A review of upadacitinib in rheumatoid arthritis

References

• Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016;388(10055):2023–38.
   PubMed Web of Science ®Google Scholar
• McInnes IB, Schett G. Pathogenetic insights from the treatment of rheumatoid arthritis. Lancet. 2017;389(10086):2328–37.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, et al EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960–77.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2016;75(1):3–15.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685–699.
   Google Scholar
• Harrold LR, Reed GW, Best J, Zlotnick S, Kremer JM. Real-world comparative effectiveness of tocilizumab monotherapy vs. tumor necrosis factor inhibitors with methotrexate in patients with rheumatoid arthritis. Rheumatol Ther. 2018;5(2):507–23.
   PubMed Web of Science ®Google Scholar
• Keystone EC, Rampakakis E, Movahedi M, Cesta A, Stutz M, Sampalis JS, et al. Toward defining primary and secondary nonresponse in rheumatoid arthritis patients treated with anti-TNF: results from the BioTRAC and OBRI registries. J Rheumatol. 2020;47(4):510–7.
   PubMedGoogle Scholar
• Bello AE, Perkins EL, Jay R, Efthimiou P. Recommendations for optimizing methotrexate treatment for patients with rheumatoid arthritis. Open Access Rheumatol. 2017;9:67–79.
   PubMed Web of Science ®Google Scholar
• Fatimah N, Salim B, Nasim A, Hussain K, Gul H, Niazi S. Frequency of methotrexate intolerance in rheumatoid arthritis patients using methotrexate intolerance severity score (MISS questionnaire). Clin Rheumatol. 2016;35(5):1341–5.
   PubMed Web of Science ®Google Scholar
• Alten R, Krüger K, Rellecke J, Schiffner-Rohe J, Behmer O, Schiffhorst G, et al. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. Patient Prefer Adherence. 2016;10:2217–28.
   PubMed Web of Science ®Google Scholar
• Louder AM, Singh A, Saverno K, Cappelleri JC, Aten AJ, Koenig AS, et al. Patient preferences regarding rheumatoid arthritis therapies: a conjoint analysis. Am Health Drug Benefits 2016;9(2):84–93.
   PubMed Web of Science ®Google Scholar
• Biggioggero M, Becciolini A, Crotti C, Agape E, Favalli EG. Upadacitinib and filgotinib: the role of JAK1 selective inhibition in the treatment of rheumatoid arthritis. Drugs Context. 2019;8:212595.
   PubMedGoogle Scholar
• Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(4):234–43.
   PubMed Web of Science ®Google Scholar
• Smolen JS, van der Heijde D, Machold KP, Aletaha D, Landewe R. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis. 2014;73(1):3–5.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Pangan AL, Emery P, Rigby W, Tanaka Y, Vargas JI, 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):2303–11.
   PubMed Web of Science ®Google Scholar
• Ghoreschi K, Laurence A, O'Shea JJ. Janus kinases in immune cell signaling. Immunol Rev. 2009;228(1):273–87.
   PubMed Web of Science ®Google Scholar
• O'Shea JJ, Kontzias A, Yamaoka K, Tanaka Y, Laurence A. Janus kinase inhibitors in autoimmune diseases. Ann Rheum Dis. 2013;72(Suppl 2):ii111–5.
   PubMed Web of Science ®Google Scholar
• Tanaka Y. Recent progress and perspective in JAK inhibitors for rheumatoid arthritis: from bench to bedside. J Biochem. 2015;158(3):173–9.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Maeshima K, Maeshima Y, Yamaoka K. In vitro and in vivo analysis of a JAK inhibitor in rheumatoid arthritis. Ann Rheum Dis. 2012;71 Suppl 2 (Suppl 2):i70–4.
   PubMedGoogle Scholar
• O'Shea JJ, Schwartz DM, Villarino AV, Gadina M, McInnes IB, Laurence A. The JAK-STAT pathway: impact on human disease and therapeutic intervention. Annu Rev Med. 2015;66:311–28.
   PubMed Web of Science ®Google Scholar
• Schwartz DM, Bonelli M, Gadina M, O'Shea JJ. Type I/II cytokines, JAKs, and new strategies for treating autoimmune diseases. Nat Rev Rheumatol. 2016;12(1):25–36.
   PubMed Web of Science ®Google Scholar
• Parmentier JM, Voss J, Graff C, Schwartz A, Argiriadi M, Friedman M, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). BMC Rheumatol. 2018;2:23
   PubMedGoogle Scholar
• Mohamed MF, Camp HS, Jiang P, Padley RJ, Asatryan A, Othman AA. Pharmacokinetics, safety and tolerability of ABT-494, a novel selective JAK 1 inhibitor, in healthy volunteers and subjects with rheumatoid arthritis. Clin Pharmacokinet. 2016;55(12):1547–58.
   PubMed Web of Science ®Google Scholar
• Kremer JM, Emery P, Camp HS, Friedman A, Wang L, Othman AA, et al. A phase IIb study of ABT-494, a selective JAK-1 inhibitor, in patients with rheumatoid arthritis and an inadequate response to anti-tumor necrosis factor therapy. Arthritis Rheumatol. 2016;68(12):2867–77.
   PubMed Web of Science ®Google Scholar
• Genovese MC, Smolen JS, Weinblatt ME, Burmester GR, Meerwein S, Camp HS, et al. Efficacy and safety of ABT-494, a selective JAK-1 inhibitor, in a phase IIb study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Rheumatol. 2016;68(12):2857–66.
   PubMed Web of Science ®Google Scholar
• Mohamed MF, Klunder B, Camp HS, Othman AA. Exposure-response analyses of upadacitinib efficacy in phase II trials in rheumatoid arthritis and basis for phase III dose selection. Clin Pharmacol Ther. 2019;106(6):1319–27.
   PubMed Web of Science ®Google Scholar
• Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, 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):2503–12.
   PubMed Web of Science ®Google Scholar
• Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, 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):2513–24.
   PubMed Web of Science ®Google Scholar
• van Vollenhoven R, Takeuchi T, Pangan AL, Friedman A, Mohamed ME, Chen S, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2018; 70(Suppl 10).
   Google Scholar
• Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, 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):1788–800.
   PubMed Web of Science ®Google Scholar
• Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, et al. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. 2019;78(11):1454–62.
   PubMed Web of Science ®Google Scholar
• Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Zhou Y, et al. Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase IIb/III study Rheumatology. 2020; doi:10.1093/rheumatology/keaa084. [Epub ahead of print].
   Google Scholar
• Cohen SB, van Vollenhoven R, Winthrop K, Zerbini C, Tanaka Y, Bessette L, Yihan LI, Khan N, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT Phase 3 clinical program. Ann Rheum Dis 2019;78(2):357.
   Google Scholar
• van der Heijde D, Song IH, Pangan AL, Deodhar A, van den Bosch F, Maksymowych WP, 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):2108–17.
   PubMed Web of Science ®Google Scholar
• RINVOQ™ (upadacitinib) meets primary and all ranked secondary endpoints in phase 3 study in psoriatic arthritis. 2019. Available from: https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-meets-primary-and-all-ranked-secondary-endpoints-in-phase-3-study-in-psoriatic-arthritis.htm
   Google Scholar
• Sandborn WJ, Feagan BG, Panes J, D'Haens GR, Colombel JF, Zhou Q, et al. Safety and efficacy of ABT-494 (upadacitinib), an oral JAK1 inhibitor, as induction therapy in patients with Crohn’s disease: results from Celest. Gastroenterology 2017;152(5):S1308–S9.
   Web of Science ®Google Scholar
• Sandborn W, Ghosh S, Panes J, Schreiber S, D’Haens G, Tanida S, et al. Efficacy and safety of upadacitinib as an induction therapy for patients with moderately-to-severely active ulcerative colitis: data from the Phase 2B study U-ACHIEVE. United European Gastroenterol J 2018;6(1):A92.
   Google Scholar
• Guttman-Yassky E, Thaci D, Pangan AL, Hong HC, Papp KA, Reich K, et al. Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. J Allergy Clin Immunol 2019;145(3):877–884.
   Google Scholar
• Lee YH, Song GG. Relative efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib in comparison to adalimumab in patients with active rheumatoid arthritis. Z Rheum 2020; doi:10.1007/s00393-020-00750-1. [Epub ahead of print].
   Google Scholar
• McInnes IB, Byers NL, Higgs RE, Lee J, Macias WL, Na S, et al. Comparison of baricitinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations. Arthritis Res Ther. 2019;21(1):183.
   PubMed Web of Science ®Google Scholar
• Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014;370(25):2377–86.
   PubMed Web of Science ®Google Scholar
• Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69(3):506–17.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment. J Rheumatol. 2019;46(1):7–18.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Atsumi T, Amano K, Harigai M, Ishii T, Kawaguchi O, et al. Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: subgroup analyses of four multinational phase 3 randomized trials. Mod Rheumatol. 2018;28(4):583–91.
   PubMed Web of Science ®Google Scholar
• Winthrop KL, Curtis JR, Lindsey S, Tanaka Y, Yamaoka K, Valdez H, et al. Herpes zoster and tofacitinib: clinical outcomes and the risk of concomitant therapy. Arthritis Rheumatol. 2017;69(10):1960–8.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Summary of opinion (initial authorisation): Rinvoq (upadacitinib) 2019. Available from: https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rinvoq_en.pdf
   Google Scholar
• Duggan S, Keam SJ. Upadacitinib: first approval. Drugs 2019;79(16):1819–28.
   PubMed Web of Science ®Google Scholar