FDA Approves Expanded Indications for Spesolimab-sbzo Injection for the Treatment of Generalized Pustular Psoriasis

The FDA has approved spesolimab-sbzo (Spevigo; Boehringer Ingelheim) injection to reduce flares of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 years and older who weigh at least 40 kg (88 pounds). This treatment is the first targeted therapy indicated for the treatment of GPP and is approved in 48 countries.

“Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, MD, PhD, a clinical professor of dermatology at Yale University and Central Connecticut Dermatology, in the press release. “[Spesolimab-sbzo] has the potential to redefine the treatment options for the patients we serve.”

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GPP is a rare, chronic, heterogenous, and inflammatory neutrophilic disease, and it is not the same as plaque psoriasis. Symptoms of GPP include painful skin manifestations, as well as fever, pain, fatigue, and other systemic symptoms.

Symptoms can range from mild to severe, and this continuum of severity can cause patient fearand anxiety about flares, reducing quality of life and impacting emotional health, social activities, school/work, and more.

“Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode,” said Carinne Brouillon, member of the Board of Managing Directors and head of Human Pharma at Boehringer Ingelheim, in the press release.

Spesolimab-sbzo is a novel, humanized, selective IgG1 antibody which blocks IL-36 receptor (IL-36R). The activation of this signaling pathway, found in the immune system, is associated with the pathogenesis of various autoinflammatory diseases.

The FDA approved spesolimab-sbzo based on the results of the 48-week phase 2 Effisayil 2 clinical trial, which showed that treatment reduced risk of GPP flares in 84% of the 123 patients enrolled compared with placebo. In a high-dose subgroup, subcutaneous spesolimab-sbzoprevented flares in 100% of participants in 4 weeks.

Effisayil 2 is part of the Effisayil clinical trial program, which is the largest to evaluate a treatment that targets the IL-36 pathway for GPP. Results from another trial in the program, Effisayil 1, show that intravenous spesolimab-sbzo also significantly reduces symptoms during flares.

The most common adverse effects (AEs) associated with intravenous spesolimab-sbzo include fatigue, nausea, vomiting, headache, itching, infusion site bruising or blood under the skin, and urinary tract infection (UTI). AEs associated with subcutaneous injection include redness, pain, swelling, skin hardening, hives, and warmth at the injection site, as well as joint pain, UTI, and itching.

There is currently an open-label extension study evaluating long-term safety and efficacy; this extension study includes patients who were previously enrolled in the phase 2 Effisayil clinical trials.

“Expanding the treatment of GPP is a critical step towards addressing patients’ needs,” said Brouillon in the press release. “[Spesolimab-sbzo]’s new approvals constitute a fundamental change for people living with GPP.”

REFERENCE

SPEVIGO® approved for expanded indications in China and the US. Boehringer Ingelheim. News Release. March 19, 2024. Accessed on March 19, 2024. https://www.boehringer-ingelheim.com/human-health/skin-diseases/gpp/spevigo-approved-expanded-indications-china-us