Novel saroglitazar significantly improved biochemical response rates in patients with primary biliary cholangitis (PBC) who had an inadequate response to ursodeoxycholic acid or couldn't tolerate it, according to the EPICS-III randomized clinical trial.
Among 148 patients, 56.7% of those randomized to oral saroglitazar (55 of 97) had a biochemical response at 52 weeks compared with 9.8% of those randomized to placebo (five of 51, P<0.001). Biochemical response was defined as alkaline phosphatase (ALP) less than 1.67 times the upper limit of normal (ULN, 116 U/L), at least a 15% decrease in ALP relative to baseline, and total bilirubin no greater than the ULN.
Biochemical response at week 52 was even greater with saroglitazar among the 93 patients who had baseline ALP no more than three times the ULN (83.1% vs 14.7%), although not a statistically significant difference, reported Raj Vuppalanchi, MBBS, of Indiana University in Indianapolis, at the European Association for the Study of the Liver annual meeting in Barcelona.
Higher baseline ALPs also trended toward greater response with the dual peroxisome proliferator activated receptor (PPAR), with rates of 18.7% on saroglitazar (six of 32) compared with 0% on placebo (none of 14), again not statistically significant.
