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  • Zhai, YinghongTongji University School of Medicine, Shanghai, China (author)

Metabolic and Nutritional Disorders Following the Administration of Immune Checkpoint Inhibitors : A Pharmacovigilance Study

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2022-01-25
  • Frontiers Media S.A.2021
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:oru-97471
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-97471URI
  • https://doi.org/10.3389/fendo.2021.809063DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:148755216URI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding agencies:National Natural Science Foundation of China (NSFC) 82073671  Leading Talents of Public Health in Shanghai GWV-10.2-XD22Shanghai Municipal Commission of Health and Family Planning Fund for Excellent Young Scholars 2018YQ47Excellent Young Scholars of public health in Shanghai GWV-10.2-YQ33Three-year Action Program of Shanghai Municipality for Strengthening the Construction of Public Health System GWV-10.1-XK05Military Key Discipline Construction Project (Health Service-Naval Health Service Organization and Command) 03
  • Background: Although several metabolic and nutritional disorders (MNDs) have been reported in the recipients of immune checkpoint inhibitors (ICIs), these events have not been fully captured and comprehensively characterized in real-world population.Objectives: To provide complete metabolic and nutritional toxicity profiles after ICIs (single and combined) initiation through an integrated big database.Methods: Reporting odds ratios (ROR) and information component (IC) based on statistical shrinkage transformation were utilized to perform disproportionality analysis using the US Food and Drug Administration Adverse Events Reporting System. Both ROR and IC were used to calculate disproportionality when compared with the whole database, but only ROR was used when comparison was made for different ICI strategies. Only when both the lower limits of 95% confidence intervals (CIs) for ROR (ROR025) and IC (IC025) exceeded specified threshold values (1 and 0, respectively) was regarded as a signal.Results: A total of 29,294,335 records were involved and 8,662 records were for MNDs in patients exposed to ICIs. Statistically significant association was detected between ICIs use and total MNDs (IC025/ROR025 = 1.06/2.19). For monotherapy, three ICI monotherapies (anti-PD-1, anti-PDL-1, and anti-CTLA-4) were all disproportionately associated with MNDs. Statistically significant differences in reporting frequencies also emerged when comparing anti-PD-1 with anti-PD-L1/anti-CTLA-4 monotherapy, with RORs of 1.11 (95%CI 1.01-1.21), and 1.35 (95%CI 1.23-1.48), respectively. Notably, combination therapy was associated with a higher reporting frequency of theses toxicities compared to monotherapy with a ROR of 1.56 (95%CI 1.48-1.64). Additionally, disproportionality analysis at High-level Group Term level highlighted eight broad entities of MNDs. Further disproportionality analysis at Preferred Term level indicated a wide range and varied strength of signals. For ICI monotherapy, nivolumab and pembrolizumab showed the broadest spectrum of MNDs. For combination therapy, a variety of signals were detected for nivolumab + ipilimumab therapy even comparable to two PD-1 monotherapies.Conclusion: Metabolic and nutritional complications could be provoked by ICI monotherapy (especially anti-PD-1) and further reinforced by combination therapy. Clinicians and patients should be informed about these potential risks that might be encountered in real-world practice. Aforehand education and regular monitoring of related biochemical parameters (calcium, sodium, potassium, protein) are recommended to ensure better cancer survivorship.

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  • Ye, XiaofeiDepartment of Health Statistics, Second Military Medical University, Shanghai, China (author)
  • Hu, FangyuanDepartment of Health Statistics, Second Military Medical University, Shanghai, China; Department of Medical Service, Naval Hospital of Eastern Theater Zhoushan, Zhejiang, China (author)
  • Xu, JinfangDepartment of Health Statistics, Second Military Medical University, Shanghai, China (author)
  • Guo, XiaojingDepartment of Health Statistics, Second Military Medical University, Shanghai, China (author)
  • Zhou, XiangTongji University School of Medicine, Shanghai, China (author)
  • Zheng, YiDepartment of Health Statistics, Second Military Medical University, Shanghai, China (author)
  • Zhao, XinxinTongji University School of Medicine, Shanghai, China (author)
  • Xu, XiaoTongji University School of Medicine, Shanghai, China (author)
  • Cao, Yang,Associate Professor,1972-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Unit of Integrative Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden,Clinical Epidemiology and Biostatistics(Swepub:oru)yco (author)
  • He, JiaTongji University School of Medicine, Shanghai, China; Department of Health Statistics, Second Military Medical University, Shanghai, China (author)
  • Tongji University School of Medicine, Shanghai, ChinaDepartment of Health Statistics, Second Military Medical University, Shanghai, China (creator_code:org_t)

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  • In:Frontiers in Endocrinology: Frontiers Media S.A.121664-2392

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