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Pharmaceutics
Special Issues
Pharmacokinetics and Clinical Practice of Monoclonal Antibodies
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Pharmacokinetics and Clinical Practice of Monoclonal Antibodies

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biologics and Biosimilars".

Deadline for manuscript submissions: closed (28 February 2023) | Viewed by 5042

Special Issue Editors

Dr. Ricardo Nalda-Molina

E-Mail Website
Guest Editor
School of Pharmacy, Miguel Hernández University, 03550 San Juan de Alicante, Spain
Interests: pharmacometrics; science comunication; model-informed precision dosing
Prof. Dr. Patricio Más-Serrano

E-Mail Website
Guest Editor
School of Pharmacy, Miguel Hernández University, 03550 San Juan de Alicante, Spain
Interests: pharmacokinetics; therapeutic drug monitoring; Immunosuppressant Drugs; transplantation; biologics; IBD
Dr. Amelia Ramon-Lopez

E-Mail Website
Guest Editor
School of Pharmacy, Miguel Hernández University, 03550 San Juan de Alicante, Spain
Interests: pharmacokinetics; drug monitoring; model-informed precision dosing

Special Issue Information

Dear Colleagues,

The use of monoclonal antibodies (mAb) in the clinical practice has grown in the last decade in different fields, such as oncology, autoimmune diseases, osteoporosis, immunosuppression, coagulopathies, among other conditions. 

The mAb match all the requirements needed to include them in model-informed precision dosing programs, and the high cost of the treatments make the dose individualization even more interesting to consider in order to increase the efficiency. However, the pharmacokinetic of many of the mAb differs from the small molecules in different aspects, including target-mediated drug disposition, which makes the PK model development more challenging.

The objective of this Special Issue is to review the state-of-the-art of two aspects. First, the new PKPD modelling strategies in mAb, and how these models could help to design phase II and III in drug development. Second, the different approaches for mAb in the model-informed precision dosing adopted in the clinical practice.

Dr. Ricardo Nalda-Molina
Prof. Dr. Patricio Más-Serrano
Dr. Amelia Ramon-Lopez
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • monoclonal antibodies
  • pharmacokinetics
  • model-informed precision dosing
  • pharmacometrics
  • therapeutic drug monitoring

Published Papers (2 papers)

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Review

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32 pages, 1640 KiB  
Review
Ulcerative Colitis and Acute Severe Ulcerative Colitis Patients Are Overlooked in Infliximab Population Pharmacokinetic Models: Results from a Comprehensive Review
by Alix Démaris, Ella S. K. Widigson, Johan F. K. F. Ilvemark, Casper Steenholdt, Jakob B. Seidelin, Wilhelm Huisinga, Robin Michelet, Linda B. S. Aulin and Charlotte Kloft
Pharmaceutics 2022, 14(10), 2095; https://doi.org/10.3390/pharmaceutics14102095 - 30 Sep 2022
Cited by 2 | Viewed by 1779
Abstract
Ulcerative colitis (UC) is part of the inflammatory bowels diseases, and moderate to severe UC patients can be treated with anti-tumour necrosis α monoclonal antibodies, including infliximab (IFX). Even though treatment of UC patients by IFX has been in place for over a [...] Read more.
Ulcerative colitis (UC) is part of the inflammatory bowels diseases, and moderate to severe UC patients can be treated with anti-tumour necrosis α monoclonal antibodies, including infliximab (IFX). Even though treatment of UC patients by IFX has been in place for over a decade, many gaps in modelling of IFX PK in this population remain. This is even more true for acute severe UC (ASUC) patients for which early prediction of IFX pharmacokinetic (PK) could highly improve treatment outcome. Thus, this review aims to compile and analyse published population PK models of IFX in UC and ASUC patients, and to assess the current knowledge on disease activity impact on IFX PK. For this, a semi-systematic literature search was conducted, from which 26 publications including a population PK model analysis of UC patients receiving IFX therapy were selected. Amongst those, only four developed a model specifically for UC patients, and only three populations included severe UC patients. Investigations of disease activity impact on PK were reported in only 4 of the 14 models selected. In addition, the lack of reported model codes and assessment of predictive performance make the use of published models in a clinical setting challenging. Thus, more comprehensive investigation of PK in UC and ASUC is needed as well as more adequate reports on developed models and their evaluation in order to apply them in a clinical setting. Full article
(This article belongs to the Special Issue Pharmacokinetics and Clinical Practice of Monoclonal Antibodies)
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Other

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18 pages, 627 KiB  
Systematic Review
Cost-Effectiveness of Therapeutic Drug Monitoring of Anti-TNF Therapy in Inflammatory Bowel Disease: A Systematic Review
by Silvia Marquez-Megias, Ricardo Nalda-Molina, Javier Sanz-Valero, Patricio Más-Serrano, Marcos Diaz-Gonzalez, Maria Remedios Candela-Boix and Amelia Ramon-Lopez
Pharmaceutics 2022, 14(5), 1009; https://doi.org/10.3390/pharmaceutics14051009 - 07 May 2022
Cited by 15 | Viewed by 2551
Abstract
Infliximab and adalimumab are monoclonal antibodies against tumor necrosis factor (anti-TNF) used to manage inflammatory bowel disease (IBD). Therapeutic Drug Monitoring (TDM) has been proven to prevent immunogenicity, to achieve better long-term clinical results and to save costs in IBD treatment. The aim [...] Read more.
Infliximab and adalimumab are monoclonal antibodies against tumor necrosis factor (anti-TNF) used to manage inflammatory bowel disease (IBD). Therapeutic Drug Monitoring (TDM) has been proven to prevent immunogenicity, to achieve better long-term clinical results and to save costs in IBD treatment. The aim of this study was to conduct a systematic review on cost-effectiveness analyses of studies that apply TDM of anti-TNF in IBD and to provide a critical analysis of the best scientific knowledge available in the literature. The quality of the included studies was assessed using Consolidated Health Economic Evaluation Reporting Standards (CHEERS). Cost-effectiveness of the TDM strategies was presented as total costs, cost savings, quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER). Thirteen studies that examined the health economics of TDM of anti-TNF in IBD from 2013 to 2021 were included. Eight of them (61.5%) achieved a score between 17 and 23 on the CHEERS checklist. The comparison between the TDM strategy and an empirical strategy was cost saving. The ICER between reactive TDM and an empirical strategy was dominated (favorable) by reactive TDM, whereas the ICER value for proactive TDM compared to an empirical strategy ranged from EUR 56,845 to 3,901,554. This systematic review demonstrated that a TDM strategy is cost-effective or cost-saving in IBD. Full article
(This article belongs to the Special Issue Pharmacokinetics and Clinical Practice of Monoclonal Antibodies)
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