The new registry will prospectively collect detailed patient-level data enabling assessment of the natural history of the disease and treatment patterns, along with the prevalence and incidence of comorbidities in patients with the disease. Granular, longitudinal outcome measures will be collected during registry visits, some of which include clinician-reported GPP outcomes, lab measures and treatment history, as well as patient-reported outcomes assessing symptom impact and quality of life. Drug safety data also will be collected, including serious adverse events and other adverse events of special interest.

“Researchers and health care professionals have made great advances with the therapy and control of comorbidities of GPP and look forward to progressing those advances further as we continue to learn about this devastating disease,” said Karen Kaucic, M.D., president, patient and advisory services, and chief medical officer, PPD clinical research business, Thermo Fisher Scientific. “The CorEvitas GPP registry will allow the prospective evaluation of GPP patients over many years, elucidating the natural history of the disease, paradigms of treatment and our ability to evaluate the impact of therapies to normalize quality of life and health outcomes of patients.”

GPP is a rare disease affecting an estimated one out of every 10,000 people in the U.S., with most studies showing it affects more women than men. It is characterized by the sudden widespread eruption of rash and sterile pustules, with or without systemic inflammation, recurring from once a year to more than three times a year. These flares are often accompanied by severe complications which, if left untreated, can be life threatening.

Thermo Fisher acquired CorEvitas, a leading provider of gold-standard real-world evidence solutions, in August 2023. CorEvitas services include autoimmune and inflammatory syndicated registries containing structured patient clinical data spanning 400 investigator sites and over 100,000 patients followed longitudinally. The CorEvitas model is being leveraged to satisfy regulatory requirements for long-term post-authorization safety studies across a variety of disease indications.

The registry was launched with clinical guidance from two leading GPP clinical experts who serve as scientific advisors: Dr. Mark Lebwohl, dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai; and Dr. Bruce Strober, clinical professor, Department of Dermatology at Yale University.