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Effect of spesolimab on sustained disease control in patients with generalized pustular psoriasis: Post hoc analysis of the EFFISAYIL 2 study. J Am Acad Dermatol 2025 Jun;92(6):1235-1242

Date

03/09/2025

Pubmed ID

40057892

DOI

10.1016/j.jaad.2025.01.089

Scopus ID

2-s2.0-86000667660 (requires institutional sign-in at Scopus site)   6 Citations

Abstract

BACKGROUND: Generalized pustular psoriasis (GPP) is a chronic inflammatory disease with an unpredictable disease course. Long-term treatment goals include sustained resolution of skin symptoms, prevention of new flares, and improvement in quality of life (QoL).

OBJECTIVE: To compare the effect of the interleukin-36 receptor monoclonal antibody spesolimab 600 mg subcutaneous (SC) loading dose (LD) followed by 300 mg SC every 4 weeks (q4w) versus placebo on skin symptoms and QoL burden in patients with GPP.

METHODS: A post hoc analysis of the EFFISAYIL 2 trial (NCT04399837) was conducted to assess the proportion of patients with sustained improvement of skin symptoms (GPP Physician Global Assessment total score, 0 or 1) and QoL burden (Dermatology Life Quality Index score, 0 or 1) at all visits up to week 48.

RESULTS: Among the patients who received spesolimab 600 mg SC LD followed by 300 mg SC q4w, 63.3% had sustained improvement of skin symptoms (vs 29.0%; placebo), and 24.1% had sustained improvement of QoL burden (vs 3.2%; placebo).

LIMITATIONS: Retrospective, descriptive, post hoc analysis.

CONCLUSION: Spesolimab 600 mg SC LD followed by 300 mg SC q4w provides sustained improvement of skin symptoms and QoL burden in a substantially higher proportion of patients with GPP versus placebo.

Author List

Gordon KB, Augustin M, Barker J, Tada Y, Lebwohl MG, Tang M, Hofmann P, Thoma C, Gottlieb AB

Author

Kenneth Brian Gordon MD Professor in the Dermatology department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Antibodies, Monoclonal, Humanized
Double-Blind Method
Drug Administration Schedule
Female
Humans
Injections, Subcutaneous
Male
Middle Aged
Psoriasis
Quality of Life
Severity of Illness Index
Treatment Outcome