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SPEVIGO® (spesolimab)

Spevigo

Effisayil™ 1 was a multicentre, randomised, double-blind, placebo-controlled trial of SPEVIGO® (Spesolimab) in patients with GPP

Effisayil™ 1 was a multicentre, randomised, double-blind, placebo-controlled trial of SPEVIGO® (spesolimab) in patients with GPP presenting with a flare1,2

Effisayil

Primary endpoint1 : Proportion of patients with a GPPGA pustulation subscore of 0 (no visible pustules) at Week 1 after treatment

Key secondary endpoint1 : Proportion of patients with a GPPGA total score of 0 or 1 (clear or almost clear skin) at Week 1 after treatment

Selected exploratory endpoints1 : GPPGA pustulation subscore and GPPGA total score over time

  • *
    Patients must have discontinued biologics, retinoids, methotrexate, and/or cyclosporine before receiving their first dose of SPEVIGO® (spesolimab) or placebo.2
  • †
    Persistent flare defined as ≥2 GPPGA total score and ≥2 GPPGA pustulation subscore.2
  • ‡
    Patients who received other medications for GPP during Week 1 were not eligible for SPEVIGO® (spesolimab) at Day 8.3
  • §
    Defined as a ≥2-point increase in GPPGA total score and GPPGA pustulation subscore ≥2 after achieving clinical response (GPPGA total score of 0 or 1).2
  • ||
    After Day 8, patients with a new flare (defined as a ≥2-point increase in GPPGA total score and pustulation subscore) could receive OL SPEVIGO® (spesolimab) if a GPPGA total score of 0 or 1 had been reached with SPEVIGO® (spesolimab) or placebo before.2
  • At the end of Week 1, 2 patients on SPEVIGO® (spesolimab) and 1 patient on placebo had received ≥1 SoC therapy. From Day 8 to the end of the trial, 4 patients in each arm received ≥1 SoC therapy.2 

GPP=Generalized Pustular Psoriasis; GPPGA=Generalized Pustular Psoriasis Physician Global Assessment; IV=intravenous; OL=open-label; SoC=standard of care.

Endpoint summary1,2

Endpoint summary

 

FACIT=Functional Assessment of Chronic Illness Therapy; GPPASI=Psoriasis Area and Severity Index for Generalized Pustular Psoriasis; PSS=Psoriasis Symptom Scale;

VAS=Visual Analogue Scale.

Patients aged 18 to 75 years with GPP, as defined by ERASPEN:

  • Primary, sterile, macroscopically visible pustules on non-acral skin (excluding cases in which pustulation is restricted to psoriatic plaques)

  • With or without systemic inflammation, with or without Plaque Psoriasis; can be either a relapsing condition (>1 episode) or a persistent condition (>3 months)

  • Evidence (or previous evidence) of systemic symptoms:

  • Fever

  • Asthenia

  • Myalgia

  • Elevated C-reactive protein level

  • Leukocytosis with peripheral blood neutrophilia (above ULN)

ERASPEN=European Rare and Severe Psoriasis Expert Network; ULN=upper limit of normal.

Patients were excluded if they presented with:

  • SAPHO syndrome

  • Plaque Psoriasis without pustules or with pustules restricted to psoriatic plaques

  • Drug-triggered AGEP 

  • Immediate, life-threatening GPP flare or required intensive care treatment 

  • Dose escalation of their maintenance treatment with cyclosporine, retinoids, or methotrexate within 2 weeks prior to randomisation

  • Treatment with any drug, including biologics and systemic drugs, considered likely to interfere with the safe conduct of the study or any prior exposure to an IL-36R inhibitor

AGEP=acute generalized exanthematous pustulosis; IL-36R=interleukin-36 receptor; SAPHO=synovitis-acne-pustulosis-hyperostosis-osteitis.

Baseline characteristics

In Effisayil™ 1, patient demographics and characteristics were evenly balanced between treatment arms2

In Effisayil

 

††   Race was reported by the patient.1

‡‡  A total of 52 patients were included; 5 patients had missing values at baseline.1

CRP=C-reactive protein; SD=standard deviation.

The GPPGA score: Based on the PGA, modified by dermatology experts to measure specific GPP treatment outcomes3,5

GPPGA score
GPPGA score

#   Flare control defined as GPPGA total score ≤1 and was reported for the 12-week study period.1

**  To receive a score of 0 or 1, the patient should be afebrile, in addition to skin presentation requirements.6

PGA=Patient Global Assessment.

The GPPGA score: Based on the PGA, modified by dermatology experts to measure specific GPP treatment outcomes3,5

References

  1. SPEVIGO® Summary of Product Characteristics. Boehringer Ingelheim Pharmaceuticals, Inc

  2. Bachelez H et al. N Engl J Med. 2021;385(26):2431-2440. doi:10.1056/NEJMoa2111563

  3. Choon SE et al. BMJ Open. 2021;11(3):e043666. doi:10.1136/bmjopen-2020-043666

  4. Navarini AA et al. J Eur Acad Dermatol Venereol. 2017;31(11):1792-1799. doi:10.1111/jdv.14386

  5. Burden AD et al. Am J Clin Dermatol. 2022;23(suppl 1):39-50. doi:10.1007/s40257-021-00653-0

GPP (07/2025) PC-GR-102302

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