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Personalized Medicine for Multiple Sclerosis
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Personalized Medicine for Multiple Sclerosis

A special issue of Journal of Personalized Medicine (ISSN 2075-4426). This special issue belongs to the section "Mechanisms of Diseases".

Deadline for manuscript submissions: closed (30 August 2022) | Viewed by 16517

Special Issue Editors

Dr. Davide Quaranta

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Guest Editor
Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
Interests: neuropsychology; cognitive impairment; mood disorders following CNS diseases
Special Issues, Collections and Topics in MDPI journals
Prof. Massimiliano Mirabella

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Guest Editor
Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
Interests: multiple sclerosis; demyelinating disorders; disease modifying therapies; real-world evidence

Special Issue Information

Dear Colleagues,

Multiple sclerosis (MS) is a chronic CNS demyelinating disease which most often affects young adults and represents the first non-traumatic cause of neurological disability in this population.

Although the exact pathogenesis has not yet been elucidated, the coexistence of inflammatory and neurodegenerative processes since disease onset is widely demonstrated.

In recent years, several drugs (disease-modifying therapies, DMT) have been approved for MS following the demonstration of their efficacy in modifying the disease course, preventing clinical and neuroradiological worsening. Nevertheless, only a few randomized clinical trials have compared different approved drugs, and the most drug comparison has come from real-world studies.

Based on patient characteristics, in MS, the main challenge is to predict disease progression and to select the most appropriate therapeutic strategy.

The contemporary approach to personalized MS therapy relies on evidence-based prognostication leading to choice of initial treatment considering both patient-related factors (comorbidities, pregnancy planning) and drug-related factors (safety, implications for treatment sequencing). Early treatment response evaluation is essential to recognize the requirement to switch therapy and has been habitually judged on the basis of relapse rate, MRI load, and disability progression. Collection of large longitudinal data sets has allowed the development of composite outcome measures including also biomarkers such as neurofilament light chain, OCT, and neuropsychological evaluations, as potential early surrogate markers of prognosis and treatment response that necessitate further validation.

This Special Issue aims to provide the clinician with useful evidence to optimize the choice of a specific DMT for a single patient by identifying risk factors for drug-specific adverse events and prospective predictors of clinical and radiological activity.

Current and emerging clinical, imaging, and molecular biomarkers in MS may contribute to better shape the concept of precision medicine in MS. Validation of predictive tools in MS and demonstration of their clinical usefulness is needed prior to being transferred into clinical practice.

We are soliciting studies that expand real-world evidence on the use of DMT for MS patients. Priority of interest is given to studies exploring potential predictors of clinical outcome and treatment discontinuation for safety or effectiveness issues for a given DMT. Studies on validation of predictive tools including non-conventional outcomes (such as non-routine radiological techniques, serological biomarkers or neuropsychological evaluations) are warmly welcome. Furthermore, we welcome studies exploring the potential of DMTs on the modulation of chronic and long-term effects of MS on cognition, psychological wellbeing, and quality of life. Availability of new data will help us to attain the complex goal of a personalized approach for the DMT choice in a given MS patient.

Dr. Davide Quaranta
Prof. Massimiliano Mirabella
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. Journal of Personalized Medicine 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

  • Multiple sclerosis
  • Disease-modifying treatment
  • Real world evidence
  • Personalized medicine
  • Predictive factors
  • Adverse events
  • Cognitive impairment
  • Mood disorders
  • Quality of life

Published Papers (6 papers)

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9 pages, 517 KiB  
Article
The Expanding Role of the Infectious Disease Expert in the Context of the MS Centre
by Matteo Lucchini, Paola Del Giacomo, Valeria De Arcangelis, Viviana Nociti, Assunta Bianco, Chiara De Fino, Giorgia Presicce, Alessandra Cicia, Vincenzo Carlomagno and Massimiliano Mirabella
J. Pers. Med. 2022, 12(4), 591; https://doi.org/10.3390/jpm12040591 - 7 Apr 2022
Viewed by 1593
Abstract
Introduction: The complexity of the MS patient’s management is constantly growing. Consequently, the MS care unit requires a multidisciplinary approach, including an infectious disease specialist to minimise the risk of infectious complications related both to the disease and DMTs. Materials and methods: We [...] Read more.
Introduction: The complexity of the MS patient’s management is constantly growing. Consequently, the MS care unit requires a multidisciplinary approach, including an infectious disease specialist to minimise the risk of infectious complications related both to the disease and DMTs. Materials and methods: We retrospectively evaluated the infectious disease consultations performed from 2015 to 2019 in our MS centre. Results: We identified 107 patients with at least one infectious disease consultation out of 1088 patients. We found a progressive increase in the number of consultations from 2015 to 2019. Nearly half of the consultations were requested at the time of starting MS treatment. The most frequent requests were represented by chronic or acute infections. The most prevalent infectious agents were Herpesviridae and Mycobacterium tuberculosis. Antibiotic or antiviral treatment and prophylactic treatment or vaccination represented together the most frequent outcomes of the consultations. Finally, a treatment delay was significantly associated with the advice of a prophylactic treatment or of a vaccination. Conclusion: There is an increasing awareness of the potential infectious complications of MS and of exposure to DMTs. The interaction between the MS neurologist and infectious disease specialist is fundamental to minimise the infectious risk related to the disease and to the DMTs, with a progressive shift from complication management to a broader prevention workup at the time of MS diagnosis, including both vaccination and prophylactic treatments. Full article
(This article belongs to the Special Issue Personalized Medicine for Multiple Sclerosis)
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11 pages, 8781 KiB  
Article
Regulation of CTLA-4 and PD-L1 Expression in Relapsing-Remitting Multiple Sclerosis Patients after Treatment with Fingolimod, IFNβ-1α, Glatiramer Acetate, and Dimethyl Fumarate Drugs
by Afshin Derakhshani, Zahra Asadzadeh, Hossein Safarpour, Patrizia Leone, Mahdi Abdoli Shadbad, Ali Heydari, Behzad Baradaran and Vito Racanelli
J. Pers. Med. 2021, 11(8), 721; https://doi.org/10.3390/jpm11080721 - 27 Jul 2021
Cited by 17 | Viewed by 3236
Abstract
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system (CNS) that is characterized by inflammation which typically results in significant impairment in most patients. Immune checkpoints act as co-stimulatory and co-inhibitory molecules and play a fundamental role in keeping [...] Read more.
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system (CNS) that is characterized by inflammation which typically results in significant impairment in most patients. Immune checkpoints act as co-stimulatory and co-inhibitory molecules and play a fundamental role in keeping the equilibrium of the immune system. Cytotoxic T-lymphocyte antigen-4 (CTLA-4) and Programmed death-ligand 1 (PD-L1), as inhibitory immune checkpoints, participate in terminating the development of numerous autoimmune diseases, including MS. We assessed the CTLA-4 and PD-L1 gene expression in the different cell types of peripheral blood mononuclear cells of MS patients using single-cell RNA-seq data. Additionally, this study outlines how CTLA-4 and PD-L1 expression was altered in the PBMC samples of relapsing-remitting multiple sclerosis (RRMS) patients compared to the healthy group. Finally, it investigates the impact of various MS-related treatments in the CTLA-4 and PD-L1 expression to restrain autoreactive T cells and stop the development of MS autoimmunity. Full article
(This article belongs to the Special Issue Personalized Medicine for Multiple Sclerosis)
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10 pages, 1684 KiB  
Article
The Change of Fingolimod Patient Profiles over Time: A Descriptive Analysis of Two Non-Interventional Studies PANGAEA and PANGAEA 2.0
by Tjalf Ziemssen and Ulf Schulze-Topphoff
J. Pers. Med. 2021, 11(6), 561; https://doi.org/10.3390/jpm11060561 - 16 Jun 2021
Cited by 4 | Viewed by 2806
Abstract
(1) Background: Fingolimod (Gilenya®) was the first oral treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Since its approval, the treatment landscape has changed enormously. (2) Methods: Data of PANGAEA and PANGAEA 2.0, two German real-world studies, were descriptively analysed for [...] Read more.
(1) Background: Fingolimod (Gilenya®) was the first oral treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Since its approval, the treatment landscape has changed enormously. (2) Methods: Data of PANGAEA and PANGAEA 2.0, two German real-world studies, were descriptively analysed for possible evolution of patient profiles and treatment behavior. Both are prospective, multi-center, non-interventional, long-term studies on fingolimod use in RRMS in real life. Data of 4229 PANGAEA patients (recruited 2011–2013) and 2441 PANGAEA 2.0 patients (recruited 2015–2018) were available. Baseline data included demographics, RRMS characteristics and disease severity. (3) Results: The mean age of PANGAEA and PANGAEA 2.0 patients was similar (38.8 vs. 39.2 years). Patients in PANGAEA 2.0 had shorter disease duration (7.1 vs. 8.2 years) and fewer relapses in the year before baseline (1.2 vs. 1.6). Disease severity at baseline estimated by EDSS and SDMT was lower in PANGAEA 2.0 patients compared to PANGAEA (EDSS difference 1.0 points; SDMT difference 3.3 points). (4) Conclusions: The results hint at an influence of changes in the treatment guidelines and the label on fingolimod patients profiles over time. Patients tended to have lower disease activity at fingolimod initiation, suggesting an earlier intervention. This indicates increased experience in using fingolimod for sub-optimally treated RRMS patients and a change in mindset towards an early treatment optimization. Full article
(This article belongs to the Special Issue Personalized Medicine for Multiple Sclerosis)
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16 pages, 2781 KiB  
Article
Thermal Liquid Biopsy (TLB) of Blood Plasma as a Potential Tool to Help in the Early Diagnosis of Multiple Sclerosis
by Ferdinanda Annesi, Sonia Hermoso-Durán, Bruno Rizzuti, Rosalinda Bruno, Domenico Pirritano, Alfredo Petrone, Francesco Del Giudice, Jorge Ojeda, Sonia Vega, Oscar Sanchez-Gracia, Adrian Velazquez-Campoy, Olga Abian and Rita Guzzi
J. Pers. Med. 2021, 11(4), 295; https://doi.org/10.3390/jpm11040295 - 13 Apr 2021
Cited by 7 | Viewed by 2492
Abstract
Background: Multiple sclerosis (MS) is frequently characterized by a variety of clinical signs, often exhibiting little specificity. The diagnosis requires a combination of medical observations and instrumental tests, and any support for its objective assessment is helpful. Objective: Herein, we describe the application [...] Read more.
Background: Multiple sclerosis (MS) is frequently characterized by a variety of clinical signs, often exhibiting little specificity. The diagnosis requires a combination of medical observations and instrumental tests, and any support for its objective assessment is helpful. Objective: Herein, we describe the application of thermal liquid biopsy (TLB) of blood plasma samples, a methodology for predicting the occurrence of MS with a noninvasive, quick blood test. Methods: TLB allows one to define an index (TLB score), which provides information about overall real-time alterations in plasma proteome that may be indicative of MS. Results: This pilot study, based on 85 subjects (45 MS patients and 40 controls), showed good performance indexes (sensitivity and specificity both around 70%). The diagnostic methods better discriminate between early stage and low-burden MS patients, and it is not influenced by gender, age, or assumption of therapeutic drugs. TLB is more accurate for patients having low disability level (≤ 3.0, measured by the expanded disability status scale, EDSS) and a relapsing–remitting diagnosis. Conclusion: Our results suggest that TLB can be applied to MS, especially in an initial phase of the disease when diagnosis is difficult and yet more important (in such cases, accuracy of prediction is close to 80%), as well as in personalized patient periodic monitoring. The next step will be determining its utility in differentiating between MS and other disorders, in particular in inflammatory diseases. Full article
(This article belongs to the Special Issue Personalized Medicine for Multiple Sclerosis)
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14 pages, 1120 KiB  
Systematic Review
B-Cell Targeted Therapies in Patients with Multiple Sclerosis and Incidence of Headache: A Systematic Review and Meta-Analysis
by Theodoros Mavridis, Nikolaos Papagiannakis, Marianthi Breza, Georgios D. Vavougios, Kostas Patas, Ariadne Daponte, Achilleas Laskaratos, Paraschos Archontakis-Barakakis, Ioannis Pantazopoulos and Dimos D. Mitsikostas
J. Pers. Med. 2022, 12(9), 1474; https://doi.org/10.3390/jpm12091474 - 8 Sep 2022
Cited by 2 | Viewed by 2352
Abstract
Background: Multiple Sclerosis treatment with B-cell targeted therapies may be associated with an increased incidence of headache. We aimed to find and compare the association of B-cell targeted therapies with the incidence of headache in patients with Multiple Sclerosis. Methods: In a systematic [...] Read more.
Background: Multiple Sclerosis treatment with B-cell targeted therapies may be associated with an increased incidence of headache. We aimed to find and compare the association of B-cell targeted therapies with the incidence of headache in patients with Multiple Sclerosis. Methods: In a systematic based approach, the following databases were searched from inception until the 6th of June 2020: Pubmed/MEDLINE, ClinicalTrials.gov, EU Clinical Trials Register. Only randomized clinical trials (RCTs) enrolling patients with Multiple Sclerosis comparing B-cell targeted therapies (Rituximab, Ocrelizumab, Ofatumumab, Ublituximab or Cladribine) with placebo were selected for the systematic review and further meta-analysis. PRISMA guidelines were followed at all stages of the systematic review. The primary outcome was an all-cause headache of B-cell targeting therapy in patients with Multiple Sclerosis. Results: Nine RCTs were included. Compared with placebo, treatment with B-cell targeting therapies revealed a trend in headache risk, but it was not statistically significant (Relative Risk 1.12 [95% Confidence Interval 0.96–1.30]; p = 0.15; I2 = 9.32%). Surprisingly, in a sub-group analysis, Cladribine was statistically significant for an increase in headache risk (RR 1.20 [95% CI 1.006–1.42]; p = 0.042; I2 = 0%; 3 studies with 2107 participants). Conclusions: Even though a trend is shown, B-cell targeted therapies do not correlate with an increased incidence of headache as an adverse effect. Sub-analyses revealed a significant association between Cladribine alone and an increased incidence of headache. Whereas a purinergic signaling cascade is proposed as a mechanism of action, further research is needed to unravel the underlying pathogenetic mechanism of headache induction and establish headache prevention strategies. Full article
(This article belongs to the Special Issue Personalized Medicine for Multiple Sclerosis)
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9 pages, 783 KiB  
Commentary
Personalizing Medicine and Technologies to Address the Experiences and Needs of People with Multiple Sclerosis
by Adam Henschke, Jane Desborough, Anne Parkinson, Crystal Brunoro, Vanessa Fanning, Christian Lueck, Nicola Brew-Sam, Anne Brüstle, Janet Drew, Katrina Chisholm, Mark Elisha, Hanna Suominen, Antonio Tricoli, Christine Phillips and Matthew Cook
J. Pers. Med. 2021, 11(8), 791; https://doi.org/10.3390/jpm11080791 - 12 Aug 2021
Cited by 3 | Viewed by 2791
Abstract
There is enormous variation in the manifestations of disease experienced by people with multiple sclerosis (PwMS). While this variation makes personalized medicine an attractive goal, there are many challenges to be overcome before this opportunity can be realized. Personalized medicine often focuses on [...] Read more.
There is enormous variation in the manifestations of disease experienced by people with multiple sclerosis (PwMS). While this variation makes personalized medicine an attractive goal, there are many challenges to be overcome before this opportunity can be realized. Personalized medicine often focuses on targeted therapies and detailed monitoring, but we also need to recognize that there will be variation in acceptance of these approaches by different PwMS. In other words, deep personalization of medicine will encompass targeted therapy, precision monitoring, tailored to variation in personal attitudes to these transformations in health care. In order to meet the promise of personalized medicine for MS, understanding the experiences of PwMS is necessary both to aid in the uptake of personalized medicine, and to ensure that personalized approaches to monitoring disease and treatment provide a net benefit to PwMS rather than placing additional burdens and stressors on them. Here, we describe recent research that identified five experiential themes for PwMS, and then interpret these themes according to the foundations of personalized medicine to provide a road map for implementation of personalized medicine solutions for PwMS. Full article
(This article belongs to the Special Issue Personalized Medicine for Multiple Sclerosis)
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