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      ANKYLOSING SPONDYLITIS

      SELECT-AXIS 1

      In bDMARD-naïve patients with active AS in AS signs and symptoms

      SELECT-AXIS 1: ASAS40 at Week 14 (NRI)1,2

      ASAS40 with RINVOQ vs placebo at Week 14 was a primary endpoint.
      Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.
      *p≤0.001 vs placebo, multiplicity-controlled.

      ASAS40 response is defined as at least 40% improvement and an absolute improvement of at least two units on a numerical rating scale of 0–10 from baseline in at least three of the following four domains, with no worsening in the remaining domain: Patient global assessment of disease activity, patient assessment of back pain, Bath Ankylosing Spondylitis Functional Index (BASFI), and inflammation defined as the mean of the BASDAI questions on severity and duration of morning stiffness.2

       

       

       patients treated with RINVOQ vs placebo achieved ASAS40 response at Week 14.1-3

      SELECT-AXIS 1: ASAS40 responses through Week 64 (NRI)1-3

      The primary endpoint of SELECT-AXIS 1: ASAS40 response for RINVOQ vs placebo at Week 14 was met.

      ASAS40 with RINVOQ vs placebo at Week 14 was the primary endpoint, all other data shown were prespecified non-ranked non-multiplicity-controlled endpoints. 

      DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.

      *p<0.001 vs placebo, comparison adjusted for multiplicity. Nominal p<0.001 vs placebo, comparison not adjusted for multiplicity.

       

      RINVOQ achieved statistically in ASDAS-CRP from baseline vs placebo at Week 141

      SELECT-AXIS 1: LS mean change in ASDAS-CRP from baseline to Week 14 (MMRM)1

      The primary endpoint of SELECT-AXIS 1: ASAS40 response at Week 14 was met. Change in ASDAS-CRP from baseline for RINVOQ vs placebo at Week 14 was a key ranked secondary multiplicity-controlled endpoint.

      Graph adapted from van der Heijde et al. 2019
      *Comparison adjusted for multiplicity, p≤0.001.
      Missing data were handled using NRI.
      ASDAS-CRP: ankylosing spondylitis disease activity score C-reactive protein; MMRM: mixed effect model for repeated measures.

      measures across ASDAS outcomes

      SELECT-AXIS 1: ASDAS response rates at Week 14 (NRI)1,2

      ASDAS inactive disease (score <1.3) was a prespecified, non-ranked, non-multiplicity-controlled efficacy endpoint. ASDAS low disease activity (score <2.1) was assessed post hoc.

      DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
      Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.
      Nominal p<0.001 vs placebo, not multiplicity-controlled.
      ASDAS: ankylosing spondylitis disease activity score.

      Significant improvement in

      SELECT-AXIS 1: BASDAI50 at Week 14 (NRI)1,2

      BASDAI50 for RINVOQ vs placebo at Week 14 was a key ranked, secondary, multiplicity-controlled endpoint.
      Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.
      p<0.01 vs placebo, multiplicity-controlled.
      BASDAI50: at least 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index

      RINVOQ signs of spinal inflammation1,2

      SELECT-AXIS 1: Change in SPARCC-MRI score from baseline to Week 14 (MMRM)1,2

      Change from baseline in SPARCC-MRI spine score was a multiplicity-controlled key secondary endpoint. The SPARCC-MRI assessment population as prespecified in the statistical analysis plan (baseline included MRI data ≤3 days after first dose of study drug and Week 14 included MRI data up to first dose of period 2 study drug).
      *p<0.0001 vs placebo, comparison adjusted for multiplicity.
      SPARCC-MRI: spondyloarthritis research consortium Canada-magnetic resonance imagery; MMRM: mixed effect model for repeated measures.

      RINVOQ demonstrated significant improvement across  of pain2-4

      SELECT-AXIS 1: Change in patient-reported measures of pain at Week 14 (MMRM)2-4

      DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

      Nominal p≤0.001 vs placebo, not multiplicity-controlled. Nominal p<0.05 vs placebo, not multiplicity controlled. *Back pain domain of the ASAS40 measure defined on a numerical 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?”. #Nocturnal back pain defined on a numerical 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?

      MMRM: mixed effect model for repeated measures

      RINVOQ physical function in patients with AS2

      SELECT-AXIS 1: Change in BASFI from baseline at Week 14 (NRI)2

      Change from baseline in BASFI was a multiplicity-controlled key secondary endpoint.
      Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.
      p<0.01 vs placebo, multiplicity-controlled.
      BASFI: bath ankylosing spondylitis functional index.

      SELECT-AXIS 1: A Phase 3 study evaluating the safety and efficacy of RINVOQ in subjects with active ankylosing spondylitis2

      ASAS40: at least 40% improvement of Assessment of SpondyloArthritis international Society criteria.

      Endpoints: 

      Primary endpoint: ASAS40 response at Week 14 for RINVOQ vs placebo

      Key secondary endpoints: 

      Statistically significantly greater improvement with RINVOQ vs placebo in:

      • BASFI at week 14
      • ASAS partial remission at Week 14 
      • WPAI at week 14 
      • MASES at week 14 
      • ASDAS score at week 14 
      • BASMI at week 14 
      • ASAS20 response at week 14 
      • MRI SPARCC score (Spine) at week 14 
      • AS QoL at week 14 
      • BASDAI50 response at week 14 
      • ASAS HI at week 14 
      • MRI SPARCC score (SI joints) at week 14

      Key Eligibility Criteria:

      • ≥18 years old
      • Fulfillment of modified New York criteria for AS based on central reading of radiographs of the sacroiliac joints
      • Active disease at baseline with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4
      • Patient’s assessment of back pain score ≥4 (numerical rating scale 0–10)
      • Inadequate response to ≥2 NSAIDS or intolerance to or contraindication for NSAIDS.
      • Patients with previous exposure to any JAK inhibitor or any biological therapy with a potential effect on spondyloarthritis were excluded.

      Graph adapted from van der Heijde et al. 2019

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      References

      1. RINVOQ (upadacitinib) SmPC.
      2. van der Heijde D, Song IH, Pangan AI, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): A multicenter, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019 doi:https://doi.org/10.1016/S0140-6736(19)32534-6.
      3. Deodhar A et al. Efficacy and Safety of Upadacitinib in Patients With Active Ankylosing Spondylitis: 1-Year Results From a Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension. 1-year SELECT AXIS 1 Abstract. American College of Rheumatology Convergence, November 2020.
      4. AbbVie Data on File. ABVRRTI71420.

      UK-UPAD-210142. Date of preparation: May 2021.

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
      Adverse events should also be reported to AbbVie on GBPV@abbvie.com