Abstract
Risankizumab is a humanized IgG1 monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23). It has demonstrated substantial clinical efficacy in the treatment of psoriasis. This chapter reviews the efficacy and safety of risankizumab for the treatment of psoriasis as evidenced by the clinical trials to date. Four phase III trials have shown risankizumab to be more effective than ustekinumab and adalimumab in terms of PASI and sPGA scores with similar safety profiles to placebo. Thus far, no significant safety concerns have emerged for this drug, though further long-term studies will be critical in confirming this.
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References
Oppmann B, Lesley R, Blom B, et al. Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity. 2000;13:715–25. https://doi.org/10.1016/S1074-7613(00)00070-4.
Girolomoni G, Strohal R, Puig L, et al. The role of IL-23 and the IL-23/TH 17 immune axis in the pathogenesis and treatment of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(10):1616–26. https://doi.org/10.1111/jdv.14433.
Chan JR, Blumenschein W, Murphy E, et al. IL-23 stimulates epidermal hyperplasia via TNF and IL-20R2-dependent mechanisms with implications for psoriasis pathogenesis. J Exp Med. 2006;203(12):2577–87. https://doi.org/10.1084/jem.20060244.
Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665–74. https://doi.org/10.1016/S0140-6736(08)60725-4.
Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675–84. https://doi.org/10.1016/S0140-6736(08)60726-6.
Tsai T-F, Ho J-C, Song M, et al. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci. 2011;63(3):154–63. https://doi.org/10.1016/j.jdermsci.2011.05.005.
Sandborn WJ, Feagan BG, Fedorak RN, et al. A randomized trial of ustekinumab, a human Interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn’s disease. Gastroenterology. 2008;135(4):1130–41. https://doi.org/10.1053/j.gastro.2008.07.014.
Lee E, Trepicchio WL, Oestreicher JL, et al. Increased expression of interleukin 23 p19 and p40 in lesional skin of patients with psoriasis vulgaris. J Exp Med. 2004;199(1):125–30. https://doi.org/10.1084/jem.20030451.
Kopp T, Riedl E, Bangert C, et al. Clinical improvement in psoriasis with specific targeting of interleukin-23. Nature. 2015;521(7551):222–6. https://doi.org/10.1038/nature14175.
Visvanathan S, Baum P, Vinisko R, et al. Psoriatic skin molecular and histopathologic profiles after treatment with risankizumab versus ustekinumab. J Allergy Clin Immunol. 2018;143:2158–69. https://doi.org/10.1016/j.jaci.2018.11.042.
Papp KA, Blauvelt A, Bukhalo M, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med. 2017;376(16):1551–60. https://doi.org/10.1056/NEJMoa1607017.
Drugs@FDA: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761105. Accessed May 23 2019.
Visvanathan S, Baum P, Salas A, et al. Selective IL-23 inhibition by risankizumab modulates the molecular profile in the colon and ileum of patients with active Crohn’s disease: results from a randomised phase II biopsy sub-study. J Crohns Colitis. 2018;12(10):1170–9. https://doi.org/10.1093/ecco-jcc/jjy099.
Feagan BG, Panés J, Ferrante M, et al. Risankizumab in patients with moderate to severe Crohn’s disease: an open-label extension study. Lancet Gastroenterol Hepatol. 2018;3(10):671–80. https://doi.org/10.1016/S2468-1253(18)30233-4.
Feagan BG, Sandborn WJ, D’Haens G, et al. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn’s disease: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2017;389(10080):1699–709. https://doi.org/10.1016/S0140-6736(17)30570-6.
Baeten D, Østergaard M, Wei JC-C, et al. Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. Ann Rheum Dis. 2018;77(9):1295–302. https://doi.org/10.1136/annrheumdis-2018-213328.
A study to evaluate risankizumab in adult and adolescent subjects with moderate to severe atopic dermatitis—full text view—ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03706040?term=risankizumab&draw=2&rank=19. Accessed May 31 2019.
Multicenter A. Randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in subjects with moderately to severely active ulcerative colitis who have failed prior biologic therapy—full text view—ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03398148?term=risankizumab&draw=5&rank=23. Accessed May 31 2019.
Efficacy and safety of BI 655066/ABBV-066 (risankizumab) in patients with severe persistent asthma—study results—ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/results/NCT02443298?term=risankizumab&draw=3&rank=14. Accessed May 31 2019.
A global study comparing risankizumab to placebo in adult participants with moderate to severe hidradenitis suppurativa—full text view—ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03926169?term=risankizumab&draw=2&rank=2. Accessed May 31 2019.
Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2015;136(1):116–124.e7. https://doi.org/10.1016/j.jaci.2015.01.018.
Suleiman AA, Khatri A, Minocha M, Othman AA. Population pharmacokinetics of the interleukin-23 inhibitor risankizumab in subjects with psoriasis and Crohn’s disease: analyses of phase I and II trials. Clin Pharmacokinet. 2019;58(3):375–87. https://doi.org/10.1007/s40262-018-0704-z.
Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population pharmacokinetics of risankizumab in healthy volunteers and subjects with moderate to severe plaque psoriasis: integrated analyses of phase I–III clinical trials. Clin Pharmacokinet. 2019;58:1309–21. https://doi.org/10.1007/s40262-019-00759-z.
Sun Pharma I. Skyrizi (risankizumab) [package insert]. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf.
Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029–72. https://doi.org/10.1016/j.jaad.2018.11.057.
Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650–61. https://doi.org/10.1016/S0140-6736(18)31713-6.
Risankizumab meets all co-primary and ranked secondary endpoints, achieving significantly greater efficacy versus standard biologic therapies in three pivotal phase 3 psoriasis studies. AbbVie News Center. https://news.abbvie.com/news/risankizumab-meets-all-co-primary-and-ranked-secondary-endpoints-achieving-significantly-greater-efficacy-versus-standard-biologic-therapies-in-three-pivotal-phase-3-psoriasis-studies.htm. Accessed June 1 2019.
Blauvelt A, Papp KA, Gooderham M, et al. Efficacy and safety of risankizumab, an interleukin-23 inhibitor, in patients with moderate-to-severe chronic plaque psoriasis: 16-week results from the phase III IMMhance trial; abstract presented at: psoriasis from gene to clinic; November 30 to December 2017.
Risankizumab meets all primary endpoints reporting positive results in fourth pivotal phase 3 psoriasis study. AbbVie News Center. https://news.abbvie.com/news/risankizumab-meets-all-primary-endpoints-reporting-positive-results-in-fourth-pivotal-phase-3-psoriasis-study.htm. Accessed June 1 2019.
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Dr. Wu is an investigator for AbbVie, Amgen, Eli Lilly, Janssen, Novartis; a consultant for AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Promius Pharma, Regeneron, Sun Pharmaceutical, and UCB, Valeant Pharmaceuticals North America LLC; and a speaker for AbbVie, Celgene, Novartis, Regeneron, Sanofi Genzyme, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America LLC. The rest of the authors have no conflicts to disclose.
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Lee, E.B., Pithadia, D.J., Reynolds, K.A., Wu, J.J. (2021). Risankizumab. In: Weinberg, J.M., Lebwohl, M. (eds) Advances in Psoriasis. Springer, Cham. https://doi.org/10.1007/978-3-030-54859-9_18
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DOI: https://doi.org/10.1007/978-3-030-54859-9_18
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