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      Asset 1

       

      *First launch of RINVOQ in RA. 183,634 patients with RA, 67,914 patients with SpA (PsA, AS, and nr-axSpA), 109,946 patients with AD, 54,780 patients with UC, and 43,308 patients with CD.2,24 †Based on the EMA CHMP summary of opinion (post authorisation).1,3-5 ‡The recommended dose of RINVOQ is 15 mg QD for adolescents (12-17 years of age) weighing at least 30 kg. If an adolescent patient does not respond adequately to RINVOQ 15 mg once daily, the dose can be increased to 30 mg once daily. The posology in adolescent patients 30 kg to <40 kg was determined using population pharmacokinetic modeling and simulation. No clinical exposure data are available in adolescents <40 kg. The safety and efficacy of RINVOQ in children with AD <12 years of age have not been established. No data are available.1

       

       

      RINVOQ’S Phase 3 clinical trials1,6-23

      | 6 trials in RA: SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE*

      | 2 trials in PsA: SELECT-PsA 1, SELECT-PsA 2

      | 2 trials in AS: SELECT-AXIS 1,† SELECT-AXIS 2 (AS bDMARD-IR)

      | 1 trial in nr-axSpA: SELECT-AXIS 2

      | 6 trials in AD: MEASURE-UP 1, MEASURE-UP 2, AD-UP,

      HEADS-UP,* LEVEL UP,*,‡ FLEX UP*,‡

      | 2 trials in UC consisting of 3 studies: U-ACHIEVE induction,

      U-ACCOMPLISH (induction), and U-ACHIEVE maintenance

      | 3 trials in CD: U-EXCEED induction, U-EXCEL induction, and

      U-ENDURE maintenance

      | 1 trial in GCA: SELECT-GCA

       

      *Nonregistrational clinical trial. †Phase 2b/3 clinical trial. ‡Phase 3b/4 clinical trial.

       

      Asset 3

       §§ELEVATE: AbbVie defines "ELEVATE" as the raising of the standards of care in AD patients, measured by WP-NRS and EASI score, treated with Dupilumab vs RINVOQ at week 16 of the head to head trials.6,7

           

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      REFERENCES

      1. RINVOQ® (upadacitinib) Summary of Product Characteristics, available at www.medicines.ie.
      2.  AbbVie. Data on File. ABVRRTI80819. 
      3. European Medicines Agency. RINVOQ (upadacitinib) Summary of Opinion (post authorisation). June 24, 2021. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-rinvoq-x-06-g_en.pdf. Accessed January 27, 2025. 
      4. European Medicines Agency. Olumiant (baricitinib) Summary of Opinion (post authorization). September 14, 2023. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-olumiant-ii-37_en.pdf. Accessed January 27, 2025. 
      5. European Medicines Agency. Cibinqo (abrocitinib) Summary of Opinion (post authorisation). February 22, 2024. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cibinqo-ii-0010_en.pdf. Accessed January 27, 2025. 
      6. Silverberg JI, Bunick CG, Hong HC, et al. Efficacy and safety of upadacitinib versus dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: week 16 results of an open-label randomized efficacy assessor-blinded head-to-head phase IIIb/IV study (Level Up). Br J Dermatol. 2024;192(1):36-45. 
      7. Blauvelt A, Teixeira HD, Simpson EL, et al. Efficacy and safety of upadacitinib vs dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized clinical trial [published correction appears in JAMA Dermatol. 2022 Feb 1;158(2):219.] [published correction appears in JAMA Dermatol. 2022 Feb 1;158(2):219.] [published correction appears in JAMA Dermatol. 2024 Mar 1;160(3):370.] [published correction appears in JAMA Dermatol. 2024 Sep 1;160(9):1012]. JAMA Dermatol. 2021;157(9):1047-1055. 
      8. Burmester GR, Kremer JM, Van den Bosch F, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391(10139):2503-2512. 
      9. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials [published correction appears in Lancet. 2021 Jun 5;397(10290):2150.]. Lancet. 2021;397(10290):2151-2168. 
      10. van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and safety of upadacitinib monotherapy in methotrexate-naive patients with moderately-to-severely active rheumatoid arthritis (SELECT-EARLY): A multicenter, multi-country, randomized, double-blind, active comparator-controlled trial. Arthritis Rheumatol. 2020;72(10):1607-1620. 
      11. Fleischmann R, 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, randomized controlled trial. Arthritis Rheumatol. 2019;71(11):1788-1800.
      12. 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 [published correction appears in Lancet. 2019 Jun 29;393(10191):2590.]. Lancet. 2019;393(10188):2303-2311. 
      13. Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513-2524. 
      14. Felson D, Smolen JS. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2021;384(1):83. 
      15. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320. 
      16. van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double blind, placebo-controlled, phase 2/3 trial. Lancet. 2019;394(10214):2108-2117. 
      17. Reich K, Teixeira HD, de Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021;397(10290):2169-2181. [published correction appears in Lancet. 2021 Jun 19;397(10292):2336.] [published correction appears in Lancet. 2021 Aug 28;398(10302):746.] 
      18. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials [published correction appears in Lancet. 2022 Sep 24;400(10357):996.]. Lancet. 2022;399(10341):2113-2128. 
      19. Loftus EV Jr, Panés J, Lacerda AP, et al. Upadacitinib induction and maintenance therapy for Crohn's disease. N Engl J Med. 2023;388(21):1966-1980. 
      20. McInnes IB, Anderson JK, Magrey M, et al. Trial of upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med. 2021;384(13):1227-1239. 
      21. Deodhar A, Van den Bosch F, Poddubnyy D, et al. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10349):369-379. 
      22. van der Heijde D, Baraliakos X, Sieper J, et al. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomised, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022;81(11):1515-1523. 
      23. Gooderham M, Imafuku S, Owczarek W, et al. Efficacy and safety of upadacitinib dose escalation and reduction in adult patients with moderate-to-severe atopic dermatitis: results of a randomized, blinded, treat-to-target, multi-center Phase 3b/4 study (Flex Up). Presented at: American Association of Dermatology (AAD) 2025, Orlando, Florida. 
      24. Lytvyn Y, Mufti A, Abduelmula A, et al. Efficacy and safety of upadacitinib for management of moderate-to-severe atopic dermatitis: an evidence-based review. Pharmaceutics. 2022;14(11):2452.

      IE-RNQD-260011 Date of Preparation: May 2026

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      Date of Preparation: October 2025 | IE-ABBV-220078