ASSESSING THE REAL-WORLD EFFECTIVENESS OF SPESOLIMAB IN GENERALIZED PUSTULAR PSORIASIS: A SYSTEMATIC LITERATURE REVIEW
Author(s)
Mark Lebwohl, Dr.1, Shinichi Imafuku, MD2, Emilie Funch, MSc3, Eydna Apol, MSc4, Angelo Marzano, MD5.
1Icahn School of Medicine at Mount Sinai, New York, NY, USA, 2Dermatology, Fukuoka University, Fukuoka, Japan, 3LEO Pharma A/S, Ballerup, Denmark, 4LEO Pharma, Ballerup, Denmark, 5Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
1Icahn School of Medicine at Mount Sinai, New York, NY, USA, 2Dermatology, Fukuoka University, Fukuoka, Japan, 3LEO Pharma A/S, Ballerup, Denmark, 4LEO Pharma, Ballerup, Denmark, 5Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
OBJECTIVES: Generalized pustular psoriasis (GPP) is an autoinflammatory, potentially life-threatening, chronic, systemic neutrophilic disease with a heterogeneous and unpredictable clinical course distinct from plaque psoriasis. The EFFISAYIL 1 and 2 trials demonstrated that spesolimab is effective and safe for the treatment and prevention of GPP flares. However, the efficacy in real-world clinical practice, where patients often present with greater complexity has not been studied. This systematic literature review evaluated the effectiveness of spesolimab in clinical practice, with a particular focus on patients with prior exposure to non-GPP-specific biologics.
METHODS: A systematic review of published real-world evidence (RWE) studies on patients with GPP treated with spesolimab was conducted. Searches of PubMed and Embase were performed on 25 March 2026 in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Reviewers independently conducted a preliminary screening of publications by assessing titles and abstracts against predefined eligibility criteria, followed by full-text review to confirm study inclusion.
RESULTS: A total of 153 patients with GPP from 64 publications were included. Among them, 60% were female and 20% had concomitant plaque psoriasis. Prior to spesolimab treatment, 61% of patients were biologic-naïve, 30% had tried 1-2 biologic treatments, while 9% had previously received three or more biologic therapies with limited efficacy for GPP. Overall, 95% of patients treated with spesolimab experienced a positive effect, whereas only 9 patients (5.9%) had negative or limited effects. No statistically significant difference in treatment effects was observed between biologic-naïve and biologic-experienced patients (p=0.49) or between patients with and without plaque psoriasis (p=0.55).
CONCLUSIONS: This systematic literature review of RWE studies found that 95% of patients with GPP treated with spesolimab achieved a positive clinical response. Furthermore, spesolimab demonstrated the potential to provide significant symptom resolution, even in patients with complex clinical profiles and in those previously refractory to other biologic therapies.
METHODS: A systematic review of published real-world evidence (RWE) studies on patients with GPP treated with spesolimab was conducted. Searches of PubMed and Embase were performed on 25 March 2026 in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Reviewers independently conducted a preliminary screening of publications by assessing titles and abstracts against predefined eligibility criteria, followed by full-text review to confirm study inclusion.
RESULTS: A total of 153 patients with GPP from 64 publications were included. Among them, 60% were female and 20% had concomitant plaque psoriasis. Prior to spesolimab treatment, 61% of patients were biologic-naïve, 30% had tried 1-2 biologic treatments, while 9% had previously received three or more biologic therapies with limited efficacy for GPP. Overall, 95% of patients treated with spesolimab experienced a positive effect, whereas only 9 patients (5.9%) had negative or limited effects. No statistically significant difference in treatment effects was observed between biologic-naïve and biologic-experienced patients (p=0.49) or between patients with and without plaque psoriasis (p=0.55).
CONCLUSIONS: This systematic literature review of RWE studies found that 95% of patients with GPP treated with spesolimab achieved a positive clinical response. Furthermore, spesolimab demonstrated the potential to provide significant symptom resolution, even in patients with complex clinical profiles and in those previously refractory to other biologic therapies.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO179
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment
Disease
Rare & Orphan Diseases, Sensory System Disorders (Ear, Eye, Dental, Skin)