EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS PREVIOUSLY TREATED WITH FIBRATES OR OBETICHOLIC ACID

Introduction and Objectives

Seladelpar was evaluated as monotherapy or with ursodeoxycholic acid in RESPONSE (NCT04620733) among patients with primary biliary cholangitis. Patients completing RESPONSE could roll over into ASSURE (NCT03301506).

Here, we present 18-month (M) data (6M of ASSURE) in patients with or without prior use of fibrates or obeticholic acid (OCA) continuing into ASSURE from RESPONSE.

Patients and Methods

Patients received oral seladelpar 10 mg or placebo during RESPONSE, followed by open-label seladelpar in ASSURE. Fibrates/OCA were prohibited during RESPONSE. Analyses included patients with or without prior fibrates/OCA use, categorized by RESPONSE assignment: continuous seladelpar or crossover from placebo. Efficacy included the proportion of patients achieving a composite biochemical response (CBR; ALP <1.67 × ULN, ALP decrease ≥15%, and total bilirubin ≤ULN). Safety evaluations included adverse events (AEs).

Results

Among patients who continued into ASSURE from RESPONSE (n=158), 16 continuous seladelpar and 11 crossover patients reported prior use of fibrates/OCA (n=27; 17%); 88 continuous seladelpar and 43 crossover patients reported no prior use of fibrates/OCA (n=131; 83%). At 18M, 9/15 (60%) continuous seladelpar patients with prior fibrates/OCA use achieved a CBR vs 54/87 (62%) patients without prior fibrates/OCA use. Among crossover patients, 7/11 (64%) patients with prior fibrates/OCA use vs 32/41 (78%) patients without prior fibrates/OCA use achieved a CBR at 6M of ASSURE. From ASSURE initiation to 6M, AE incidence was similar across all patients, regardless of prior fibrates/OCA use; no treatment-related serious AEs were reported.

Conclusions

Interim results show seladelpar achieved comparable, sustained biochemical responses and favorable safety irrespective of prior fibrates/OCA use.

Conflict of interest: Yes, Gilead Sciences, Inc.