Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation

Introduction: Generalized pustular psoriasis (GPP) is a rare form of psoriasis (less of 1% of cases). Currently, GPP is recognized as a clinical entity, distinguished from plaque psoriasis. However, there are not guidelines for GPP management and treatments are often derived from plaque psoriasis. Therefore, conventional systemic drugs are usually used as first-line treatment options, and biologics are still used off label. Recently, spesolimab, an anti-IL36 receptor humanized IgG1 monoclonal antibody, has been specifically approved for GPP disease, revolutionizing treatment scenario. Areas covered: The aim of this review is to investigate current literature on the use of spesolimab for GPP management to underline its potential role in GPP and offer a current clinical perspective. Literature research using the Google Scholar, Pubmed, Embase, Cochrane Skin, and clinicaltrials.gov databases was performed, selecting the most relevant manuscripts. Expert opinion: Spesolimab is efficacious and has a consistent and favorable safety profile in patients presenting with a GPP flare. However, despite excellent results in terms of safety and efficacy have been reported by both clinical trials and very limited real-life experiences, long-term data, especially in flare-up prevention, are scant. Thus, while the available data are encouraging, further research is warranted to understand the efficacy, safety, and long-term outcomes associated with spesolimab treatment in GPP.