The 25th World Congress of Dermatology took place this year from July 3 to 8, 2023. During the Congress, stakeholders throughout the medical industry convened to discuss research, trends, and clinical practices. One such presentation focused on the results from the Phase 2b Effisayil 2 study. This study explored the use of Spevigo (spesolimab) for individuals living with generalized pustular psoriasis (GPP). In particular, the research team wanted to understand how Spevigo controlled GPP “flares,” or periods of severe symptoms that may last up to a few weeks at a time. Those affected often have periods of remission and clear skin between flares.

Researching Spevigo

The National Psoriasis Foundation describes Spevigo as:

a novel antibody that blocks the activation of the interleukin 36 receptor (IL-36R). The interleukin 36 signaling pathway, part of the immune system, has been shown to be involved in causing GPP flares.

This intravenous injection was developed by Boehringer Ingelheim.

According to Healio, 123 participants enrolled in the study to evaluate Spevigo for GPP. Participants received either:

• A 300mg loading dose followed by 150mg Spevigo every 12 weeks
• 600mg loading dose followed by 300mg every 12 weeks
• A 600mg loading dose followed by 300mg every 4 weeks
• Placebo

The study found that Spevigo was safe across all doses. It also showed surprising efficacy in treating GPP. Over a 48-week period, Spevigo reduced the risk of flares by 84% when compared to a placebo. The most efficacy was seen in the high-dose Spevigo group (600mg loading dose followed by 300mg every 4 weeks). No participants in this cohort experienced any flares within the first 4 weeks and, long-term, also seemed to have the most reduced risk of flares.

About Generalized Pustular Psoriasis (GPP)

Also known as: von Zumbusch psoriasis

Generalized pustular psoriasis is a rare and severe form of psoriasis, a chronic skin disorder. It is characterized by widespread areas of skin that become red, inflamed, and painful, as well as small pus-filled blisters (pustules). The National Psoriasis Foundation explains that infections, stress, corticosteroid treatment withdrawal, and pregnancy are the most frequent GPP causes. GPP typically affects adults but can occur in children, often due to genetic mutations in the IL36RN gene. This causes abnormal inflammation in the skin, which can cause damage. Slightly over half of those affected by generalized pustular psoriasis also have plaque psoriasis. A slight majority are also female.

Outside of the skin manifestations and pustules, symptoms and characteristics of GPP may include:

• Fever
• Extreme fatigue
• Increased white blood cell counts
• Headache
• Uveitis, iritis, or conjunctivitis
• Muscle weakness
• Sudden drop in blood pressure

Spevigo offers one treatment route for people with GPP. Other measures include emollients and moisturizers, IV fluids, topical agents, phototherapy, antibiotics, and biologics or non-biologic therapies. This condition can lead to serious and life-threatening complications, so pursuing care is extremely important.