{"title":"Hepatic Events During Immune Checkpoint Inhibitor Treatment Between Liver and Non‐Liver Malignancies in Hepatitis B Endemic Areas","authors":"Yi‐Ping Hung, Pei‐Chang Lee, Yen‐Hwa Chang, Muh‐Hwa Yang, Chao‐Hua Chiu, Ming‐Huang Chen, Keng‐Hsin Lan, I‐Cheng Lee, Ming‐Chih Hou, Yee Chao, Yi‐Hsiang Huang","doi":"10.1111/apt.18403","DOIUrl":"https://doi.org/10.1111/apt.18403","url":null,"abstract":"BackgroundNotable advances have been made in immune checkpoint inhibitors (ICIs) for cancer treatment. However, the adverse effects of ICIs, especially hepatotoxicity, remain a challenging problem. Whether patients in hepatitis B virus (HBV)‐endemic areas are prone to developing hepatic adverse events during ICI treatment warrants further exploration.MethodsFrom 2014 to 2020, the data of all patients with cancer who received ICI treatment at Taipei Veterans General Hospital were retrospectively reviewed. The incidence of and risk factors for hepatic adverse events, including hepatitis flare, immune‐related hepatitis (irHepatitis) and HBV reactivation (HBVr), were analysed through a Cox proportional hazard regression model.ResultsA total of 1283 patients with cancer (190 hepatocellular carcinoma [HCC] patients and 1093 patients with non‐HCC malignancies) were eligible for analysis, of whom 283 (22.1%) were HBsAg‐positive. The incidence of hepatitis flare events of any grade was significantly higher in HCC patients than in non‐HCC patients (45.8% vs. 25.6%, <jats:italic>p</jats:italic> < 0.001). HCC and baseline alanine aminotransferase (ALT) > 40 U/L were independent risk factors for ≥ grade 3 hepatitis flare events. No difference was observed in irHepatitis risk between HCC patients and non‐HCC patients. ALT > 40 U/L was an independent risk factor for irHepatitis. Among 283 HBsAg‐positive patients, six patients (2.1%) experienced HBVr. HCC patients had a higher risk of HBVr than non‐HCC patients (4.4% vs. 0.6%). No specific risk factor for HBVr could be identified. However, none of the patients under nucleos/tide analogue (NUC) prophylaxis experienced HBVr in this study.ConclusionsUnder ICI treatment, HCC patients had a higher risk of hepatitis flare events than non‐HCC patients. Abnormal baseline ALT levels are a risk factor for hepatic adverse events. NUC prophylaxis can minimise the risk of HBVr.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"6 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142697087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparative Efficacy and Safety of Three Janus Kinase Inhibitors in Ulcerative Colitis: A Real‐World Multicentre Study in Japan","authors":"Shintaro Akiyama, Hiromichi Shimizu, Akiko Tamura, Kaoru Yokoyama, Toshiyuki Sakurai, Mariko Kobayashi, Makoto Eizuka, Shunichi Yanai, Kei Nomura, Tomoyoshi Shibuya, Masahiro Takahara, Sakiko Hiraoka, Minako Sako, Atsushi Yoshida, Kozo Tsuruta, Shinichiro Yoshioka, Miki Koroku, Teppei Omori, Masayuki Saruta, Takayuki Matsumoto, Ryuichi Okamoto, Kiichiro Tsuchiya, Toshimitsu Fujii","doi":"10.1111/apt.18406","DOIUrl":"https://doi.org/10.1111/apt.18406","url":null,"abstract":"BackgroundThree Janus kinase (JAK) inhibitors are approved for ulcerative colitis (UC) in Japan.AimTo compare the real‐world efficacy and safety of these three JAK inhibitors in UC.MethodsThis was a multicentre, retrospective study of patients with UC started on JAK inhibitors. The primary outcome was clinical remission at 10, 26 and 58 weeks, and at the most recent follow‐up. To compare the efficacy and safety among the JAK inhibitors, we created three matched cohorts (upadacitinib vs. filgotinib, tofacitinib vs. filgotinib and upadacitinib vs. tofacitinib) using propensity score matching.ResultsWe identified 228 upadacitinib‐treated patients (median follow‐up 49 weeks; IQR 25–72), 215 filgotinib‐treated patients (follow‐up 56 weeks; IQR 17–82) and 159 tofacitinib‐treated patients (follow‐up 112 weeks; IQR 10–258). Clinical remission rates for upadacitinib, filgotinib and tofacitinib at the most recent follow‐up were 72.8%, 50.6% and 45.8%, respectively. Over 70% of the patients previously treated with other biologics or JAK inhibitors achieved clinical remission with upadacitinib. On multivariate analysis, the number of previous advanced therapies was inversely associated with the efficacy of filgotinib and tofacitinib. Comparative analysis showed that upadacitinib‐treated patients had higher efficacy and lower risk of discontinuation than patients treated with other JAK inhibitors. However, upadacitinib had a significant risk of acne.ConclusionsConsidering the particularly high efficacy of upadacitinib, even in patients with refractory UC, filgotinib or tofacitinib may be considered as an upfront JAK inhibitor before using upadacitinib.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"1 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2024-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter: Towards Better Intervention Strategies for MASLD and MetALD—What Are We Missing?","authors":"Qiang Hu, Xiyin Yang","doi":"10.1111/apt.18375","DOIUrl":"https://doi.org/10.1111/apt.18375","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"7 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2024-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter: Towards Better Intervention Strategies for MASLD and MetALD—What Are We Missing? Authors' Reply","authors":"Yewan Park, Jooyi Jung, Gi‐Ae Kim","doi":"10.1111/apt.18412","DOIUrl":"https://doi.org/10.1111/apt.18412","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"20 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2024-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gian Paolo Caviglia, Piero Fariselli, Roberta D'Ambrosio, Piero Colombatto, Elisabetta Degasperi, Gabriele Ricco, Maria Lorena Abate, Giovanni Birolo, Giulia Troshina, Francesco Damone, Barbara Coco, Daniela Cavallone, Riccardo Perbellini, Sara Monico, Giorgio Maria Saracco, Maurizia Rossana Brunetto, Pietro Lampertico, Alessia Ciancio
{"title":"Development and Validation of a PIVKA-II-Based Model for HCC Risk Stratification in Patients With HCV-Related Cirrhosis Successfully Treated With DAA","authors":"Gian Paolo Caviglia, Piero Fariselli, Roberta D'Ambrosio, Piero Colombatto, Elisabetta Degasperi, Gabriele Ricco, Maria Lorena Abate, Giovanni Birolo, Giulia Troshina, Francesco Damone, Barbara Coco, Daniela Cavallone, Riccardo Perbellini, Sara Monico, Giorgio Maria Saracco, Maurizia Rossana Brunetto, Pietro Lampertico, Alessia Ciancio","doi":"10.1111/apt.18409","DOIUrl":"https://doi.org/10.1111/apt.18409","url":null,"abstract":"Patients with hepatitis C virus (HCV)-related cirrhosis with sustained virological response (SVR) to direct-acting antivirals (DAA) remain at risk of developing hepatocellular carcinoma (HCC). Recently, serum protein induced by vitamin K absence or antagonist-II (PIVKA-II) has shown promising results as an HCC-predictive biomarker. We aimed to develop and validate a PIVKA-II-based model for HCC risk stratification in cirrhotic patients with SVR to DAA.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"170 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Editorial: Is There a Role for Therapeutic Drug Monitoring of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease?","authors":"Konstantinos Papamichael, Adam S Cheifetz","doi":"10.1111/apt.18360","DOIUrl":"10.1111/apt.18360","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":" ","pages":""},"PeriodicalIF":6.6,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142666231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sung Noh Hong, Joo Hye Song, Sung Jin Kim, Yoon Ha Park, Chang Wan Choi, Ji Eun Kim, Eun Ran Kim, Dong Kyung Chang, Young-Ho Kim
{"title":"Subcutaneous Infliximab Concentration Thresholds for Mucosal and Transmural Healing in Patients With Crohn's Disease.","authors":"Sung Noh Hong, Joo Hye Song, Sung Jin Kim, Yoon Ha Park, Chang Wan Choi, Ji Eun Kim, Eun Ran Kim, Dong Kyung Chang, Young-Ho Kim","doi":"10.1111/apt.18354","DOIUrl":"https://doi.org/10.1111/apt.18354","url":null,"abstract":"<p><strong>Background: </strong>Predose trough concentrations (C<sub>trough</sub>) of intravenous infliximab (IV-IFX) during maintenance therapy are associated with therapeutic outcomes in patients with Crohn's disease (CD). A subcutaneous formulation of infliximab (SC-IFX) has shown high C<sub>trough</sub> values due to its favourable pharmacokinetics.</p><p><strong>Aims: </strong>To evaluate the association of C<sub>trough</sub> of SC-IFX with therapeutic outcomes and the threshold of SC-IFX C<sub>trough</sub> for achieving mucosal healing (MH) and transmural healing (TH) in patients with CD.</p><p><strong>Methods: </strong>We performed this cross-sectional study in patients with CD who had received SC-IFX maintenance therapy for ≥ 6 months. We measured SC-IFX C<sub>trough</sub> immediately before SC-IFX injection. We performed ileocolonoscopy/single-balloon enteroscopy and/or magnetic resonance enterography within 3 months of SC-IFX C<sub>trough</sub> measurement. MH was defined as SES-CD-ulcerated surface subscore of 0. TH was defined as simplified MaRIA score of 0.</p><p><strong>Results: </strong>We enrolled 124 patients with MH in 77.9% (74/95) and TH in 36.3% (37/102). SC-IFX C<sub>trough</sub> was significantly higher in patients with MH (24.1 vs.16.9 μg/mL; p = 0.001) and TH (26.0 vs. 20.5 μg/mL; p = 0.007) than in those without. ROC analysis identified that the threshold of SC-IFX C<sub>trough</sub> for MH and TH were 17.5 and 30.3 μg/mL, respectively. Multivariate logistic regression showed that SC-IFX C<sub>trough</sub> was significantly associated with MH (OR 1.16; 95% CI 1.05-1.27; p = 0.002) and TH (OR 1.08; 95% CI 1.02-1.14; p = 0.005).</p><p><strong>Conclusions: </strong>SC-IFX C<sub>trough</sub> was positively associated with MH (≥ 18 μg/mL) and TH (≥ 30 μg/mL) in patients with CD, which may guide treatment decisions to optimise therapeutic response in the era of treat-to-target.</p>","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":" ","pages":""},"PeriodicalIF":6.6,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}