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

Rapid IMPROVEMENT
IN ASAS40 FOR AS

  • ASAS40 Primary Endpoint at Week 14 (44.5% vs 18.2% placebo, p<0.0001)1,2
  • ASAS40 Responses observed as early as Week 4 (22% vs 12% placebo, p<0.05*)1,2

Treatment with RINVOQ results in improvement from baseline
in Total & Nocturnal back pain, Inflammation (Morning Stiffness),
hs-CRP, and Physical Function (BASFI) at Week 141,2

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; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; 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,
and Physical Function (BASFI) at Week 141,2

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; hs-CRP=high-sensitivity C-reactive protein; IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

*P-value obtained through nominal statistical testing.

Clinical Trial Overview

Clinical Trial Overview

 

SELECT-AXIS 2: Clinical Trial Overview

*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.

See Study Details

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

improvement in
total back pain1
As measured by ΔTotal Back Pain from baseline at Week 14 vs placebo

SELECT-AXIS 2 Study 1: AS
Total Back Pain2,4,5,*
A study in biologic DMARD‑IR patients

RINVOQ is indicated for
TNFi-IR patients

SELECT-AXIS 2 Study 1: AS Total Back Pain2,4,5,*
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

~2x improvement vs placebo at Week 14

SELECT-AXIS 2: Total Back Pain over time

Week 1: % Improvement from baseline (AO):
RINVOQ, 15%; placebo, 8%;
Change from baseline (MMRM):
RINVOQ -1.19 (baseline=7.47; n=208);
placebo -0.70 (baseline=7.38; n=204)

*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<0.00015

~2x improvement vs placebo at Week 14

DATA LIMITATIONS:2 Data labeled as a 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.

See Total Back Pain Criteria
See Study Details
See Footnotes and Definitions

*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<0.00015

improvement in
NOCTURNAL BACK PAIN2,4,5
As measured by ΔNocturnal Back Pain from baseline at Week 14 vs placebo

SELECT-AXIS 2 Study 1: AS
Nocturnal Back Pain2,4,5,*
A study in biologic DMARD‑IR patients

RINVOQ is indicated for
TNFi-IR patients

SELECT-AXIS 2 Study 1: AS Nocturnal Back Pain2,4,5,*
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

Greater Improvement vs placebo at Week 14

SELECT‑AXIS 2: Nocturnal Back Pain over time

Week 1: % Improvement from baseline (AO):
RINVOQ, 12%; placebo, 14%;
Change from baseline (MMRM):
RINVOQ -1.19 (baseline=7.14; n=200);
placebo -0.92 (baseline=7.14; n=197)

*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?”6
†P<0.00012

Greater Improvement vs placebo at Week 14

DATA LIMITATIONS:2 Data labeled as a 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.

See Nocturnal Back Pain Criteria
See Nocturnal Back Pain Criteria
See Study Details
See Footnotes and Definitions

*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?”6
†P<0.00012

improvement IN Objective and Patient-Reported MEASURES OF INFLAMMATION1,2,5
As measured by Δhs-CRP and ΔInflammation (Morning Stiffness) from
baseline at Week 14 vs placebo

Objective Measure

SELECT-AXIS 2 Study 1: AS hs-CRP1,2,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 1: AS hs-CRP1,2,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for
TNFi-IR patients

>11 POINT reduction in
hs-CRP vs placebo1,2,5

SELECT-AXIS 2: hs-CRP at Week 14
*P<0.0001; P-value obtained through nominal statistical testing.2

>11 POINT reduction
in hs-CRP vs placebo1,2,5

DATA LIMITATIONS:2 Prespecified additional endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established.

See hs-CRP Criteria
See Study Details
See Footnotes and Definitions

Patient-Reported
Outcome

Patient-Reported Outcome

SELECT-AXIS 2 Study 1: AS
Inflammation
(Morning Stiffness)2-5,*
A study in biologic DMARD‑IR patients

RINVOQ is indicated for
TNFi-IR patients

SELECT-AXIS 2 Study 1: AS Inflammation (Morning Stiffness)2-5,*
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT‑AXIS 2: Inflammation over time

Week 1: % Improvement from baseline (AO):
RINVOQ, 15%; placebo, 10%;
Change from baseline (MMRM):
RINVOQ -1.01 (baseline=6.89; n=209);
placebo -0.72 (baseline=6.74; n=205)

*Inflammation defined as mean of BASDAI questions 5 and 6 assessing morning stiffness severity and duration: 0=best, 10=worst.2
†P<0.0001; P-value obtained through nominal statistical testing.5

DATA LIMITATIONS:2 Prespecified additional endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established.

See Inflammation Criteria
See Study Details
See Footnotes and Definitions
*Inflammation defined as mean of BASDAI questions 5 and 6 assessing morning stiffness severity and duration: 0=best, 10=worst.2
†P<0.0001; P-value obtained through nominal statistical testing.5

improvement
IN Physical FUNCTION FOR PATIENTS1,4,5
As measured by ΔBASFI from baseline at Week 14 vs placebo

SELECT-AXIS 2 Study 1: AS BASFI1,4,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-AXIS 2 Study 1: AS BASFI1,4,5
A study in biologic DMARD‑IR patients

RINVOQ is indicated for
TNFi-IR patients

35% improvement at Week 145

SELECT-AXIS 2: BASFI

Week 1: % Improvement from baseline (AO):
RINVOQ, 8%; placebo, 7%;
Change from baseline (MMRM):
RINVOQ -0.60 (baseline=6.27; n=208);
placebo -0.52 (baseline=6.18; n=204)

*P<0.00015

35% improvement
at Week 145

DATA LIMITATIONS:2 Data labeled as a 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.

See BASFI Criteria
See Study Details
See Footnotes and Definitions
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RINVOQ SAFETY DATA

Review the safety profile of RINVOQ,
including both short- and long-term analyses

SEE SAFETY PROFILE