Spevigo (spesolimab) has a conditional marketing authorisation for the treatment of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy

▼This medicinal product is subject to additional monitoring. * Additional efficacy and safety data are being collected.

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SPEVIGO®▼ (spesolimab) blocks the key inflammatory pathway in GPP by targeting the IL-36 receptor^1-3

Unregulated IL-36R signalling leads to a neutrophilic inflammatory response in GPP^4-7

IL-36 agonists and antagonists work together to regulate the IL-36 pathway, ensuring a balanced immune response^8,9
When IL-36 agonists are over expressed or the IL-36 receptor antagonist is not functioning properly, it leads to excessive inflammation and the development of sterile pustules, a characteristic hallmark of GPP^4-7

SPEVIGO® is the only licensed treatment to block the key inflammatory pathway in GPP by targeting the IL-36 receptor^1-3

SPEVIGO® is a humanised antagonistic monoclonal antibody that binds to the IL-36R and blocks activation by cognate ligands¹
SPEVIGO® blocks downstream inflammatory and pro-fibrotic pathways simultaneously^10,11

Additional important information can be found here, including prescribing information

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See how SPEVIGO® works

GPP=Generalised Pustular Psoriasis; IL-36=interleukin-36; IL-36R=interleukin-36 receptor.

References

SPEVIGO® Summary of Product Characteristics. Boehringer Ingelheim.
Bachelez H, Choon SE, Marrakchi S, et al; for the Efﬁsayil 1 Trial Investigators. Trial of spesolimab for generalised pustular psoriasis. N Engl J Med. 2021;385(26):2431-2440.
Johnston A, Xing X, Wolterink L, et al. IL-1 and IL-36 are dominant cytokines in generalised pustular psoriasis. J Allergy Clin Immunol. 2017;140(1):109-120.
Navarini AA, Burden AD, Capon F, et al; for the ERASPEN Network. European consensus statement on phenotypes of pustular psoriasis. J Eur Acad Dermatol Venereol. 2017;31(11):1792-1799.
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.
Gabay C, Towne JE. Regulation and function of interleukin-36 cytokines in homeostasis and pathological conditions. J Leukoc Biol. 2015;97(4):645-652.
Marrakchi S, Guigue P, Renshaw BR, et al. Interleukin-36–receptor antagonist deficiency and generalised pustular psoriasis. N Engl J Med. 2011;365(77):620-628.
Bassoy EY, Towne JE, Gabay C. Regulation and function of interleukin-36 cytokines. Immunol Rev. 2018;281(1):169-178.
Carrier Y, Ma HL, Ramon HE, et al. Inter-regulation of Th17 cytokines and the IL-36 cytokines in vitro and in vivo: implications in psoriasis pathogenesis. J Invest Dermatol. 2011;131(12):2428-2437.
Melton E, Hongyu Q. Interleukin-36 cytokine/receptor signaling: a new target for tissue fibrosis. Int J Mol Sci. 2020;21(18):6458.
Elias M, Zhao S, Le HT, et al. IL-36 in chronic inflammation and fibrosis — bridging the gap? J Clin Invest. 2021;131(2):e144336.

PC-GB-109364 V2 | March 2025

Reporting adverse events

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).

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SPEVIGO®▼ (spesolimab) blocks the key inflammatory pathway in GPP by targeting the IL-36 receptor1-3

Unregulated IL-36R signalling leads to a neutrophilic inflammatory response in GPP4-7

SPEVIGO® is the only licensed treatment to block the key inflammatory pathway in GPP by targeting the IL-36 receptor1-3