Two-year, phase 3 data on seladelpar show biochemical and clinical improvements in pruritus and liver injury in PBC, with or without compensated liver cirrhosis.
MILAN — Seladelpar, an investigational selective peroxisome proliferator-activated receptor delta agonist, achieves both biochemical and clinically meaningful improvements in pruritus and liver injury in patients with primary biliaryThe first analysis of 337 patients with PBC, with and without cirrhosis, showed that treatment with seladelpar had a durable effect up to 2 years onand markers of liver injury, as well as a sustained reduction in pruritus, Palak Trivedi, MD, associate professor at...
For patients rolled over from RESPONSE, 102 received 18 months of treatment with seladelpar, and 29 received 24 months of treatment. A total of 62% of patients in the 18-month group achieved the composite endpoint, and 33% achieved ALP normalization, while 72% of the 24-month group reached the composite endpoint, and 17% had ALP normalization.
This level of reduction in NRS is"considered clinically significant" and takes patients from a level of moderate to severe itching down to mild, said Carrie Frenette, MD, executive director, Global Medical Affairs, Liver Diseases, Gilead Sciences, Foster City, California, and a former hepatologist of 20 years with a special interest inFrenette also noted that UDCA, the current first-line treatment for PBC, is inadequate in up to 40% of patients, and second-line treatments,...
A total of 11 participants met the composite endpoint at 24 months, with ALP normalization in four patients . The overall mean percent change from baseline in ALP was approximately −30% and in total bilirubin was around −14%. Other changes in biochemical markers included reductions from baseline in GGT and ALT of approximately −30% and −10%, respectively. No change was observed in AST.
Gallbladder Disease Liver Aminotransferase Ast Liver Enzymes Liver Studies Alt Transaminase Liver Disease Hepatic Impairment Transplantation Of The Liver Hepatic Transplantation Liver Transplantation Cirrhosis Pruritus Pruritis Itch Wound Management Wound Care Injury Hospitals Hypertension Quality Of Life QOL Health Related Quality Of Life
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