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A Randomized, Controlled, Phase 2 Study of Maralixibat in the Treatment of Itching Associated With Primary Biliary Cholangitis. | LitMetric

AI Article Synopsis

  • - Primary biliary cholangitis (PBC) can cause high bile acid levels and intense itching (pruritus), which is often hard to treat; this study tested maralixibat, a new treatment, against a placebo in PBC patients experiencing pruritus.
  • - The trial involved 66 patients, with a focus on measuring changes in itching levels over 13 weeks using a specific scoring system, but findings showed no significant difference in itching reduction between those treated with maralixibat and those on placebo.
  • - Both groups experienced various adverse effects, mostly gastrointestinal issues; the study highlights the challenges in evaluating pruritus treatments and emphasizes the need for careful trial design in future research.

Article Abstract

Primary biliary cholangitis (PBC) is typically associated with elevated serum bile acid levels and pruritus, but pruritus is often refractory to treatment with existing therapies. This phase 2 study assessed the efficacy and safety of maralixibat, a selective, ileal, apical, sodium-dependent, bile acid transporter inhibitor, in adults with PBC and pruritus. Adults with PBC and pruritus who had received ursodeoxycholic acid (UDCA) for ≥6 months or were intolerant to UDCA were randomized 2:1 to maralixibat (10 or 20 mg/day) or placebo for 13 weeks in combination with UDCA (when tolerated). The primary outcome was change in Adult Itch Reported Outcome (ItchRO™) average weekly sum score (0, no itching; 70, maximum itching) from baseline to week 13/early termination (ET). The study enrolled 66 patients (maralixibat [both doses combined], n = 42; placebo, n = 24). Mean ItchRO™ weekly sum scores decreased from baseline to week 13/ET with maralixibat (-26.5; 95% confidence interval [CI], -31.8, -21.2) and placebo (-23.4; 95% CI, -30.3, -16.4). The difference between groups was not significant (= 0.48). In the maralixibat and placebo groups, adverse events (AEs) were reported in 97.6% and 70.8% of patients, respectively. Gastrointestinal disorders were the most frequently reported AEs (maralixibat, 78.6%; placebo, 50.0%). Reductions in pruritus did not differ significantly between maralixibat and placebo. However, a large placebo effect may have confounded assessment of pruritus. Lessons learned from this rigorously designed and executed trial are indispensable for understanding how to approach trials assessing pruritus as the primary endpoint and the therapeutic window of bile acid uptake inhibition as a therapeutic strategy in PBC.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396374PMC
http://dx.doi.org/10.1002/hep4.1305DOI Listing

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