Spesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial

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Alice Gottlieb
Bruce Strober
Joseph Merola
Arash Mostaghimi
Aaron Farberg
Jason Guercio
Ming Tang
Christian Thoma
Mark Lebwohl

Keywords

spesolimab, generalized pustular psoriasis, efficacy

Abstract

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the percentage of patients achieving clear skin (Physician’s Global Assessment for GPP [GPPGA]=0)1 over time from patients who were treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Measurements were completed for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). The data were analyzed as observed. Proportion of patients with GPPGA total score of 0 increased over time under spesolimab treatment (10.0% (N=3/30) at baseline, 27.6% (N=8/29) at Week 4, 48.1% (N=13/27) at Week 16, and 52.2% (N=12/23) at Week 48). Continuous treatment with spesolimab SC improved skin symptoms in GPP, with 50% of patients achieving clear skin at Week 48. These findings suggest a role of spesolimab in complete resolution of GPP skin symptoms.

References

1. Morita A, et al. Lancet. 2023;402:1541–51.

2. SPEVIGO® prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761244s003lbl.pdf
(accessed Aug 8, 2024).

3. Burden AD, et al. BJD. 2023;189:138–40.

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