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Authors = Giorgio Parisi

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14 pages, 1816 KiB  
Article
Bifidobacterium adolescentis PRL2019 in Pediatric Irritable Bowel Syndrome: A Multicentric, Randomized, Double-Blind, Placebo-Controlled Trial
by Valentina Giorgio, Giovanna Quatrale, Maurizio Mennini, Marisa Piccirillo, Silvia Furio, Giuseppe Stella, Alessandro Ferretti, Pasquale Parisi, Melania Evangelisti, Enrico Felici, Paolo Quitadamo and Giovanni Di Nardo
Microorganisms 2025, 13(3), 627; https://doi.org/10.3390/microorganisms13030627 - 10 Mar 2025
Viewed by 1401
Abstract
The gut microbiota plays a pivotal role in gastrointestinal inflammation and immune response since changes in microbiota may result in abnormal neurotransmitter expression, inducing changes in gastrointestinal sensory–motor function and leading to symptom onset in irritable bowel syndrome (IBS) patients. The [...] Read more.
The gut microbiota plays a pivotal role in gastrointestinal inflammation and immune response since changes in microbiota may result in abnormal neurotransmitter expression, inducing changes in gastrointestinal sensory–motor function and leading to symptom onset in irritable bowel syndrome (IBS) patients. The Bifidobacterium adolescentis species has a documented immunomodulatory effect through its ability to produce γ-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the mammalian central nervous system, which is reduced in IBS patients. This is a multicentric, randomized, double-blind, placebo-controlled, parallel-arm trial aimed at evaluating the effectiveness of Bifidobacterium adolescentis PRL2019 in children with IBS. IBS children diagnosed according to Rome IV criteria were enrolled and randomized into two groups to receive one stick containing 20 × 109 colony-forming unit of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy) or an equivalent placebo once a day, in a 1:1 ratio, for 12 weeks. Clinical evaluation of symptoms was performed every four weeks using validated scores. Bowel habit characteristics were assessed using the Bristol Stool Chart (BSC). Seventy-two subjects (mean age 12.2 ± 1.8 years, 30 males) were enrolled and randomized into two groups, each of thirty-six patients. No significant differences were observed between the two groups regarding demographic characteristics, distribution of IBS subtypes, or baseline measures of IBS severity and BSC. The proportion of patients achieving complete remission was significantly higher in the BA Group (19/36; 52.8%) than in the Placebo Group (7/36; 19.4%, p = 0.003, odds ratio [OR] 0.216, 95% confidence interval [CI] 0.075–0.619). Both groups obtained a reduction in Total IBS Symptom Severity Scale (IBS SSS), Pain Intensity Score (PIS), Pain Frequency Score (PFS), and Life Interference Score (LIS) from T0 to T12. However, upon intergroup comparison, only in the BA group did the IBS-SSS (p = 0.001), PIS (p = 0.001), LIS (p = 0.015), and PFS (p = 0.005) significantly improve between T0 and T12. BSC showed a greater representation of normal stools (type 3–4) at the end of treatment in the BA group compared with baseline (25% vs. 58.3%, p = 0.004), especially in patients who presented an IBS–constipation subtype at T0 (44.5% vs. 19.4%, p = 0.02). In our study, Bifidobacterium adolescentis PRL2019 reduces the severity and frequency of symptoms in children with IBS, positively affecting bowel habits in children with the IBS–constipation subtype. Full article
(This article belongs to the Section Medical Microbiology)
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26 pages, 7283 KiB  
Review
Validated and Optimized Strategies for Preserving Historical Heritage Towards Natural and Anthropic Risks: Insights from the DETECT-AGING Project
by Gian Piero Lignola, Nicola Buratti, Serena Cattari, Fulvio Parisi, Filippo Ubertini, Sara Alfano, Laura Ierimonti, Andrea Meoni, Daniele Sivori and Giorgio Virgulto
Buildings 2025, 15(5), 693; https://doi.org/10.3390/buildings15050693 - 22 Feb 2025
Cited by 1 | Viewed by 1198
Abstract
This paper summarizes simple and practically attractive new methodologies based on validated and optimized strategies for preserving historical heritage towards natural or anthropic risks in order to assist public administrations and stakeholders involved at various levels in the protection of cultural heritage. This [...] Read more.
This paper summarizes simple and practically attractive new methodologies based on validated and optimized strategies for preserving historical heritage towards natural or anthropic risks in order to assist public administrations and stakeholders involved at various levels in the protection of cultural heritage. This represents the outcome of the PRIN 2017 project DETECT-AGING—degradation effects on structural safety of cultural heritage constructions through simulations and health monitoring. Results were built on recent advances in structural performance modelling of historical masonry structures, interpretation of effects of degradation, advanced numerical simulations, and structural health monitoring, with the final aim to go beyond the state of the art in regard to assessing and establishing: (i) degradation effects from the level of materials to the scale of components; (ii) methodologies able to transfer information on mechanical behaviour from a micro-scale to a macro-scale; (iii) the use of ambient vibration measurements to address epistemic modelling uncertainties in historical masonry buildings; (iv) structural health monitoring (SHM) to detect the occurrence of damage and locate/quantify damage; (v) the capability of equivalent frame models (EFMs) to support the SHM of masonry structures in place of more refined 3D finite element models (FEMs); (vi) variations in the structural response that can be monitored by sensor networks as a function of simulated degradation. Full article
(This article belongs to the Section Building Structures)
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12 pages, 794 KiB  
Article
Early Surgical Resection in Pediatric Patients with Localized Ileo-Cecal Crohn’s Disease: Results of a Retrospective Multicenter Study
by Isabella Madaffari, Edoardo Maria Muttillo, Alice La Franca, Fanny Massimi, Giorgio Castagnola, Alessandro Coppola, Silvia Furio, Marisa Piccirillo, Alessandro Ferretti, Maurizio Mennini, Pasquale Parisi, Denis A. Cozzi, Silvia Ceccanti, Enrico Felici, Pini Prato Alessio, Gabriele Lisi, Maria Teresa Illiceto, Isabella Sperduti, Giovanni Di Nardo and Paolo Mercantini
J. Clin. Med. 2025, 14(2), 404; https://doi.org/10.3390/jcm14020404 - 10 Jan 2025
Cited by 1 | Viewed by 1152
Abstract
Background: Crohn’s disease (CD) is an inflammatory bowel disease (IBD) that also affects pediatric patients. It frequently presents as a localized disease, affecting the ileocecal area, ileum, or colon. It requires targeted therapy to achieve a good quality of life and long-term [...] Read more.
Background: Crohn’s disease (CD) is an inflammatory bowel disease (IBD) that also affects pediatric patients. It frequently presents as a localized disease, affecting the ileocecal area, ileum, or colon. It requires targeted therapy to achieve a good quality of life and long-term control of disease activity. Despite multiple medical therapies available, several patients benefit from surgical treatment. The aim of our study is to demonstrate how an early surgical approach can bring an improvement in disease activity, evaluating the Simple Endoscopic Score for Crohn’s Disease (SES-CD) and the Pediatric Crohn’s Disease Activity Index (PCDAI). Methods: A retrospective multicenter study was carried out from 2008 to 2023, including 29 patients, affected by localized CD. These data were analyzed: demographics, SES-CD, and PCDAI, before and after surgery. The differences between groups were analyzed using Student’s t-test for continuous variables, and Pearson’s Chi-squared test or Fisher’s exact test for categorical variables. Results: The SES-CD significantly decreased from 12 (median, range 1–15) to 0 (median, range 0–6) (p < 0.0001) and the PCDAI decreased from 30 (median, range 10–50) to 0 (median, range 0–15) (p < 0.0001). The rate of patients receiving enteral nutrition decreased from 51.7% preoperatively to 0% postoperatively (p = 0.0001). The rate of antibiotic use decreased from 13.8% to 0% (p = 0.0001). The rate of patients receiving ≥2 drugs decreased from 10.3% to 0% (p = 0.0001). Conclusions: The early surgical approach can be considered an excellent therapeutic strategy in patients with localized CD. Both parameters examined, SES-CD and PCDAI, demonstrated a clear improvement in the endoscopic images and in disease activity. Full article
(This article belongs to the Section General Surgery)
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10 pages, 1148 KiB  
Article
Effectiveness and Predictors of Long-Term Treatment Response to Tofacitinib in Rheumatoid Arthritis Cohort: General Analysis and Focus on High-Cardiovascular-Risk Subgroup—A Multicenter Study
by Marta Priora, Andrea Becciolini, Eleonora Celletti, Myriam Di Penta, Alberto Lo Gullo, Marino Paroli, Elena Bravi, Romina Andracco, Valeria Nucera, Francesca Ometto, Federica Lumetti, Antonella Farina, Patrizia Del Medico, Matteo Colina, Viviana Ravagnani, Palma Scolieri, Maddalena Larosa, Elisa Visalli, Olga Addimanda, Rosetta Vitetta, Alessandro Volpe, Alessandra Bezzi, Francesco Girelli, Aldo Biagio Molica Colella, Rosalba Caccavale, Eleonora Di Donato, Giuditta Adorni, Daniele Santilli, Gianluca Lucchini, Eugenio Arrigoni, Emanuela Sabatini, Ilaria Platè, Natalia Mansueto, Aurora Ianniello, Enrico Fusaro, Maria Chiara Ditto, Vincenzo Bruzzese, Dario Camellino, Gerolamo Bianchi, Francesca Serale, Rosario Foti, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Massimo Reta, Alessia Fiorenza, Guido Rovera, Antonio Marchetta, Maria Cristina Focherini, Fabio Mascella, Simone Bernardi, Gilda Sandri, Dilia Giuggioli, Carlo Salvarani, Veronica Franchina, Francesco Molica Colella, Giulio Ferrero, Alarico Ariani and Simone Parisiadd Show full author list remove Hide full author list
Medicina 2024, 60(12), 1982; https://doi.org/10.3390/medicina60121982 - 2 Dec 2024
Viewed by 1782
Abstract
Background and Objectives: The treatment landscape for Rheumatoid Arthritis (RA) has evolved significantly with the introduction of Janus kinase inhibitors (JAKi), such as Tofacitinib (TOFA), which offer a new therapeutic option for patients who have failed or are intolerant to conventional synthetic disease-modifying [...] Read more.
Background and Objectives: The treatment landscape for Rheumatoid Arthritis (RA) has evolved significantly with the introduction of Janus kinase inhibitors (JAKi), such as Tofacitinib (TOFA), which offer a new therapeutic option for patients who have failed or are intolerant to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Safety concerns, particularly related to cardiovascular and cancer risks, prompted a need for additional investigation in real-world clinical settings. This study aimed to evaluate the long-term effectiveness and predictors of response to TOFA in two subpopulations of RA patients, categorized by differing cardiovascular risk profiles. Materials and Methods: This was a retrospective, multicenter observational study conducted as part of the BIRRA project, involving 23 Italian rheumatological referral centers. A total of 213 patients diagnosed with RA and treated with TOFA were included, with data collected on baseline demographics, clinical history, disease activity, and comorbidities. Patients were divided into high-risk and low-risk cardiovascular groups based on age (≥65 years) and the presence of at least one cardiovascular risk factor. Disease activity was assessed at baseline, 6 months, and 12 months using DAS28-ESR and DAS28-CRP. Treatment response was evaluated using intention-to-treat (ITT) and per-protocol (PP) approaches. Predictors of low disease activity (LDA) and remission were assessed through logistic regression, and clustering analyses were used to identify subgroups of patients with different therapeutic responses. Results: The study included 213 patients, with 129 classified as high-risk. For the overall cohort, patients achieving LDA and remission at 6 months were 20% and 12%, respectively, for the ITT analysis, and 29% and 14% for the PP analysis. At 12 months, 26% of patients reached LDA, and 17% achieved remission according to ITT, while for the PP analysis, these rates were 30% and 19%, respectively. No significant differences in remission or LDA rates were observed between the high-risk and low-risk groups. In the high-risk subgroup, 17% of patients reached LDA and 9% achieved remission at 6 months (ITT analysis), while these rates increased to 22% and 13%, respectively, in the PP analysis. At 12 months, 22% achieved LDA and 13% achieved remission in the ITT analysis, while 28% and 17% did so in the PP analysis. The reduction in DAS28-ESR and DAS28-CRP scores was significant (p < 0.001) across all time points for both high-risk and low-risk patients. Logistic regression analyses revealed that none of the baseline characteristics—including age, sex, comorbidities, rheumatoid factor, anti-citrullinated protein antibody (ACPA) positivity, initial disease severity, or treatment history—were significant predictors of remission or LDA at 6 or 12 months. The clustering analysis suggested that older patients, particularly those with worse baseline DAS28 scores, tended to show a less favorable response to treatment, potentially indicating impacts of age-related factors such as immunosenescence on therapeutic outcomes. Conclusions: Tofacitinib demonstrated similar effectiveness in both high- and low-risk cardiovascular subgroups of RA patients, with significant reductions in disease activity observed at both 6 and 12 months. Despite safety concerns related to cardiovascular risk, TOFA remained an effective treatment option across patient subgroups, with no significant differences in remission or LDA rates based on cardiovascular risk profiles. Age appeared to negatively impact treatment response, highlighting the role of immunosenescence in RA management. These findings support the use of TOFA as a personalized therapeutic option for RA, emphasizing the need for careful evaluation of cardiovascular and age-related risks in clinical decision-making. Full article
(This article belongs to the Special Issue Recent Advances in Autoimmune Rheumatic Diseases: 2nd Edition)
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13 pages, 2903 KiB  
Systematic Review
Planning Accuracy and Stem Offset Assessment in Digital Two-Dimensional Versus Three-Dimensional Planning in Cementless Hip Arthroplasty: A Systematic Review and Meta-Analysis
by Francesco Rosario Parisi, Biagio Zampogna, Andrea Zampoli, Augusto Ferrini, Giorgio Albimonti, Alessandro Del Monaco, Pierangelo Za, Giuseppe Francesco Papalia and Rocco Papalia
J. Clin. Med. 2024, 13(21), 6566; https://doi.org/10.3390/jcm13216566 - 31 Oct 2024
Cited by 5 | Viewed by 1156
Abstract
Background/Objectives: Total hip arthroplasty (THA) planning is crucial for restoring hip function and minimizing complications. The present systematic review and meta-analysis aimed to assess and compare the accuracy of 2D versus 3D preoperative planning in THA. Methods: The inclusion criteria were randomized [...] Read more.
Background/Objectives: Total hip arthroplasty (THA) planning is crucial for restoring hip function and minimizing complications. The present systematic review and meta-analysis aimed to assess and compare the accuracy of 2D versus 3D preoperative planning in THA. Methods: The inclusion criteria were randomized controlled trials (RCTs) and observational studies (ROSs) published in English comparing the accuracy of 2D and 3D preoperative planning for total hip arthroplasty. We excluded review articles, registers, studies not written in English, studies that did not report the cup sizing accuracy or stem sizing accuracy or give a description of the preoperative planning method used, and non-comparative studies. In June 2024, following the PRISMA 2020 statement, a systematic review and a meta-analysis of the literature were conducted in PubMed, Scopus, and the Cochrane Library. The statistical analysis software Review Manager (RevMan) version 5.4 was used to perform the meta-analysis to compare the accuracy of 2D and 3D planning, and to assess the risk of bias, the ROBINS-I tool was used. Results: The analysis included 777 patients from six studies. The analysis showed that 3D planning offers superior precision compared to 2D planning, both for the cup (96.92% vs. 87.14%) and the stem (94.72% vs. 86.28%). The forest plots assessed a better trend for 3D planning in terms of exact size prediction and accuracy within ±1 size. Conclusions: The three-dimensional method was more precise and accurate than two-dimensional planning, both for the stem and the cup. It offered a detailed three-dimensional view of the patient’s anatomy. The main limitation was the challenge in finding homogeneous data regarding biomechanical parameters, surgical approaches, and different planning systems for both three-dimensional and two-dimensional methods. Full article
(This article belongs to the Special Issue Orthopedic Surgery: Latest Advances and Future Prospects)
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9 pages, 449 KiB  
Article
Influence of Safety Warnings on the Prescribing Attitude of JAK Inhibitors for Rheumatoid Arthritis in Italy
by Marino Paroli, Andrea Becciolini, Alberto Lo Gullo, Simone Parisi, Elena Bravi, Romina Andracco, Valeria Nucera, Francesca Ometto, Federica Lumetti, Antonella Farina, Patrizia Del Medico, Matteo Colina, Viviana Ravagnani, Palma Scolieri, Maddalena Larosa, Marta Priora, Elisa Visalli, Olga Addimanda, Rosetta Vitetta, Alessandro Volpe, Alessandra Bezzi, Francesco Girelli, Aldo Biagio Molica Colella, Rosalba Caccavale, Eleonora Di Donato, Giuditta Adorni, Daniele Santilli, Gianluca Lucchini, Eugenio Arrigoni, Ilaria Platè, Natalia Mansueto, Aurora Ianniello, Enrico Fusaro, Maria Chiara Ditto, Vincenzo Bruzzese, Dario Camellino, Gerolamo Bianchi, Francesca Serale, Rosario Foti, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Massimo Reta, Alessia Fiorenza, Guido Rovera, Antonio Marchetta, Maria Cristina Focherini, Fabio Mascella, Simone Bernardi, Gilda Sandri, Dilia Giuggioli, Carlo Salvarani, Maria Ilenia De Andres, Veronica Franchina, Francesco Molica Colella, Giulio Ferrero, Bernd Raffeiner and Alarico Arianiadd Show full author list remove Hide full author list
J. Clin. Med. 2024, 13(13), 3929; https://doi.org/10.3390/jcm13133929 - 4 Jul 2024
Cited by 2 | Viewed by 2444
Abstract
Background/Objectives: The Janus kinase inhibitors (JAKi) tofacitinib (TOFA), baricitinib (BARI), upadacitinib (UPA), and filgotinib (FILGO) are effective drugs for the treatment of rheumatoid arthritis. However, the US Food and Drug Administration (FDA) raised concerns about the safety of TOFA after its approval. This [...] Read more.
Background/Objectives: The Janus kinase inhibitors (JAKi) tofacitinib (TOFA), baricitinib (BARI), upadacitinib (UPA), and filgotinib (FILGO) are effective drugs for the treatment of rheumatoid arthritis. However, the US Food and Drug Administration (FDA) raised concerns about the safety of TOFA after its approval. This prompted the European Medicines Agency (EMA) to issue two safety warnings for limiting TOFA use, then extended a third warning to all JAKi in patients at high risk of developing serious adverse effects (SAE). These include thrombosis, major adverse cardiac events (MACE), and cancer. The purpose of this work was to analyze how the first two safety warnings from the EMA affected the prescribing of JAKi by rheumatologists in Italy. Methods: All patients with rheumatoid arthritis who had been prescribed JAKi for the first time in a 36-month period from 1 July 2019, to 30 June 2022 were considered. Data were obtained from the medical records of 29 Italian tertiary referral rheumatology centers. Patients were divided into three groups of 4 months each, depending on whether the JAKi prescription had occurred before the EMA’s first safety alert (1 July–31 October 2019, Group 1), between the first and second alerts (1 November 2019–29 February 2020, Group 2), or between the second and third alerts (1 March 2021–30 June 2021, Group 3). The percentages and absolute changes in the patients prescribed the individual JAKi were analyzed. Differences among the three groups of patients regarding demographic and clinical characteristics were also assessed. Results: A total of 864 patients were prescribed a JAKi during the entire period considered. Of these, 343 were identified in Group 1, 233 in Group 2, and 288 in Group 3. An absolute reduction of 32% was observed in the number of patients prescribed a JAKi between Group 1 and Group 2 and 16% between Group 1 and Group 3. In contrast, there was a 19% increase in the prescription of a JAKi in patients between Group 2 and Group 3. In the first group, BARI was the most prescribed drug (227 prescriptions, 66.2% of the total), followed by TOFA (115, 33.5%) and UPA (1, 0.3%). In the second group, the most prescribed JAKi was BARI (147, 63.1%), followed by TOFA (65, 27.9%) and UPA (33, 11.5%). In the third group, BARI was still the most prescribed JAKi (104 prescriptions, 36.1%), followed by UPA (89, 30.9%), FILGO (89, 21.5%), and TOFA (33, 11.5%). The number of patients prescribed TOFA decreased significantly between Group 1 and Group 2 and between Group 2 and Group 3 (p ˂ 0.01). The number of patients who were prescribed BARI decreased significantly between Group 1 and Group 2 and between Group 2 and Group 3 (p ˂ 0.01). In contrast, the number of patients prescribed UPA increased between Group 2 and Group 3 (p ˂ 0.01). Conclusions: These data suggest that the warnings issued for TOFA were followed by a reduction in total JAKi prescriptions. However, the more selective JAKi (UPA and FILGO) were perceived by prescribers as favorable in terms of the risk/benefit ratio, and their use gradually increased at the expense of the other molecules. Full article
(This article belongs to the Special Issue Rheumatoid Arthritis: Clinical Updates on Diagnosis and Treatment)
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17 pages, 5240 KiB  
Article
The Power Board of the KM3NeT Digital Optical Module: Design, Upgrade, and Production
by Sebastiano Aiello, Arnauld Albert, Sergio Alves Garre, Zineb Aly, Antonio Ambrosone, Fabrizio Ameli, Michel Andre, Eleni Androutsou, Mancia Anguita, Laurent Aphecetche, Miguel Ardid, Salva Ardid, Hicham Atmani, Julien Aublin, Francesca Badaracco, Louis Bailly-Salins, Zuzana Bardacova, Bruny Baret, Adriana Bariego, Suzan Basegmez Du Pree, Yvonne Becherini, Meriem Bendahman, Francesco Benfenati, Marouane Benhassi, David M. Benoit, Edward Berbee, Vincent Bertin, Simone Biagi, Markus Boettcher, Danilo Bonanno, Jihad Boumaaza, Mohammed Bouta, Mieke Bouwhuis, Cristiano Bozza, Riccardo Maria Bozza, Horea Branzas, Felix Bretaudeau, Ronald Bruijn, Jurgen Brunner, Riccardo Bruno, Ernst Jan Buis, Raffaele Buompane, Jose Busto, Barbara Caiffi, David Calvo, Stefano Campion, Antonio Capone, Francesco Carenini, Víctor Carretero, Théophile Cartraud, Paolo Castaldi, Vincent Cecchini, Silvia Celli, Luc Cerisy, Mohamed Chabab, Michael Chadolias, Cèdric Champion, Andrew Chen, Silvio Cherubini, Tommaso Chiarusi, Marco Circella, Rosanna Cocimano, João Coelho, Alexis Coleiro, Stephane Colonges, Rosa Coniglione, Paschal Coyle, Alexandre Creusot, Giacomo Cuttone, Richard Dallier, Yara Darras, Antonio De Benedittis, Maarten de Jong, Paul de Jong, Bianca De Martino, Els de Wolf, Valentin Decoene, Riccardo Del Burgo, Ilaria Del Rosso, Umberto Maria Di Cerbo, Letizia Stella Di Mauro, Irene Di Palma, Antonio Diaz, Cristian Díaz Martín, Dídac Diego-Tortosa, Carla Distefano, Alba Domi, Corinne Donzaud, Damien Dornic, Manuel Dörr, Evangelia Drakopoulou, Doriane Drouhin, Rastislav Dvornický, Thomas Eberl, Eliska Eckerova, Ahmed Eddymaoui, Maximilian Eff, Imad El Bojaddaini, Sonia El Hedri, Alexander Enzenhöfer, Giovanna Ferrara, Miroslav Filipovic, Francesco Filippini, Dino Franciotti, Luigi Antonio Fusco, Omar Gabella, Jean-Louis Gabriel, Silvia Gagliardini, Tamas Gal, Juan García Méndez, Alfonso Andres Garcia Soto, Clara Gatius Oliver, Nicole Geißelbrecht, Houria Ghaddari, Lucio Gialanella, Brad K. Gibson, Emidio Giorgio, Isabel Goos, Pranjupriya Goswami, Damien Goupilliere, Sara Rebecca Gozzini, Rodrigo Gracia, Kay Graf, Carlo Guidi, Benoît Guillon, Miguel Gutiérrez, Aart Heijboer, Amar Hekalo, Lukas Hennig, Juan-Jose Hernandez-Rey, Walid Idrissi Ibnsalih, Giulia Illuminati, Peter Jansweijer, Bouke Jisse Jung, Piotr Kalaczyński, Oleg Kalekin, Uli Katz, Amina Khatun, Giorgi Kistauri, Claudio Kopper, Antoine Kouchner, Vincent Kueviakoe, Vladimir Kulikovskiy, Ramaz Kvatadze, Marc Labalme, Robert Lahmann, Giuseppina Larosa, Chiara Lastoria, Alfonso Lazo, Sebastien Le Stum, Grégory Lehaut, Emanuele Leonora, Nadja Lessing, Giuseppe Levi, Miles Lindsey Clark, Pietro Litrico, Fabio Longhitano, Jerzy Mańczak, Jhilik Majumdar, Leonardo Malerba, Fadahat Mamedov, Alberto Manfreda, Martina Marconi, Annarita Margiotta, Antonio Marinelli, Christos Markou, Lilian Martin, Juan Antonio Martínez-Mora, Fabio Marzaioli, Massimo Mastrodicasa, Stefano Mastroianni, Sandra Miccichè, Gennaro Miele, Pasquale Migliozzi, Emilio Migneco, Saverio Minutoli, Maria Lucia Mitsou, Carlos Maximiliano Mollo, Lizeth Morales Gallegos, Michele Morga, Abdelilah Moussa, Ivan Mozun Mateo, Rasa Muller, Paolo Musico, Maria Rosaria Musone, Mario Musumeci, Sergio Navas, Amid Nayerhoda, Carlo Alessandro Nicolau, Bhuti Nkosi, Brían Ó Fearraigh, Veronica Oliviero, Angelo Orlando, Enzo Oukacha, Daniele Paesani, Juan Palacios González, Gogita Papalashvili, Vittorio Parisi, Emilio Pastor, Alice Paun, Gabriela Emilia Pavalas, Giuliano Pellegrini, Santiago Pena Martinez, Mathieu Perrin-Terrin, Jerome Perronnel, Valentin Pestel, Rebekah Pestes, Paolo Piattelli, Chiara Poirè, Vlad Popa, Thierry Pradier, Jorge Prado, Sara Pulvirenti, Gilles Quemener, Carlos Quiroz, Ushak Rahaman, Nunzio Randazzo, Richard Randriatoamanana, Soebur Razzaque, Immacolata Carmen Rea, Diego Real, Giorgio Riccobene, Joshua Robinson, Andrey Romanov, Adrian Saina, Francisco Salesa Greus, Dorothea Franziska Elisabeth Samtleben, Agustín Sánchez Losa, Simone Sanfilippo, Matteo Sanguineti, Claudio Santonastaso, Domenico Santonocito, Piera Sapienza, Jan-Willem Schmelling, Jutta Schnabel, Johannes Schumann, Hester Schutte, Jordan Seneca, Nour-Eddine Sennan, Bastian Setter, Irene Sgura, Rezo Shanidze, Ankur Sharma, Yury Shitov, Fedor Šimkovic, Andreino Simonelli, Anna Sinopoulou, Mikhail Smirnov, Bernardino Spisso, Maurizio Spurio, Dimitris Stavropoulos, Ivan Štekl, Mauro Taiuti, Yahya Tayalati, Hannes Thiersen, Iara Tosta e Melo, Efi Tragia, Benjamin Trocme, Vasileios Tsourapis, Ekaterini Tzamariudaki, Antonin Vacheret, Angel Valer Melchor, Veronica Valsecchi, Vincent van Beveren, Thijs van Eeden, Daan van Eijk, Véronique Van Elewyck, Hans van Haren, Godefroy Vannoye, George Vasileiadis, Francisco Vazquez De Sola, Cedric Verilhac, Alessandro Veutro, Salvatore Viola, Daniele Vivolo, Joern Wilms, Harold Yepes Ramirez, Giorgos Zarpapis, Sandra Zavatarelli, Angela Zegarelli, Daniele Zito, Juan de Dios Zornoza, Juan Zuñiga and Natalia Zywuckaadd Show full author list remove Hide full author list
Electronics 2024, 13(11), 2044; https://doi.org/10.3390/electronics13112044 - 24 May 2024
Cited by 1 | Viewed by 1846
Abstract
The KM3NeT Collaboration is building an underwater neutrino observatory at the bottom of the Mediterranean Sea, consisting of two neutrino telescopes, both composed of a three-dimensional array of light detectors, known as digital optical modules. Each digital optical module contains a set of [...] Read more.
The KM3NeT Collaboration is building an underwater neutrino observatory at the bottom of the Mediterranean Sea, consisting of two neutrino telescopes, both composed of a three-dimensional array of light detectors, known as digital optical modules. Each digital optical module contains a set of 31 three-inch photomultiplier tubes distributed over the surface of a 0.44 m diameter pressure-resistant glass sphere. The module also includes calibration instruments and electronics for power, readout, and data acquisition. The power board was developed to supply power to all the elements of the digital optical module. The design of the power board began in 2013, and ten prototypes were produced and tested. After an exhaustive validation process in various laboratories within the KM3NeT Collaboration, a mass production batch began, resulting in the construction of over 1200 power boards so far. These boards were integrated in the digital optical modules that have already been produced and deployed, which total 828 as of October 2023. In 2017, an upgrade of the power board, to increase reliability and efficiency, was initiated. The validation of a pre-production series has been completed, and a production batch of 800 upgraded boards is currently underway. This paper describes the design, architecture, upgrade, validation, and production of the power board, including the reliability studies and tests conducted to ensure safe operation at the bottom of the Mediterranean Sea throughout the observatory’s lifespan. Full article
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12 pages, 655 KiB  
Article
Long-Term Outcomes in Two-Year Follow-Up after Primary Treatment in Patients with a Prior Venous Thromboembolic Event: A Prospective, Observational, Real-Life Study
by Gualtiero Palareti, Emilia Antonucci, Eugenio Bucherini, Antonella Caronna, Antonio Chistolini, Angela Di Giorgio, Rosella Di Giulio, Anna Falanga, Vittorio Fregoni, Mariagrazia Garzia, Daniela Mastroiacovo, Marco Marzolo, Roberta Pancani, Daniele Pastori, Gian Marco Podda, Anna Maria Rigoni, Luigi Ria, Piera Sivera, Sophie Testa, Adriana Visonà, Roberto Parisi, Daniela Poli and on behalf of the START POST VTE Investigatorsadd Show full author list remove Hide full author list
J. Clin. Med. 2024, 13(5), 1343; https://doi.org/10.3390/jcm13051343 - 27 Feb 2024
Cited by 2 | Viewed by 1495
Abstract
Background: Patients with acute venous thromboembolism (VTE) need anticoagulation (AC) therapy for at least 3/6 months (primary treatment); after that period, they should receive a decision on the duration of therapy. Methods: This study examined the complications occurring during two years of follow-up [...] Read more.
Background: Patients with acute venous thromboembolism (VTE) need anticoagulation (AC) therapy for at least 3/6 months (primary treatment); after that period, they should receive a decision on the duration of therapy. Methods: This study examined the complications occurring during two years of follow-up (FU) in patients with a first VTE who were recruited in 20 clinical centers and had discontinued or prolonged AC. They were included in the START2-POST-VTE prospective observational study. Results: A total of 720 patients (53.5% males) who, after the completion of primary treatment, had received the decision to continue (n = 281, 39%; 76.1% with a DOAC) or discontinue (n = 439, 61%) AC were followed up for 2 years (total FU = 1318 years). The decision to prolong or suspend AC was made in similar proportions in patients with unprovoked or provoked index events. Courses of sulodexide treatment or Aspirin (100 mg daily) were prescribed to 20.3% and 4.5%, respectively, of the patients who discontinued AC. The bleeding rate was significantly higher in patients who extended AC (1.6% pt/y) than in those who stopped AC (0.1% pt/y; p = 0.001) and was higher in patients using standard-dose DOACs (3.1% pt/y) than in those using reduced-dose DOACs (0.4% pt/y). The recurrent VTE rates were similar between the two groups (2.2% pt/y during AC vs. 3% pt/y off AC). Conclusion: Physicians’ decisions about AC duration were independent of the unprovoked/provoked nature of the index event. The bleeding rate was higher in patients who continued AC using standard-dose DOACs. Surprisingly, the rate of thrombotic recurrence was not different between those who continued or discontinued AC. Randomized studies comparing different procedures to decide on the duration of AC after a first VTE are needed. Full article
(This article belongs to the Special Issue Advances in Thrombotic Disorders and Antithrombotic Treatments)
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10 pages, 452 KiB  
Article
MITO39: Efficacy and Tolerability of Pegylated Liposomal Doxorubicin (PLD)–Trabectedin in the Treatment of Relapsed Ovarian Cancer after Maintenance Therapy with PARP Inhibitors—A Multicenter Italian Trial in Ovarian Cancer Observational Case-Control Study
by Margherita Turinetto, Andrea Ricotti, Claudia Marchetti, Carmela Pisano, Claudio Zamagni, Chiara Cassani, Paola Malaguti, Alessandra Baldoni, Paolo Scollo, Giuseppa Scandurra, Alessandro Parisi, Grazia Artioli, Innocenza Palaia, Laura Vertechy, Alice Bergamini, Elisa Picardo, Valentina Tuninetti, Giulia Scotto, Giovanni Scambia, Sandro Pignata and Giorgio Valabregaadd Show full author list remove Hide full author list
Cancers 2024, 16(1), 41; https://doi.org/10.3390/cancers16010041 - 20 Dec 2023
Cited by 3 | Viewed by 1873
Abstract
Objective: While PLD-Trabectedin is an approved treatment for relapsed platinum-sensitive ovarian cancer, its efficacy and tolerability has so far not been tested extensively in patients who progress after poly ADP-ribose polymerase inhibitor (PARPi) treatment. Methodology: This multicenter, retrospective analysis had the objective of [...] Read more.
Objective: While PLD-Trabectedin is an approved treatment for relapsed platinum-sensitive ovarian cancer, its efficacy and tolerability has so far not been tested extensively in patients who progress after poly ADP-ribose polymerase inhibitor (PARPi) treatment. Methodology: This multicenter, retrospective analysis had the objective of comparing patients receiving PLD-Trabectedin after being treated with PARP-I (cases) with PARPi-naïve patients. Descriptive and survival analyses were performed for each group. Results: Data from 166 patients were collected, composed of 109 cases and 57 controls. In total, 135 patients were included in our analyses, composing 46 controls and 89 cases. The median PFS was 11 months (95% IC 10–12) in the control group vs. 8 months (95% IC 6–9) in the case group (p value 0.0017). The clinical benefit rate was evaluated, with an HR for progression of 2.55 (1.28–5.06) for the case group (p value 0.008), persisting when adjusted for BRCA and line with treatment. We compared hematological toxicity, gastro-intestinal toxicity, hand–foot syndrome (HFS), fatigue, and liver toxicity, and no statistically significant disparity was noted, except for HFS with a p value of 0.006. The distribution of G3 and G4 toxicities was also equally represented. Conclusion: The MITO39 study showed a statistically significant difference in terms of PFS, suggesting that previous exposure to PARPi might inhibit the efficacy of PLD-Trabectedin. Regarding tolerability, no remarkable disparity was noted; PLD-Trabectedin was confirmed to be a well-tolerated scheme in both groups. To our knowledge, these are the first data regarding this topic, which we deem to be of great relevance in the current landscape. Full article
(This article belongs to the Special Issue New Challenges in Gynaecological Cancers Diagnosis and Treatment)
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13 pages, 1044 KiB  
Article
Long-Term Retention Rate of Tofacitinib in Rheumatoid Arthritis: An Italian Multicenter Retrospective Cohort Study
by Marino Paroli, Andrea Becciolini, Elena Bravi, Romina Andracco, Valeria Nucera, Simone Parisi, Francesca Ometto, Federica Lumetti, Antonella Farina, Patrizia Del Medico, Matteo Colina, Alberto Lo Gullo, Viviana Ravagnani, Palma Scolieri, Maddalena Larosa, Marta Priora, Elisa Visalli, Olga Addimanda, Rosetta Vitetta, Alessandro Volpe, Alessandra Bezzi, Francesco Girelli, Aldo Biagio Molica Colella, Rosalba Caccavale, Eleonora Di Donato, Giuditta Adorni, Daniele Santilli, Gianluca Lucchini, Eugenio Arrigoni, Ilaria Platè, Natalia Mansueto, Aurora Ianniello, Enrico Fusaro, Maria Chiara Ditto, Vincenzo Bruzzese, Dario Camellino, Gerolamo Bianchi, Francesca Serale, Rosario Foti, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Massimo Reta, Alessia Fiorenza, Guido Rovera, Antonio Marchetta, Maria Cristina Focherini, Fabio Mascella, Simone Bernardi, Gilda Sandri, Dilia Giuggioli, Carlo Salvarani, Veronica Franchina, Francesco Molica Colella, Giulio Ferrero and Alarico Arianiadd Show full author list remove Hide full author list
Medicina 2023, 59(8), 1480; https://doi.org/10.3390/medicina59081480 - 17 Aug 2023
Cited by 14 | Viewed by 2902
Abstract
Background: Tofacitinib (TOFA) was the first Janus kinase inhibitor (JAKi) to be approved for the treatment of rheumatoid arthritis (RA). However, data on the retention rate of TOFA therapy are still far from definitive. Objective: The goal of this study is [...] Read more.
Background: Tofacitinib (TOFA) was the first Janus kinase inhibitor (JAKi) to be approved for the treatment of rheumatoid arthritis (RA). However, data on the retention rate of TOFA therapy are still far from definitive. Objective: The goal of this study is to add new real-world data on the TOFA retention rate in a cohort of RA patients followed for a long period of time. Methods: A multicenter retrospective study of RA subjects treated with TOFA as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was conducted in 23 Italian tertiary rheumatology centers. The study considered a treatment period of up to 48 months for all included patients. The TOFA retention rate was assessed with the Kaplan–Meier method. Hazard ratios (HRs) for TOFA discontinuation were obtained using Cox regression analysis. Results: We enrolled a total of 213 patients. Data analysis revealed that the TOFA retention rate was 86.5% (95% CI: 81.8–91.5%) at month 12, 78.8% (95% CI: 78.8–85.2%) at month 24, 63.8% (95% CI: 55.1–73.8%) at month 36, and 59.9% (95% CI: 55.1–73.8%) at month 48 after starting treatment. None of the factors analyzed, including the number of previous treatments received, disease activity or duration, presence of rheumatoid factor and/or anti-citrullinated protein antibody, and presence of comorbidities, were predictive of the TOFA retention rate. Safety data were comparable to those reported in the registration studies. Conclusions: TOFA demonstrated a long retention rate in RA in a real-world setting. This result, together with the safety data obtained, underscores that TOFA is a viable alternative for patients who have failed treatment with csDMARD and/or biologic DMARDs (bDMARDs). Further large, long-term observational studies are urgently needed to confirm these results. Full article
(This article belongs to the Special Issue Recent Advances in Rheumatoid Arthritis)
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10 pages, 1640 KiB  
Article
Retinal Thickness Deviation: A New OCT Parameter for Assessing Diabetic Macular Edema
by Paola Marolo, Enrico Borrelli, Francesco Gelormini, Giacomo Boscia, Guglielmo Parisi, Matteo Fallico, Costanza Barresi, Giorgio Lari, Alessandro Berni, Francesco Bandello and Michele Reibaldi
J. Clin. Med. 2023, 12(12), 3976; https://doi.org/10.3390/jcm12123976 - 11 Jun 2023
Cited by 4 | Viewed by 1857
Abstract
(1) Purpose: To determine the “retinal thickness deviation” (RTD) in diabetic macular edema (DME) eyes treated with intravitreal therapy and to establish associations between RTD and best-corrected visual acuity (BCVA). (2) Methods: We conducted a retrospective study, including consecutive patients with DME eyes [...] Read more.
(1) Purpose: To determine the “retinal thickness deviation” (RTD) in diabetic macular edema (DME) eyes treated with intravitreal therapy and to establish associations between RTD and best-corrected visual acuity (BCVA). (2) Methods: We conducted a retrospective study, including consecutive patients with DME eyes undergoing intravitreal therapy with two years of follow-up. BCVA and central subfield thickness (CST) were collected at baseline and at 12 months and 24 months of follow-up. RTD was calculated as the absolute difference between measured and normative CST values at each time point. Linear regression analyses were performed between RTD and BCVA and between CST and BCVA. (3) Results: One hundred and four eyes were included in the analysis. The RTD was 177.0 (117.2) μm at baseline, 97.0 (99.7) μm at 12 months and 89.9 (75.3) μm at 24 months of follow-up (p < 0.001). RTD showed a moderate association with BCVA at baseline (R2 = 0.134, p < 0.001) and 12 months (R2 = 0.197, p < 0.001) and a substantial association at 24 months (R2 = 0.272, p < 0.001). The CST showed a moderate association with BCVA at baseline (R2 = 0.132, p < 0.001) and 12 months (R2 = 0.136, p < 0.001), while the association was weak at 24 months (R2 = 0.065, p = 0.009). (4) Conclusions: RTD showed a good association with visual outcome in patients with DME eyes undergoing intravitreal treatment. Full article
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11 pages, 1017 KiB  
Article
Therapeutic Effects of Apremilast on Enthesitis and Dactylitis in Real Clinical Setting: An Italian Multicenter Study
by Alberto Lo Gullo, Andrea Becciolini, Simone Parisi, Patrizia Del Medico, Antonella Farina, Elisa Visalli, Ylenia Dal Bosco, Aldo Biagio Molica Colella, Federica Lumetti, Rosalba Caccavale, Palma Scolieri, Romina Andracco, Francesco Girelli, Elena Bravi, Matteo Colina, Alessandro Volpe, Aurora Ianniello, Maria Chiara Ditto, Valeria Nucera, Veronica Franchina, Ilaria Platé, Eleonora Di Donato, Giorgio Amato, Carlo Salvarani, Simone Bernardi, Gianluca Lucchini, Francesco De Lucia, Francesco Molica Colella, Daniele Santilli, Natalia Mansueto, Giulio Ferrero, Antonio Marchetta, Eugenio Arrigoni, Rosario Foti, Gilda Sandri, Vincenzo Bruzzese, Marino Paroli, Enrico Fusaro and Alarico Arianiadd Show full author list remove Hide full author list
J. Clin. Med. 2023, 12(12), 3892; https://doi.org/10.3390/jcm12123892 - 7 Jun 2023
Cited by 3 | Viewed by 1801
Abstract
Introduction: Enthesitis and dactylitis are difficult-to-treat features of psoriatic arthritis (PsA), leading to disability and affecting quality of life. Objective: The aim of this study is to evaluate enthesitis (using the Leed enthesitis index (LEI)) and dactylitis at 6 and 12 months in [...] Read more.
Introduction: Enthesitis and dactylitis are difficult-to-treat features of psoriatic arthritis (PsA), leading to disability and affecting quality of life. Objective: The aim of this study is to evaluate enthesitis (using the Leed enthesitis index (LEI)) and dactylitis at 6 and 12 months in patients treated with apremilast. Methods: Patients affected by PsA from fifteen Italian rheumatological referral centers were screened. The inclusion criteria were: (a) enthesitis or dactylitisphenotype; (b) treatment with apremilast 30 mg bid. Clinical and treatment history, including PsA disease activity, were recorded. Mann–Whitney and chi-squared tests were used to assess the differences between independent groups, and Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A p-value of <0.05 was considered statistically significant. Results: The Eph cohort consisted of 118 patients (median LEI 3); the Dph cohort included 96 patients with a median dactylitis of 1 (IQR 1–2). According to an intention to treat analysis, 25% and 34% of patients with enthesitis achieved remission (i.e., LEI = 0) in T1 and T2. The remission of dactylitis was 47% in T1 and 44% in T2. The per protocol analysis (patients observed for at least 12 months) showed that both dactylitis and LEI significantly improved in T1 (median LEI 1 (IQR 1–3)) and T2 (median LEI 0 (IQR 1–2)). Conclusion: Eph and Dph PsA patients treated with apremilast experienced a significant improvement in enthesitis and dactylitis activity. After 1 year, enthesitis and dactylitis remission was achieved in more than one-third of patients. Full article
(This article belongs to the Section Immunology)
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12 pages, 1829 KiB  
Article
Retinitis Pigmentosa Associated with EYS Gene Mutations: Disease Severity Staging and Central Retina Atrophy
by Giorgio Placidi, Paolo Enrico Maltese, Maria Cristina Savastano, Elena D’Agostino, Valentina Cestrone, Matteo Bertelli, Pietro Chiurazzi, Martina Maceroni, Angelo Maria Minnella, Lucia Ziccardi, Vincenzo Parisi, Stanislao Rizzo and Benedetto Falsini
Diagnostics 2023, 13(5), 850; https://doi.org/10.3390/diagnostics13050850 - 23 Feb 2023
Cited by 3 | Viewed by 3134
Abstract
Background. Eyes shut homolog (EYS) gene mutations are estimated to affect at least 5% of patients with autosomal recessive retinitis pigmentosa. Since there is no mammalian model of human EYS disease, it is important to investigate its age-related changes and the degree of [...] Read more.
Background. Eyes shut homolog (EYS) gene mutations are estimated to affect at least 5% of patients with autosomal recessive retinitis pigmentosa. Since there is no mammalian model of human EYS disease, it is important to investigate its age-related changes and the degree of central retinal impairment. Methods. A cohort of EYS patients was studied. They underwent full ophthalmic examination as well as assessment of retinal function and structure, by full-field and focal electroretinograms (ERGs) and spectral domain optical coherence tomography (OCT), respectively. The disease severity stage was determined by the RP stage scoring system (RP-SSS). Central retina atrophy (CRA) was estimated from the automatically calculated area of the sub-retinal pigment epithelium (RPE) illumination (SRI). Results. The RP-SSS was positively correlated with age, showing an advanced severity score (≥8) at an age of 45 and a disease duration of 15 years. The RP-SSS was positively correlated with the CRA area. LogMAR visual acuity and ellipsoid zone width, but not ERG, were correlated with CRA. Conclusions. In EYS-related disease, the RP-SSS showed advanced severity at a relative early age and was correlated with the central area of the RPE/photoreceptor atrophy. These correlations may be relevant in view of therapeutic interventions aimed at rescuing rods and cones in EYS-retinopathy. Full article
(This article belongs to the Section Pathology and Molecular Diagnostics)
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15 pages, 1810 KiB  
Article
Ki67 as a Predictor of Response to PARP Inhibitors in Platinum Sensitive BRCA Wild Type Ovarian Cancer: The MITO 37 Retrospective Study
by Valentina Tuninetti, Eleonora Ghisoni, Sandro Pignata, Elisa Picardo, Francesco Raspagliesi, Claudia Andreetta, Elena Maldi, Grazia Artioli, Serafina Mammoliti, Lucia Zanchi, Angelica Sikokis, Nicoletta Biglia, Alessandro Parisi, Vincenzo Dario Mandato, Claudia Carella, Gennaro Cormio, Marco Marinaccio, Andrea Puppo, Biagio Paolini, Lucia Borsotti, Giulia Scotto, Margherita Turinetto, Dario Sangiolo, Massimo Di Maio and Giorgio Valabregaadd Show full author list remove Hide full author list
Cancers 2023, 15(4), 1032; https://doi.org/10.3390/cancers15041032 - 6 Feb 2023
Cited by 2 | Viewed by 2766
Abstract
Background: There is compelling need for novel biomarkers to predict response to PARP inhibitors (PARPi) in BRCA wild-type (WT) ovarian cancer (OC). Methods: MITO 37 is a multicenter retrospective study aiming at correlating Ki67 expression at diagnosis with a clinical outcome following platinum [...] Read more.
Background: There is compelling need for novel biomarkers to predict response to PARP inhibitors (PARPi) in BRCA wild-type (WT) ovarian cancer (OC). Methods: MITO 37 is a multicenter retrospective study aiming at correlating Ki67 expression at diagnosis with a clinical outcome following platinum treatment and PARPi maintenance. Clinical data were collected from high grade serous or endometroid BRCAWT OC treated with niraparib or rucaparib maintenance between 2010–2021 in 15 centers. Ki67 expression was assessed locally by certified pathologists on formalin-fixed paraffin embedded (FFPE) tissues. Median Ki67 was used as a cut-off. Results: A total of 136 patients were eligible and included in the analysis. Median Ki67 was 45.7% (range 1.0–99.9). The best response to platinum according to median Ki67 was 26.5% vs. 39.7% complete response (CR), 69.1% vs. 58.8% partial response (PR), 4.4% vs. 1.5% stable disease (SD). The best response to PARPi according to median Ki67 was 19.1% vs. 36.8% CR, 26.5% vs. 26.5% PR, 26.5 vs. 25% SD, 27.9% vs. 16.2% progressive disease (PD). No statistically significant differences in progression free survival (PFS) and overall survival (OS) were identified between low and high Ki67. PFS and OS are in line with registration trials. Conclusions: Ki67 at diagnosis did not discriminate responders to PARPi. Full article
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9 pages, 1010 KiB  
Article
Predictors of DAPSA Response in Psoriatic Arthritis Patients Treated with Apremilast in a Retrospective Observational Multi-Centric Study
by Andrea Becciolini, Simone Parisi, Patrizia Del Medico, Antonella Farina, Elisa Visalli, Aldo Biagio Molica Colella, Federica Lumetti, Rosalba Caccavale, Palma Scolieri, Romina Andracco, Francesco Girelli, Elena Bravi, Matteo Colina, Alessandro Volpe, Aurora Ianniello, Maria Chiara Ditto, Valeria Nucera, Veronica Franchina, Ilaria Platè, Eleonora Di Donato, Giorgio Amato, Carlo Salvarani, Simone Bernardi, Gianluca Lucchini, Francesco De Lucia, Francesco Molica Colella, Daniele Santilli, Natalia Mansueto, Giulio Ferrero, Antonio Marchetta, Eugenio Arrigoni, Rosario Foti, Gilda Sandri, Vincenzo Bruzzese, Marino Paroli, Enrico Fusaro and Alarico Arianiadd Show full author list remove Hide full author list
Biomedicines 2023, 11(2), 433; https://doi.org/10.3390/biomedicines11020433 - 2 Feb 2023
Cited by 3 | Viewed by 2670
Abstract
Background: To date, only a few real-world-setting studies evaluated apremilast effectiveness in psoriatic arthritis (PsA). The aims of this retrospective observational study are to report long-term Disease Activity Index for Psoriatic Arthritis (DAPSA) response of apremilast in PsA patients and to analyze the [...] Read more.
Background: To date, only a few real-world-setting studies evaluated apremilast effectiveness in psoriatic arthritis (PsA). The aims of this retrospective observational study are to report long-term Disease Activity Index for Psoriatic Arthritis (DAPSA) response of apremilast in PsA patients and to analyze the predictors of clinical response. Methods: All PsA consecutive patients treated with apremilast in fifteen Italian rheumatological referral centers were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline, 6 months, and 12 months were recorded. The Mann–Whitney test and chi-squared tests assessed the differences between independent groups, whereas the Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. Logistic regressions verified if there were factors associated with achievement of DAPSA low disease activity or remission at 6 and 12 months. Results: DAPSA low disease activity or remission rates at 6 and 12 months were observed, respectively, in 42.7% (n = 125) and 54.9% (n = 161) patients. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio (OR) 0.841, 95% confidence interval (CI) 0.804–0.879; p < 0.01) and at 12 months (OR 0.911, 95% CI 0.883–0.939; p < 0.01). Conclusions: Almost half of the PsA patients receiving apremilast achieved DAPSA low disease activity or remission at 6 and 12 months. The only factor associated with achievement of low disease activity or remission at both 6 and 12 months was baseline DAPSA. Full article
(This article belongs to the Section Immunology and Immunotherapy)
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