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      RINVOQ, a once-daily oral selective JAK inhibitor

      SIGNIFICANTLY GREATER REMISSION vs adalimumab + MTX

      RINVOQ + MTX demonstrated significant  remission vs adalimumab at every timepoint  from Week 8 to Week 156 (DAS28-CRP <2.6)*†‡2

      *SELECT-COMPARE is a Phase III double-blind randomised control trial (n=1,629) in MTX-IR RA patient population.4

      The primary endpoint of clinical remission (DAS28- CRP <2.6) for RINVOQ + MTX vs PBO + MTX at Week 12 (p≤0.001) was met.4

      Nominal p value for RINVOQ + MTX vs ADA + MTX at Weeks 8, 18, and 144: p≤0.01; nominal p value for all other timepoints: p≤0.001.2,8

      CONSISTENT EFFICACY

       

      RINVOQ demonstrated consistent efficacy with or without MTX2,3

      RINVOQ achieved consistent remission rates across patient populations studied2-6

      DEMONSTRATED SAFETY PROFILE

      Safety profile established across Phase III clinical trials involving more than 4,400 patients and more than 7,000 patient-years of exposure to RINVOQ 15 mg7

      RINVOQ's safety profile is comparable to adalimumab with similar rates of MACE, VTE and malignancy (excluding NMSC)7

      JAKs Mode of Actions Video

      NICE publishes positive Technology Appraisal Guidance (TAG) for RINVOQ for treating moderate rheumatoid arthritis.9

      NICE publishes positive Technology Appraisal Guidance (TAG) for RINVOQ for treating severe rheumatoid arthritis10

       

      1. Recommendations 

      1.1 NICE has published a positive TAG recommending RINVOQ (upadacitinib), with methotrexate (MTX), as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with 2 or more conventional disease modifying antirheumatic drugs (DMARDs), only if:

      • disease is moderate (a disease activity score [DAS28] of 3.2 to 5.1) and
      • the company provides upadacitinib according to the commercial arrangement

      1.2 RINVOQ can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the criteria in section 1.1 are met.

      1. NICE has published a positive TAG recommending RINVOQ (upadacitinib) with methotrexate (MTX) as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to:

      a) intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if:

      • disease is severe (a disease activity score [DAS28] of more than 5.1) and
      • AbbVie provides RINVOQ according to the commercial arrangement (simple discount patient access scheme (PAS))

      b) or who cannot have other DMARDs, including at least 1 biological DMARD, only if:

      • disease is severe (a DAS28 of more than 5.1) and
      • they cannot have rituximab and
      • AbbVie provides RINVOQ with the discount agreed in the commercial arrangement

      c) rituximab and at least 1 biological DMARD, only if:

      • disease is severe (a DAS28 of more than 5.1) and
      • AbbVie provides RINVOQ with the discount agreed in the commercial arrangement

      2. RINVOQ can be used as monotherapy for patients for who are intolerant to methotrexate, or for whom methotrexate is contraindicated, when the criteria 1a, 1b, and 1c are met.

      RINVOQ is accepted for use within NHS Scotland in patients with active RA with severe disease11

      Indication under review: for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

      SMC restriction:  

      • in patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs
      • in patients with severe disease inadequately controlled by a TNF antagonist in whom rituximab is not appropriate.

      Upadacitinib (with or without methotrexate) compared with placebo, significantly improved signs and symptoms of RA in patients with an inadequate response to conventional DMARDs and in patients with an inadequate response to biological DMARDs. Upadacitinib was non-inferior to a biologic DMARD in patients who had an inadequate response to methotrexate. This advice applies only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.

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      References

      1. RINVOQ (Upadacitinib) SmPC.
      2. Fleischmann R, Mysler E, Bessette L, et al. 2021 EULAR E-Congress; POS0087.
      3. 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 III study. Lancet. 2019;393(10188):2303. doi:10.1016/S0140-6736(19)30419-2.
      4. Fleischmann RM, Pangan AL, Song IH, et al. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III, double-blind, randomised controlled trial [published online July 9, 2019]. Arthritis Rhematol. doi:10.1002/art.41032.
      5. Fleischmann RM, Genovese MC, Enejosa JV, et al. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternative therapy in patients with insufficient response. Ann Rheum Dis. 2019:78(11):1452-1462.
      6. Fleischmann RM, Song IH, Enejosa JV, et al. Long-term safety and effectiveness of upadacitinib or adalimumab in patients with rheumatoid arthritis: Results at 72 weeks from the SELECT-COMPARE study. 2020 EULAR
      7. Cohen SB, van Vollenhoven R, Vurtis JR, et al. 2021 EULAR E-Congress; POS0220.
      8. Data on File: ABVRRTI72704.
      9. NICE 2021 Upadacitinib for treating moderate rheumatoid arthritis: Technology Appraisal Guidance; TA 744. Accessed at: https://www.nice.org.uk/guidance/ta744.
      10. NICE (2020). Upadacitinib for treating severe rheumatoid arthritis; Technology Appraisal Guidance; TA665. Accessed at: https://www.nice.org.uk/guidance/ta665.
      11. SMC Detailed Advice Document (SMC2315). Upadacitinib (RINVOQ). First published: 8th February 2021. Available at: https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-full-smc2315/.

      UK-UPAD-210313. Date of preparation: November 2021.

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
      Adverse events should also be reported to AbbVie on GBPV@abbvie.com