IN ADULT AND PEDIATRIC PATIENTS WITH GENERALIZED PUSTULAR PSORIASIS (GPP)
SPEVIGO® has the power to treat GPP1
SPEVIGO® (spesolimab injection/spesolimab for injection) is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
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® IV (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)
† One-sided p-value.
The phase IIb clinical trial, EFFISAYIL® 2, evaluated the efficacy and safety of SPEVIGO® SC.
SPEVIGO® SC demonstrated efficacy in the primary and key secondary endpoints vs. placebo:‡
- SPEVIGO® SC demonstrated 84% reduction in instantaneous risk of time to first GPP flare§ up to Week 48 vs. placebo (HR¶ 0.16 [95% CI: 0.05, 0.54]; p=0.0005||; 10% [n=30] for SPEVIGO® vs. 51.6% [n=31] for placebo)1,3,4#
Significantly fewer patients experienced ≥1 GPP flare up to Week 48 with SPEVIGO® SC vs. placebo: 10% (n=30) vs. 51.6% (n=31), respectively (adjusted RD -39.0% [95% CI: -62.1, -15.9]; p=0.0013**, key secondary endpoint)1,3,4#
§ GPP flare was defined by a GPPGA pustulation subscore of ≥2 and an increase in GPPGA total score by ≥2 from baseline.
HeadStart Go™ Program
Mechanism of Action
Efficacy Data
CI=confidence interval; HR=hazard ratio; IL-36=interleukin-36; IV=intravenous; q4w=every 4 weeks; RD=risk difference; SC=subcutaneous.
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*
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 EFFISAYIL® 1 could receive up to 2 doses of 900 mg SPEVIGO® IV. Primary endpoint was the proportion of patients with a GPPGA pustulation subscore of 0 (indicating no visible pustules) at Week 1.
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‡
EFFISAYIL® 2: A randomized, double-blind, placebo-controlled phase IIb study in adults and adolescent patients (weighing at least 40 kg) with a history of at least two GPP flares of moderate-to-severe intensity in the past. Patients were randomized if they had a GPPGA total score of 0 or 1 at screening and randomization. These patients must have had a history of flaring while on concomitant treatment for GPP or a history of flaring upon dose reduction or discontinuation of these concomitant medications. While 3 dosing regimens were studied, the recommended dosing regimen for GPP flare prevention is a SC loading dose of 600 mg SPEVIGO® followed by 300 mg SC q4w. Patients who experienced a flare were eligible to receive up to two open-label, IV doses of SPEVIGO®. Primary endpoint was the time to the first GPP flare, up to Week 48 (defined by a GPPGA pustulation subscore of ≥2 and an increase in GPPGA total score by ≥2 from baseline). Key secondary endpoint of the study was the occurrence of at least one GPP flare up to Week 48.
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¶
Cox regression model stratified by the use of systemic GPP medications at randomization.
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||
Log-rank test stratified by the use of systemic GPP medications at randomization, one-sided p-value.
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#
The use of IV SPEVIGO® treatment or investigator-prescribed standard of care to treat GPP worsening were considered as onset of GPP flare.
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**
Cochran-Mantel-Haenszel test after multiple imputation, stratified by the use of systemic GPP medications at randomization, one-sided p-value.
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††
Comparative clinical significance is unknown.
