Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial
Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial
Objective: To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA). Design: Secondary analysis of the PITCHES trial (ISRCTN91918806). Setting: United Kingdom. Population or Sample: 527 women with ICP. Methods: Subgroup analyses were performed to determine whether baseline bile acid concentrations or baseline itch scores moderated a woman’s response to treatment with UDCA. Main outcome measures: Bile acid concentration and itch score. Results: In women with baseline bile acid concentrations less than 40 μmol/l, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00–1.41, P = 0.048). A test of interaction showed no significance (P = 0.647). A small, clinically insignificant difference was seen in itch response in women with a high baseline itch score (–6.0 mm, 95% CI −11.80 to −0.21, P = 0.042), with a test of interaction not showing significance (P = 0.640). Further subgroup analyses showed no significance. Across all women there was a weak relationship between bile acid concentrations and itch severity. Conclusions: There was no subgroup of women with ICP in whom a beneficial effect of treatment with UDCA on bile acid concentration or itch score could be identified. This confirms that its routine use in women with this condition for improvement of bile acid concentration or itch score should be reconsidered. Tweetable abstract: PITCHES: No group of women with ICP has been found in whom UDCA reduces bile acid concentrations or pruritus.
Cholestasis, perinatal, pregnancy, stillbirth, ursodeoxycholic acid
1066-1075
Fleminger, J.
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Seed, P. T.
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Smith, A.
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Juszczak, Edmund
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Dixon, P. H.
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Chambers, J.
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Dorling, J.
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Williamson, Catherine
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Thornton, J. G.
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Chappell, L. C.
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9 April 2021
Fleminger, J.
ce06d3c6-36e5-487c-bad5-ed32eb011637
Seed, P. T.
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Smith, A.
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Juszczak, Edmund
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Dixon, P. H.
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Chambers, J.
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Dorling, J.
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Williamson, Catherine
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Thornton, J. G.
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Chappell, L. C.
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Fleminger, J., Seed, P. T., Smith, A., Juszczak, Edmund, Dixon, P. H., Chambers, J., Dorling, J., Williamson, Catherine, Thornton, J. G. and Chappell, L. C.
(2021)
Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial.
BJOG: An International Journal of Obstetrics and Gynaecology, 128 (6), .
(doi:10.1111/1471-0528.16567).
Abstract
Objective: To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA). Design: Secondary analysis of the PITCHES trial (ISRCTN91918806). Setting: United Kingdom. Population or Sample: 527 women with ICP. Methods: Subgroup analyses were performed to determine whether baseline bile acid concentrations or baseline itch scores moderated a woman’s response to treatment with UDCA. Main outcome measures: Bile acid concentration and itch score. Results: In women with baseline bile acid concentrations less than 40 μmol/l, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00–1.41, P = 0.048). A test of interaction showed no significance (P = 0.647). A small, clinically insignificant difference was seen in itch response in women with a high baseline itch score (–6.0 mm, 95% CI −11.80 to −0.21, P = 0.042), with a test of interaction not showing significance (P = 0.640). Further subgroup analyses showed no significance. Across all women there was a weak relationship between bile acid concentrations and itch severity. Conclusions: There was no subgroup of women with ICP in whom a beneficial effect of treatment with UDCA on bile acid concentration or itch score could be identified. This confirms that its routine use in women with this condition for improvement of bile acid concentration or itch score should be reconsidered. Tweetable abstract: PITCHES: No group of women with ICP has been found in whom UDCA reduces bile acid concentrations or pruritus.
Text
BJOG - 2020 - Fleminger - Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy a secondary analysis of the
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More information
Accepted/In Press date: 8 October 2020
e-pub ahead of print date: 16 October 2020
Published date: 9 April 2021
Additional Information:
Funding Information:
The trial was funded by the National Institute for Health Research Efficacy and Mechanism Evaluation Programme (Reference 12/164/16), following external peer review, including patient and public review. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Funding Information:
LCC is funded by the National Institute for Health Research (NIHR) Professorship, RP‐2014–05–019. Paul T Seed is partly funded by King’s Health Partners Institute of Women and Children’s Health, Tommy’s (Registered charity no. 1060508) and by ARC South London (NIHR). The views expressed in this publication are those of the authors and not necessarily those of KHP, Tommy's, the NHS, the NIHR or the Department of Health. We thank the independent Trial Steering Committee (David Williams, Judith Hibbert, Julia Sanders, Deborah Stocken, Julian Walters, Win Tin) and the independent Data Monitoring Committee (John Norrie, William McGuire, Jenny Myers).
Funding Information:
The trial was funded by the National Institute for Health Research Efficacy and Mechanism Evaluation Programme (Reference 12/164/16), following external peer review, including patient and public review. The trial was funded by the National Institute for Health Research Efficacy and Mechanism Evaluation Programme (Reference 12/164/16), following external peer review, including patient and public review. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. LCC is funded by the National Institute for Health Research (NIHR) Professorship, RP-2014–05–019. Paul T Seed is partly funded by King’s Health Partners Institute of Women and Children’s Health, Tommy’s (Registered charity no. 1060508) and by ARC South London (NIHR). The views expressed in this publication are those of the authors and not necessarily those of KHP, Tommy's, the NHS, the NIHR or the Department of Health. We thank the independent Trial Steering Committee (David Williams, Judith Hibbert, Julia Sanders, Deborah Stocken, Julian Walters, Win Tin) and the independent Data Monitoring Committee (John Norrie, William McGuire, Jenny Myers).
Publisher Copyright:
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd
Keywords:
Cholestasis, perinatal, pregnancy, stillbirth, ursodeoxycholic acid
Identifiers
Local EPrints ID: 485434
URI: http://eprints.soton.ac.uk/id/eprint/485434
ISSN: 1470-0328
PURE UUID: a3cf6d1d-2fcb-469e-8014-ec2e5ccdedf5
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Date deposited: 06 Dec 2023 17:41
Last modified: 18 Mar 2024 04:17
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Contributors
Author:
J. Fleminger
Author:
P. T. Seed
Author:
A. Smith
Author:
Edmund Juszczak
Author:
P. H. Dixon
Author:
J. Chambers
Author:
J. Dorling
Author:
Catherine Williamson
Author:
J. G. Thornton
Author:
L. C. Chappell
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