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    • The study evaluated 2 doses of upadacitinib, 15 mg and 30 mg QD. The results presented here are for RINVOQ (upadacitinib) 15 mg once daily, which is the approved dose for Rheumatoid Arthritis.

      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

      Primary
      RINVOQ 15 mg vs MTX for DAS28 (CRP) <2.6 at Week 24 or ACR50 at Week 12 

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

      ACR: American College of Rheumatology; ACR50: improvement of at least 50% in the American College of Rheumatology core criteria; CDAI: Clinical Disease Activity Index; DAS28 (CRP): disease activity score with 28 joint count (C-reactive protein); JAK: Janus kinase; MACE: major adverse cardiovascular events; MTX: methotrexate; QD: once daily; VTE: venous thromboembolic event.

      RINVOQ monotherapy data

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

      *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.

      Joint protection with RINVOQ monotherapy 

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

       

      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
      ||Indicates multiplicity-controlled comparison of RINVOQ vs MTX.

       mTSS: modified total Sharp score; MTX:methotrexate.



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      Referanser

      1. RINVOQ SPC avsnitt 5.1, sist oppdatert 30.05.2022.

       

      NO-RNQ-200013v2.0juni/2021