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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-MONOTHERAPY: Study design

      A Phase 3 study investigating the efficacy and safety of RINVOQ monotherapy after switching from MTX compared with cMTX for the treatment of moderate to severe RA in patients who had an inadequate response to MTX2

      Primary
      RINVOQ 15 mg vs cMTX at Week 14 for DAS28 (CRP) <3.2 or ACR20 

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

      ACR: American College of Rheumatology;  ACR20: improvement of at least 20% in the American College of Rheumatology core criteria; cMTX: continued methotrexate; DAS28 (CRP): disease activity score with 28 joint count (C-reactive protein); MACE: major adverse cardiovascular event; MTX: methotrexate;  QD: once daily; VTE: venous thromboembolic event.

      RINVOQ 15 mg monotherapy: Efficacy across endpoints

      SELECT-MONOTHERAPY: Low disease activity and remission at Week 14 (NRI)1,2

      *P≤0.001 vs cMTX

      cMTX: continued methotrexate; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); NRI: nonresponder imputation.

      SELECT-MONOTHERAPY: Adverse events through 14 weeks of treatment2

      *Serious infection: In the methotrexate group, there was 1 case of urosepsis. In the RINVOQ 15-mg group, there was 1 limb abscess.
      Opportunistic infection: In the methotrexate group, there was 1 case of fungal esophagitis. 
      Hepatic disorder: In the methotrexate group, there were 4 cases of liver enzyme elevations. In the RINVOQ 15-mg group, there were 3 cases of liver enzyme elevations and 1 mild hepatic cyst. 
      §Malignancies: In the methotrexate group, there was 1 basal cell carcinoma. In the RINVOQ 15-mg group, there was 1 non-Hodgkin lymphoma and 1 breast cancer.
      IIVenous thromboembolism: In the RINVOQ 15-mg group, there was 1 pulmonary embolism in a patient on estrogen hormone therapy with a body mass index of 44.9; investigator deemed as unrelated to study drug.
      Major adverse cardiovascular event (adjudicated): In the RINVOQ 15-mg group, there was 1 hemorrhagic stroke due to ruptured aneurysm (fatal); investigator deemed as unrelated to study drug. 
      #Death: In the RINVOQ 15-mg group, there was 1 hemorrhagic stroke due to ruptured aneurysm.

       

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      Referanser

      1. RINVOQ SPC avsnitt 5.1, sist oppdatert 21.05.2021.
      2. Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT- MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019;393(10188):2303‍-‍2311. doi:10.1016/S0140-6736(19)30419-2

       

      NO-RNQ-200016v2.0juni/2021