BACKGROUND AND PURPOSE:

• Ursodeoxycholic acid (UDCA), a bile acid, is frequently used to treat intrahepatic cholestasis of pregnancy (ICP), despite limited evidence for its efficacy
• The PITCHES RCT found no evidence of benefit from UDCA treatment in women with ICP
• In a secondary analysis of the PITCHES trial, Fleminger et al. (BJOG, 2021) performed a subgroup analysis to determine whether UDCA may benefit particular groups of patients with ICP 

METHODS:

• Secondary analysis of the PITCHES trial
  • See ‘Related ObG Topics’ below for review of the PITCHES RCT
  • Primary outcome of PITCHES RCT: Composite of perinatal death, preterm delivery and NICU admission
• Participants
  • Women with ICP
  • Between 20w0d and 40w6d
• Interventions
  • UDCA
  • Placebo
• Study design
  • Subgroup definitions
    • Bile acid concentrations: Accepted thresholds related to perinatal risk
    • Itch: Median itch at baseline in the trial participants
• Primary outcomes
  • Beneficial effect of UDCA on
    • Bile acid concentrations
    • Perceived itching

RESULTS:

• 527 women
• Bile acid concentrations decreased in both the UDCA and placebo groups
• Baseline bile acid concentrations did not impact bile acid response to UDCA treatment
  • In women with baseline bile acid concentrations <40 μmol/l, treatment with UDCA resulted in increased bile acid concentrations but was not statistically significant (P=0.647)
• In women with a high baseline itch score, there was an improvement in itch response that was not significant (P=0.640)
• There was a weak relationship between bile acid concentrations and itch severity
• Results did not change based on whether the analysis was limited to women taking >90% of prescribed medication (self‐report)

CONCLUSION:

• Subgroup analysis of the PITCHES RCT demonstrated that baseline bile acid concentrations and initial itch scores did not alter response to UDCA in women with ICP
• Bile acid concentrations did not correlate well with itch
• The authors conclude

The secondary analysis presented here identified no subgroup of women in whom a reduction in bile acid concentration or itch score in response to treatment with UDCA was found

Routine use of UDCA to reduce bile acid concentrations or itch scores should be reconsidered, and there is no justification for targeting women with high bile acid concentrations or high itch scores at presentation

Learn More – Primary Sources:

Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial

Related ObG Topics:

PITCHES RCT: Ursodeoxycholic Acid and Intrahepatic Cholestasis of Pregnancy

Risk of Stillbirth with Intrahepatic Cholestasis of Pregnancy: What do Bile Acid Concentrations Tell Us?

SMFM Recommendations: Intrahepatic Cholestasis of Pregnancy

Is Rifampin an Option for the Treatment of Intrahepatic Cholestasis in Pregnancy?