Spesolimab prevented generalized pustular psoriasis flares in Effisayil 2 trial
At the 25th World Congress of Dermatology (WCD), Boehringer Ingelheim presented new late-breaking data from the Effisayil 2 trial showing that spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo
Furthermore, in the trial with 123 patients, no flares were observed after Week 4 of spesolimab treatment in the high dose group (n=30).
“Effisayil 2 is the first and largest multinational randomized clinical trial to evaluate a treatment for the prevention of GPP flares,” said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology. “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.”
GPP flares, characterized by painful pustules all over the body, may require emergency care and can lead to serious, life-threatening complications such as sepsis, shock and multisystem organ failure. In addition to the acute distress of a GPP flare, living with the uncertainty of the impact of the next flare can have a significant emotional burden on patients.
"Through our comprehensive Effisayil clinical program we have already delivered spesolimab as a major advancement for GPP patients," said 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."
The Effisayil 2 trial showed a similar incidence of patients with adverse events across spesolimab and placebo treatment arms.
It is the first approved treatment for GPP flares in adults that has been evaluated in a statistically-powered, randomized, placebo-controlled trial. To date, Spegivo (spesolimab) has been approved by regulatory authorities in almost 40 countries including the US, Japan, Mainland China, and the European Union to treat GPP flares in adults.
The Effisayil clinical trial program evaluated the largest and broadest population of GPP patients in trials of a therapy specifically targeting the IL-36 pathway for GPP: Effisayil 1: A Phase II study that demonstrated treatment with a single intravenous dose of spesolimab significantly improved signs and symptoms of generalized pustular psoriasis (GPP) in patients experiencing a flare. These results supported the approval of spesolimab (SPEVIGO) as the first specific treatment for GPP flares in adults in major markets. Effisayil 2: A Phase IIb study that showed spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. In the trial with 123 patients, no flares were observed after Week 4 of spesolimab treatment in the high dose group (n=30). Effisayil ON: An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP, who have completed previous spesolimab trials.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.