Noninvasive tests identify candidates for Rezdiffra, predict response in patients with MASH
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Key takeaways:
- MRI-PDFF was the “best predictor for resmetirom response on biopsy” in patients with MASH.
- Other noninvasive tests that improved and may predict response included adiponectin, ELF, ProC3, ALT, CAP and CK-18.
WASHINGTON — Researchers have determined that several noninvasive tests could help identify candidates for treatment with Rezdiffra, as well as predict response, in metabolic dysfunction-associated steatohepatitis.
“We wanted to identify if we could predict response to treatment among patients treated with resmetirom,” Rohit Loomba, MD, MHSc, professor of medicine and chief of the division of gastroenterology and hepatology at University of California, San Diego, School of Medicine and director of the MASLD Research Center, told Healio. “This will be helpful to clinicians to assess therapeutic response as they initiate resmetirom and follow their patients on it over time.”
Using data from the 54-month, randomized, double-blind, placebo-controlled phase 3 MAESTRO-NASH trial, which evaluated the efficacy and safety of 80 mg and 100 mg doses of Rezdiffra (resmetirom, Madrigal Pharmaceuticals) among adults with biopsy-proven MASH, Loomba and colleagues sought to determine which noninvasive tests could predict response to treatment.
Guided by AI technology, they identified MRI-proton density fat fraction (MRI-PDFF), alanine transaminase, FibroScan controlled attenuation parameter (CAP) and vibration-controlled transient elastography (VCTE), and enhanced liver fibrosis (ELF) as possible predictors.
“We found that noninvasive tests can help us identify who needs to be treated [with resmetirom] and who needs to be treated for liver stiffness,” Loomba said. “For predicting histologic treatment response, we found that improvements in MRI-PDFF, adiponectin, ELF, ProC3, ALT, CAP and CK-18 can predict treatment response.”
At Digestive Disease Week, Loomba told attendees that MRI-PDFF improvement “is the best predictor for resmetirom response on biopsy for both NASH resolution and fibrosis improvement.”
Among patients on resmetirom 100 mg, at least a 30% improvement in MRI-PDFF was reported in 96% and 88% for NASH resolution and fibrosis improvement, respectively.
Further, CAP improved and was stable over 3 years with resmetirom, as did VCTE, which had a greater relative response vs. placebo between years 2 and 3.
“Lack of change or worsening in VCTE at week 52 did not predict low NASH or fibrosis response on biopsy,” Loomba told attendees. “Less than 10% of resmetirom-treated patients showed 30% worsening of liver stiffness at 2 to 3 years of treatment compared with 20% of placebo.”
According to Loomba, both 80 mg and 100 mg doses of resmetirom significantly reduced ALT by nearly 30% compared with placebo.
“These data are helpful in assessing who needs resmetirom and how to follow patients on resmetirom,” Loomba told Healio. “Noninvasive tests can be used to find candidates for resmetirom treatment and also predict treatment response to resmetirom.”
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Loomba R, et al. ALT, VCTE and CAP as predictive markers of resmetirom biopsy response. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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