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Special Issue "Personalisation the Management of Inflammatory Diseases"

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

Deadline for manuscript submissions: 15 July 2023 | Viewed by 4616

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Special Issue Editors

Prof. Dr. Daniel J. Touw

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Guest Editor

Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, 9713 GZ Groningen, The Netherlands
Interests: analytical method development; pharmacokinetics; therapeutic drug monitoring; toxicology

Dr. Paola Mian

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Guest Editor

Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, 9713 GZ Groningen, The Netherlands
Interests: perinatal pharmacology; paediatric pharmacology; pharmacometrics

Special Issue Information

Dear Colleagues,

In inflammatory diseases (ID) such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), pharmacotherapy should be personalized. ID treatment is complex, with highly different treatment modalities ranging from small-molecular anti-inflammatory drugs and corticosteroids to important developments such as monoclonal antibodies (mAbs). In the case of mAbs, an extra dimension is caused by the production of anti-drug antibodies, complicating the choice and dose of the drug. Evidence is emerging that drug choice and especially drug dosing should be personalized and target concentration is driven. Detailed pharmacological knowledge including pharmacogenetics, pharmacodynamics and concentration-effect relationships is essential for choosing the right drug, in the right dose, in the right administration form, at the right time, for each individual patient. We are pleased to invite you to make a contribution to this Special Issue that is devoted to the personalization of inflammatory disease management.

This Special Issue aims to give an overview of the clinical pharmacodynamic and pharmacokinetic considerations needed for tailoring treatment with the most common anti-inflammatory drugs for various classes of inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Special interest is for the treatment of women with inflammatory diseases of reproductive age and for the emergence of concentration-targeted therapy using therapeutic drug monitoring in inflammatory diseases.

In this Special Issue, original research articles and reviews are welcome. Research areas may include (but are not limited to) the following: clinical pharmacodynamics and pharmacokinetics of non-steroid and non-antibody classes of anti-inflammatory drugs, clinical pharmacodynamics and pharmacokinetics of monoclonal antibody anti-inflammatory drugs and the role of anti-drug antibodies, the role of therapeutic drug monitoring in inflammatory diseases, treatment of pregnant women with inflammatory diseases, treatment of inflammatory diseases in lactating women, treatment of children with inflammatory diseases.

We look forward to receiving your contributions.

Prof. Dr. Daniel J. Touw
Dr. Paola Mian
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 2600 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

inflammation
monoclonal antibody
therapeutic drug monitoring
anti-drug antibody
anti-inflammatory drugs
thiopurines

Published Papers (3 papers)

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Research

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Open AccessArticle

Optimization of a Quantitative Anti-Drug Antibodies against Infliximab Assay with the Liquid Chromatography-Tandem Mass Spectrometry: A Method Validation Study and Future Perspectives

Erin H. Smeijsters

Kim C. M. van der Elst

and

Pharmaceutics 2023, 15(5), 1477; https://doi.org/10.3390/pharmaceutics15051477 - 12 May 2023

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Abstract

Monoclonal antibodies (mAbs), such as infliximab, are important treatment options for different diseases. Immunogenicity is a major risk, resulting in anti-drug antibodies (ADAs), being associated with adverse events and loss of response, influencing long-term outcomes. The development of ADAs against infliximab is primarily measured by immunoassays like radioimmunoassay (RIA). Although liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly utilized across different fields, this technique is currently not used for ADAs against infliximab measurements. Therefore, we developed the first LC-MS/MS method. Stable isotopically labeled infliximab antigen-binding fragments (SIL IFX F(ab’)₂) were used to bind and measure ADAs indirectly. Protein A magnetic beads were used to capture IgG, including ADAs, whereafter SIL IFX F(ab’)₂ was added for labeling. After washing, internal standard addition, elution, denaturation and digestion samples were measured by LC-MS/MS. Internal validation showed good linearity between 0.1 and 16 mg/L (R² > 0.998). Sixty samples were used for cross-validation with RIA, and no significant difference between ADA concentrations was found. The methods had high correlation (R = 0.94, p < 0.001) and excellent agreement, intraclass correlation coefficient = 0.912 (95% confidence interval 0.858–0.947, p < 0.001). We present the first ADA against the infliximab LC-MS/MS method. The method is amendable for quantifying other ADAs, making it applicable as a template for future ADA methods. Full article

(This article belongs to the Special Issue Personalisation the Management of Inflammatory Diseases)

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Open AccessArticle

Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study

Lennard P. L. Gilissen

Adriaan A. van Bodegraven

Floris C. Loeff

Theo Rispens

and

Luc J. J. Derijks

Pharmaceutics 2023, 15(3), 972; https://doi.org/10.3390/pharmaceutics15030972 - 17 Mar 2023

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Abstract

There are limited data on therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) patients treated with vedolizumab (VDZ). Although an exposure–response relation has been demonstrated in the post-induction phase, this relationship is more uncertain in the maintenance phase of treatment. The aim of our study was to determine whether there is an association between VDZ trough concentration and clinical and biochemical remission in the maintenance phase. A prospective, observational multicenter study has been performed on patients with IBD on VDZ in the maintenance treatment (≥14 weeks). Patient demographics, biomarkers, and VDZ serum trough concentrations were collected. Clinical disease activity was scored by the Harvey Bradshaw Index (HBI) for Crohn’s disease (CD) and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Clinical remission was determined as HBI < 5 and SCCAI < 3. Biochemical remission was defined as fecal calprotectin <250 mg/kg and serum CRP <5 mg/L. A total of 159 patients (59 CD, 100 UC) were included. In none of the patient groups, a statistically significant correlation between trough VDZ concentration and clinical remission was observed. Patients in biochemical remission had higher VDZ trough concentrations (p = 0.019). In this population, higher trough VDZ concentrations were associated with biochemical remission but not with clinical remission. Full article

(This article belongs to the Special Issue Personalisation the Management of Inflammatory Diseases)

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Review

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Open AccessReview

Interpreting the Benefit and Risk Data in Between-Drug Comparisons: Illustration of the Challenges Using the Example of Mefenamic Acid versus Ibuprofen

and

Pharmaceutics 2022, 14(10), 2240; https://doi.org/10.3390/pharmaceutics14102240 - 20 Oct 2022

Cited by 1 | Viewed by 2761

Abstract

Evidence-based pain therapy should rely on precisely defined and personalized criteria. This includes balancing the benefits and risks not only of single drugs but often requires complex between-drug comparisons. Non-steroidal anti-inflammatory drugs (NSAIDs) have been available for several decades and their use is described in an abundance of guidelines. Most of these guidelines recommend that ‘the selection of a particular NSAID should be based on the benefit-risk balance for each patient’. However, head-to-head studies are often lacking or of poor quality, reflecting the lower standards for clinical research and regulatory approval at the time. The inconsistency of approved indications between countries due to national applications adds to the complexity. Finally, a fading research interest once drugs become generic points to a general deficit in the post-marketing evaluation of medicines. Far from claiming completeness, this narrative review aimed to illustrate the challenges that physicians encounter when trying to balance benefits and risks in a situation of incomplete and inconsistent data on longstanding treatment concepts. Ibuprofen and mefenamic acid, the most frequently sold NSAIDs in Austria, serve as examples. The illustrated principles are, however, not specific to these drugs and are generalizable to any comparison of older drugs in daily clinical practice. Full article

(This article belongs to the Special Issue Personalisation the Management of Inflammatory Diseases)

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