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FOR US HEALTHCARE PROFESSIONALS

For Generalized Pustular Psoriasis (GPP)

GENERALIZED PUSTULAR PSORIASIS (GPP) hero image GENERALIZED PUSTULAR PSORIASIS (GPP) hero image
first and only
FDA-approved
for GPP1,2

Help contain GPP with
the power
of
SPEVIGO1

Only SPEVIGO targets GPP at the source1,3,4

GPP, generalized pustular psoriasis; IL-36, interleukin-36; IV, intravenous; MOA, mechanism of action; SC, subcutaneous.

aThe precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.1

bPustular clearance defined as GPPPGA pustulation subscore of 0 (no visible pustules).1

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Indication

SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg (88 lb).

Please see the full Prescribing Information, including Medication Guide and Instructions for Use.

Important Safety Information

Contraindications

  • SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS) and anaphylaxis. If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (eg, systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion.

Warnings and Precautions

  • Infections: SPEVIGO may increase the risk of infections. In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO. Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with SPEVIGO. If a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated.
  • Risk of Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Avoid use of SPEVIGO in patients with active TB infection. Consider initiating anti-TB therapy prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SPEVIGO treatment.
  • Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during and following administration of SPEVIGO. These reactions can occur with the first dose or subsequent doses.
  • Vaccinations: Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines.

Adverse Reactions

  • The most common adverse reactions with SPEVIGO when experiencing a flare include asthenia and fatigue, headache, nausea, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.
  • The most common adverse reactions with SPEVIGO when not experiencing a flare include injection site reaction, urinary tract infection, arthralgia, and pruritus.

Please see the full Prescribing Information, including Medication Guide and Instructions for Use.

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References

1. SPEVIGO. Prescribing Information. LEO Pharma Inc.

2. Elewski B, Lebwohl MG. Management of chronic generalized pustular psoriasis: a review and expert opinion. J Psoriasis Psoriatic Arthritis. 2025;10(2):58-66. doi:10.1177/24755303251318976

3. 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

4. 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