Prevalence, clinical course, and predictive factors of immune checkpoint inhibitor monotherapy‐associated hepatitis in Japan
Background and Aim Immune checkpoint inhibitors (ICI) have revolutionized anti‐malignancy therapy and thus have been increasingly used. Although ICI may cause immune‐related adverse events (irAE) in various organs, including the liver, the prevalence and predictive factors of irAE have not been clar...
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| Veröffentlicht in: | Journal of gastroenterology and hepatology 2020-10, Vol.35 (10), p.1782-1788 |
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| creator | Kitagataya, Takashi Suda, Goki Nagashima, Kazunori Katsurada, Takehiko Yamamoto, Koji Kimura, Megumi Maehara, Osamu Yamada, Ren Shigesawa, Taku Suzuki, Kazuharu Nakamura, Akihisa Ohara, Masatsugu Umemura, Machiko Kawagishi, Naoki Nakai, Masato Sho, Takuya Natsuizaka, Mitsuteru Morikawa, Kenichi Ogawa, Koji Ohnishi, Shunsuke Komatsu, Yoshito Hata, Hiroo Takeuchi, Satoshi Abe, Takashige Sakakibara‐Konishi, Jun Teshima, Takanori Homma, Akihiro Sakamoto, Naoya |
| description | Background and Aim
Immune checkpoint inhibitors (ICI) have revolutionized anti‐malignancy therapy and thus have been increasingly used. Although ICI may cause immune‐related adverse events (irAE) in various organs, including the liver, the prevalence and predictive factors of irAE have not been clarified.
Methods
In this retrospective study, consecutive patients who had malignancies and were treated with ICI without other chemotherapeutic agents at Hokkaido University Hospital between 2014 and 2019 were screened. Patients were excluded if they were |
| doi_str_mv | 10.1111/jgh.15041 |
| format | Article |
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Immune checkpoint inhibitors (ICI) have revolutionized anti‐malignancy therapy and thus have been increasingly used. Although ICI may cause immune‐related adverse events (irAE) in various organs, including the liver, the prevalence and predictive factors of irAE have not been clarified.
Methods
In this retrospective study, consecutive patients who had malignancies and were treated with ICI without other chemotherapeutic agents at Hokkaido University Hospital between 2014 and 2019 were screened. Patients were excluded if they were < 20 years old and had insufficient clinical data.
Results
Of the 233 patients screened, 202 patients met the inclusion criteria and were included in the analysis. The patients were aged 25–92 years, and 60.9% were male. The patients received nivolumab (n = 137), pembrolizumab (n = 45), ipilimumab (n = 17), atezolizumab (n = 2), and avelumab (n = 1). The prevalence of any grade and grade ≥ 3 irAE hepatitis was 8.4% (17/202) and 4.0% (8/202), respectively. irAE hepatitis occurred at a median duration of 42 days in any grade and 36 days in grade ≥ 3 after ICI initiation. The clinical course of grade ≥ 3 irAE hepatitis was generally favorable; however, 50% required corticosteroid treatment and two patients required additional mycophenolate mofetil. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.
Conclusions
Grade ≥ 3 irAE hepatitis was observed in 4.0% of the patients who were treated with ICI. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.</description><identifier>ISSN: 0815-9319</identifier><identifier>EISSN: 1440-1746</identifier><identifier>DOI: 10.1111/jgh.15041</identifier><identifier>PMID: 32187734</identifier><language>eng</language><publisher>Australia: Wiley Subscription Services, Inc</publisher><subject>adverse events ; Chemotherapy ; Corticosteroids ; female ; Hepatitis ; immune checkpoint inhibitor ; Immune checkpoint inhibitors ; immune system ; irAE ; Malignancy ; Monoclonal antibodies ; Mycophenolate mofetil ; Mycophenolic acid ; Patients ; Pembrolizumab ; risk factor</subject><ispartof>Journal of gastroenterology and hepatology, 2020-10, Vol.35 (10), p.1782-1788</ispartof><rights>2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd</rights><rights>2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4981-adf50bec1391a15a7a81ba8bc284733fcd8b663aedcae78fb5b3fc94ef9f58063</citedby><cites>FETCH-LOGICAL-c4981-adf50bec1391a15a7a81ba8bc284733fcd8b663aedcae78fb5b3fc94ef9f58063</cites><orcidid>0000-0002-3891-5113 ; 0000-0003-0098-9106 ; 0000-0003-1194-4149 ; 0000-0002-2953-6242</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%2Fjgh.15041$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjgh.15041$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32187734$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kitagataya, Takashi</creatorcontrib><creatorcontrib>Suda, Goki</creatorcontrib><creatorcontrib>Nagashima, Kazunori</creatorcontrib><creatorcontrib>Katsurada, Takehiko</creatorcontrib><creatorcontrib>Yamamoto, Koji</creatorcontrib><creatorcontrib>Kimura, Megumi</creatorcontrib><creatorcontrib>Maehara, Osamu</creatorcontrib><creatorcontrib>Yamada, Ren</creatorcontrib><creatorcontrib>Shigesawa, Taku</creatorcontrib><creatorcontrib>Suzuki, Kazuharu</creatorcontrib><creatorcontrib>Nakamura, Akihisa</creatorcontrib><creatorcontrib>Ohara, Masatsugu</creatorcontrib><creatorcontrib>Umemura, Machiko</creatorcontrib><creatorcontrib>Kawagishi, Naoki</creatorcontrib><creatorcontrib>Nakai, Masato</creatorcontrib><creatorcontrib>Sho, Takuya</creatorcontrib><creatorcontrib>Natsuizaka, Mitsuteru</creatorcontrib><creatorcontrib>Morikawa, Kenichi</creatorcontrib><creatorcontrib>Ogawa, Koji</creatorcontrib><creatorcontrib>Ohnishi, Shunsuke</creatorcontrib><creatorcontrib>Komatsu, Yoshito</creatorcontrib><creatorcontrib>Hata, Hiroo</creatorcontrib><creatorcontrib>Takeuchi, Satoshi</creatorcontrib><creatorcontrib>Abe, Takashige</creatorcontrib><creatorcontrib>Sakakibara‐Konishi, Jun</creatorcontrib><creatorcontrib>Teshima, Takanori</creatorcontrib><creatorcontrib>Homma, Akihiro</creatorcontrib><creatorcontrib>Sakamoto, Naoya</creatorcontrib><title>Prevalence, clinical course, and predictive factors of immune checkpoint inhibitor monotherapy‐associated hepatitis in Japan</title><title>Journal of gastroenterology and hepatology</title><addtitle>J Gastroenterol Hepatol</addtitle><description>Background and Aim
Immune checkpoint inhibitors (ICI) have revolutionized anti‐malignancy therapy and thus have been increasingly used. Although ICI may cause immune‐related adverse events (irAE) in various organs, including the liver, the prevalence and predictive factors of irAE have not been clarified.
Methods
In this retrospective study, consecutive patients who had malignancies and were treated with ICI without other chemotherapeutic agents at Hokkaido University Hospital between 2014 and 2019 were screened. Patients were excluded if they were < 20 years old and had insufficient clinical data.
Results
Of the 233 patients screened, 202 patients met the inclusion criteria and were included in the analysis. The patients were aged 25–92 years, and 60.9% were male. The patients received nivolumab (n = 137), pembrolizumab (n = 45), ipilimumab (n = 17), atezolizumab (n = 2), and avelumab (n = 1). The prevalence of any grade and grade ≥ 3 irAE hepatitis was 8.4% (17/202) and 4.0% (8/202), respectively. irAE hepatitis occurred at a median duration of 42 days in any grade and 36 days in grade ≥ 3 after ICI initiation. The clinical course of grade ≥ 3 irAE hepatitis was generally favorable; however, 50% required corticosteroid treatment and two patients required additional mycophenolate mofetil. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.
Conclusions
Grade ≥ 3 irAE hepatitis was observed in 4.0% of the patients who were treated with ICI. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.</description><subject>adverse events</subject><subject>Chemotherapy</subject><subject>Corticosteroids</subject><subject>female</subject><subject>Hepatitis</subject><subject>immune checkpoint inhibitor</subject><subject>Immune checkpoint inhibitors</subject><subject>immune system</subject><subject>irAE</subject><subject>Malignancy</subject><subject>Monoclonal antibodies</subject><subject>Mycophenolate mofetil</subject><subject>Mycophenolic acid</subject><subject>Patients</subject><subject>Pembrolizumab</subject><subject>risk factor</subject><issn>0815-9319</issn><issn>1440-1746</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp10c-K1TAUBvAginNndOELSMCNA3YmaZMmWcrg_GNAF7oup-mpzbVNatKO3M3gI_iMPolx7uhCMJvAyY-PcD5CXnB2wvM53X4eTrhkgj8iGy4EK7gS9WOyYZrLwlTcHJDDlLaMMcGUfEoOqpJrpSqxIXcfIt7CiN7iG2pH552FkdqwxpQH4Ds6R-ycXdwt0h7sEmKioadumlaP1A5ov8zB-YU6P7jW5Xc6BR-WASPMu5_ff0BKwTpYsKMDzrC4xaWM6TXM4J-RJz2MCZ8_3Efk0_m7j2eXxc37i6uztzeFFUbzArpeshYtrwwHLkGB5i3o1pZaqKrqbafbuq4AOwuodN_KNg-NwN70UrO6OiKv97lzDF9XTEszuWRxHMFjWFNTVsqwkhmjMn31D93mbfj8u6YUwihpai2zOt4rG0NKEftmjm6CuGs4a36X0uRSmvtSsn35kLi2E3Z_5Z8WMjjdg29uxN3_k5rri8t95C9JzJnA</recordid><startdate>202010</startdate><enddate>202010</enddate><creator>Kitagataya, Takashi</creator><creator>Suda, Goki</creator><creator>Nagashima, Kazunori</creator><creator>Katsurada, Takehiko</creator><creator>Yamamoto, Koji</creator><creator>Kimura, Megumi</creator><creator>Maehara, Osamu</creator><creator>Yamada, Ren</creator><creator>Shigesawa, Taku</creator><creator>Suzuki, Kazuharu</creator><creator>Nakamura, Akihisa</creator><creator>Ohara, Masatsugu</creator><creator>Umemura, Machiko</creator><creator>Kawagishi, Naoki</creator><creator>Nakai, Masato</creator><creator>Sho, Takuya</creator><creator>Natsuizaka, Mitsuteru</creator><creator>Morikawa, Kenichi</creator><creator>Ogawa, Koji</creator><creator>Ohnishi, Shunsuke</creator><creator>Komatsu, Yoshito</creator><creator>Hata, Hiroo</creator><creator>Takeuchi, Satoshi</creator><creator>Abe, Takashige</creator><creator>Sakakibara‐Konishi, Jun</creator><creator>Teshima, Takanori</creator><creator>Homma, Akihiro</creator><creator>Sakamoto, Naoya</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3891-5113</orcidid><orcidid>https://orcid.org/0000-0003-0098-9106</orcidid><orcidid>https://orcid.org/0000-0003-1194-4149</orcidid><orcidid>https://orcid.org/0000-0002-2953-6242</orcidid></search><sort><creationdate>202010</creationdate><title>Prevalence, clinical course, and predictive factors of immune checkpoint inhibitor monotherapy‐associated hepatitis in Japan</title><author>Kitagataya, Takashi ; Suda, Goki ; Nagashima, Kazunori ; Katsurada, Takehiko ; Yamamoto, Koji ; Kimura, Megumi ; Maehara, Osamu ; Yamada, Ren ; Shigesawa, Taku ; Suzuki, Kazuharu ; Nakamura, Akihisa ; Ohara, Masatsugu ; Umemura, Machiko ; Kawagishi, Naoki ; Nakai, Masato ; Sho, Takuya ; Natsuizaka, Mitsuteru ; Morikawa, Kenichi ; Ogawa, Koji ; Ohnishi, Shunsuke ; Komatsu, Yoshito ; Hata, Hiroo ; Takeuchi, Satoshi ; Abe, Takashige ; Sakakibara‐Konishi, Jun ; Teshima, Takanori ; Homma, Akihiro ; Sakamoto, Naoya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4981-adf50bec1391a15a7a81ba8bc284733fcd8b663aedcae78fb5b3fc94ef9f58063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>adverse events</topic><topic>Chemotherapy</topic><topic>Corticosteroids</topic><topic>female</topic><topic>Hepatitis</topic><topic>immune checkpoint inhibitor</topic><topic>Immune checkpoint inhibitors</topic><topic>immune system</topic><topic>irAE</topic><topic>Malignancy</topic><topic>Monoclonal antibodies</topic><topic>Mycophenolate mofetil</topic><topic>Mycophenolic acid</topic><topic>Patients</topic><topic>Pembrolizumab</topic><topic>risk factor</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kitagataya, Takashi</creatorcontrib><creatorcontrib>Suda, Goki</creatorcontrib><creatorcontrib>Nagashima, Kazunori</creatorcontrib><creatorcontrib>Katsurada, Takehiko</creatorcontrib><creatorcontrib>Yamamoto, Koji</creatorcontrib><creatorcontrib>Kimura, Megumi</creatorcontrib><creatorcontrib>Maehara, Osamu</creatorcontrib><creatorcontrib>Yamada, Ren</creatorcontrib><creatorcontrib>Shigesawa, Taku</creatorcontrib><creatorcontrib>Suzuki, Kazuharu</creatorcontrib><creatorcontrib>Nakamura, Akihisa</creatorcontrib><creatorcontrib>Ohara, Masatsugu</creatorcontrib><creatorcontrib>Umemura, Machiko</creatorcontrib><creatorcontrib>Kawagishi, Naoki</creatorcontrib><creatorcontrib>Nakai, Masato</creatorcontrib><creatorcontrib>Sho, Takuya</creatorcontrib><creatorcontrib>Natsuizaka, Mitsuteru</creatorcontrib><creatorcontrib>Morikawa, Kenichi</creatorcontrib><creatorcontrib>Ogawa, Koji</creatorcontrib><creatorcontrib>Ohnishi, Shunsuke</creatorcontrib><creatorcontrib>Komatsu, Yoshito</creatorcontrib><creatorcontrib>Hata, Hiroo</creatorcontrib><creatorcontrib>Takeuchi, Satoshi</creatorcontrib><creatorcontrib>Abe, Takashige</creatorcontrib><creatorcontrib>Sakakibara‐Konishi, Jun</creatorcontrib><creatorcontrib>Teshima, Takanori</creatorcontrib><creatorcontrib>Homma, Akihiro</creatorcontrib><creatorcontrib>Sakamoto, Naoya</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kitagataya, Takashi</au><au>Suda, Goki</au><au>Nagashima, Kazunori</au><au>Katsurada, Takehiko</au><au>Yamamoto, Koji</au><au>Kimura, Megumi</au><au>Maehara, Osamu</au><au>Yamada, Ren</au><au>Shigesawa, Taku</au><au>Suzuki, Kazuharu</au><au>Nakamura, Akihisa</au><au>Ohara, Masatsugu</au><au>Umemura, Machiko</au><au>Kawagishi, Naoki</au><au>Nakai, Masato</au><au>Sho, Takuya</au><au>Natsuizaka, Mitsuteru</au><au>Morikawa, Kenichi</au><au>Ogawa, Koji</au><au>Ohnishi, Shunsuke</au><au>Komatsu, Yoshito</au><au>Hata, Hiroo</au><au>Takeuchi, Satoshi</au><au>Abe, Takashige</au><au>Sakakibara‐Konishi, Jun</au><au>Teshima, Takanori</au><au>Homma, Akihiro</au><au>Sakamoto, Naoya</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prevalence, clinical course, and predictive factors of immune checkpoint inhibitor monotherapy‐associated hepatitis in Japan</atitle><jtitle>Journal of gastroenterology and hepatology</jtitle><addtitle>J Gastroenterol Hepatol</addtitle><date>2020-10</date><risdate>2020</risdate><volume>35</volume><issue>10</issue><spage>1782</spage><epage>1788</epage><pages>1782-1788</pages><issn>0815-9319</issn><eissn>1440-1746</eissn><abstract>Background and Aim
Immune checkpoint inhibitors (ICI) have revolutionized anti‐malignancy therapy and thus have been increasingly used. Although ICI may cause immune‐related adverse events (irAE) in various organs, including the liver, the prevalence and predictive factors of irAE have not been clarified.
Methods
In this retrospective study, consecutive patients who had malignancies and were treated with ICI without other chemotherapeutic agents at Hokkaido University Hospital between 2014 and 2019 were screened. Patients were excluded if they were < 20 years old and had insufficient clinical data.
Results
Of the 233 patients screened, 202 patients met the inclusion criteria and were included in the analysis. The patients were aged 25–92 years, and 60.9% were male. The patients received nivolumab (n = 137), pembrolizumab (n = 45), ipilimumab (n = 17), atezolizumab (n = 2), and avelumab (n = 1). The prevalence of any grade and grade ≥ 3 irAE hepatitis was 8.4% (17/202) and 4.0% (8/202), respectively. irAE hepatitis occurred at a median duration of 42 days in any grade and 36 days in grade ≥ 3 after ICI initiation. The clinical course of grade ≥ 3 irAE hepatitis was generally favorable; however, 50% required corticosteroid treatment and two patients required additional mycophenolate mofetil. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.
Conclusions
Grade ≥ 3 irAE hepatitis was observed in 4.0% of the patients who were treated with ICI. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.</abstract><cop>Australia</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32187734</pmid><doi>10.1111/jgh.15041</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-3891-5113</orcidid><orcidid>https://orcid.org/0000-0003-0098-9106</orcidid><orcidid>https://orcid.org/0000-0003-1194-4149</orcidid><orcidid>https://orcid.org/0000-0002-2953-6242</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0815-9319 |
| ispartof | Journal of gastroenterology and hepatology, 2020-10, Vol.35 (10), p.1782-1788 |
| issn | 0815-9319 1440-1746 |
| language | eng |
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| source | Access via Wiley Online Library |
| subjects | adverse events Chemotherapy Corticosteroids female Hepatitis immune checkpoint inhibitor Immune checkpoint inhibitors immune system irAE Malignancy Monoclonal antibodies Mycophenolate mofetil Mycophenolic acid Patients Pembrolizumab risk factor |
| title | Prevalence, clinical course, and predictive factors of immune checkpoint inhibitor monotherapy‐associated hepatitis in Japan |
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