Spesolimab demonstrated superiority vs. placebo in preventing generalized pustular psoriasis (GPP) flares up to 48 weeks.

Spesolimab reduced the risk of generalized pustular psoriasis (GPP) flares flares by 84% over 48 weeks compared to placebo, according to late-breaking data from the EFFISAYIL™ 2 trial presebted at the at the 25th World Congress of Dermatology (WCD) in Singapore.

Furthermore, the trial with 123 patients demonstrated no flares after Week 4 of spesolimab treatment in the high dose group, the study showed.

Spesolimab is a novel, humanized, selective antibody that specifically blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. Spesolimab (marketed as SPEVIGO has recently received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as an investigational treatment for the prevention of GPP flares.

“EFFISAYIL 2 is the first and largest multinational randomized clinical trial to evaluate a treatment for the prevention of GPP flares,” says Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology, in a news release. “These results provide further compelling clinical evidence for the role IL-36 signaling 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.”

In the EFFISAYIL 2 trial, spesolimab was shown to have a favorable safety profile, with a similar incidence of patients with adverse events across spesolimab and placebo treatment arms.

“At IFPA we meet people living with GPP, who share their story of physical pain due to the symptoms of the disease, and the mental burden that comes with the flares,” adds Frida Dunger Johnsson, Executive Director, IFPA. “Any progress made to ease the burden of the disease improves the quality of life of people living with GPP.”

"Through our comprehensive EFFISAYIL clinical program we have already delivered spesolimab as a major advancement for flaring GPP patients," says Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. "The EFFISAYIL 2 trial results build on this success bringing us closer to achieving our ultimate goal of a flare-free future for everyone living with GPP."