New spesolimab data show clinically significant improvement in patients with generalized pustular psoriasis (GPP) flares

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New data from the pivotal Effisayil 1 trial will be presented at the American Academy of Dermatology (AAD) Annual Meeting in Boston in 2022, according to Boehringer Ingelheim.

The Effisayil 1 trial, which was recently published in The New England Journal of Medicine, found that therapy with a single intravenous dosage of spesolimab versus placebo resulted in considerable clearance of cutaneous pustules in patients with GPP flares during the first week.

4 According to statistics given at AAD, this effect lasted for 12 weeks, with 84.4 percent of patients having no visible pustules after the 12-week study and 81.3 percent having clear/almost clear skin. 

“GPP is an unpredictable, painful, and potentially life-threatening rare skin disease with no available approved or efficacious treatment options in most countries. The findings presented at this year’s AAD Annual Meeting show that the efficacy of spesolimab is sustained over 12 weeks, providing further evidence of the rapid benefit that spesolimab could bring to patients living with the burden of GPP flares,” 

said Boni Elewski, M.D., trial investigator and Chair, Department of Dermatology at The University of Alabama School of Medicine.

Generalized pustular psoriasis, unlike plaque psoriasis, is an uncommon, possibly life-threatening neutrophilic skin condition. GPP flares have a significant impact on a person’s quality of life and can lead to serious and sometimes fatal complications such as heart failure, renal failure, and sepsis. 

Further research presented at the AAD Annual Meeting found that the rapid skin clearance seen after spesolimab treatment was consistent across subgroups, including age, gender, ethnicity, and IL-36 gene mutation status.

2 After therapy with spesolimab, clinically significant improvements in patient-reported outcomes related to pain, fatigue, quality of life, and skin complaints were seen after one week. 

“With these additional data, we are gaining a more complete picture of spesolimab as a potential first-in-class treatment for people living with GPP. “GPP flares have a significant physical and emotional impact on a patient’s life. Our goal is to bring Spesolimab to patients as quickly as possible,”

  said Kay Tetzlaff, Head of Medicine, Therapeutic Area Inflammation, Boehringer Ingelheim. 

Regulatory agencies are presently reviewing Spesolimab. For the treatment of GPP flares, spesolimab has received Breakthrough Therapy Designation in the United States, China, and Taiwan, Priority Review in the United States and China, Orphan Drug Designation in the United States, Korea, Switzerland, and Australia, Rare Disease Designation in the United States, and Fast Track in Taiwan. The marketing authorization application for spesolimab in GPP was validated by the European Medicines Agency in October 2021, and the submission is presently being evaluated.

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