Spesolimab Treatment for the Prevention of Flares in People with Generalized Pustular Psoriasis (GPP): A Video Summary of the EFFISAYIL® 2 Study

In this video article, Professor Akimichi Morita presents the findings of the EFFISAYIL® 2 clinical trial, which investigated spesolimab treatment for the prevention of GPP flares.

Generalized pustular psoriasis (GPP) is a rare, unpredictable, and lifelong disease. Patients with GPP often have chronic symptoms and may experience flares (disease worsening), which can lead to potentially life-threatening complications requiring hospitalization. During a flare, levels of a molecule called interleukin-36 (IL-36) increase, leading to inflammation in the skin, painful pus-filled blisters, and systemic effects such as fever, pain, and fatigue.

Until recently, there were no approved therapies to prevent GPP flares. Spesolimab, a medication that is injected under the skin, targets the IL-36 receptor, stopping inflammation and the formation of pus-filled blisters. Based on a previous clinical trial, EFFISAYIL® 1, spesolimab was approved for the treatment of GPP flares in the US, Europe, and several countries around the world.

EFFISAYIL® 2 studied how effective and safe spesolimab was at preventing GPP flares in 123 participants aged 12–75 years, from 60 medical centers, across 20 countries. Participants were randomly divided into four groups to receive a placebo (non-active drug), or one of three different doses of spesolimab and were assessed every 4 weeks until Week 48. At the end of the study, 93 entered a long-term study to receive spesolimab for up to 5 years. Results showed that long-term treatment with spesolimab (initial dose of 600 mg followed by 300 mg every 4 weeks) reduced the risk of flares and prevented worsening of symptoms and quality of life over a 48-week period.

Meet the author:

Professor Akimichi Morita graduated from Nagoya City University and received his MD in 1989. He later received his PhD in basic immunology from Aichi Cancer Center in Nagoya. As a Humboldt Foundation Fellow, he studied photobiology and photoimmunology at Düsseldorf University in Düsseldorf, Germany, and underwent further training at the University of Texas Southwestern Medical Center in Dallas, TX, USA. Since then, he has introduced numerous standard phototherapies to Japan. He was appointed Professor and Chairman of the Department of Geriatric and Environmental Dermatology at Nagoya City University Graduate School of Medical Sciences in 2003 and currently holds the position of Vice Director of Nagoya City University Hospital. Professor Morita’s main research interests are photobiology, phototherapy, cutaneous immunology, skin aging, cutaneous T-cell lymphoma, and psoriasis.

Professor Morita holds the title of President of the Japanese Society for Psoriasis Research (2022) and is on the board of directors for the International Council of Psoriasis (2023). He was the President of the Japanese Society for Photomedicine and Photobiology (2018–2022) and the President of the Japanese Society for Investigative Dermatology (2017–2020). He is an editorial board member of several prestigious medical journals and currently serves as Editor-in-Chief of Experimental Dermatology. He also served as Editor-in-Chief of the journal Photodermatology, Photomedicine & Photoimmunology (2018–2021) and Editor-in-Chief of the Journal of Dermatological Science (2008–2013). In addition, he has published over 300 articles in peer-reviewed journals (H-index: 53) and written 26 books or book chapters.

Original article(s):

Morita A, Strober B, Burden AD, et al. Spesolimab treatment for the prevention of flares in people with generalized pustular psoriasis (GPP): a plain language summary of the Effisayil™ 2 study. Fut Rare Dis. 2024;4(1):FRD57. doi: 10.2217/frd-2023-0023.

Click on the links below to read the Plain Language Summary of Publication (PLSP) and Original Research Article.