed† vs placebo, n=157, 22.3%*) Patients Achieved ASAS40 Primary Endpoint at Week 141-3
*P<0.00012 , 5
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
AS=ankylosing spondylitis; 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; IR=intolerance or inadequate response; nr-axSpA=non-radiographic axial spondyloarthritis; TNFi=tumor necrosis factor inhibitor
Responses observed as early as Week 4 (AS) and Week 2 (nr-axSpA)1-3,5
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 2 NSAIDs and 1 or 2 bDMARDs. Patients were randomized to receive RINVOQ 15 mg once daily or placebo. Patients could continue background NSAIDs.
SELECT-AXIS 2 Study 2: nr-axSpA Design Intro:1,3
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.
DATA LIMITATIONS:2,3 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.
*P<0.00012,5
†Mixed=67% bDMARD-naïve & 33% bDMARD-IR3
‡P<0.00012,5
§P<0.05; P-value obtained through nominal statistical testing.2,5
AS=ankylosing spondylitis; 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; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; MRI=magnetic resonance imaging; NRI-MI=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; nr-axSpA=non-radiographic axial spondyloarthritis; NSAID=nonsteroidal anti-inflammatory drug; QD=once daily; TNFi=tumor necrosis factor inhibitor; ULN=upper limit of normal
*Mean of BASDAI questions 5 and 6 assessing morning stiffness severity and duration.
†Includes 3 phase 2 and 6 phase 3 RA trials, 2 phase 3 PsA trials, 1 phase 2/3 and 1 phase 3 AS trials, 1 phase 3 nr-axSpA trials, 1 phase 2 and 3 phase 3 AD trials, and 3 phase 3 UC trials. RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: RINVOQ 15 mg, upadacitinib 30 mg; AS: RINVOQ 15 mg; nr-axSpA: RINVOQ 15 mg; AD: RINVOQ 15 mg and RINVOQ 30 mg; UC: RINVOQ 15 mg, 30 mg, and 45 mg. RINVOQ 15 mg is the approved dose in RA, PsA, AS, and nr-axSpA; RINVOQ 15 mg and 30 mg are the approved doses in AD; RINVOQ 15 mg, 30 mg and 45 mg are the approved doses in UC.1,10
‡In PsA: ~5.0 years maximum exposure (~2.9 years median) to RINVOQ 15 mg as of 08/2022. In AS: ~3.8 years maximum exposure (~1.7 years median) to RINVOQ 15 mg as of 08/2022. In nr-axSpA: ~2.4 years maximum exposure (~1.0 years median) to RINVOQ 15 mg as of 08/2022.10
§RINVOQ is on a preferred tier or otherwise has preferred status on the plan's formulary.
**Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
AD=atopic dermatitis; 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; BASFI=Bath Ankylosing Spondylitis Functional Index; bDMARD=biologic disease-modifying antirheumatic drug; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; LDA=low disease activity; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis
RINVOQ is indicated for the treatment of:
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.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis or Crohn’s disease, 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
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
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
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
