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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-BEYOND: Study design

      A Phase 3 study investigating the efficacy and safety of RINVOQ + csDMARDs compared to placebo + csDMARDs in patients with moderate to severe RA and an inadequate response to bDMARDs1

      Primary
      RINVOQ 15 mg + csDMARD(s) vs placebo + csDMARD(s) at Week 12 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; bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; 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.

       

      SELECT-BEYOND: Previous bDMARD received1

      Adapted from Tabel 1, Genovese MC et al. Lancet 2018;391(10139):2513-2524

      RINVOQ 15 mg: Efficacy across endpoints

      SELECT-BEYOND: Low disease activity and remission at Week 12 in patients with an inadequate response to bDMARDs (NRI)1,2

      *P≤0.001 vs placebo + csDMARD(s) 

      bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); NRI: nonresponder imputation.

      SELECT-BEYOND: Adverse events through 12 weeks of treatment1,2

      No patients reported tuberculosis, nonmelanoma skin cancer, or lymphoma.

      *These were oral candidiasis.
      Most cases were mild and all but 1 was a single dermatome; 2 cases were serious.
      One malignant melanoma in RINVOQ 15-mg group, Weeks 0–12.
      §One ischemic stroke in Weeks 0–12 in RINVOQ 15-mg group.

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      Referanser

      1. Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease- modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513‍-‍2524. doi:10.1016/S0140- 6736(18)31116-4
      2. RINVOQ SPC avsnitt 5.1, sist oppdatert 21.05.2022.

       

      NO-RNQ-200017v2.0juni/2021