Header
Beställ material
SPEVIGO® (Spesolimab)

Evaluated for the treatment of GPP flares

SPEVIGO® (Spesolimab)

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

*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

 

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 outcomes6,7

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.

References

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

  2. Rentz AM et al. J Dermatolog Treat. 2020;31(5):460-469. doi:10.1080/09546634.2019.1709612

  3. Gould D et al. J Clin Nurs. 2001;10(5):697-706. doi:10.1046/j.1365-2702.2001.00525.

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

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

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

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

Spevigo® (spesolimab), interleukinhämmare, 450 mg koncentrat till infusionsvätska, lösning. Rx. EF.

▼Detta läkemedel är föremål för utökad övervakning. 

Indikationer: behandling av skov hos vuxna och ungdomar från 12 års ålder med generaliserad pustulös psoriasis (GPP) som monoterapi. Kontraindikationer: Kliniskt relevanta aktiva infektioner (t.ex. aktiv tbc). Varningar och försiktighet: Kan öka infektionsrisk. Vid överkänslighetsreaktioner, pausa infusionen för att hantera reaktionen. Uppmärksamma symtom på nydebuterad perifer neuropati. Samtidig användning med andra immunsuppressiva medel rekommenderas inte. Beakta intervall mellan vaccination med levande vaccin och behandling. Bör undvikas under graviditet. Boehringer Ingelheim AB, tel 08-721 21 00. För ytterligare information samt priser se www.fass.se. Senaste översyn av produktresumén: 09/2024.

PC-SE-103623_March 2025