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      RINVOQ is not approved for the treatment of MTX-naive patients

      SELECT-EARLY: Study design

      A Phase 3 study investigating the efficacy and safety of RINVOQ monotherapy compared with MTX in MTX-naive patients with moderately to severely active RA1,2

      Rescue therapy from Weeks 12–24: In patients with <20% improvement in TJC and SJC at 2 consecutive visits, background medications were optimized.

      *Rescue protocol from Week 26: group 1 if CDAI ≤2.8, patients continued their original study drug; group 2 if ≥20% improvement from baseline in tender joint count (TJC), and swollen joint count (SJC), but CDAI >2.8, background medications were optimized; group 3 if <20% improvement from baseline in TJC and SJC, and CDAI >2.8, RINVOQ 15 mg or upadacitinib 30 mg were added by rerandomization according to 1:1 ratio for those initially randomized to MTX, and MTX was added for those initially randomized to RINVOQ 15 mg or upadacitinib 30 mg.
      Study drug assignments remain the same in the blinded extension while allowing initiation of, or change in, background RA medication(s) as per local label.

       

      Primary
      RINVOQ 15 mg and upadacitinib 30 mg vs MTX for DAS28 (CRP) <2.6 at Week 24 (EMA) or ACR50 at Week 12 (FDA)

      Safety
      Adverse events, serious adverse events, adverse event of special interest (e.g., serious infections, opportunistic infections, MACEs, VTEs, malignancies)

      • Patients ≥18 years of age were eligible to participate. 
      • Diagnosis of RA for ≥6 weeks fulfilling the 2010 ACR/EULAR classification for RA with active disease (at least 6 swollen joints out of 66, at least 6 tender joints out of 68, and hsCRP ≥5 mg/L) and ≥1 erosion on x-ray OR positive for both RF and ACCP. 
      • Patients were naive to MTX or received no more than 3 weekly MTX doses and completed a 4-week MTX washout. 
      • No prior intolerance to MTX, or no prior exposure to a JAK inhibitor or bDMARD.

      The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose.

      ACCP: anti-cyclic citrullinated protein; ACR: American College of Rheumatology; ACR50: improvement of at least 50% in the American College of Rheumatology core criteria; bDMARD: biological disease-modifying antirheumatic drug; CDAI: Clinical Disease Activity Index; DAS28 (CRP): disease activity score with 28 joint count (C-reactive protein); EMA: European Medicines Agency; EULAR: European League Against Rheumatism; FDA: Food and Drug Administration; hsCRP: high-sensitivity C-reactive protein; JAK: Janus kinase; MACE: major adverse cardiovascular events; MTX: methotrexate; QD: once daily; RF: rheumatoid factor; SJC: swollen joint count; TJC: tender joint count; VTE: venous thromboembolic event.

      RINVOQ is not approved for the treatment of MTX-naive patients

      RINVOQ monotherapy data

      SELECT-EARLY: Remission (primary endpoint) and low disease activity at Week 24 in MTX-naive patients1,3*

      *RINVOQ is not indicated for MTX-naive patients. 
       P<0.001 vs MTX 

      DAS28 (CRP): disease activity score with 28 joint counts (C-reactive protein); MTX: methotrexate.

      The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose.

      RINVOQ is not approved for the treatment of MTX-naive patients

      Joint protection with RINVOQ monotherapy 

      SELECT-EARLY: Inhibition of structural joint damage progression as monotherapy in MTX-naive patients* at Week 241,3

       

      Change in mTSS for RINVOQ vs MTX at Week 24 was a ranked secondary endpoint controlled for multiplicity. All other data shown for RINVOQ vs MTX were prespecified nonranked endpoints not controlled for multiplicity; nominal P-values are provided.

      *RINVOQ is not indicated for MTX-naive patients.
      P≤0.01 vs MTX
      P≤0.001 vs MTX
      § P≤0.05 vs MTX
      ||Indicates multiplicity-controlled comparison of RINVOQ vs MTX.

      LS: least squares; mTSS: modified total Sharp score; MTX: methotrexate.

      The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose.

      RINVOQ is not approved for the treatment of MTX-naive patients

      SELECT-EARLY: Adverse events through 24 weeks of treatment1

      *Deaths: In the methotrexate group, there was 1 sudden CV death. In the RINVOQ 15 mg group, there was 1 CV death, 1 death due to metastatic malignant melanoma.
      Herpes zoster: All non-serious, 12 were single dermatome.
      Malignancies: In the methotrexate group, there was 1 case of ovarian cancer. In the RINVOQ 15-mg group, there was 1 metastatic malignant melanoma, 1 squamous cell carcinoma of the lung, 1 uterine carcinoma in situ. 
      §Major adverse cardiovascular events (adjudicated): In the methotrexate group, there was 1 CV death. In the RINVOQ 15-mg group, there was 1 nonfatal MI and 1 CV death due to other CV causes. 

      CV: cardiovascular; GI: gastrointestinal; MI: myocardial infarction; MTX: methotrexate.

      The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose.

      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: 16 december 2021. 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 15/30 mg subventioneras för patienter >12 år med måttlig till svår atopisk dermatit, när konventionell topikal eller systemisk behandling gett otillräcklig effekt eller inte är lämplig. 

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      Referenser

      1. van Vollenhoven R, Takeuchi T, Pangan AL, et al. A phase 3 randomized, controlled trial comparing upadacitinib monotherapy to MTX monotherapy in MTX-naive patients with active rheumatoid arthritis. Presented at: American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting; October 19–24, 2018; Chicago, IL.
      2. van Vollenhoven R, Takeuchi T, Pangan AL, et al. Monotherapy with upadacitinib in MTX-naive patients with rheumatoid arthritis: results at 48 weeks from the SELECT-EARLY study. Poster presented at: European Congress of Rheumatology (EULAR); June 12–15, 2019; Madrid, Spain.
      3. RINVOQ produktresumé 16 december 2021

       

      SE-RNQ-220007 v.1.0 Senast uppdaterad 2022-03-10