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SPEVIGO® was evaluated for the treatment of GPP flares1

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

Trial data is a multi-center, randomised, double-blind, placebo-controlled trial of SPEVIGO®.

*Patients must have discontinued biologics, retinoids, methotrexate, and/or cyclosporine before receiving their first dose of SPEVIGO® 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® 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® if a GPPGA total score of 0 or 1 had been reached with SPEVIGO® or placebo before.2

At the end of Week 1, 2 patients on SPEVIGO® 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

Key takeaways from trial data period.

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.

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

Flare control scoreboard.

#Flare control defined as GPPGA total score ≤1 and was reported for the 12-week study period.2

**To receive a score of 0 or 1, the patient should be afebrile, in addition to skin presentation requirements.3

PGA=Patient Global Assessment.

Baseline characteristics

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

Patient demographics and characteristics.

††Race was reported by the patient.2

‡‡A total of 52 patients were included; 5 patients had missing values at baseline.2

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

References

  1. SPEVIGO® Summary of Product Characteristics. Boehringer Ingelheim Pharmaceuticals, Inc; 2022.

  2. Bachelez H, Choon SE, Marrakchi S, et al; for the Effisayil 1 Trial Investigators. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431-2440. doi:10.1056/NEJMoa2111563

  3. 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

  4. 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. doi:10.1111/jdv.14386

  5. Burden AD, Choon SE, Gottlieb AB, Navarini AA, Warren RB. Clinical disease measures in generalized pustular psoriasis. Am J Clin Dermatol. 2022;23(suppl 1):39-50. doi:10.1007/s40257-021-00653-0