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12 results on '"Villa, Maria Rosaria"'

1. Pattern of use and clinical outcomes with rIX‐FP in pediatric/adolescent patients with haemophilia B in Italy: Results from IDEAL real‐world study.

Author

Giordano, Paola, Pollio, Berardino, Sottilotta, Gianluca, Biasoli, Chiara, Daniele, Filomena, De Cristofaro, Raimondo, Peyvandi, Flora, Villa, Maria Rosaria, Castaman, Giancarlo, Banov, Laura, Borchiellini, Alessandra, Coppola, Antonio, Cultrera, Dorina, Cipolla, Antonino, Demartis, Francesco, Marchesini, Emanuela, Margaglione, Maurizio, Marino, Renato, Radossi, Paolo, and Santoro, Cristina

Subjects
HEMOPHILIACS, TREATMENT effectiveness, TEENAGERS
Abstract

Objectives: To evaluate pattern of use and clinical outcomes in pediatric/adolescent patients enrolled in the IDEAL study. Methods: This post‐hoc analysis of IDEAL retrospective‐prospective observational study focused on patients <18 years, 100% on prophylaxis during the entire observation period. Results: Thirteen subjects (median age 10.0 years; 61.5% ≤ 11 years) were analyzed. The infusion frequency changed from 2/week in 84.6% (N = 11) of patients with previous rFIX, to less than 1/weekly in 76.9% (N = 9) with rIX‐FP and the annualized number of infusions reduced of 57% (p =.002), from a mean ± SD of 95.1 ± 22.77 to 40.4 ± 6.79, respectively. Annualized mean consumption decreased of about 56% (p =.001), from 3748.4 ± 1155.40 IU/kg with previous rFIX, to 1656.8 ± 456.63 IU/kg of rIX‐FP. Mean FIX trough level changed from 3.0% ± 1.98% to 10.92% ± 3.6%. Low mean Annualized Bleeding Rate was maintained across all prophylaxis regimens (0.8 ± 1.69 vs. 0.3 ± 0.89) and zero bleeding patients moved from 69.2% (N = 9) with previous rFIX to 84.6% (N = 11) with rIX‐FP (p =.63). Two adverse events, none related to rIX‐FP, occurred in two patients. No inhibitors development was reported. Conclusions: The results in this pediatric/adolescent subgroup support rIX‐FP prophylaxis may reduce infusion frequency, while providing high FIX trough levels, stable annualized bleeding rate and a good safety profile. [ABSTRACT FROM AUTHOR]

Published
2024
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2. IDEAL study: A real‐world assessment of pattern of use and clinical outcomes with recombinant coagulation factor IX albumin fusion protein (rIX‐FP) in patients with haemophilia B in Italy

Author

Tagliaferri, Annarita, primary, Molinari, Angelo Claudio, additional, Peyvandi, Flora, additional, Coppola, Antonio, additional, Demartis, Francesco, additional, Biasoli, Chiara, additional, Borchiellini, Alessandra, additional, Cultrera, Dorina, additional, De Cristofaro, Raimondo, additional, Daniele, Filomena, additional, Giordano, Paola, additional, Marchesini, Emanuela, additional, Margaglione, Maurizio, additional, Marino, Renato, additional, Pollio, Berardino, additional, Radossi, Paolo, additional, Santoro, Cristina, additional, Santoro, Rita Carlotta, additional, Siragusa, Sergio, additional, Sottilotta, Gianluca, additional, Tosetto, Alberto, additional, Piscitelli, Lydia, additional, Villa, Maria Rosaria, additional, Zanon, Ezio, additional, Finardi, Adele, additional, Schiavetti, Irene, additional, Vaccari, Daniella, additional, and Castaman, Giancarlo, additional

Published
2022
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3. Adding hydroxyurea in combination with ruxolitinib improves clinical responses in hyperproliferative forms of myelofibrosis

Author

Pugliese, Novella, primary, Giordano, Claudia, additional, Nappi, Davide, additional, Luciano, Luigiana, additional, Cerchione, Claudio, additional, Annunziata, Mario, additional, Casale, Beniamino, additional, Crisà, Elena, additional, Villa, Maria Rosaria, additional, Pezzullo, Luca, additional, Iovine, Maria, additional, Picardi, Marco, additional, Grimaldi, Francesco, additional, Pane, Fabrizio, additional, and Martinelli, Vincenzo, additional

Published
2019
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4. Adding Hydroxyurea in Combination with Ruxolitinib Improves Clinical Responses in Hyperproliferative Forms of Myelofibrosis

Author

Pugliese, Novella, primary, Giordano, Claudia, additional, Nappi, Davide, additional, Luciano, Luigia, additional, Cerchione, Claudio, additional, Annunziata, Mario, additional, Casale, Beniamino, additional, Crisà, Elena, additional, Villa, Maria Rosaria, additional, Pezzullo, Luca, additional, Iovine, Mariolina, additional, Picardi, Marco, additional, Grimaldi, Francesco, additional, Monteverde, Maria, additional, and Pane, Fabrizio, additional

Published
2018
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5. Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials

Author

Gentile, Massimo, primary, Zirlik, Katja, additional, Ciolli, Stefania, additional, Mauro, Francesca R., additional, Di Renzo, Nicola, additional, Mastrullo, Lucia, additional, Angrilli, Francesco, additional, Molica, Stefano, additional, Tripepi, Giovanni, additional, Giordano, Annamaria, additional, Di Raimondo, Francesco, additional, Selleri, Carmine, additional, Coscia, Marta, additional, Musso, Maurizio, additional, Orsucci, Lorella, additional, Mannina, Donato, additional, Rago, Angela, additional, Giannotta, Angela, additional, Ferrara, Felicetto, additional, Herishanu, Yair, additional, Shvidel, Lev, additional, Tadmor, Tamar, additional, Scortechini, Ilaria, additional, Ilariucci, Fiorella, additional, Murru, Roberta, additional, Guarini, Attilio, additional, Musuraca, Gerardo, additional, Mineo, Giuseppe, additional, Vincelli, Iolanda, additional, Arcari, Annalisa, additional, Tarantini, Giuseppe, additional, Caparrotti, Giuseppe, additional, Chiarenza, Annalisa, additional, Levato, Luciano, additional, Villa, Maria Rosaria, additional, De Paolis, Maria Rosaria, additional, Zinzani, Pier Luigi, additional, Polliack, Aaron, additional, and Morabito, Fortunato, additional

Published
2016
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7. Initial Therapeutic Approach and Relationship with Clinical and Biological Characteristics at Diagnosis in 2418 Patients of the Registro Italiano Trombocitemie (RIT)

Author

Gugliotta, Luigi, primary, Iurlo, Alessandra, additional, Gugliotta, Gabriele, additional, Tieghi, Alessia, additional, Candoni, Anna, additional, Cattaneo, Daniele, additional, Ricco, Alessandra, additional, Lunghi, Monia, additional, Rumi, Elisa, additional, Scalzulli, Potito Rosario, additional, Dragani, Alfredo, additional, Antonioli, Elisabetta, additional, Martinelli, Vincenzo, additional, Randi, Maria Luigia, additional, Maschio, Nilla, additional, De Biasi, Ercole, additional, Appolloni, Viviana, additional, Cantore, Nicola, additional, Palmieri, Raffaele, additional, Santoro, Cristina, additional, Polverelli, Nicola, additional, Rago, Angela, additional, Cacciola, Rossella R, additional, Villa, Maria Rosaria, additional, Codeluppi, Katia, additional, Pierri, Ivana, additional, Fama, Angelo, additional, Piccin, Andrea, additional, Martino, Bruno, additional, Vianelli, Nicola, additional, Rupoli, Serena, additional, Santoro, Umberto, additional, Miglio, Rossella, additional, Monari, Paola, additional, and Mazzucconi, Maria Gabriella, additional

Published
2014
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8. Bendamustine in Combination with Rituximab for Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients: An Italian Retrospective Multicentre Study

Author

Gentile, Massimo, primary, Ciolli, Stefania, additional, Molica, Stefano, additional, Di Renzo, Nicola, additional, Selleri, Carmine, additional, Villa, Maria Rosaria, additional, De Paolis, Maria Rosaria, additional, Scortechini, Ilaria, additional, Giannotta, Angela, additional, Minoia, Carla, additional, Rago, Angela, additional, Boncompagni, Riccardo, additional, Bonanno, Vincenza, additional, Levato, Luciano, additional, Musso, Maurizio, additional, Mastrullo, Lucia, additional, Melpignano, Angela, additional, Murru, Roberta, additional, Angelucci, Emanuele, additional, Tarantini, Giuseppe, additional, Caparrotti, Giuseppe, additional, Guarini, Attilio, additional, Ferrara, Felicetto, additional, Cimino, Giuseppe, additional, Zinzani, Pier Luigi, additional, and Morabito, Fortunato, additional

Published
2014
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9. Prognostic role of translocator protein and oxidative stress markers in chronic lymphocytic leukemia patients treated with bendamustine plus rituximab.

Author

DE ROSA, ANIELLO, ZAPPAVIGNA, SILVIA, VILLA, MARIA ROSARIA, IMPROTA, SALVATORE, CESARIO, ELENA, MASTRULLO, LUCIA, CARAGLIA, MICHELE, and STIUSO, PAOLA

Subjects
MITOCHONDRIAL membranes, TRANSLOCATOR proteins, APOPTOSIS, CELL proliferation, BIOSYNTHESIS, IMMUNOREGULATION
Abstract

Principally located in the outer mitochondrial membrane, the translocator protein (TSPO) is an 18-kDa transmembrane protein that is a key component of the mitochondrial permeability transition pore. TSPO is associated with a number of biological processes, including apoptosis, the regulation of cellular proliferation, porphyrin transport and heme biosynthesis, immunomodulation, anion transport and the regulation of steroidogenesis. Thus, numerous studies have proposed TSPO as a promising target for novel therapeutic agents, particularly for the treatment of cancer. In the present study, the response of 30 consecutive chronic lymphocytic leukemia (CLL) patients to bendamustine and rituximab treatment was evaluated according to TSPO expression levels. Furthermore, thiobarbituric acid reactive substances (TBARS) and nitric oxide (NO) levels, as well as caspase-3 activity were determined. Compared with the lymphocytes of healthy donors, the 30 consecutive CLL patients exhibited increased TSPO expression levels, decreased TBARS and NO levels and reduced caspase-3 activity. Six months after the treatment commenced, the TSPO/mitochondria ratio resembled that of the healthy controls in 24/30 CLL patients. In addition, an increase in TBARS and NO levels, two markers of oxidative stress, and a potentiation of caspase-3 activity in all responder patients was observed. Notably, the six patients who appeared to be resistant to treatment also displayed higher TSPO levels, and lower caspase-3 activity and TBARS levels. These data indicate that TSPO expression may be a molecular prognostic factor in CLL patients. [ABSTRACT FROM AUTHOR]

Published
2015
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10. IDEAL study: A real‐world assessment of pattern of use and clinical outcomes with recombinant coagulation factor IX albumin fusion protein (rIX‐FP) in patients with haemophilia B in Italy

Author

Annarita Tagliaferri, Angelo Claudio Molinari, Flora Peyvandi, Antonio Coppola, Francesco Demartis, Chiara Biasoli, Alessandra Borchiellini, Dorina Cultrera, Raimondo De Cristofaro, Filomena Daniele, Paola Giordano, Emanuela Marchesini, Maurizio Margaglione, Renato Marino, Berardino Pollio, Paolo Radossi, Cristina Santoro, Rita Carlotta Santoro, Sergio Siragusa, Gianluca Sottilotta, Alberto Tosetto, Lydia Piscitelli, Maria Rosaria Villa, Ezio Zanon, Adele Finardi, Irene Schiavetti, Daniella Vaccari, Giancarlo Castaman, Tagliaferri, Annarita, Molinari, Angelo Claudio, Peyvandi, Flora, Coppola, Antonio, Demartis, Francesco, Biasoli, Chiara, Borchiellini, Alessandra, Cultrera, Dorina, De Cristofaro, Raimondo, Daniele, Filomena, Giordano, Paola, Marchesini, Emanuela, Margaglione, Maurizio, Marino, Renato, Pollio, Berardino, Radossi, Paolo, Santoro, Cristina, Santoro, Rita Carlotta, Siragusa, Sergio, Sottilotta, Gianluca, Tosetto, Alberto, Piscitelli, Lydia, Villa, Maria Rosaria, Zanon, Ezio, Finardi, Adele, Schiavetti, Irene, Vaccari, Daniella, and Castaman, Giancarlo

Subjects
ABR, Trough levels, annual consumption, extended half-life FIX, infusion frequency, real life, Hematology, General Medicine, Genetics (clinical)
Abstract

Introduction: Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX-FP is an extended half-life albumin-fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit.Aims: To describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX-FP treatment during routine clinical practice in Italy.Methods: Patients with moderate/severe haemophilia B on prophylaxis with rIX-FP for >= 6 months, were enrolled in this observational study from October 2017 to February 2019 and followed-up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX-FP).Results: Data were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2-3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX-FP at the 2nd-year fol low-up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX-FP.Conclusion: Treatment with rIX-FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile.

Published
2022

11. Combination of bendamustine and rituximab as frontline therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials

Author

Maurizio Musso, Donato Mannina, Nicola Di Renzo, Francesca Romana Mauro, Maria Rosaria De Paolis, Fortunato Morabito, Ilaria Scortechini, Stefania Ciolli, Lucia Mastrullo, Katja Zirlik, Pier Luigi Zinzani, Iolanda Vincelli, Gerardo Musuraca, Giuseppe Tarantini, Annamaria Giordano, Attilio Guarini, Francesco Angrilli, Tamar Tadmor, Angela Giannotta, Maria Rosaria Villa, Aaron Polliack, Annalisa Chiarenza, Annalisa Arcari, Massimo Gentile, Yair Herishanu, Lev Shvidel, Felicetto Ferrara, Giuseppe Caparrotti, Roberta Murru, Fiorella Ilariucci, Lorella Orsucci, Luciano Levato, Giuseppe Mineo, Angela Rago, Francesco Di Raimondo, Stefano Molica, Carmine Selleri, Giovanni Tripepi, Marta Coscia, Gentile, Massimo, Zirlik, Katja, Ciolli, Stefania, Mauro, Francesca R., Di Renzo, Nicola, Mastrullo, Lucia, Angrilli, Francesco, Molica, Stefano, Tripepi, Giovanni, Giordano, Annamaria, Di Raimondo, Francesco, Selleri, Carmine, Coscia, Marta, Musso, Maurizio, Orsucci, Lorella, Mannina, Donato, Rago, Angela, Giannotta, Angela, Ferrara, Felicetto, Herishanu, Yair, Shvidel, Lev, Tadmor, Tamar, Scortechini, Ilaria, Ilariucci, Fiorella, Murru, Roberta, Guarini, Attilio, Musuraca, Gerardo, Mineo, Giuseppe, Vincelli, Iolanda, Arcari, Annalisa, Tarantini, Giuseppe, Caparrotti, Giuseppe, Chiarenza, Annalisa, Levato, Luciano, Villa, Maria Rosaria, De Paolis, Maria Rosaria, Zinzani, Pier Luigi, Polliack, Aaron, and Morabito, Fortunato

Subjects
Adult, Male, Bendamustine, medicine.medical_specialty, Chronic lymphocytic leukaemia, Cancer Research, Phases of clinical research, Neutropenia, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Bendamustine Hydrochloride, Humans, Aged, Retrospective Studies, business.industry, Rituximab, Therapy, Oncology, Middle Aged, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, Surgery, Clinical trial, Regimen, Treatment Outcome, bendamustine, chronic lymphocytic leukaemia, rituximab, therapy, cancer research, oncology, 030220 oncology & carcinogenesis, Cohort, Female, IGHV@, business, 030215 immunology, medicine.drug
Abstract

Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine–rituximab (BR) in untreated chronic lymphocytic leukaemia (CLL) patients enrolled in a phase II study. Here, we report a retrospective international multicenter study of CLL patients treated with BR as front-line therapy. The cohort included 279 patients with progressive CLL from 33 centers (29 Italian, 3 Israeli and 1 German) who received at least 1 cycle of BR as first-line treatment during the 2008–2014 period. The primary objective of this study was to evaluate the efficacy and safety of BR administered as front-line therapy, outside of controlled clinical trials. Median age was 70 years (range, 43–86 years); 62.4% were males and 35.8% had Binet stage C. Forty-two patients (15.2%) were unfit (cumulative illness rating scale [CIRS] score ≥7), and 140 (50.2%) had creatinine clearance ≤70 ml/min. Fluorescent in situ hybridisation analysis, available for 192 cases, showed that 21 (10.9%) had del11q and 18 (9.4%) del17p. The overall response rate (ORR) was 86.4%, with a complete remission rate of 28%. Patients with del17p had an ORR of 66.7%. After median follow-up of 24 months, the 2-year progression-free survival (PFS) was 69.9%; CIRS ≥7, immunoglobulin heavy-chain variable-region (IGHV) unmutated status, del17p and BR dose intensity

Published
2016

12. IDEAL study: A real-world assessment of pattern of use and clinical outcomes with recombinant coagulation factor IX albumin fusion protein (rIX-FP) in patients with haemophilia B in Italy.

Author

Tagliaferri A, Molinari AC, Peyvandi F, Coppola A, Demartis F, Biasoli C, Borchiellini A, Cultrera D, De Cristofaro R, Daniele F, Giordano P, Marchesini E, Margaglione M, Marino R, Pollio B, Radossi P, Santoro C, Santoro RC, Siragusa S, Sottilotta G, Tosetto A, Piscitelli L, Villa MR, Zanon E, Finardi A, Schiavetti I, Vaccari D, and Castaman G

Subjects
Adult, Humans, Male, Albumins, Hemorrhage prevention & control, Hemorrhage drug therapy, Italy, Prospective Studies, Recombinant Fusion Proteins therapeutic use, Retrospective Studies, Factor IX therapeutic use, Hemophilia B drug therapy
Abstract

Introduction: Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX-FP is an extended half-life albumin-fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit., Aims: To describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX-FP treatment during routine clinical practice in Italy., Methods: Patients with moderate/severe haemophilia B on prophylaxis with rIX-FP for ≥6 months, were enrolled in this observational study from October 2017 to February 2019 and followed-up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX-FP)., Results: Data were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2-3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX-FP at the 2nd-year follow-up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX-FP., Conclusion: Treatment with rIX-FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile., (© 2022 CSL Behring S.p.A. Haemophilia published by John Wiley & Sons Ltd.)

Published
2023
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