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IN ADULT PATIENTS WITH GENERALIZED PUSTULAR PSORIASIS (GPP)

SPEVIGO® has the power to treat GPP flares1

SPEVIGO® (spesolimab for injection) is indicated for the treatment of flares in adult patients with generalized pustular psoriasis (GPP).

In the EFFISAYIL-1 clinical trial, the Generalized Pustular Psoriasis Physician Global Assessment (GPPGA), which ranges from 0 (clear) to 4 (severe), was used to assess the efficacy of SPEVIGO® (spesolimab for injection).

At Week 1, SPEVIGO® demonstrated efficacy in the primary and secondary endpoints vs. placebo:1*

  • GPPGA pustulation subscore of 0 (no visible pustules): 54.3% (n=19) vs. 5.6% (n=1) with placebo (p=0.0004†) (primary endpoint)
  • GPPGA total score of 0 or 1 (clear or almost clear skin): 42.9% (n=15) vs. 11.1% (n=2) with placebo (p=0.0118†) (secondary endpoint)

The first and only medication in Canada indicated in the treatment of GPP flares1,2‡

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HeadStartGo™ Program

Considering SPEVIGO®? Enroll your GPP patients into our HeadStartGo™ Program
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A SPEVIGO® patient from the Effisayil-1 trial. Two images of a patient who received a single 900 mg IV dose of SPEVIGO®, following baseline assessment. This patient had a GPPGA pustulation subscore of 3 at baseline, and 0 at Week 1. Their GPPGA total score (a secondary endpoint) was 3 at baseline and 1 at Week 1.

Efficacy Data

With SPEVIGO®, 54.3% (n=19) of patients achieved a GPPGA pustulation subscore of 0 (no visible pustules) at Week 1 vs. 5.6% (n=1) placebo (p=0.0004)1*† 
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IL-36=interleukin-36.

  • *
    EFFISAYIL-1: A randomized, double-blind, placebo-controlled trial in adults with flares of GPP. Patients were randomized if they had a flare of GPP of moderate-to-severe intensity, as defined by a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score (which ranges from 0 [clear] to 4 [severe]) of at least 3 (moderate), presence of fresh pustules (new appearance or worsening of pustules), GPPGA pustulation subscore of at least 2 (mild) and at least 5% of body surface area (BSA) covered with erythema and the presence of pustules. Patients received a single intravenous dose of 900 mg SPEVIGO® (n=35) or placebo (n=18), with optional second dose at Day 8 (follow up to 12 weeks). Patients in either treatment arm who still experienced flare symptoms at Week 1 were eligible to receive a single intravenous dose of open-label 900 mg SPEVIGO®. Primary endpoint was the proportion of patients with a GPPGA pustulation subscore of 0 (indicating no visible pustules) at Week 1. 
  • †
    One-sided p-value.
  • ‡
    Clinical significance is unknown.
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