Upadacitinib for the treatment of adult patients with active psoriatic arthritis

References

• Ogdie A, Weiss P. The epidemiology of psoriatic arthritis. Rheumatol Dis Clin N Am. 2015;41(4):545–68. doi: 10.1016/j.rdc.2015.07.001
   PubMed Web of Science ®Google Scholar
• Salvarani C, Lo Scocco G, Macchioni P, et al. Prevalence of psoriatic arthritis in Italian psoriatic patients. J Rheumatol. 1995;22:1499–1503.
   PubMed Web of Science ®Google Scholar
• Scotti L, Franchi M, Marchesoni A, et al. Prevalence and incidence of psoriatic arthritis: a systematic review and meta-analysis. Semin Arthritis Rheum. 2018;48(1):28–34. doi: 10.1016/j.semarthrit.2018.01.003
   PubMed Web of Science ®Google Scholar
• Scher JU, Ogdie A, Merola JF, et al. Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition. Nat Rev Rheumatol. 2019;15(3):153–66. doi: 10.1038/s41584-019-0175-0
   PubMed Web of Science ®Google Scholar
• Charlton R, Green A, Shaddick G, et al. Risk of uveitis and inflammatory bowel disease in people with psoriatic arthritis: a population-based cohort study. Ann Rheum Dis. 2018;77(2):277–80. doi: 10.1136/annrheumdis-2017-212328
   PubMed Web of Science ®Google Scholar
• Gupta S, Syrimi Z, Hughes DM, et al. Comorbidities in psoriatic arthritis: a systematic review and meta‐analysis. Rheumatol Inter. 2021;41:275–284. doi: 10.1007/s00296-020-04775-2
   PubMed Web of Science ®Google Scholar
• Geijer M, Alenius G-D, Andre L, et al. Health-related quality of life in early psoriatic arthritis compared with early rheumatoid arthritis and a general population. Sem Arthritis Rheum. 2021;51(1):246–252. doi: 10.1016/j.semarthrit.2020.10.010
   PubMed Web of Science ®Google Scholar
• Kerschbaumer A, Baker D, Smolen JS, et al. The effects of structural damage on functional disability in psoriatic arthritis. Ann Rheum Dis. 2017;76(12):2038–45. doi: 10.1136/annrheumdis-2017-211433
   PubMed Web of Science ®Google Scholar
• Bavière W, Deprez X, Houvenagel E, et al. Association between comorbidities and quality of life in psoriatic arthritis: results from a multicentric cross-sectional study. J Rheumatol. 2020;47(3):369–76. doi: 10.3899/jrheum.181471
   PubMed Web of Science ®Google Scholar
• Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and psoriatic arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(Aug):465–479. doi: 10.1038/s41584-022-00798-0
   PubMedGoogle Scholar
• Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700–712. doi: 10.1136/annrheumdis-2020-217159
   PubMed Web of Science ®Google Scholar
• Mease PJ, Smolen JS, Behrens F, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79(1):123–131. doi: 10.1136/annrheumdis-2019-215386
   PubMed Web of Science ®Google Scholar
• McInnes IB, Behrens F, Mease PJ, et al. EXCEED study group. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020;395(10235):1496–505. doi: 10.1016/S0140-6736(20)30564-X
   PubMed Web of Science ®Google Scholar
• Mease P, McInnes I, Lai-Shan T, et al. Comparative effectiveness of guselkumab in psoriatic arthritis: results from systematic literature review and network metanalysis. Rheumatology (Oxford). 2021;60(5):2109–2121. doi: 10.1093/rheumatology/keab119
   PubMed Web of Science ®Google Scholar
• Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010;69(1):48–53. doi: 10.1136/ard.2008.102053
   PubMed Web of Science ®Google Scholar
• Gossec L, McGonagle D, Korotaeva T, et al. Minimal disease activity as a treatment target in psoriatic arthritis: a review of the literature. J Rheumatol. 2018;45(1):6–13. doi: 10.3899/jrheum.170449
   PubMed Web of Science ®Google Scholar
• Brahe CH, Ornbjerg LM, Jacobsson L, et al. Retention and response rates in 14 261 PsA patients starting TNF inhibitor treatment—results from 12 countries in EuroSpA. Rheumatology (Oxford). 2020;59(7):1640–1650. doi: 10.1093/rheumatology/kez427
   PubMed Web of Science ®Google Scholar
• Michelson B, Georgiadis S, Di Giuseppe D, et al. Real-world six- and twelve-month drug retention, remission, and response rates of secukinumab in 2,017 patients with psoriatic arthritis in thirteen european countries. Arthritis Care Res. 2022;74(7):1205–1218. doi: 10.1002/acr.24560
   Web of Science ®Google Scholar
• Tanaka Y, Luo Y, O’Shea JJ et al. Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach. Nat Rev Rheumatol. 2022;18(3):133–145. doi: 10.1038/s41584-021-00726-8
   PubMed Web of Science ®Google Scholar
• Reddy V, Cohen S. Inhibitors: JAK. What is new? Curr Rheumatol Rep. 2020;22(9):50. doi: 10.1007/s11926-020-00931-6
   PubMed Web of Science ®Google Scholar
• Schreiber S, Puig L, Gonçalves J, et al. Critical appraisal and future outlook on anti-inflammatory biosimilar use in chronic immune-mediated inflammatory diseases. Sem Arthitis Rheum. 2022;55:152023. doi: 10.1016/j.semarthrit.2022.152023
   PubMedGoogle Scholar
• PubChem. Upadacitinib. https://pubchem.ncbi.nlm.nih.gov/compound/58557659
   Google Scholar
• Parmentier JM, Voss J, Graff C, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). Bmc Rheumatology. 2018;2(1):23. doi: 10.1186/s41927-018-0031-x
   PubMedGoogle Scholar
• Schwartz DM, Kanno Y, Villarino A, et al. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Rheumatol. 2021;16(12):843–862. doi: 10.1038/nrd.2017.201
   Google Scholar
• 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):2503–12. doi: 10.1016/S0140-6736(18)31115-2
   PubMed Web of Science ®Google Scholar
• www.rinvoq.com
   Google Scholar
• https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq#overview-section
   Google Scholar
• Klunder B, Mohamed MF, Othman AA. Population pharmacokinetics of upadacitinib in healthy subjects and subjects with rheumatoid arthritis: analyses of phase I and II clinical trials. Clin Pharmacokinet. 2018;57:977–988. doi: 10.1007/s40262-017-0605-6
   PubMed Web of Science ®Google Scholar
• Klünder B, Mittapalli RK, Mohamed M-E, et al. Population pharmacokinetics of upadacitinib using the immediate-release and extended-release formulations in healthy subjects and subjects with rheumatoid arthritis: analyses of phase I–III clinical trials. Clin Pharmacokinet. 2019;58(8):1045–1058. doi: 10.1007/s40262-019-00739-3
   PubMed Web of Science ®Google Scholar
• Mohamed M-E, Klünder B, Othman AA. Clinical pharmacokinetics of upadacitinib: review of data relevant to the rheumatoid arthritis indication. Clin Pharmacokinet. 2020;59(5):531–544. doi: 10.1007/s40262-019-00855-0
   PubMed Web of Science ®Google Scholar
• Mohamed MF, Camp HS, Jiang P, et al. 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):1547–1558. doi: 10.1007/s40262-016-0419-y
   PubMed Web of Science ®Google Scholar
• Muensterman E, Engelhardt B, Gopalakrishnan S, et al. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients –analyses of phase III clinical trials. Clin Transl Sci. 2022;15(1):267–78. doi: 10.1111/cts.13146
   PubMed Web of Science ®Google Scholar
• Nader A, Mohamed M-E, Winzenborg I, et al. Exposure–response analyses of upadacitinib efficacy and safety in phase II and III studies to support benefit–risk assessment in rheumatoid arthritis. Clin Pharmacol Ther. 2020;107(4):994–1003. doi: 10.1002/cpt.1671
   PubMed Web of Science ®Google Scholar
• McInnes IB, Anderson JK, Magrey, et al. Trial of upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med. 2021;384(13):1227–1239. doi: 10.1056/NEJMoa2022516
   PubMed Web of Science ®Google Scholar
• Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312–20. doi: 10.1136/annrheumdis-2020-218870
   PubMed Web of Science ®Google Scholar
• McInnes IB, Kato K, Magrey M, et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021 Oct;7(3):e001838. doi: 10.1136/rmdopen-2021-001838 Erratum in: RMD Open. 2021 Nov;7(3): PMID: 34663636; PMCID: PMC8524381.
   PubMed Web of Science ®Google Scholar
• McInnes IB, Kato K, Magrey M, et al. Efficacy and safety of upadacitinib in patients with psoriatic arthritis: 2-year results from the phase 3 SELECT-PsA 1 study. Rheumatol Ther. 2023;10(1):275–92. doi: 10.1007/s40744-022-00499-w.
   PubMed Web of Science ®Google Scholar
• Mease PJ, Lertratanakul A, Papp KA, et al. Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 56-week data from the randomized controlled phase 3 SELECT-PsA 2 study. Rheumatol Ther. 2021;8(2):903–19. doi: 10.1007/s40744-021-00305-z
   PubMed Web of Science ®Google Scholar
• Strand V Mease PJ, Soriano ER, et al. Improvement in patient-reported outcomes in patients with psoriatic arthritis treated with upadacitinib versus placebo or adalimumab: results from SELECT-PsA 1. Rheumatol Ther. 2021;8(4):1789–808. doi: 10.1007/s40744-021-00379-9
   PubMed Web of Science ®Google Scholar
• Strand V, Van den Bosch F, Ranza R, et al. Patient-reported outcomes in psoriatic arthritis patients with an inadequate response to biologic disease-modifying antirheumatic drugs: SELECT-PsA 2. Rheumatol Ther. 2021;8(4):1827–44. doi: 10.1007/s40744-021-00377-x
   PubMed Web of Science ®Google Scholar
• Mease P, Kavanaugh A, Gladman D, et al. Disease control with upadacitinib in patients with psoriatic arthritis: a post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022;9:1181–1191. doi: 10.1007/s40744-022-00449-6
   PubMed Web of Science ®Google Scholar
• Coates LC, Garrood T, Gullick N, et al. Upadacitinib response rates in patients with psoriatic arthritis enrolled in the SELECT-PsA-1 and SELECT-PsA-2 trials assessed according to modified PsARC. Rheumatology. 2023;62(1):e1–e3. doi: 10.1093/rheumatology/keac388
   Web of Science ®Google Scholar
• Baraliakos X, Ranza R, Ostor A, et al. Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies. Arthritis Res Ther. 2023 [cited 2023 Apr 10];25:56. doi: 10.1186/s13075-023-03027-5
   PubMed Web of Science ®Google Scholar
• Nash P, Richette P, Gossec L, et al. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology. 2022;61(8):3257–68. doi: 10.1093/rheumatology/keab905
   PubMed Web of Science ®Google Scholar
• Taylor W, Gladman D, Helliwell P, et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006;54(8):2665–73. doi: 10.1002/art.21972
   PubMed Web of Science ®Google Scholar
• Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical program. Ann Rheum Dis. 2021;80(3):304–311. doi: 10.1136/annrheumdis-2020-218510
   PubMed Web of Science ®Google Scholar
• Burmester GR, Winthrop K, Blanco R, et al. Safety profile of upadacitinib up to 3 years in psoriatic arthritis: an integrated analysis of two pivotal phase 3 trials. Rheumatol Ther. 2022;9:521–539.
   PubMed Web of Science ®Google Scholar
• Fleischmann R, Mysler E, Bessette L, et al. Long-term safety and efficacy of upadacitinib or adalimumab in patients with rheumatoid arthritis: results through 3 years from the SELECT-COMPARE study. RMD Open. 2022 Feb;8(1):e002012.
   PubMed Web of Science ®Google Scholar
• Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386(4):316–26. doi: 10.1056/NEJMoa2109927
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. RINVOQ™ (upadacitinib): highlights of prescribing information 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf
   Google Scholar
• European Medicines Agency. RINVOQ (upadacitinib): summary of product characteristics 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq#product-information-section
   Google Scholar
• van der Heijde D, Song I-H, 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. doi: 10.1016/S0140-6736(19)32534-6
   PubMed Web of Science ®Google Scholar
• Deodhar A, Van den Bosch P, 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. The Lancet. 2022;400(10349):369–379. doi: 10.1016/S0140-6736(22)01212-0
   PubMed Web of Science ®Google Scholar
• Xie W, Huang Y, Xiao S, et al. Impact of janus kinase inhibitors on risk of cardiovascular events in patients with rheumatoid arthritis: systematic review and meta-analysis of randomized controlled trials. Ann Rheum Dis. 2019;78(8):1048–1054. doi: 10.1136/annrheumdis-2018-214846
   PubMed Web of Science ®Google Scholar
• Winthrop KL, Cohen SB. Oral surveillance and JAK inhibitor safety: the theory of relativity. Nat Rev Rheumatol. 2022;18(5):301–4. doi: 10.1038/s41584-022-00767-7
   PubMed Web of Science ®Google Scholar
• Hoisnard L, Vegas LP, Dray-Spira R, et al. Risk of major adverse cardiovascular and venous thromboembolism events in patients with rheumatoid arthritis exposed to JAK inhibitors versus adalimumab: a nationwide cohort study. Ann Rheum Dis. 2023;82(2):182–8. doi: 10.1136/ard-2022-222824
   PubMed Web of Science ®Google Scholar
• Molander V, Bower H, Frisell T, et al. Venous thromboembolism with JAK inhibitors and other immune-modulatory drugs: a Swedish comparative safety study among patients with rheumatoid arthritis. Ann Rheum Dis. 2023;82(2):189–97. doi: 10.1136/ard-2022-223050
   PubMed Web of Science ®Google Scholar
• Weber B, Liao KP. Evidence for biologic drug modifying anti-rheumatoid drugs and association with cardiovascular disease risk mitigation in inflammatory arthritis. Rheum Dis Clin North Am. 2023;49(1):165–78. doi: 10.1016/j.rdc.2022.08.005
   PubMed Web of Science ®Google Scholar
• Sarabia S, Ranjith B, Koppikar S, et al. Efficacy and safety of JAK inhibitors in the treatment of psoriasis and psoriatic arthritis: a systematic review and meta-analysis. Bmc Rheumatol. 2022;6(1):71. doi: 10.1186/s41927-022-00287-7
   PubMedGoogle Scholar