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Review

Tildrakizumab for treatment of moderate to severe psoriasis: an expert opinion of efficacy, safety, and use in special populations

ORCID Icon, ORCID Icon, , , , , , , , , , , & show all
Pages 367-376 | Received 30 Aug 2021, Accepted 29 Sep 2021, Published online: 12 Oct 2021

References

  • Boehncke WH, Schon MP. Psoriasis. Lancet. 2015;386(9997):983–994.
  • Christophers E. Psoriasis − epidemiology and clinical spectrum. Clin Exp Dermatol. 2001;26(4):314–320.
  • Di Cesare A, Di Meglio P, Nestle FO. The IL-23/Th17 axis in the immunopathogenesis of psoriasis. J Invest Dermatol. 2009;129(6):1339–1350.
  • Tonel G, Conrad C, Laggner U, et al. Cutting edge: a critical functional role for IL-23 in psoriasis. J Immunol. 2010;185(10):5688–5691.
  • Gaspari AA, Tyring S. New and emerging biologic therapies for moderate-to-severe plaque psoriasis: mechanistic rationales and recent clinical data for IL-17 and IL-23 inhibitors. Dermatol Ther. 2015;28(4):179–193.
  • Bangert C, Kopp T. Tildrakizumab for the treatment of psoriasis. Immunotherapy. 2018;10(13):1105–1122.
  • Kopp T, Riedl E, Bangert C, et al. Clinical improvement in psoriasis with specific targeting of interleukin-23. Nature. 2015;521(7551):222–226.
  • Kok Y, Nicolopoulos J, Dolianitis C. Tildrakizumab as a potential long-term therapeutic agent for severe hidradenitis suppurativa: a 15 months experience of an Australian institution. Australas J Dermatol. 2021;62(2):e313–e6.
  • Kok Y, Nicolopoulos J, Howard A, et al. Tildrakizumab in the treatment of moderate-to-severe hidradenitis suppurativa. Australas J Dermatol. 2020;61(4):e488–e90.
  • John JM, Sinclair RD. Tildrakizumab for treatment of refractory pyoderma gangrenosum of the penis and polymyalgia rheumatica: killing two birds with one stone. Australas J Dermatol. 2020;61(2):170–171.
  • Kerkemeyer KL, Pinczewski J, Sinclair R. Successful treatment of recalcitrant lichen planus pemphigoides with tildrakizumab. Australas J Dermatol. 2020;61(3):e366–e8.
  • Kok Y, Nicolopoulos J, Varigos G, et al. Tildrakizumab in the treatment of PASH syndrome: a potential novel therapeutic target. Australas J Dermatol. 2020;61(3):e373–e4.
  • Licata G, Gambardella A, Calabrese G, et al. SAPHO syndrome successful treated with tildrakizumab. Dermatol Ther. 2021;34(1):e14758.
  • Trindade de Carvalho L, Meah N, Wall D, et al. Recalcitrant lichen planopilaris and frontal fibrosing alopecia responding to tildrakizumab. Dermatol Ther. 2020;33(4):e13694.
  • Papp K, Thaci D, Reich K, et al. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015;173(4):930–939.
  • Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017;390(10091):276–288.
  • Reich K, Warren RB, Iversen L, et al. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020;182(3):605–617.
  • Thaci D, Piaserico S, Warren RB, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate to severe psoriasis who respond at week 28: pooled analyses of two randomised phase 3 clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021;185(2): 323–334.
  • Kimball AB, Papp KA, Reich K, et al. Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies. Br J Dermatol. 2020;182(6):1359–1368.
  • Gordon KB, Reich K, Crowley JJ, et al. Disease activity and treatment efficacy using patient-level psoriasis area and severity index scores from tildrakizumab phase 3 clinical trials. J Dermatolog Treat. 2020:1–10.
  • Blauvelt A, Sofen H, Papp K, et al. Tildrakizumab efficacy and impact on quality of life up to 52 weeks in patients with moderate-to-severe psoriasis: a pooled analysis of two randomized controlled trials. J Eur Acad Dermatol Venereol. 2019;33(12):2305–2312.
  • Menter MA, Murakawa GJ, Glover H, et al. Clearance of head and neck involvement in plaque psoriasis with tildrakizumab treatment in the phase 3 reSURFACE 1 study. J Eur Acad Dermatol Venereol. 2020;34(12):e803–e5.
  • Ismail FF, May J, Moi J, et al. Clinical improvement in psoriatic nail disease and psoriatic arthritis with tildrakizumab treatment. Dermatol Ther. 2020;33(2):e13216.
  • Simpson K, Low ZM, Howard A, et al. Successful management of treatment resistant nail psoriasis with tildrakizumab. Australas J Dermatol. 2021;62(3):390–393.
  • Tsianakas A, Kirsch A, Diemert S. Interim analysis of the non-interventional study TILOT: effectiveness of tildrakizumab in long-term treatment of moderate to severe plaque psoriasis in routine practice. Presented at EADV 2020.
  • Burlando M, Castelli R, Cozzani E, et al. Treatment of moderate-to-severe plaque psoriasis with tildrakizumab in the real-life setting. Drugs Context. 2021;10:2021-2-6. DOI: https://doi.org/10.7573/dic.2021-2-6.
  • Megna M, Potestio L, Fabbrocini G, et al. Tildrakizumab: a new therapeutic option for erythrodermic psoriasis? Dermatol Ther. 2021;e15030. DOI: https://doi.org/10.1111/dth.15030.
  • European Medicines Agency. Ilumetri (tildrakizumab): EU summary of product characteristics. 2018 .
  • Mease PJ, Chohan S, García Fructuoso FJ, et al. OP0230 efficacy and safety of tildrakizumab, a high-affinity anti–interleukin-23P19 monoclonal antibody, in patients with active psoriatic arthritis in a randomised, double-blind, placebo-controlled, multiple-dose, phase 2B study. Ann Rheum Dis. 2020;79(Suppl 1):145–146.
  • Takeshita J, Grewal S, Langan SM, et al. Psoriasis and comorbid diseases: epidemiology. J Am Acad Dermatol. 2017;76(3):377–390.
  • Gooderham M, Elewski BE, Pariser DM, et al. THU0291 Incidence of serious gastrointestinal events and inflammatory bowel disease among tildrakizumab-treated patients with moderate to severe plaque psoriasis: data from 3 large randomised clinical trials. Ann Rheum Dis. 2018;77:364.
  • Lambert JLW, Segaert S, Ghislain PD, et al. Practical recommendations for systemic treatment in psoriasis in case of coexisting inflammatory, neurologic, infectious or malignant disorders (BETA-PSO: Belgian evidence-based treatment advice in psoriasis; part 2). J Eur Acad Dermatol Venereol. 2020;34(9):1914–1923.
  • Samarasekera EJ, Neilson JM, Warren RB, et al. Incidence of cardiovascular disease in individuals with psoriasis: a systematic review and meta-analysis. J Invest Dermatol. 2013;133(10):2340–2346.
  • Bissonnette R, Fernandez-Penas P, Puig L, et al. Incidence of cardiovascular events among tildrakizumab-treated patients with moderate-to-severe plaque psoriasis: pooled data from three large randomised clinical trials. J Eur Acad Dermatol Venereol. 2020;34(1):e21–e4.
  • Augustin M, Thaci D, Pinter A, et al. Long-term efficacy and safety of tildrakizumab: 5-year results from the reSURFACE 1 and 2 phase III trials in patients with moderate-to-severe plaque psoriasis. EMJ Dermatol. 2021;9(Suppl 1):2–11
  • Singh S, Young P, Armstrong AW. An update on psoriasis and metabolic syndrome: a meta-analysis of observational studies. PLoS One. 2017;12(7):e0181039.
  • Menter A, Draelos Z, Heim J, et al. Impact of body weight on efficacy of tildrakizumab in moderate to severe plaque psoriasis. Presented at AAD 2019.
  • Lebwohl MG, Leonardi CL, Mehta NN, et al. Tildrakizumab efficacy and safety are not altered by metabolic syndrome status in patients with psoriasis: post hoc analysis of 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2). J Am Acad Dermatol. 2020;82(2):519–522.
  • Lebwohl MG, Leonardi CL, Mehta NN, et al. Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: long-term results from 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2). J Am Acad Dermatol. 2021;84(2):398–407.
  • Lebwohl MG, Mehta NN, Gottlieb AB, et al. Safety of tildrakizumab in patients with preexisting metabolic syndrome: long term data from the post hoc analysis of 2 phase 3 clinical studies (reSURFACE 1 and reSURFACE 2). Presented at AAD 2020.
  • Lebwoh MG, Menter A, Rozzo SJ, et al. Relationship of serum glucose to tildrakizumab efficacy and safety in patients with and without metabolic syndrome. Presented at AAD 2020.
  • Haycraft K, DiRuggiero D, Rozzo SJ, et al. Outcomes of pregnancies from the tildrakizumab phase I-III clinical development programme. Br J Dermatol. 2020;183(1):184–186.
  • Russo R, Gasparini G, Cozzani E, et al. Considerations on inhibition of IL-23 in psoriatic women of childbearing potential. Dermatol Ther. 2021;34(3) ;e14931.
  • Cargill M, Schrodi SJ, Chang M, et al. A large-scale genetic association study confirms IL12B and leads to the identification of IL23R as psoriasis-risk genes. Am J Hum Genet. 2007;80(2):273–290.
  • Nair RP, Duffin KC, Helms C, et al. Genome-wide scan reveals association of psoriasis with IL-23 and NF-κB pathways. Nat Genet. 2009;41(2):199–204.
  • Jeon C, Sekhon S, Yan D, et al. Monoclonal antibodies inhibiting IL-12, −23, and −17 for the treatment of psoriasis. Hum Vaccin Immunother. 2017;13(10):2247–2259.
  • Kleinschek MA, Muller U, Brodie SJ, et al. IL-23 enhances the inflammatory cell response in cryptococcus neoformans infection and induces a cytokine pattern distinct from IL-12. J Immunol. 2006;176(2):1098–1106.
  • Kulig P, Musiol S, Freiberger SN, et al. IL-12 protects from psoriasiform skin inflammation. Nat Commun. 2016;7(1):13466.
  • Naslund-Koch C, Zachariae C, Skov L. Tildrakizumab: an evidence-based review of its use in the treatment of moderate-to-severe chronic plaque psoriasis. Ther Clin Risk Manag. 2020;16:903–916.
  • Gooderham MJ, Papp KA, Lynde CW. Shifting the focus - the primary role of IL-23 in psoriasis and other inflammatory disorders. J Eur Acad Dermatol Venereol. 2018;32(7):1111–1119.
  • Puig L. The role of IL 23 in the treatment of psoriasis. Expert Rev Clin Immunol. 2017;13(6):525–534.
  • Mehta H, Mashiko S, Angsana J, et al. Differential Changes In Inflammatory Mononuclear Phagocyte and T-cell profiles within psoriatic skin during treatment with Guselkumab vs. Secukinumab. J Invest Dermatol. 2021;141(7):1707–18 e9.
  • Warren RB, Carrascosa JM, Fumero E, et al. Time to relapse after tildrakizumab withdrawal in patients with moderate-to-severe psoriasis who were responders at week 28: post hoc analysis through 64 weeks from reSURFACE 1 trial. J Eur Acad Dermatol Venereol. 2021;35(4):919–927.
  • Cheuk S, Wiken M, Blomqvist L, et al. Epidermal Th22 and Tc17 cells form a localized disease memory in clinically healed psoriasis. J Immunol. 2014;192(7):3111–3120.
  • Kryczek I, Zhao E, Liu Y, et al. Human TH17 cells are long-lived effector memory cells. Sci Transl Med. 2011;3(104):104ra0.
  • Clark RA. Gone but not forgotten: lesional memory in psoriatic skin. J Invest Dermatol. 2011;131(2):283–285.
  • Park CO, Kupper TS. The emerging role of resident memory T cells in protective immunity and inflammatory disease. Nat Med. 2015;21(7):688–697.
  • Martins LMS, Perez MM, Pereira CA, et al. Interleukin-23 promotes intestinal T helper type17 immunity and ameliorates obesity-associated metabolic syndrome in a murine high-fat diet model. Immunology. 2018;154(4):624–636.
  • Girolomoni G, Griffiths CE, Krueger J, et al. Early intervention in psoriasis and immune-mediated inflammatory diseases: a hypothesis paper. J Dermatolog Treat. 2015;26(2):103–112.
  • Kaushik SB, Lebwohl MG. Psoriasis: which therapy for which patient: psoriasis comorbidities and preferred systemic agents. J Am Acad Dermatol. 2019;80(1):27–40.
  • Kaushik SB, Lebwohl MG. Psoriasis: which therapy for which patient: focus on special populations and chronic infections. J Am Acad Dermatol. 2019;80(1):43–53.