Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials
Tóm tắt
Từ khóa
Tài liệu tham khảo
Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl 2):14–7.
Coates LC, Kavanaugh A, Mease PJ, et al. Group for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendations for psoriatic arthritis. Arthritis Rheumatol. 2016;68(5):1060–71.
Singh JA, Guyatt G, Ogdie A, et al. Special article: 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5–32.
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):700–12.
Parmentier JM, Voss J, Graff C, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). BMC Rheumatol. 2018;2:23.
European Medicines Agency. Upadacitinib summary of product characteristics. 2021. https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf. Accessed 6 Apr 2021
Food and Drug Administration. Upadacitinib prescribing information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf. Accessed 6 Apr 2021
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):2513–24.
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. Lancet. 2019;393(10188):2303–11.
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):1788–800.
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):1607–20.
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.
Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80:312–20.
McInnes IB, Anderson JK, Magrey M, et al. Trial of upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med. 2021;384(13):1227–39.
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):2108–17.
McInnes I, Kato K, Magrey M, et al. Long-term safety and effectiveness of upadacitinib in patients with psoriatic arthritis: results at 56 weeks from the SELECT-PsA 1 study. Ann Rheum Dis. 2021;80(Suppl 1):1288–9.
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. https://doi.org/10.1007/s40744-021-00305-z.
Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2020;80(3):304–11.
Ramiro S, Sepriano A, Chatzidionysiou K, et al. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2017;76(6):1101–36.
Desai RJ, Thaler KJ, Mahlknecht P, et al. Comparative risk of harm associated with the use of targeted immunomodulators: a systematic review. Arthritis Care Res (Hoboken). 2016;68(8):1078–88.
Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open. 2018;4(2):e000723.
Combe B, Rahman P, Kameda H, et al. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020;22(1):14.
Burmester GR, Curtis JR, Yun H, et al. An integrated analysis of the safety of tofacitinib in psoriatic arthritis across phase III and long-term extension studies with comparison to real-world observational data. Drug Saf. 2020;43(4):379–92.
Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(4):234–43.
Choy EH. Clinical significance of Janus kinase inhibitor selectivity. Rheumatology. 2018;58(6):953–62.
Chen Y-H, Chen Y-M, Smolen JS, et al. FRI0164 Incidence rate and characterization of herpes zoster in patients with moderate-to-severe rheumatoid arthritis: an update from baricitinib clinical studies. Ann Rheum Dis. 2019;78(Suppl 2):755.
Winthrop KL, Lebwohl M, Cohen AD, et al. Herpes zoster in psoriasis patients treated with tofacitinib. J Am Acad Dermatol. 2017;77(2):302–9.
Curtis JR, Xie F, Yang S, et al. Risk for herpes zoster in tofacitinib-treated rheumatoid arthritis patients with and without concomitant methotrexate and glucocorticoids. Arthritis Care Res (Hoboken). 2019;71(9):1249–54.
European Medicines Agency. PRAC recommendations on signals. 2021. https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-7-10-june-2021-prac-meeting_en.pdf. Accessed 18 Aug 2021
Food and Drug Administration. Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib). 2021. https://www.fda.gov/media/145590/download. Accessed 18 Aug 2021
Food and Drug Administration. FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. 2021. https://www.fda.gov/media/151936/download. Accessed 10 Sept 2021
Scott IC, Hider SL, Scott DL. Thromboembolism with Janus kinase (JAK) inhibitors for rheumatoid arthritis: How real is the risk? Drug Saf. 2018;41(7):645–53.
Ogdie A, Kay McGill N, Shin DB, et al. Risk of venous thromboembolism in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: a general population-based cohort study. Eur Heart J. 2017;39(39):3608–14.
Ogdie A, Yu Y, Haynes K, et al. Risk of major cardiovascular events in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: a population-based cohort study. Ann Rheum Dis. 2015;74(2):326–32.
Charles-Schoeman C, DeMasi R, Valdez H, et al. Risk factors for major adverse cardiovascular events in phase III and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2019;71(9):1450–9.
Mease P, Charles-Schoeman C, Cohen S, et al. Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data. Ann Rheum Dis. 2020;79(11):1400–13.
Taylor PC, Weinblatt ME, Burmester GR, et al. Cardiovascular safety during treatment with baricitinib in rheumatoid arthritis. Arthritis Rheumatol. 2019;71(7):1042–55.
Franks AL, Slansky JE. Multiple associations between a broad spectrum of autoimmune diseases, chronic inflammatory diseases and cancer. Anticancer Res. 2012;32(4):1119–36.
Vaengebjerg S, Skov L, Egeberg A, Loft ND. Prevalence, incidence, and risk of cancer in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis. JAMA Dermatol. 2020;156(4):421–9.
Schwartz DM, Kanno Y, Villarino A, Ward M, Gadina M, O’Shea JJ. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov. 2017;17(1):78.
Rida MA, Chandran V. Challenges in the clinical diagnosis of psoriatic arthritis. Clin Immunol. 2020;214:108390.
Sandborn WJ, Ghosh S, Panes J, et al. Efficacy of upadacitinib in a randomized trial of patients with active ulcerative colitis. Gastroenterology. 2020;158(8):2139-49.e14.
Inokuma S, Kono H, Nakayama H, Yamazaki J. Immunoglobulin and lymphocyte decrease concurrent with adverse reactions induced by methotrexate for RA. Ann Rheum Dis. 2000;59:490.
Gelfand JM, Wan J, Zhang H, et al. Risk of liver disease in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis receiving methotrexate: a population-based study. J Am Acad Dermatol. 2021;84(6):1636–43.
Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377(16):1525–36.
Smolen JS, Genovese MC, Takeuchi 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.
Queeney K, Housley W, Sokolov J, Long A. FRI0131 Elucidating the mechanism underlying creatine phosphokinase upregulation with upadacitinib. Ann Rheum Dis. 2019;78(Suppl 2):734–5.