The Food and Drug Administration (FDA) has approved Spevigo® (spesolimab-sbzo) for the treatment of generalized pustular psoriasis 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 treatment is administered as a single intravenous (IV) infusion; an additional dose may be given if generalized pustular psoriasis flare symptoms persist.
The approval was based on data from the 12-week Effisayil 1 study (ClinicalTrials.gov Identifier: NCT03782792), which evaluated the safety and efficacy of spesolimab compared with placebo in patients with generalized pustular psoriasis presenting with an acute flare of moderate to severe intensity. Patients (mean age, 43; 32% men, 68% women) were randomly assigned to receive a single IV dose of spesolimab 900mg (n=35) or placebo (n=18) during the double-blind portion of the study.
The primary endpoint was the proportion of patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) pustulation subscore of 0 (indicating no visible pustules) at week 1 after treatment. At baseline, 43% and 36% of patients had a GPPPGA pustulation subscore of 3 (moderate) or 4 (severe), respectively.
Results showed that a greater proportion of patients treated with spesolimab achieved a GPPPGA pustulation subscore of 0 at week 1 compared with placebo (54% vs 6%; risk difference vs placebo, 49% [95% CI, 21-67]).
Patients who continued to experience flare symptoms at week 1 were eligible to receive a single, open-label, IV dose of spesolimab 900mg (second dose for the spesolimab group and first dose for the placebo group). At week 2, 42% (n=5/12) of patients who were randomized to spesolimab and received another dose at week 1 had a GPPPGA pustulation subscore of 0.
According to product labeling, it is unclear whether responses would be different based on sex, age, race, baseline GPPPGA postulation subscore or baseline GPPPGA total score as the study did not include a sufficient number of patients.
The most common adverse reactions reported with treatment were asthenia/fatigue, nausea/vomiting, headache, pruritus/prurigo, infusion site hematoma/bruising, and urinary tract infection. Spevigo may also increase the risk of infections and has been associated with severe hypersensitivity reactions in clinical trials (eg, anaphylaxis, drug reaction with eosinophilia syndrome symptoms [DRESS]). Treatment is not recommended in patients with active tuberculosis infection.
Spevigo is supplied in a single-dose vial; each 7.5mL vial contains 450mg of spesolimab-sbzo in a preservative-free solution.
- FDA approves the first treatment option for generalized pustular psoriasis flares in adults. News release. Accessed September 2, 2022. https://www.prnewswire.com/news-releases/fda-approves-the-first-treatment-option-for-generalized-pustular-psoriasis-flares-in-adults-301616844.html
- Spevigo. Package insert. Boehringer Ingelheim; 2022. Accessed September 2, 2022. https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Spevigo/Spevigo.pdf?DMW_FORMAT=pdf