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The ongoing ASSURE Phase 3 trial is investigating Seladelpar's long-term effects on patients who transitioned from the RESPONSE Phase 3 registrational study or participated in earlier legacy studies (ENHANCE and others). The goal of this report was to provide interim 2-year results, focusing on the efficacy and safety of Seladelpar in these patient populations.
Seladelpar consistently improves biochemical markers and pruritus in primary biliary cholangitis patients, demonstrating sustained efficacy and safety.
The ongoing ASSURE Phase 3 trial is investigating Seladelpar's long-term effects on patients who transitioned from the RESPONSE Phase 3 registrational study or participated in earlier legacy studies (ENHANCE and others). The goal of this report was to provide interim 2-year results, focusing on the efficacy and safety of Seladelpar in these patient populations.
ASSURE included individuals with inadequate response or intolerance to ursodeoxycholic acid, the first-line primary biliary cholangitis treatment, who participated in previous Seladelpar trials. The key outcomes encompassed a composite biochemical response (alkaline phosphatase [ALP] <1.67×upper limit of normal [ULN], ALP reduction ≥15%, and bilirubin ≤ULN), ALP normalization.
Pruritus assessment was done with the help of a numerical rating scale (NRS; 0–10). For ASSURE volunteers transitioning from RESPONSE, the baseline was defined as their entry point into RESPONSE, with analysis conducted based on continuous Seladelpar treatment or crossover from placebo. Legacy patients were analyzed independently, with their baseline set at the time of entry into ASSURE.
Overall, 158 RESPONSE and 179 legacy volunteers were treated with 10 mg Seladelpar daily for a period of 155 weeks in ASSURE. Among RESPONSE volunteers, 61.7% fulfilled the composite endpoint at 12 months versus 20% for placebo. Continued Seladelpar use in ASSURE revealed 61.8% and 72.4% meeting the endpoint at 6 and 12 months, respectively, while placebo crossover patients attained 75% (6 months) and 93.8% (12 months). ALP normalization rates were 33.3% and 17.2% at 6 and 12 months for continuous Seladelpar, and 26.9% and 50% for crossover patients.
Pruritus NRS reductions in ASSURE were −3.8 in continuous and −3.7 in crossover patients at 6 months, closely matching the improvements observed in RESPONSE. In legacy patients, 73.2% and 69.7% met the composite endpoint at 12 and 24 months, respectively. ALP normalization was achieved by 42.1% at 12 months and 42.4% at 24 months, with reductions in pruritus NRS of −3.8 and −3.1 from baseline. Seladelpar was well-tolerated, with no therapy-linked serious adverse events.
Long-term Seladelpar use sustained biochemical and symptom improvements in primary biliary cholangitis patients from RESPONSE and legacy trials, offering a promising, well-tolerated therapeutic option.
Official Journal of the American College of Gastroenterology
Long-Term Efficacy and Safety of Open-Label Seladelpar Treatment in Patients With Primary Biliary Cholangitis: Interim Results for 2 Years From the ASSURE Study
Palak Trivedi et al.
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