Data reported from the trial showed that GPP patients in the high dose group had no flares after four weeks. Credit: Kinga Krzeminska / Getty Images.

Generalised pustular psoriasis (GPP) patients on a high dose of spesolimab have had no flare-ups after four weeks of treatment.

Boehringer Ingelheim reported data from the EFFISAYIL 2 trial (NCT04399837) at the World Congress of Dermatology held in Singapore, showing that spesolimab, marketed as SPEVIGO, significantly reduced the risk of GPP flare-ups by 84% over 48 weeks compared to placebo.

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The double-blind, randomised, open-label trial with 123 patients demonstrated no flare-ups after week four of spesolimab treatment in the high-dose group.

Yale University dermatology clinical professor Dr Bruce Strober said: “EFFISAYIL 2 is the first and largest multinational randomised clinical trial to evaluate a treatment for the prevention of GPP flares.

“These results provide further compelling clinical evidence for the role IL-36 signalling plays in the pathogenesis of GPP. Moving forward, our hope is that dermatologists not only have a specific treatment for GPP flares, but that we can effectively prevent them in the future.”

Spesolimab is a novel, humanised, selective antibody that specifically blocks the activation of the interleukin-36 receptor, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.

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No safety concerns were raised in the trial, with a similar incident rate reported between patients receiving both the active drug and the placebo. EFFISAYIL 2 is among a series of trials currently being conducted to determine the safety and efficacy of spesolimab for GPP patients.

Approval for use in GPP patients

Spesolimab received breakthrough therapy designation from the US Food and Drug Administration (FDA) in May 2023 and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as an investigational treatment for flare prevention.

SPEVIGO has been approved by regulatory authorities in almost 40 countries, including the US, Japan, Mainland China, and the EU, to treat GPP flare-ups in adults. The therapy is also undergoing investigation for the treatment of other IL-36-mediated skin diseases, including ulcerative colitis, Netherton syndrome, and other types of psoriasis.

What is GPP?

Also known as von Zumbusch psoriasis, GPP often presents with flares, fever, shivers, intense itching, rapid pulse, fatigue, headache, nausea, muscle weakness, and joint pain.

GPP flare-ups cause painful pustules on the body, which can require emergency treatment and may lead to serious, life-threatening complications such as sepsis, shock, and multisystem organ failure.

GlobalData reports there are ten pipelines and 63 marketed drugs for GPP.

GlobalData is a parent company of the Clinical Trials Arena.