Spevigo Gets Expanded Approval for Generalized Pustular Psoriasis

The Food and Drug Administration (FDA) has expanded the approval of Spevigo^® (spesolimab-sbzo) to include the treatment of generalized pustular psoriasis (GPP) in adult and pediatric patients 12 years of age and older and weighing at least 40kg. Previously, the treatment was only approved for GPP flares in adults.

Spevigo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling, thereby preventing the subsequent activation of the IL-36 receptor and downstream activation of proinflammatory and profibrotic pathways. 

The approval was based on data from the randomized, double-blind, placebo-controlled phase 2 Effisayil-2 study (ClinicalTrials.gov Identifier: NCT04399837), which evaluated the efficacy and safety of spesolimab for subcutaneous (SC) administration in patients 12 years of age and older and weighing at least 40kg, with a history of at least 2 GPP flares of moderate to severe intensity. Prior to or at study randomization, systemic and topical therapies for GPP were required to be discontinued. 

Study participants were randomly assigned to receive either spesolimab 600mg SC loading dose followed by 300mg SC every 4 weeks or placebo. The primary endpoint was time to first GPP flare up to week 48, defined as Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) sub score of at least 2 and an increase in GPPPGA total score by at least 2 from baseline.

Results showed that treatment with spesolimab reduced the risk of GPP flares by 84% compared with placebo. Moreover, 10% of patients (n=3/30) who received spesolimab had at least 1 GPP flare up to week 48 compared with 52% of those (n=16/31) who received placebo (risk difference, -39 [95% CI, -62, -16]). These results were generally consistent across subgroups.

As for safety, spesolimab had an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared with placebo.

“Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology. “Spevigo has the potential to redefine the treatment options for the patients we serve.”

Spevigo is supplied in 150mg/mL prefilled syringes for SC use and is expected to be available in April 2024. The new prefilled syringes are to be administered for the treatment of GPP when patients are not experiencing a flare. 

Spevigo is currently available in 450mg/7.5mL single-dose vials for intravenous (IV) infusion for the treatment of GPP flare.