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Efficacy data

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®.

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)

With a single dose of 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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With a single dose of SPEVIGO®, 42.9% (n=15) of patients achieved a GPPGA total score of 0 or 1 at Week 1 vs. 11.1% (n=2) with placebo (p=0.0118)1*† 

Graph showing percentage of patients with GPPGA total score of 0 or 1. Click graph full text for description.

 

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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.

Image is of a SPEVIGO® patient. Used with permission.

CI=confidence interval; IV=intravenous.