Dyax Corp. (NASDAQ:DYAX) today announced a study published evaluating the Company’s novel Patient Reported Outcome Measures (PROs) used to assess hereditary angioedema (HAE) attacks affirmed the PROs as valuable instruments in capturing HAE symptom severity and impact of treatment. The study, “Psychometric Validation of Two Patient-Reported Outcome Measures to Assess Symptom Severity and Changes in Symptoms in Hereditary Angioedema,” examined the PROs used in Dyax’s HAE clinical development program and was published in the September issue of the journal Quality of Life Research.
The overall analysis supported the robust measurement properties, including reliability and validity, of the two disease-specific PROs created by Dyax as efficacy measurements in the Company’s Phase 3 HAE clinical program. In addition, the study researcher and lead author Margaret Vernon, PhD, Research Scientist of the United BioSource Corporation, Center for Health Outcomes Research concluded that the two PRO instruments comprehensively evaluate all the possible signs and symptoms experienced by patients during an HAE attack.
“HAE is a complex disease that can manifest in multiple swelling patterns of differing severities and symptoms in a single acute episode,” Dr. Vernon noted, “There is a critical need for measures that can take into account all the relevant symptoms of an attack, including capturing the signs and symptoms that are known only to the patient (such as internal swelling, stomach cramping and pain).” Previous instruments, used in other HAE studies to evaluate such attacks, are limited as they assess only a single symptom and cannot accurately depict the complexity and variability of an attack.