Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation

References

• Langley RGB, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(Suppl 2):ii18–23. discussion ii24-5. doi: 10.1136/ard.2004.033217
   PubMed Web of Science ®Google Scholar
• Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet (London, England). 2007;370(9583):263–271. doi: 10.1016/S0140-6736(07)61128-3
   PubMed Web of Science ®Google Scholar
• Megna M, Ocampo-Garza SS, Potestio L, et al. New-onset psoriatic arthritis under biologics in psoriasis patients: an increasing challenge? Biomedicines. 2021;9(10). doi: 10.3390/biomedicines9101482
   PubMed Web of Science ®Google Scholar
• Yamazaki F. Psoriasis: comorbidities. J Dermatol. 2021;48(6):732–740. doi: 10.1111/1346-8138.15840
   PubMed Web of Science ®Google Scholar
• Navarini AA, Burden AD, Capon F, et al. European consensus statement on phenotypes of pustular psoriasis. J Eur Acad Dermatol Venereol. 2017;31(11):1792–1799. doi: 10.1111/jdv.14386
   PubMed Web of Science ®Google Scholar
• Yamamoto T. Similarity and difference between palmoplantar pustulosis and pustular psoriasis. J Dermatol. 2021;48(6):750–760. doi: 10.1111/1346-8138.15826
   PubMed Web of Science ®Google Scholar
• Genovese G, Moltrasio C, Cassano N, et al. Pustular psoriasis: from pathophysiology to treatment. Biomedicines. 2021;9(12). doi: 10.3390/biomedicines9121746
   Web of Science ®Google Scholar
• Romiti R, Hirayama AL, Arnone M, et al. Generalized pustular psoriasis (von Zumbusch). An Bras Dermatol. 2022;97(1):63–74. doi: 10.1016/j.abd.2021.05.011
   PubMed Web of Science ®Google Scholar
• Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23(Suppl 1):13–19. doi: 10.1007/s40257-021-00655-y
   PubMed Web of Science ®Google Scholar
• Hoegler KM, John AM, Handler MZ, et al. Generalized pustular psoriasis: a review and update on treatment. J Eur Acad Dermatol Venereol. 2018;32(10):1645–1651. doi: 10.1111/jdv.14949
   PubMed Web of Science ®Google Scholar
• Karampinis E, Gravani A, Gidarokosta P, et al. Pustular eruption following COVID-19 vaccination: a narrative case-based review. Vaccines. 2023;11(8). doi: 10.3390/vaccines11081298
   Web of Science ®Google Scholar
• Martora F, Villani A, Battista T, et al. COVID-19 vaccination and inflammatory skin diseases. J Cosmet Dermatol. 2023;22(1):32–33. doi: 10.1111/jocd.15414
   PubMed Web of Science ®Google Scholar
• Martora F, Villani A, Marasca C, et al. Skin reaction after SARS-CoV-2 vaccines reply to “cutaneous adverse reactions following SARS-CoV-2 vaccine booster dose: a real-life multicentre experience”. J Eur Acad Dermatol Venereol. 2023;37(1):e43–e44. doi: 10.1111/jdv.18531
   PubMed Web of Science ®Google Scholar
• Potestio L, Villani A, Fabbrocini G, et al. Cutaneous reactions following booster dose of COVID-19 mRNA vaccination: what we should know? J Cosmet Dermatol. 2022 Aug;21(11):5339–5340. Published online. doi: 10.1111/jocd.15331
   PubMed Web of Science ®Google Scholar
• Megna M, Potestio L, Battista T, et al. Immune response to covid-19 mRNA vaccination in psoriasis patients undergoing treatment with biologics. Clin Exp Dermatol. 2022 Sep;47(12):2310–2312. Published online. doi: 10.1111/ced.15395
   PubMed Web of Science ®Google Scholar
• Martora F, Fabbrocini G, Nappa P, et al. Impact of the COVID-19 pandemic on hospital admissions of patients with rare diseases: an experience of a southern Italy referral center. Int J Dermatol. 2022;61(7):e237–e238. doi: 10.1111/ijd.16236
   PubMed Web of Science ®Google Scholar
• Ly K, Beck KM, Smith MP, et al. Diagnosis and screening of patients with generalized pustular psoriasis. Psoriasis Auckland. 2019;9:37–42. doi: 10.2147/PTT.S181808
   PubMed Web of Science ®Google Scholar
• Camela E, Potestio L, Fabbrocini G, et al. The holistic approach to psoriasis patients with comorbidities: the role of investigational drugs. Expert Opin Investig Drugs. 2023 Jun;32(6):1–16. Published online. doi: 10.1080/13543784.2023.2219387
   PubMed Web of Science ®Google Scholar
• Megna M, Camela E, Ruggiero A, et al. Use of biological therapies for the management of pustular psoriasis: a New era? Clin Cosmet Investig Dermatol. 2023;16:1677–1690. doi: 10.2147/CCID.S407812
   PubMed Web of Science ®Google Scholar
• Camela E, Potestio L, Fabbrocini G, et al. New frontiers in personalized medicine in psoriasis. Expert Opin Biol Ther. 2022 Aug;1–3. Published online. doi: 10.1080/14712598.2022.2113872
   Web of Science ®Google Scholar
• Kodali N, Blanchard I, Kunamneni S, et al. Current management of generalized pustular psoriasis. Exp Dermatol. 2023 Feb;32(8):1204–1218. Published online. doi: 10.1111/exd.14765
   PubMed Web of Science ®Google Scholar
• Takeichi T, Akiyama M. Generalized pustular psoriasis: clinical management and update on autoinflammatory aspects. Am J Clin Dermatol. 2020;21(2):227–236. doi: 10.1007/s40257-019-00492-0
   PubMed Web of Science ®Google Scholar
• Megna M, Camela E, Battista T, et al. Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part II: focus on elderly patients. Expert Opin Drug Saf. 2023 Feb;22(1):1–16. Published online. doi: 10.1080/14740338.2023.2173171
   PubMed Web of Science ®Google Scholar
• Megna M, Camela E, Battista T, et al. Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part I: focus on pediatric patients. Expert Opin Drug Saf. 2023 Feb;22(1):1–17. Published online. doi: 10.1080/14740338.2023.2173170
   PubMed Web of Science ®Google Scholar
• Megna M, Potestio L, Fabbrocini G, et al. Treating psoriasis in the elderly: biologics and small molecules. Expert Opin Biol Ther. 2022 Jun;1–18. Published online. doi: 10.1080/14712598.2022.2089020
   Web of Science ®Google Scholar
• 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):1029–1072. doi: 10.1016/j.jaad.2018.11.057
   PubMed Web of Science ®Google Scholar
• Megna M, Potestio L, Camela E, et al. Ixekizumab and brodalumab indirect comparison in the treatment of moderate to severe psoriasis: results from an Italian single-center retrospective study in a real-life setting. Dermatol Ther. 2022 Jun;35(9):e15667. Published online. doi: 10.1111/dth.15667
   PubMed Web of Science ®Google Scholar
• Martora F, Megna M, Battista T, et al. Adalimumab, Ustekinumab, and secukinumab in the management of Hidradenitis Suppurativa: a review of the real-life experience. Clin Cosmet Investig Dermatol. 2023;16:135–148. doi: 10.2147/CCID.S391356
   PubMed Web of Science ®Google Scholar
• Potestio L, Camela E, Cacciapuoti S, et al. Biologics for the management of erythrodermic psoriasis: an updated review. Clin Cosmet Investig Dermatol. 2023;16:2045–2059. doi: 10.2147/CCID.S407813
   PubMed Web of Science ®Google Scholar
• Menter A, Van Voorhees AS, Hsu S. Pustular psoriasis: a narrative review of recent developments in pathophysiology and therapeutic options. Dermatol Ther (Heidelb). 2021;11(6):1917–1929. doi: 10.1007/s13555-021-00612-x
   PubMed Web of Science ®Google Scholar
• Ruggiero A, Potestio L, Cacciapuoti S, et al. Tildrakizumab for the treatment of moderate to severe psoriasis: results from a single center preliminary real-life study. Dermatol Ther. 2022;35(12):e15941. doi: 10.1111/dth.15941
   PubMed Web of Science ®Google Scholar
• Megna M, Ruggiero A, Battista T, et al. Long-term efficacy and safety of Risankizumab for moderate to severe psoriasis: a 2-year real-life retrospective study. J Clin Med. 2023;12(9):3233. doi: 10.3390/jcm12093233
   PubMed Web of Science ®Google Scholar
• Megna M, Battista T, Potestio L, et al. A case of erythrodermic psoriasis rapidly and successfully treated with Bimekizumab. J Cosmet Dermatol. 2023;22(3):1146–1148. doi: 10.1111/jocd.15543
   PubMed Web of Science ®Google Scholar
• Choon SE, Lai NM, Mohammad NA, et al. Clinical profile, morbidity, and outcome of adult-onset generalized pustular psoriasis: analysis of 102 cases seen in a tertiary hospital in Johor, Malaysia. Int J Dermatol. 2014;53(6):676–684. doi: 10.1111/ijd.12070
   PubMed Web of Science ®Google Scholar
• Hawkes JE, Yan BY, Chan TC, et al. Discovery of the IL-23/IL-17 signaling pathway and the treatment of psoriasis. J Immunol. 2018;201(6):1605–1613. doi: 10.4049/jimmunol.1800013
   PubMed Web of Science ®Google Scholar
• Johnston A, Xing X, Wolterink L, et al. IL-1 and IL-36 are dominant cytokines in generalized pustular psoriasis. J Allergy Clin Immunol. 2017;140(1):109–120. doi: 10.1016/j.jaci.2016.08.056
   PubMed Web of Science ®Google Scholar
• Bassoy EY, Towne JE, Gabay C. Regulation and function of interleukin-36 cytokines. Immunol Rev. 2018;281(1):169–178. doi: 10.1111/imr.12610
   PubMed Web of Science ®Google Scholar
• Buhl AL, Wenzel J. Interleukin-36 in infectious and inflammatory skin diseases. Front Immunol. 2019;10:1162. doi: 10.3389/fimmu.2019.01162
   PubMed Web of Science ®Google Scholar
• Iznardo H, Puig L. Exploring the role of IL-36 cytokines as a New target in psoriatic disease. Int J Mol Sci. 2021;22(9):4344. doi: 10.3390/ijms22094344
   PubMed Web of Science ®Google Scholar
• Boutet MA, Nerviani A, Pitzalis C. IL-36, IL-37, and IL-38 cytokines in skin and joint inflammation: a comprehensive review of their therapeutic potential. Int J Mol Sci. 2019;20(6):1257. doi: 10.3390/ijms20061257
   PubMed Web of Science ®Google Scholar
• Furue K, Yamamura K, Tsuji G, et al. Highlighting interleukin-36 signalling in plaque psoriasis and pustular psoriasis. Acta Derm Venereol. 2018;98(1):5–13. doi: 10.2340/00015555-2808
   PubMed Web of Science ®Google Scholar
• Hussain S, Berki DM, Choon SE, et al. IL36RN mutations define a severe autoinflammatory phenotype of generalized pustular psoriasis. J Allergy Clin Immunol. 2015;135(4):1067–1070.e9. doi: 10.1016/j.jaci.2014.09.043
   PubMed Web of Science ®Google Scholar
• Twelves S, Mostafa A, Dand N, et al. Clinical and genetic differences between pustular psoriasis subtypes. J Allergy Clin Immunol. 2019;143(3):1021–1026. doi: 10.1016/j.jaci.2018.06.038
   PubMed Web of Science ®Google Scholar
• Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15(9):907–919. doi: 10.1080/1744666X.2019.1648209
   PubMed Web of Science ®Google Scholar
• Mössner R, Wilsmann-Theis D, Oji V, et al. The genetic basis for most patients with pustular skin disease remains elusive. Br J Dermatol. 2018;178(3):740–748. doi: 10.1111/bjd.15867
   PubMed Web of Science ®Google Scholar
• Sugiura K, Muto M, Akiyama M. CARD14 c.526G>C (p.Asp176His) is a significant risk factor for generalized pustular psoriasis with psoriasis vulgaris in the Japanese cohort. J Invest Dermatol. 2014;134(6):1755–1757. doi: 10.1038/jid.2014.46
   PubMed Web of Science ®Google Scholar
• Mahil SK, Twelves S, Farkas K, et al. AP1S3 mutations cause skin autoinflammation by disrupting keratinocyte autophagy and up-regulating IL-36 production. J Invest Dermatol. 2016;136(11):2251–2259. doi: 10.1016/j.jid.2016.06.618
   PubMed Web of Science ®Google Scholar
• Linares-Espinós E, Hernández V, Domínguez-Escrig JL, et al. Methodology of a systematic review. Actas Urol Esp. 2018;42(8):499–506. doi: 10.1016/j.acuro.2018.01.010
   PubMed Web of Science ®Google Scholar
• Ratnarajah K, Jfri A, Litvinov IV, et al. Spesolimab: a novel treatment for pustular psoriasis. J Cutan Med Surg. 2020;24(2):199–200. doi: 10.1177/1203475419888862
   PubMed Web of Science ®Google Scholar
• Bachelez H, Choon SE, Marrakchi S, et al. Inhibition of the interleukin-36 pathway for the treatment of generalized pustular psoriasis. N Engl J Med. 2019;380(10):981–983. doi: 10.1056/NEJMc1811317
   PubMed Web of Science ®Google Scholar
• Spesolimab (SPEVIGO) Summary of product characteristic. [cited 2023 Jun 30]. Available from: https://www.ema.europa.eu/en/documents/product-information/spevigo-epar-product-information_en.pdf.
   Google Scholar
• Joseph D, Thoma C, Haeufel T, et al. Assessment of the pharmacokinetics and safety of spesolimab, a humanised anti-interleukin-36 receptor monoclonal antibody, in healthy non-Japanese and Japanese subjects: results from Phase I clinical studies. Clin Pharmacokinet. 2022;61(12):1771–1787. doi: 10.1007/s40262-022-01176-5
   PubMed Web of Science ®Google Scholar
• BI655130 Single Dose in Generalized Pustular Psoriasis. [cited 2023 Jun 30]. Available from: https://clinicaltrials.gov/study/NCT02978690?cond=NCT02978690&rank=1.
   Google Scholar
• Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11(3):e043666. doi: 10.1136/bmjopen-2020-043666
   PubMedGoogle Scholar
• Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431–2440. doi: 10.1056/NEJMoa2111563
   PubMed Web of Science ®Google Scholar
• Burden AD, Okubo Y, Zheng M, et al. Efficacy of spesolimab for the treatment of generalized pustular psoriasis flares across pre-specified patient subgroups in the Effisayil 1 study. Exp Dermatol. 2023 May;32(8):1279–1283. Published online. doi: 10.1111/exd.14824
   PubMed Web of Science ®Google Scholar
• Morita A, Choon SE, Bachelez H, et al. Design of EffisayilTM 2: a randomized, double-blind, placebo-controlled study of spesolimab in preventing flares in patients with generalized pustular psoriasis. Dermatol Ther (Heidelb). 2023;13(1):347–359. doi: 10.1007/s13555-022-00835-6
   PubMed Web of Science ®Google Scholar
• EffisayilTM ON: a study to test long-term treatment with spesolimab in people with generalized pustular psoriasis who took Part in a previous study. [cited 2023 Jun 30]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT03886246.
   Google Scholar
• Ran D, Yang B, Sun L, et al. Rapid and sustained response to spesolimab in five Chinese patients with generalized pustular psoriasis. Clin Exp Dermatol. 2023 Mar;48(7):803–805. Published online. doi: 10.1093/ced/llad108
   PubMed Web of Science ®Google Scholar
• Müller VL, Kreuter A. [Remission of recalcitrant generalized pustular psoriasis under interleukin-36 receptor inhibitor spesolimab]. Dermatologie. 2023 Mar:1–4. Published online. doi: 10.1007/s00105-023-05140-7
   Google Scholar
• PMS of spesolimab I.V. in GPP patients with acute symptoms. [cited 2023 Jun 30]. Available from: https://clinicaltrials.gov/study/NCT05670821?cond=spesolimab&term=gpp&rank=1.
   Google Scholar
• Burden AD. Spesolimab, an interleukin-36 receptor monoclonal antibody, for the treatment of generalized pustular psoriasis. Expert Rev Clin Immunol. 2023;19(5):473–481. doi: 10.1080/1744666X.2023.2195165
   PubMed Web of Science ®Google Scholar
• Ruggiero A, Fabbrocicni G, Cacciapuoti S, et al. Tildrakizumab for the treatment of moderate-to-severe psoriasis: results from 52 weeks real-life retrospective study. Clin Cosmet Investig Dermatol. 2023;16:529–536. doi: 10.2147/CCID.S402183
   PubMed Web of Science ®Google Scholar
• Ruggiero A, Camela E, Potestio L, et al. Drug safety evaluation of tildrakizumab for psoriasis: a review of the current knowledge. Expert Opin Drug Saf. 2022;21(12):1445–1451. doi: 10.1080/14740338.2022.2160447
   PubMed Web of Science ®Google Scholar
• Ruggiero A, Potestio L, Martora F, et al. Bimekizumab treatment in patients with moderate to severe plaque psoriasis: a drug safety evaluation. Expert Opin Drug Saf. 2023 May;22(5):355–362. Published online. doi: 10.1080/14740338.2023.2218086
   PubMed Web of Science ®Google Scholar
• Gargiulo L, Narcisi A, Ibba L, et al. Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study-IL PSO (Italian landscape psoriasis). Front Med. 2023;10:1243843. doi: 10.3389/fmed.2023.1243843
   Web of Science ®Google Scholar
• Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23(Suppl 1):21–29. doi: 10.1007/s40257-021-00654-z
   PubMed Web of Science ®Google Scholar
• Krueger J, Puig L, Thaçi D. Treatment options and goals for patients with generalized pustular psoriasis. Am J Clin Dermatol. 2022;23(Suppl 1):51–64. doi: 10.1007/s40257-021-00658-9
   PubMed Web of Science ®Google Scholar
• Carrascosa JM, Puig L, Belinchón Romero I, et al. Practical update of the recommendations Published by the psoriasis group of the Spanish Academy of Dermatology and Venereology (GPS) on the treatment of psoriasis with biologic therapy. Part 1. Concepts and general management of psoriasis with biologic therapy. Actas Dermosifiliogr. 2022;113(3):261–277. doi: 10.1016/j.ad.2021.10.003
   PubMed Web of Science ®Google Scholar
• Kearns DG, Chat VS, Zang PD, et al. Review of treatments for generalized pustular psoriasis. J DermatolTreat. 2021;32(5):492–494. doi: 10.1080/09546634.2019.1682502
   Google Scholar
• Sugiura K. Role of interleukin 36 in generalised pustular psoriasis and beyond. Dermatol Ther (Heidelb). 2022;12(2):315–328. doi: 10.1007/s13555-021-00677-8
   PubMed Web of Science ®Google Scholar
• Ganesan R, Raymond EL, Mennerich D, et al. Generation and functional characterization of anti-human and anti-mouse IL-36R antagonist monoclonal antibodies. MAbs. 2017;9(7):1143–1154. doi: 10.1080/19420862.2017.1353853
   PubMed Web of Science ®Google Scholar
• Calabrese L, Fiocco Z, Satoh TK, et al. Therapeutic potential of targeting interleukin-1 family cytokines in chronic inflammatory skin diseases. Br J Dermatol. 2022;186(6):925–941. doi: 10.1111/bjd.20975
   PubMed Web of Science ®Google Scholar