A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis
Background/Purpose Although ursodeoxycholic acid (UDCA) is a first‐line treatment for primary biliary cholangitis (PBC), 20%‐30% of patients with PBC exhibit an incomplete response to UDCA. Recently, the UDCA Response Score was proposed for predicting response to UDCA using pretreatment parameters i...
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| Veröffentlicht in: | Liver international 2020-08, Vol.40 (8), p.1926-1933 |
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| creator | Yagi, Minami Matsumoto, Kosuke Komori, Atsumasa Abe, Masanori Hashimoto, Naoaki Inao, Mie Namisaki, Tadashi Kawata, Kazuhito Ninomiya, Masashi Fujii, Hideki Takahashi, Atsushi Kang, Jong‐Hon Takamura, Masaaki Arakawa, Mie Joshita, Satoru Sato, Ken Itakura, Jun Nomura, Takako Kakisaka, Keisuke Kaneko, Akira Tamura, Yamato Miura, Ryo Aiso, Mitsuhiko Arizumi, Toshihiko Asaoka, Yoshinari Kikuchi, Kentaro Takikawa, Yasuhiro Masaki, Tsutomu Umemura, Takeji Honda, Akira Ohira, Hiromasa Kawada, Norifumi Yoshiji, Hitoshi Mochida, Satoshi Takikawa, Hajime Tanaka, Atsushi |
| description | Background/Purpose
Although ursodeoxycholic acid (UDCA) is a first‐line treatment for primary biliary cholangitis (PBC), 20%‐30% of patients with PBC exhibit an incomplete response to UDCA. Recently, the UDCA Response Score was proposed for predicting response to UDCA using pretreatment parameters in patients with PBC. We aimed to validate the UDCA Response Score in Japanese patients with PBC.
Methods
Registry data of Japanese patients (n = 873) were collected. Patients with data on all clinical parameters required for calculating the UDCA Response Score were selected. The endpoint was UDCA response, defined as alkaline phosphatase |
| doi_str_mv | 10.1111/liv.14534 |
| format | Article |
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Although ursodeoxycholic acid (UDCA) is a first‐line treatment for primary biliary cholangitis (PBC), 20%‐30% of patients with PBC exhibit an incomplete response to UDCA. Recently, the UDCA Response Score was proposed for predicting response to UDCA using pretreatment parameters in patients with PBC. We aimed to validate the UDCA Response Score in Japanese patients with PBC.
Methods
Registry data of Japanese patients (n = 873) were collected. Patients with data on all clinical parameters required for calculating the UDCA Response Score were selected. The endpoint was UDCA response, defined as alkaline phosphatase <1.67 times the upper limit of the normal value after 12 months of UDCA treatment.
Results
All parameters were available in 804 patients (male/female = 120/684, age 58.9 [interquartile range 51.1‐66.9] years). Bezafibrate was commenced within 12 months of UDCA in 78 patients (9.7%) because of the lack of an early response. We found that the endpoint was not reached in these 78 patients, and the area under the receiver operating characteristic curve (AUROC) of the score was 0.74 (95% confidence interval [CI] 0.70‐0.79). The AUROC was 0.77 (95% CI 0.70‐0.83) in patients undergoing UDCA monotherapy (n = 726). Finally, the AUROC of the modified UDCA Response Score using only data from the treatment start date was 0.80 (95% CI 0.70‐0.90) in patients receiving a combination therapy of UDCA and bezafibrate (n = 160).
Conclusion
The validity of the UDCA Response Score was acceptable in Japanese patients; this score will be informative in patients treated with a combination therapy of UDCA and bezafibrate.</description><identifier>ISSN: 1478-3223</identifier><identifier>EISSN: 1478-3231</identifier><identifier>DOI: 10.1111/liv.14534</identifier><identifier>PMID: 32438508</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Alkaline phosphatase ; Bezafibrate ; Cholangitis ; Cohort analysis ; cohort study ; Confidence intervals ; endpoint ; Parameters ; Patients ; treatment response ; Ursodeoxycholic acid ; validation</subject><ispartof>Liver international, 2020-08, Vol.40 (8), p.1926-1933</ispartof><rights>2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><rights>This article is protected by copyright. All rights reserved.</rights><rights>2020 John Wiley & Sons A/S</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3534-cf82cebb530aee8ee011246dce6b67c676e5b13cf467f140e53728982cf8df2d3</citedby><cites>FETCH-LOGICAL-c3534-cf82cebb530aee8ee011246dce6b67c676e5b13cf467f140e53728982cf8df2d3</cites><orcidid>0000-0002-4986-8578 ; 0000-0002-6364-9654 ; 0000-0001-9627-138X ; 0000-0002-3158-5318 ; 0000-0003-0568-8361 ; 0000-0001-7985-919X ; 0000-0002-6358-5283</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fliv.14534$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fliv.14534$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32438508$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yagi, Minami</creatorcontrib><creatorcontrib>Matsumoto, Kosuke</creatorcontrib><creatorcontrib>Komori, Atsumasa</creatorcontrib><creatorcontrib>Abe, Masanori</creatorcontrib><creatorcontrib>Hashimoto, Naoaki</creatorcontrib><creatorcontrib>Inao, Mie</creatorcontrib><creatorcontrib>Namisaki, Tadashi</creatorcontrib><creatorcontrib>Kawata, Kazuhito</creatorcontrib><creatorcontrib>Ninomiya, Masashi</creatorcontrib><creatorcontrib>Fujii, Hideki</creatorcontrib><creatorcontrib>Takahashi, Atsushi</creatorcontrib><creatorcontrib>Kang, Jong‐Hon</creatorcontrib><creatorcontrib>Takamura, Masaaki</creatorcontrib><creatorcontrib>Arakawa, Mie</creatorcontrib><creatorcontrib>Joshita, Satoru</creatorcontrib><creatorcontrib>Sato, Ken</creatorcontrib><creatorcontrib>Itakura, Jun</creatorcontrib><creatorcontrib>Nomura, Takako</creatorcontrib><creatorcontrib>Kakisaka, Keisuke</creatorcontrib><creatorcontrib>Kaneko, Akira</creatorcontrib><creatorcontrib>Tamura, Yamato</creatorcontrib><creatorcontrib>Miura, Ryo</creatorcontrib><creatorcontrib>Aiso, Mitsuhiko</creatorcontrib><creatorcontrib>Arizumi, Toshihiko</creatorcontrib><creatorcontrib>Asaoka, Yoshinari</creatorcontrib><creatorcontrib>Kikuchi, Kentaro</creatorcontrib><creatorcontrib>Takikawa, Yasuhiro</creatorcontrib><creatorcontrib>Masaki, Tsutomu</creatorcontrib><creatorcontrib>Umemura, Takeji</creatorcontrib><creatorcontrib>Honda, Akira</creatorcontrib><creatorcontrib>Ohira, Hiromasa</creatorcontrib><creatorcontrib>Kawada, Norifumi</creatorcontrib><creatorcontrib>Yoshiji, Hitoshi</creatorcontrib><creatorcontrib>Mochida, Satoshi</creatorcontrib><creatorcontrib>Takikawa, Hajime</creatorcontrib><creatorcontrib>Tanaka, Atsushi</creatorcontrib><creatorcontrib>Japan PBC Study Group (JPBCSG)</creatorcontrib><title>A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis</title><title>Liver international</title><addtitle>Liver Int</addtitle><description>Background/Purpose
Although ursodeoxycholic acid (UDCA) is a first‐line treatment for primary biliary cholangitis (PBC), 20%‐30% of patients with PBC exhibit an incomplete response to UDCA. Recently, the UDCA Response Score was proposed for predicting response to UDCA using pretreatment parameters in patients with PBC. We aimed to validate the UDCA Response Score in Japanese patients with PBC.
Methods
Registry data of Japanese patients (n = 873) were collected. Patients with data on all clinical parameters required for calculating the UDCA Response Score were selected. The endpoint was UDCA response, defined as alkaline phosphatase <1.67 times the upper limit of the normal value after 12 months of UDCA treatment.
Results
All parameters were available in 804 patients (male/female = 120/684, age 58.9 [interquartile range 51.1‐66.9] years). Bezafibrate was commenced within 12 months of UDCA in 78 patients (9.7%) because of the lack of an early response. We found that the endpoint was not reached in these 78 patients, and the area under the receiver operating characteristic curve (AUROC) of the score was 0.74 (95% confidence interval [CI] 0.70‐0.79). The AUROC was 0.77 (95% CI 0.70‐0.83) in patients undergoing UDCA monotherapy (n = 726). Finally, the AUROC of the modified UDCA Response Score using only data from the treatment start date was 0.80 (95% CI 0.70‐0.90) in patients receiving a combination therapy of UDCA and bezafibrate (n = 160).
Conclusion
The validity of the UDCA Response Score was acceptable in Japanese patients; this score will be informative in patients treated with a combination therapy of UDCA and bezafibrate.</description><subject>Alkaline phosphatase</subject><subject>Bezafibrate</subject><subject>Cholangitis</subject><subject>Cohort analysis</subject><subject>cohort study</subject><subject>Confidence intervals</subject><subject>endpoint</subject><subject>Parameters</subject><subject>Patients</subject><subject>treatment response</subject><subject>Ursodeoxycholic acid</subject><subject>validation</subject><issn>1478-3223</issn><issn>1478-3231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp1kctOwzAQRS0EoqWw4AeQJTawSOtXXsuq4lFUCQko2yhxJtRVGoc4acnf45DSBRLejGUdH83MReiSkjG1Z5Kr7ZgKl4sjNKTCDxzOOD0-3BkfoDNj1oTQMHTpKRpwJnjgkmCIzBRv41ylca10gU3dpC3WGa5XgJeV0Snor1audK4knkqV4hcwpS4M4FepK8CqwE9xGRdgX0rrgKI2eKfqFS4rtYmrFicqV13tJHHxoWplztFJFucGLvZ1hJb3d2-zR2fx_DCfTReO5HYWR2YBk5AkLicxQABAKGXCSyV4iedLz_fATSiXmfD8jAoCLvdZENpPWZBmLOUjdNN7y0p_NmDqaKOMhNz2AboxERPE4yS0e7Do9R90rZuqsN1Zirk-DYnoqNuekpU2poIs2k8ZURJ1SUQ2iegnCcte7Y1NsoH0QP6u3gKTHtipHNr_TdFi_t4rvwFCT5O3</recordid><startdate>202008</startdate><enddate>202008</enddate><creator>Yagi, Minami</creator><creator>Matsumoto, Kosuke</creator><creator>Komori, Atsumasa</creator><creator>Abe, Masanori</creator><creator>Hashimoto, Naoaki</creator><creator>Inao, Mie</creator><creator>Namisaki, Tadashi</creator><creator>Kawata, Kazuhito</creator><creator>Ninomiya, Masashi</creator><creator>Fujii, Hideki</creator><creator>Takahashi, Atsushi</creator><creator>Kang, Jong‐Hon</creator><creator>Takamura, Masaaki</creator><creator>Arakawa, Mie</creator><creator>Joshita, Satoru</creator><creator>Sato, Ken</creator><creator>Itakura, Jun</creator><creator>Nomura, Takako</creator><creator>Kakisaka, Keisuke</creator><creator>Kaneko, Akira</creator><creator>Tamura, Yamato</creator><creator>Miura, Ryo</creator><creator>Aiso, Mitsuhiko</creator><creator>Arizumi, Toshihiko</creator><creator>Asaoka, Yoshinari</creator><creator>Kikuchi, Kentaro</creator><creator>Takikawa, Yasuhiro</creator><creator>Masaki, Tsutomu</creator><creator>Umemura, Takeji</creator><creator>Honda, Akira</creator><creator>Ohira, Hiromasa</creator><creator>Kawada, Norifumi</creator><creator>Yoshiji, Hitoshi</creator><creator>Mochida, Satoshi</creator><creator>Takikawa, Hajime</creator><creator>Tanaka, Atsushi</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-4986-8578</orcidid><orcidid>https://orcid.org/0000-0002-6364-9654</orcidid><orcidid>https://orcid.org/0000-0001-9627-138X</orcidid><orcidid>https://orcid.org/0000-0002-3158-5318</orcidid><orcidid>https://orcid.org/0000-0003-0568-8361</orcidid><orcidid>https://orcid.org/0000-0001-7985-919X</orcidid><orcidid>https://orcid.org/0000-0002-6358-5283</orcidid></search><sort><creationdate>202008</creationdate><title>A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis</title><author>Yagi, Minami ; Matsumoto, Kosuke ; Komori, Atsumasa ; Abe, Masanori ; Hashimoto, Naoaki ; Inao, Mie ; Namisaki, Tadashi ; Kawata, Kazuhito ; Ninomiya, Masashi ; Fujii, Hideki ; Takahashi, Atsushi ; Kang, Jong‐Hon ; Takamura, Masaaki ; Arakawa, Mie ; Joshita, Satoru ; Sato, Ken ; Itakura, Jun ; Nomura, Takako ; Kakisaka, Keisuke ; Kaneko, Akira ; Tamura, Yamato ; Miura, Ryo ; Aiso, Mitsuhiko ; Arizumi, Toshihiko ; Asaoka, Yoshinari ; Kikuchi, Kentaro ; Takikawa, Yasuhiro ; Masaki, Tsutomu ; Umemura, Takeji ; Honda, Akira ; Ohira, Hiromasa ; Kawada, Norifumi ; Yoshiji, Hitoshi ; Mochida, Satoshi ; Takikawa, Hajime ; Tanaka, Atsushi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3534-cf82cebb530aee8ee011246dce6b67c676e5b13cf467f140e53728982cf8df2d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Alkaline phosphatase</topic><topic>Bezafibrate</topic><topic>Cholangitis</topic><topic>Cohort analysis</topic><topic>cohort study</topic><topic>Confidence intervals</topic><topic>endpoint</topic><topic>Parameters</topic><topic>Patients</topic><topic>treatment response</topic><topic>Ursodeoxycholic acid</topic><topic>validation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yagi, Minami</creatorcontrib><creatorcontrib>Matsumoto, Kosuke</creatorcontrib><creatorcontrib>Komori, Atsumasa</creatorcontrib><creatorcontrib>Abe, Masanori</creatorcontrib><creatorcontrib>Hashimoto, Naoaki</creatorcontrib><creatorcontrib>Inao, Mie</creatorcontrib><creatorcontrib>Namisaki, Tadashi</creatorcontrib><creatorcontrib>Kawata, Kazuhito</creatorcontrib><creatorcontrib>Ninomiya, Masashi</creatorcontrib><creatorcontrib>Fujii, Hideki</creatorcontrib><creatorcontrib>Takahashi, Atsushi</creatorcontrib><creatorcontrib>Kang, Jong‐Hon</creatorcontrib><creatorcontrib>Takamura, Masaaki</creatorcontrib><creatorcontrib>Arakawa, Mie</creatorcontrib><creatorcontrib>Joshita, Satoru</creatorcontrib><creatorcontrib>Sato, 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Atsushi</creatorcontrib><creatorcontrib>Japan PBC Study Group (JPBCSG)</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Liver international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yagi, Minami</au><au>Matsumoto, Kosuke</au><au>Komori, Atsumasa</au><au>Abe, Masanori</au><au>Hashimoto, Naoaki</au><au>Inao, Mie</au><au>Namisaki, Tadashi</au><au>Kawata, Kazuhito</au><au>Ninomiya, Masashi</au><au>Fujii, Hideki</au><au>Takahashi, Atsushi</au><au>Kang, Jong‐Hon</au><au>Takamura, Masaaki</au><au>Arakawa, Mie</au><au>Joshita, Satoru</au><au>Sato, Ken</au><au>Itakura, Jun</au><au>Nomura, Takako</au><au>Kakisaka, Keisuke</au><au>Kaneko, Akira</au><au>Tamura, Yamato</au><au>Miura, Ryo</au><au>Aiso, Mitsuhiko</au><au>Arizumi, Toshihiko</au><au>Asaoka, Yoshinari</au><au>Kikuchi, Kentaro</au><au>Takikawa, Yasuhiro</au><au>Masaki, Tsutomu</au><au>Umemura, Takeji</au><au>Honda, Akira</au><au>Ohira, Hiromasa</au><au>Kawada, Norifumi</au><au>Yoshiji, Hitoshi</au><au>Mochida, Satoshi</au><au>Takikawa, Hajime</au><au>Tanaka, Atsushi</au><aucorp>Japan PBC Study Group (JPBCSG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis</atitle><jtitle>Liver international</jtitle><addtitle>Liver Int</addtitle><date>2020-08</date><risdate>2020</risdate><volume>40</volume><issue>8</issue><spage>1926</spage><epage>1933</epage><pages>1926-1933</pages><issn>1478-3223</issn><eissn>1478-3231</eissn><abstract>Background/Purpose
Although ursodeoxycholic acid (UDCA) is a first‐line treatment for primary biliary cholangitis (PBC), 20%‐30% of patients with PBC exhibit an incomplete response to UDCA. Recently, the UDCA Response Score was proposed for predicting response to UDCA using pretreatment parameters in patients with PBC. We aimed to validate the UDCA Response Score in Japanese patients with PBC.
Methods
Registry data of Japanese patients (n = 873) were collected. Patients with data on all clinical parameters required for calculating the UDCA Response Score were selected. The endpoint was UDCA response, defined as alkaline phosphatase <1.67 times the upper limit of the normal value after 12 months of UDCA treatment.
Results
All parameters were available in 804 patients (male/female = 120/684, age 58.9 [interquartile range 51.1‐66.9] years). Bezafibrate was commenced within 12 months of UDCA in 78 patients (9.7%) because of the lack of an early response. We found that the endpoint was not reached in these 78 patients, and the area under the receiver operating characteristic curve (AUROC) of the score was 0.74 (95% confidence interval [CI] 0.70‐0.79). The AUROC was 0.77 (95% CI 0.70‐0.83) in patients undergoing UDCA monotherapy (n = 726). Finally, the AUROC of the modified UDCA Response Score using only data from the treatment start date was 0.80 (95% CI 0.70‐0.90) in patients receiving a combination therapy of UDCA and bezafibrate (n = 160).
Conclusion
The validity of the UDCA Response Score was acceptable in Japanese patients; this score will be informative in patients treated with a combination therapy of UDCA and bezafibrate.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32438508</pmid><doi>10.1111/liv.14534</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-4986-8578</orcidid><orcidid>https://orcid.org/0000-0002-6364-9654</orcidid><orcidid>https://orcid.org/0000-0001-9627-138X</orcidid><orcidid>https://orcid.org/0000-0002-3158-5318</orcidid><orcidid>https://orcid.org/0000-0003-0568-8361</orcidid><orcidid>https://orcid.org/0000-0001-7985-919X</orcidid><orcidid>https://orcid.org/0000-0002-6358-5283</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1478-3223 |
| ispartof | Liver international, 2020-08, Vol.40 (8), p.1926-1933 |
| issn | 1478-3223 1478-3231 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2406309508 |
| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Alkaline phosphatase Bezafibrate Cholangitis Cohort analysis cohort study Confidence intervals endpoint Parameters Patients treatment response Ursodeoxycholic acid validation |
| title | A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T00%3A25%3A42IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20validation%20study%20of%20the%20Ursodeoxycholic%20Acid%20Response%20Score%20in%20Japanese%20patients%20with%20primary%20biliary%20cholangitis&rft.jtitle=Liver%20international&rft.au=Yagi,%20Minami&rft.aucorp=Japan%20PBC%20Study%20Group%20(JPBCSG)&rft.date=2020-08&rft.volume=40&rft.issue=8&rft.spage=1926&rft.epage=1933&rft.pages=1926-1933&rft.issn=1478-3223&rft.eissn=1478-3231&rft_id=info:doi/10.1111/liv.14534&rft_dat=%3Cproquest_cross%3E2425719048%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2425719048&rft_id=info:pmid/32438508&rfr_iscdi=true |