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) achieved the primary endpoint within the Effisayil^TM 1 study^1,2

With SPEVIGO®, 54.3% of patients achieved complete pustular clearance at Week 1.

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*Missing values or any use of other medication for GPP within the first week of the trial was regarded as non-response for the analysis of the endpoint.²

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GPP=Generalised Pustular Psoriasis; GPPGA=Generalised Pustular Psoriasis Physician Global Assessment; IL-36RN=interleukin-36 receptor antagonist; IV=intravenous.

SPEVIGO® achieved the secondary endpoint within the Effisayil^TM1 study^1,2

*Missing values or any use of other medication for GPP within the first week of the trial was regarded as non-response for the analysis of the endpoint.²

GPP=Generalised Pustular Psoriasis; GPPGA=Generalised Pustular Psoriasis Physician Global Assessment; IL-36RN=interleukin-36 receptor antagonist; IV=intravenous.

In Effisayil^TM 1, a GPPGA score of 0 or 1 (clear or almost clear skin) was sustained with SPEVIGO® for the 12 weeks study period²

Flare control was sustained with SPEVIGO® for the 12 week study period.

*At day 8, patients with GPPGA total score ≥2 and GPPGA pustulation subscore ≥2 could receive open-label SPEVIGO®.

^†Defined as an increase of ≥2 points in both the GPPGA total score and the pustulation subscore after a GPPGA total score of 0 or 1 had been reached.

GPP=Generalised Pustular Psoriasis; GPPGA=Generalised Pustular Psoriasis Physician Global Assessment.

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.
SPEVIGO® Data on File SPE-23-07.

PC-GB-109366 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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Efficacy

SPEVIGO®▼ (spesolimab) achieved the primary endpoint within the EffisayilTM 1 study1,2