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    • SELECT-AXIS 1: Study design

      A Phase 2/3 study investigating the efficacy and safety of RINVOQ for the treatment of bDMARD-naive patients with active AS1,2

      Permitted concomitant medications were csDMARDs (methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine), oral glucocorticoids, NSAIDs, and analgesics.    

       

      Primary 
      ASAS40 response for RINVOQ vs placebo at Week 14    

      Secondary (RINVOQ vs placebo at Week 14)*
      • Change from baseline ASDAS
      • Change from baseline in SPARCC MRI spine score
      • BASDAl 50
      • ASAS partial remission
      • Change from baseline in BASFI
      • Change from baseline in ASQoL
      • Change from baseline in BASMI
      • Change from baseline in MASES
      • Change from baseline in WPAI§
      • Change from baseline in ASAS health index

      Safety 
      Data for treatment-emergent adverse events and laboratory assessments were collected during the study. Treatment-emergent adverse events were defined as adverse events that began or worsened in severity after the first dose of study medication through 30 days after the last dose.    

      *The multiplicity-controlled secondary endpoints were tested in a sequential manner: ASDAS, SPARCC MRI spine, group of endpoints tested by Hochberg procedure (BASDAl 50, ASQoL, ASAS partial remission, BASFI, BASMI, MASES, and WPAI), and ASAS Health Index. ASAS Health Index could not be evaluated within the multiplicity-controlled sequence because some endpoints in the Hochberg procedure were not significant (NS).
      Statistically significant in multiplicity-controlled analysis.
      Not multiplicity-controlled; nominal P<0.05 vs placebo. No clinical inferences can be drawn. 
      §Not multiplicity-controlled. No clinical inferences can be drawn.

      ASAS: Assessment of Ankylosing Spondylitis International Society; ASDAS: Ankylosing Spondylitis Disease Activity Score; ASQoL: ankylosing spondylitis quality of life; BASDAI 50: at least 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; BASMI: Bath Ankylosing Spondylitis Metrology Index; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; SPARCC MRI: Spondyloarthritis Research Consortium of Canada magnetic resonance imaging; WPAI: Work Productivity and Activity Impairment.

      • Patients ≥18 years of age were eligible to participate 
      • Met the modified New York criteria for ankylosing spondylitis based on central reading of radiographs of the sacroiliac joints
      • BASDAI score ≥4 at baseline
      • Patient assessed back pain score ≥4 at screening and baseline
      • Had inadequate response to at least 2 NSAIDs or intolerance to or contraindication for NSAIDs
      • Patients with previous exposure to any JAK therapy or any biologic therapy with a potential effect on spondyloarthritis were excluded
      • Patients with total spinal ankylosis were excluded from the study

      Most patients were men (132 [71%]), were HLA-B27 positive (143 [76%]), and were receiving concomitant nonsteroidal anti-inflammatory drugs at baseline (152 [81%]). Baseline disease characteristics were generally balanced between the two groups.

      ASAS40: at least 40% improvement in Assessment of Ankylosing Spondylitis International Working Group criteria; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; bDMARD: biologic disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug;  JAK: Janus kinase; NSAID: nonsteroidal anti-inflammatory drug; QD: once daily.    

        

      In patients with active AS and an inadequate response to conventional therapy

      Significant improvement in AS signs and symptoms

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

      A numerical difference between treatment groups was observed at week 2 and response was maintained through week 641.

      *P≤0.001 vs placebo, statistically significant in multiplicity-controlled analysis. Missing data were handled using NRI.

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

      ASAS40: at least 40% improvement in Assessment of Ankylosing Spondylitis International Working Group criteria; NRI: nonresponder imputation; QD: once daily.

       

      In patients with active AS and an inadequate response to conventional therapy

      RINVOQ achieved statistically significant change from baseline to Week 14 in ASDAS-CRP vs placebo

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

      *P≤0.001 vs placebo, statistically significant in multiplicity-controlled analysis. Missing data were handled using MMRM.

      ASDAS-CRP: Ankylosing Spondylitis Disease Activity Score with C-reactive protein; LS: least squares; MMRM: mixed-effect model for repeated measures; QD: once daily.

       

      In patients with active AS and an inadequate response to conventional therapy

      Disease control measures across ASDAS outcomes

      SELECT-AXIS 1: ASDAS-ID and ASDAS-LDA response rates at Week 14 (NRI)1

      Nominal P≤0.001 vs placebo, not multiplicity-controlled. No clinical inferences can be drawn.

      DATA LIMITATIONS: Data not labeled as a ranked primary or secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity with nominal P-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Missing data were handled using NRI.

      ASDAS: Ankylosing Spondylitis Disease Activity Index; ASDAS-ID: Ankylosing Spondylitis Disease Activity inactive disease; ASDAS-LDA: Ankylosing Spondylitis Disease Activity low disease activity; NRI: nonresponder imputation; QD: once daily.

       

       

      In patients with active AS and an inadequate response to conventional therapy

      Significant improvement in disease activity

      SELECT-AXIS 1: BASDAI 50 at Week 14 (NRI)1,2

      P≤0.01 vs placebo, statistically significant in multiplicity-controlled analysis. Missing data were handled using NRI.

      BASDAI 50: at least 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index; NRI: nonresponder imputation; QD: once daily.

               

      In patients with active AS and an inadequate response to conventional therapy

      Significant improvement in signs of spinal inflammation

      SELECT-AXIS 1: Change in SPARCC MRI score from baseline to Week 141

      At week 14, significant improvement of inflammatory signs in the spine was observed in patients treated with RINVOQ compared to placebo.1

      Signs of inflammation were assessed by MRI and expressed as change from baseline in the SPARCC score for spine. 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). Missing data were handled using MMRM.

       

      MMRM: mixed-effect model for repeated measures; SPARCC MRI: Spondyloarthritis Research Consortium of Canada magnetic resonance imaging.
          

      The safety profile of RINVOQ in AS was consistent with previously reported results in RA1,2

      SELECT-AXIS 1: Adverse events through Week 14 and 641-3

      The most common adverse event with RINVOQ through Week 14 was increased creatine phosphokinase.2

      No serious infections, active tuberculosis, venous thromboembolic events, gastrointestinal perforation, major adverse cardiovascular events, renal dysfunction, or deaths were reported. *Cardiovascular disorder, reported as mild circulation dysregulation. Spinal osteoarthritis, reported as moderate worsening of cervical spondylosis 4/5. Dyspepsia (n=1), blood creatine phosphokinase increased (n=1), and atlantoaxial instability (n=1). §Otitis media (n=1) and myalgia (n=1). Esophageal candidiasis in patient with gastro-esophageal reflux disease; study drug continued after treatment with fluconazole. ¥Including nonmelanoma skin cancer, malignancy other than nonmelanoma skin cancer, and lymphoma. #All seven hepatic disorders were based on asymptomatic alanine aminotransferase or aspartate aminotransferase increases, and none led to premature discontinuation of study drug. **All asymptomatic except for one patient in the placebo group. ††Two nonserious events of esophageal candidiasis in the same patient. ‡‡Five events in four patients; all nonserious and limited to one dermatome. ##Majority based on asymptomatic alanine aminotransferase/aspartate aminotransferase elevations; all were nonserious and none led to study drug discontinuation. §§All events were nonserious and none led to study drug discontinuation. ¥¥Squamous cell carcinoma of tongue in 61-year-old former smoker; no reasonable possibility to be study drug-related per investigator.
          

      Minimiinformation

      RINVOQ® (upadacitinib), depottablett 15 mg (F), depottablett 30 mg (F), Rx, ATC-kod L04AA44 selektivt immunsuppressivt medel, JAK-hämmare. Indikationer: måttlig till svår aktiv reumatoid artrit hos vuxna patienter med otillräckligt behandlingssvar på eller intolerans mot ett eller flera DMARDs i monoterapi eller i kombination med metotrexat. Aktiv psoriasisartrit hos vuxna patienter med otillräckligt behandlingssvar på eller intolerans mot ett eller flera DMARDs, i monoterapi eller i kombination med metotrexat. Aktiv ankyloserande spondylit hos vuxna patienter med otillräckligt behandlingssvar på konventionell behandling. Måttlig till svår atopisk dermatit hos vuxna och ungdomar 12 år och äldre vilka är aktuella för systemisk behandling. Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne. Aktiv tuberkulos (TB) eller aktiv allvarlig infektion. Gravt nedsatt leverfunktion. Graviditet. Varningar och försiktighet: RINVOQ ska inte påbörjas hos patienter med aktiva, allvarliga infektioner, inkl. lokala infektioner och TB. Avbryt behandling om en patient utvecklar en allvarlig infektion eller en opportunistisk infektion. Virusreaktivering, inkl. fall av reaktivering av herpesvirus (t.ex. herpes zoster), har rapporterats i kliniska studier. Vid herpes zoster ska behandlingsavbrott övervägas tills episoden upphört. Påbörja inte eller avbryt tillfälligt behandling om onormala lab-värden som anemi, neutropeni, lymfopeni och levertransaminaser påträffas. Upadacitinib associerades med ökade lipidparametrar i kliniska studier. Behandla patienter enl. kliniska riktlinjer för hyperlipidemi. Divertikulit har rapporteras i kliniska prövningar och från klinisk erfarenhet efter godkännandet för försäljning. Upadacitinib ska användas med försiktighet till patienter med divertikelsjukdom och särskilt till patienter som samtidigt långtidsbehandlas med läkemedel som medför ökad risk för divertikulit såsom NSAID, kortikosteroider och opioider. VTE har rapporterats hos patienter på upadacitinib. Avsluta behandling om symptom på DVT/LE uppstår. För fullständig information om indikation, kontraindikationer, varningar och försiktighet, biverkningar, pris och dosering, se Fass.se. För information: kontakta AbbVie AB, 08 684 44 600. Datum för översyn av produktresumén: 30 maj 2022. Begränsning av läkemedelsförmån reumatologi: RINVOQ 15 mg ingår i läkemedelsförmånerna med begränsad subvention när behandling med TNF-hämmare gett otillräcklig effekt eller inte är lämplig. Begränsning av läkemedelsförmån dermatologi: RINVOQ subventioneras för patienter >12 år med måttlig till svår atopisk dermatit, när konventionell topikal eller systemisk behandling gett otillräcklig effekt eller inte är lämplig. 

      ▼ Detta läkemedel är föremål för utökad övervakning.

      SE-RNQ-220026 v 1. Senast uppdaterad 2022-07-01

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      Referenser

      1. RINVOQ produktresumé 16 december 2021
      2. van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019;394(10214):2108-2117. doi:10.1016/S0140-6736(19)32534-6
      3. Deodhar A, van der Heijde D, Sieper J, 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 [ACR abstract 2023]. Arthritis Rheumatol. 2020;72(suppl 10).

       

      SE-RNQ-220012 v.1.0 Senast uppdaterad 2022-03-10