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1. Immunosuppression with Generics in Liver and Kidney Transplantation: A Real-World Evidence Study

Author

Finocchietti M, Marino ML, Rosa AC, Bellini A, Masiero L, Cardillo M, Massari M, Spila Alegiani S, Pierobon S, Ferroni E, Zanforlini M, Leoni O, Ledda S, Garau D, Davoli M, Addis A, and Belleudi V

Subjects
transplant, maintenance therapy, tacrolimus, cyclosporine, mycophenolate, uptake generics, risk-benefit profile, sustainability, Therapeutics. Pharmacology, RM1-950
Abstract

Marco Finocchietti,1,* Maria Lucia Marino,1,* Alessandro C Rosa,1 Arianna Bellini,1 Lucia Masiero,2 Massimo Cardillo,2 Marco Massari,3 Stefania Spila Alegiani,3 Silvia Pierobon,4 Eliana Ferroni,4 Martina Zanforlini,5 Olivia Leoni,6 Stefano Ledda,7 Donatella Garau,7 Marina Davoli,1 Antonio Addis,1 Valeria Belleudi1 On behalf of CESIT Study Group1Department of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy; 2Italian National Transplant Center, Istituto Superiore di Sanità, Rome, Italy; 3National Center for Drug Research and Evaluation, Istituto Superiore Di Sanità, Rome, Italy; 4Azienda Zero, Veneto Region, Padua, Italy; 5The innovation and procurement regional company, A.R.I.A. S.p.A.-Lombardy Region, Milan, Italy; 6Regional Epidemiological Observatory, Lombardy Region, Milan, Italy; 7General Directorate for Health, Sardinia Region, Cagliari, Italy*These authors contributed equally to this workCorrespondence: Valeria Belleudi, Department of Epidemiology, ASL Roma 1, Lazio Region, Via Cristoforo Colombo, 112, Roma, 00147, Italy, Tel +39.06.99722133, Fax +39.06.99722111, Email v.belleudi@deplazio.itPurpose: This study evaluates the use, benefit-risk profile, and economic impact of generic immunosuppressants (tacrolimus-TAC, cyclosporine-CsA, and mycophenolate-MYC) in kidney and liver transplant recipients compared to brand-name drugs.Patients and Methods: A retrospective multicentre observational study, involving four Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data. The analysis focused on incident patients who received kidney and liver transplants between 2013 and 2019 and evaluated the use of generic of CsA, TAC, and MYC during the 30-day period following discharge. For each type of transplant and immunosuppressive agent, the benefit-risk profile of generic vs branded drugs in a two-year window was estimated by multivariate Cox models (HR; 95% CI). Furthermore, the potential cost savings per person associated with one year of treatment using generics were calculated.Results: The utilization of generic drugs showed a significant increase; over the study years, the proportion of users among kidney recipients ranged from 14.2% to 40.5% for TAC, from 36.9% to 56.7% for MYC, and from 18.2% to 94.7% for CsA. A great variability in generic uptake for region was found. A comparable risk-benefit profile between generic and branded formulations was shown for all immunosuppressors considered. Choosing generic immunosuppressants during maintenance could result in yearly savings of around 2000 euros per person for each therapy ingredient.Conclusion: The study shows an increasing proportion of patients using generic immunosuppressive drugs over time suggesting a growing acceptance of generics within the transplant community and reveals comparable risk-benefit profiles between the generic and branded formulations of TAC, CsA, and MYC. A significant variability in the use of generics immunosuppressive agents was found both at the regional level and among transplant centers and future research should delve into regional prescribing variations.Keywords: transplant, maintenance therapy, tacrolimus, cyclosporine, mycophenolate, uptake generics, risk-benefit profile, sustainability

Published
2024

2. Survival of Hospitalized COVID-19 Patients in Northern Italy: A Population-Based Cohort Study by the ITA-COVID-19 Network

Author

Ferroni E, Giorgi Rossi P, Spila Alegiani S, Trifirò G, Pitter G, Leoni O, Cereda D, Marino M, Pellizzari M, Fabiani M, Riccardo F, Sultana J, and Massari M

Subjects
covid-19, survival, cohort study, hospitalized patients, italy, Infectious and parasitic diseases, RC109-216
Abstract

Eliana Ferroni,1 Paolo Giorgi Rossi,2 Stefania Spila Alegiani,3 Gianluca Trifirò,4 Gisella Pitter,1 Olivia Leoni,5 Danilo Cereda,5 Massimiliano Marino,2 Michele Pellizzari,1 Massimo Fabiani,6 Flavia Riccardo,6 Janet Sultana,4 Marco Massari3 On behalf of The ITA-COVID Working Group1Azienda Zero of the Veneto Region, Padua, Italy; 2Azienda Unità Sanitaria Locale – IRCCS, Reggio Emilia, Italy; 3National Center for Drug Research and Evaluation, Istituto Superiore Di Sanità, Rome, Italy; 4Department of Biomedical and Dental Sciences and Morphofunctional Imaging – University of Messina, Messina, Italy; 5Department of Health of Lombardy Region, Milan, Italy; 6Department of Infectious Diseases, Istituto Superiore Di Sanità, Rome, ItalyCorrespondence: Stefania Spila AlegianiIstituto Superiore Di Sanità, Viale Regina Elena, 299, Rome 00161, ItalyTel +39 0649904249Fax +39 0649904248Email stefania.spila@iss.itPaolo Giorgi RossiAzienda Unità Sanitaria Locale – IRCCS, Reggio Emilia, via Amendola 2, Reggio Emilia 42122, ItalyTel +39 0522335490Email paolo.giorgirossi@ausl.re.itIntroduction: COVID-19 case fatality rate in hospitalized patients varies across countries and studies. Reliable estimates, specific for age, sex, and comorbidities, are needed to monitor the epidemic, to compare the outcome in different settings, and to correctly design trials for COVID-19 interventions. The aim of this study was to provide population-based survival curves of hospitalized COVID-19 patients.Materials and Methods: A cohort study was conducted in three areas of Northern Italy, heavily affected by SARS-CoV-2 infection (Lombardy and Veneto Regions, and Reggio Emilia province), using a loco-regional COVID-19 surveillance system, linked to hospital discharge databases. We included all patients testing positive for SARS-CoV-2 RNA by RT-PCR on nasopharyngeal/throat swab samples who were hospitalized from 21 February to 21 April 2020. Kaplan–Meier survival estimates were calculated at 14 and 30 days for death in any setting, stratifying by age, sex, and the Charlson Index.Results: Overall, 42,926 hospitalized COVID-19 patients were identified. Patients’ median age was 69 years (IQR: 57– 79), 62.6% were males, and 6.0% had a Charlson Index ≥ 3. Survival curves showed that 22.0% (95% CI 21.6– 22.4) of patients died within 14 days and 27.6% (95% CI 27.2– 28.1) within 30 days from hospitalization. Survival was higher in younger patients and in females. The negative impact of comorbidities on survival was more pronounced in younger age groups.Conclusion: The high fatality rate observed in the study (28% at 30 days) suggests that studies should focus on death as primary endpoint during a follow-up of at least one month.Keywords: COVID-19, survival, cohort study, hospitalized patients, Italy

Published
2020

3. Post-marketing active surveillance of Guillain Barré Syndrome following COVID-19 vaccination in persons aged ≥12 years in Italy: A multi-database self-controlled case series study

Author

Morciano, C., Spila Alegiani, Stefania, Menniti Ippolito, F., Belleudi, V., Trifirò, G., Zanoni, G., Puccini, A., Sapigni, E., Mores, Nadia, Leoni, O., Monaco, G., Clagnan, E., Zappetti, C., Bovo, E., Cutillo, M., Da Cas, R., Massari, M., Spila Alegiani S., Mores N. (ORCID:0000-0002-4197-0914), Morciano, C., Spila Alegiani, Stefania, Menniti Ippolito, F., Belleudi, V., Trifirò, G., Zanoni, G., Puccini, A., Sapigni, E., Mores, Nadia, Leoni, O., Monaco, G., Clagnan, E., Zappetti, C., Bovo, E., Cutillo, M., Da Cas, R., Massari, M., Spila Alegiani S., and Mores N. (ORCID:0000-0002-4197-0914)

Abstract

Background: Recently published studies have reported association of COVID-19 vaccine ChAdOx1-S (Vaxzevria) with Guillain Barré Syndrome (GBS). Less is known about the safety of other COVID-19 vaccines with respect to GBS outcome. This study investigated the association of COVID-19 vaccines with GBS in more than 15 million persons aged ≥12 years in Italy. Methods: Study population was all individuals aged ≥12 years who received at least one dose of COVID-19 vaccines, admitted to emergency care/hospital for GBS from 27 December 2020-30 September 2021 in Italy. Identification of GBS cases and receipt of at least one dose of mRNA-1273 (Elasomeran), BNT162b2 (Tozinameran), ChAdOx1-S (Vaxzevria) and Ad26.COV2.S (Janssen) through record linkage between regional health care and vaccination registries. Relative Incidence (RI) was estimated Self-controlled case series method adapted to event-dependent exposure using in the 42-day exposure risk period after each dose compared with other observation periods. Results: Increased risk of GBS was found after first (RI = 6.83; 95% CI 2.14-21.85) and second dose (RI = 7.41; 2.35-23.38) of mRNA-1273 and first dose of ChAdOx1-S (RI = 6.52; 2.88-14.77). Analysis by age found an increased risk among those aged≥60 years after first (RI = 8.03; 2.08-31.03) and second dose (RI = 7.71; 2.38-24.97) of mRNA-1273. The first dose of ChAdOx1-S was associated with GBS in those aged 40-59 (RI = 4.50; 1.37-14.79) and in those aged ≥ 60 years (RI = 6.84; 2.56-18.28). Conclusions: mRNA-1273 and ChAdOx1-S vaccines were associated with an increased risk of GBS however this risk resulted in a small number of excess cases. Limitations were loss of GBS outpatient cases and imprecision of the estimates in the subgroup analysis due to a low number of events.

Published
2024

4. Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project

Author

Trifiro, G., Isgro, V., Ingrasciotta, Y., Ientile, V., L'Abbate, L., Foti, S. S., Belleudi, V., Poggi, F., Fontana, A., Moretti, U., Lora, R., Sabaini, A., Senesi, I., Sorrentino, C., Puzo, M. R., Padula, A., Fusco, M., Giordana, R., Solfrini, V., Puccini, A., Rossi, P., Del Zotto, S., Leoni, O., Zanforlini, M., Ancona, D., Bavaro, V., Garau, D., Ledda, S., Scondotto, S., Allotta, A., Tuccori, M., Gini, R., Bucaneve, G., Franchini, D., Cavazzana, A., Biasi, V., Spila Alegiani, S., Massari, M., Andretta, I., Tanaglia, M., Carriero, A., Sassano, S., De Sarro, G., Mirarchi, S., Palleria, C., Sarro, C., Balestrieri, M., Rostan, S., Capuano, A., Bernardi, F. F., Trama, U., Russo, A., Fumo, M. G., Addis, A., Musicco, F., Sapigni, E., Mazzetti, I., Podetti, D., Potenza, A. M., Nikitina, V., Ricciardelli, R., Mogheiseh, N., Croce, S., Pettinelli, A., Ejlli, L., Fortino, I., Ercolanoni, M., Mazzone, A., Nisic, A., Schiatti, S., Ludergnani, M., Mancini, M., Patregnani, L., Fabbietti, P., Antonicelli, E., Mangano, A., Campomori, A., Urru, S. A., Costa, G., Guarrera, G. M., Stella, P., Serra, E., Carta, P., Vannacci, A., Lucenteforte, E., Parrilli, M., Convertino, I., De Giorgi, M., Rocchi, R. E., Rossi, M., Scroccaro, G., Deambrosis, P., Grindelli, G., Ferroni, E., Trifiro, G., Isgro, V., Ingrasciotta, Y., Ientile, V., L'Abbate, L., Foti, S. S., Belleudi, V., Poggi, F., Fontana, A., Moretti, U., Lora, R., Sabaini, A., Senesi, I., Sorrentino, C., Puzo, M. R., Padula, A., Fusco, M., Giordana, R., Solfrini, V., Puccini, A., Rossi, P., Del Zotto, S., Leoni, O., Zanforlini, M., Ancona, D., Bavaro, V., Garau, D., Ledda, S., Scondotto, S., Allotta, A., Tuccori, M., Gini, R., Bucaneve, G., Franchini, D., Cavazzana, A., Biasi, V., Spila Alegiani, S., Massari, M., Andretta, I., Tanaglia, M., Carriero, A., Sassano, S., De Sarro, G., Mirarchi, S., Palleria, C., Sarro, C., Balestrieri, M., Rostan, S., Capuano, A., Bernardi, F. F., Trama, U., Russo, A., Fumo, M. G., Addis, A., Musicco, F., Sapigni, E., Mazzetti, I., Podetti, D., Potenza, A. M., Nikitina, V., Ricciardelli, R., Mogheiseh, N., Croce, S., Pettinelli, A., Ejlli, L., Fortino, I., Ercolanoni, M., Mazzone, A., Nisic, A., Schiatti, S., Ludergnani, M., Mancini, M., Patregnani, L., Fabbietti, P., Antonicelli, E., Mangano, A., Campomori, A., Urru, S. A., Costa, G., Guarrera, G. M., Stella, P., Serra, E., Carta, P., Vannacci, A., Lucenteforte, E., Parrilli, M., Convertino, I., De Giorgi, M., Rocchi, R. E., Rossi, M., Scroccaro, G., Deambrosis, P., Grindelli, G., and Ferroni, E.

Subjects
Male, medicine.medical_specialty, Population, Postmarketing surveillance, Rate ratio, REGISTRIES, Retrospective Studie, Internal medicine, BIOSIMILARS, medicine, Adalimumab, Humans, Pharmacology (medical), Original Research Article, education, Adverse effect, ANTI-TNF THERAPY, RHEUMATOID-ARTHRITIS, RISK, PHARMACOVIGILANCE, BIOSIMILARS, EXPERIENCE, REGISTRIES, PSORIASIS, MEDICINES, ACCESS, Biosimilar Pharmaceuticals, Retrospective Studies, RISK, Delivery of Health Care, Female, Infliximab, Italy, SARS-CoV-2, COVID-19, Pharmacology, education.field_of_study, PSORIASIS, business.industry, Biosimilar, ANTI-TNF THERAPY, General Medicine, medicine.disease, RHEUMATOID-ARTHRITIS, PHARMACOVIGILANCE, MEDICINES, EXPERIENCE, Immune-mediated inflammatory diseases, ACCESS, business, Human, Biosimilar Pharmaceutical, Biotechnology, medicine.drug
Abstract

Background Biological drugs have improved the management of immune-mediated inflammatory diseases (IMIDs) despite being associated with important safety issues such as immunogenicity, infections, and malignancies in real-world settings. Objective The aim of this study was to explore the potential of a large Italian multi-database distributed network for use in the postmarketing surveillance of biological drugs, including biosimilars, in patients with IMID. Methods A retrospective cohort study was conducted using 13 Italian regional claims databases during 2010–2019. A tailor-made R-based tool developed for distributed analysis of claims data using a study-specific common data model was customized for this study. We measured the yearly prevalence of biological drug users and the frequency of switches between originator and biosimilars for infliximab, etanercept, and adalimumab separately and stratified them by calendar year and region. We then calculated the cumulative number of users and person-years (PYs) of exposure to individual biological drugs approved for IMIDs. For a number of safety outcomes (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-COV-2] infection), we conducted a sample power calculation to estimate the PYs of exposure required to investigate their association with individual biological drugs approved for IMIDs, considering different strengths of association. Results From a total underlying population of almost 50 million inhabitants from 13 Italian regions, we identified 143,602 (0.3%) biological drug users, with a cumulative exposure of 507,745 PYs during the entire follow-up. The mean age ± standard deviation of biological drug users was 49.3 ± 16.3, with a female-to-male ratio of 1.2. The age-adjusted yearly prevalence of biological drug users increased threefold from 0.7 per 1000 in 2010 to 2.1 per 1000 in 2019. Overall, we identified 40,996 users of biosimilars of tumor necrosis factor (TNF)-α inhibitors (i.e., etanercept, adalimumab, and infliximab) in the years 2015–2019. Of these, 46% (N = 18,845) switched at any time between originator and biosimilars or vice versa. To investigate a moderate association (incidence rate ratio 2) between biological drugs approved for IMIDs and safety events of interest, such as optic neuritis (lowest background incidence rate 10.4/100,000 PYs) or severe infection (highest background incidence rate 4312/100,000 PYs), a total of 43,311 PYs and 104 PYs of exposure to individual biological drugs, respectively, would be required. As such, using this network, of 15 individual biological drugs approved for IMIDs, the association with those adverse events could be investigated for four (27%) and 14 (93%), respectively. Conclusion The VALORE project multi-database network has access to data on more than 140,000 biological drug users (and > 0.5 million PYs) from 13 Italian regions during the years 2010–2019, which will be further expanded with the inclusion of data from other regions and more recent calendar years. Overall, the cumulated amount of person-time of exposure to biological drugs approved for IMIDs provides enough statistical power to investigate weak/moderate associations of almost all individual compounds and the most relevant safety outcomes. Moreover, this network may offer the opportunity to investigate the interchangeability of originator and biosimilars of several TNFα inhibitors in different therapeutic areas in real-world settings. Supplementary Information The online version contains supplementary material available at 10.1007/s40259-021-00498-3.

Published
2021

5. The Di Bella Multitherapy Trial

Author

Liberati, Alessandro, Magrini, Nicola, Patoia, Lucio, Pagliaro, Luigi, Raschetti, R., Greco, D., Menniti-Ippolito, F., Spila-Alegiani, S., Traversa, G., Benagiano, G., Bruzzi, P., Müllner, Marcus, and Evans, Stephen J. W.

Published
1999

7. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial

Author

Menichetti, F, Popoli, P, Puopolo, M, Spila Alegiani, S, Tiseo, G, Bartoloni, A, De Socio, G, Luchi, S, Blanc, P, Puoti, M, Toschi, E, Massari, M, Palmisano, L, Marano, G, Chiamenti, M, Martinelli, L, Franchi, S, Pallotto, C, Suardi, L, Luciani Pasqua, B, Merli, M, Fabiani, P, Bertolucci, L, Borchi, B, Modica, S, Moneta, S, Marchetti, G, d'Arminio Monforte, A, Stoppini, L, Ferracchiato, N, Piconi, S, Fabbri, C, Beccastrini, E, Saccardi, R, Giacometti, A, Esperti, S, Pierotti, P, Bernini, L, Bianco, C, Benedetti, S, Lanzi, A, Bonfanti, P, Sani, S, Saracino, A, Castagna, A, Trabace, L, Lanza, M, Focosi, D, Mazzoni, A, Pistello, M, Falcone, M, Menichetti, Francesco, Popoli, Patrizia, Puopolo, Maria, Spila Alegiani, Stefania, Tiseo, Giusy, Bartoloni, Alessandro, De Socio, Giuseppe Vittorio, Luchi, Sauro, Blanc, Pierluigi, Puoti, Massimo, Toschi, Elena, Massari, Marco, Palmisano, Lucia, Marano, Giuseppe, Chiamenti, Margherita, Martinelli, Laura, Franchi, Silvia, Pallotto, Carlo, Suardi, Lorenzo Roberto, Luciani Pasqua, Barbara, Merli, Marco, Fabiani, Plinio, Bertolucci, Luca, Borchi, Beatrice, Modica, Sara, Moneta, Sara, Marchetti, Giulia, d'Arminio Monforte, Antonella, Stoppini, Laura, Ferracchiato, Nadia, Piconi, Stefania, Fabbri, Claudio, Beccastrini, Enrico, Saccardi, Riccardo, Giacometti, Andrea, Esperti, Sara, Pierotti, Piera, Bernini, Laura, Bianco, Claudia, Benedetti, Sara, Lanzi, Alessandra, Bonfanti, Paolo, Sani, Spartaco, Saracino, Annalisa, Castagna, Antonella, Trabace, Luigia, Lanza, Maria, Focosi, Daniele, Mazzoni, Alessandro, Pistello, Mauro, Falcone, Marco, Menichetti, F, Popoli, P, Puopolo, M, Spila Alegiani, S, Tiseo, G, Bartoloni, A, De Socio, G, Luchi, S, Blanc, P, Puoti, M, Toschi, E, Massari, M, Palmisano, L, Marano, G, Chiamenti, M, Martinelli, L, Franchi, S, Pallotto, C, Suardi, L, Luciani Pasqua, B, Merli, M, Fabiani, P, Bertolucci, L, Borchi, B, Modica, S, Moneta, S, Marchetti, G, d'Arminio Monforte, A, Stoppini, L, Ferracchiato, N, Piconi, S, Fabbri, C, Beccastrini, E, Saccardi, R, Giacometti, A, Esperti, S, Pierotti, P, Bernini, L, Bianco, C, Benedetti, S, Lanzi, A, Bonfanti, P, Sani, S, Saracino, A, Castagna, A, Trabace, L, Lanza, M, Focosi, D, Mazzoni, A, Pistello, M, Falcone, M, Menichetti, Francesco, Popoli, Patrizia, Puopolo, Maria, Spila Alegiani, Stefania, Tiseo, Giusy, Bartoloni, Alessandro, De Socio, Giuseppe Vittorio, Luchi, Sauro, Blanc, Pierluigi, Puoti, Massimo, Toschi, Elena, Massari, Marco, Palmisano, Lucia, Marano, Giuseppe, Chiamenti, Margherita, Martinelli, Laura, Franchi, Silvia, Pallotto, Carlo, Suardi, Lorenzo Roberto, Luciani Pasqua, Barbara, Merli, Marco, Fabiani, Plinio, Bertolucci, Luca, Borchi, Beatrice, Modica, Sara, Moneta, Sara, Marchetti, Giulia, d'Arminio Monforte, Antonella, Stoppini, Laura, Ferracchiato, Nadia, Piconi, Stefania, Fabbri, Claudio, Beccastrini, Enrico, Saccardi, Riccardo, Giacometti, Andrea, Esperti, Sara, Pierotti, Piera, Bernini, Laura, Bianco, Claudia, Benedetti, Sara, Lanzi, Alessandra, Bonfanti, Paolo, Sani, Spartaco, Saracino, Annalisa, Castagna, Antonella, Trabace, Luigia, Lanza, Maria, Focosi, Daniele, Mazzoni, Alessandro, Pistello, Mauro, and Falcone, Marco

Abstract

Importance: Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. Objective: To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia. Design, setting, and participants: This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible. Interventions: Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations. Main outcomes and measures: The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization. Results: Of the 487 randomized patients (241 to CP plus ST; 246 to ST alone), 312 (64.1%) were men; the median (IQR) age was 64 (54.0-74.0) years. The modified intention-to-treat population included 473 patients. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). Adverse events occurred more frequently in the CP group (12 of 241 [5.0%]) compared with the control group (4 of 246 [1.6%]; P = .04). Conclusions and relevance: In patients with moderate to severe COVID-19 pneumonia, high-titer anti-SARS-CoV-2 CP did not reduce t

Published
2021

10. Patterns and trends of utilization of incretin-based medicines between 2008 and 2014 in three Italian geographic areas

Author

Roberto, G., Barone-Adesi, F., Giorgianni, F. (Francesco), Pizzimenti, V. (Valeria), Ferrajolo, C. (Carmen), Tari, M.G. (Michele Giuseppe), Bartolini, C., da Cas, R. (Roberto), Maggini, M., Spila-Alegiani, S., Francesconi, P. (Paolo), Trifirò, G. (Gianluca), Poluzzi, E. (Elisabetta), Baccetti, F., Gini, R. (Rosa), Roberto, G., Barone-Adesi, F., Giorgianni, F. (Francesco), Pizzimenti, V. (Valeria), Ferrajolo, C. (Carmen), Tari, M.G. (Michele Giuseppe), Bartolini, C., da Cas, R. (Roberto), Maggini, M., Spila-Alegiani, S., Francesconi, P. (Paolo), Trifirò, G. (Gianluca), Poluzzi, E. (Elisabetta), Baccetti, F., and Gini, R. (Rosa)

Abstract

Background: The incretin-based medicines GLP1 analogues (GLP1a) and dipeptidyl peptidase-4 inhibitors (DPP4i) are hypoglycaemic agents licensed for the treatment of type 2 diabetes mellitus (T2DM). Although these drugs possess comparable efficacy and low risk of hypoglycaemia, differences in terms of route of administration (subcutaneous versus oral), effect on body weight and gastrointestinal tolerabily can impact their actual use in clinical practice. This study aimed to describe the real-world utilization of incretin-based medicines in the Italian clinical practice. Methods: A multi-database, population-based, descriptive, cohort study was performed using administrative data collected between 2008 and 2014 from three Italian geographic areas. Subjects aged ≥18 were selected. New users were defined as those with ≥1 dispensing of GLP1a or DPP4i during the year of interest and none in the past. Trends of cumulative annual incidence of use in the general adult population were observed. New users of GLP1a or DPP4i were respectively described in terms of demographic characteristics and use of antidiabetic drugs during 1 year before and after the first incretin dispensing. Results: The overall study population included 4,943,952 subjects. A total of 7357 new users of GLP1a and 41,907 of DPP4i were identified during the study period. Incidence of use increased between 2008 (0.2‰ for both GLP1a and DPP4i) and 2011 (GLP1a = 0.6‰; DPP4i = 2.5‰) and slightly decreased thereafter. In 2014, 61% of new GLP1a users received once-daily liraglutide while 52% of new DPP4i users received metformin/DPP4i in fixed-dose. The percentage of new DPP4i users older than 65 years of age increased from 30.9 to 62.6% during the study period. Around 12% of new users had not received any antidiabetic before starting an incretin. Conclusions: During the study period, DPP4i rapidly became the most prescribed incretin-based medicine, particularly among older new user. The choice of the specific inc

Published
2019
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11. Patterns and trends of utilization of incretin-based medicines between 2008 and 2014 in three Italian geographic areas

Author

Roberto, G, Barone-Adesi, F, Giorgianni, F, Pizzimenti, V, Ferrajolo, Carmen, Tari, M, Bartolini, C, Da Cas, R, Maggini, M, Spila-Alegiani, S, Francesconi, P, Trifiro, Gianluca, Poluzzi, E, Baccetti, F, Gini, R, Roberto, G, Barone-Adesi, F, Giorgianni, F, Pizzimenti, V, Ferrajolo, Carmen, Tari, M, Bartolini, C, Da Cas, R, Maggini, M, Spila-Alegiani, S, Francesconi, P, Trifiro, Gianluca, Poluzzi, E, Baccetti, F, and Gini, R

Published
2019

17. Memantine in moderately-severe-to-severe Alzheimer's disease: a post-marketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A, Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, BELLELLI, GIUSEPPE, Ratti, PL, Giusti, MC, Margarito, FP, Chinaglia, CN, Salvi, GP, Saviotti, FM, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A, Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, BELLELLI, GIUSEPPE, Ratti, PL, Giusti, MC, Margarito, FP, Chinaglia, CN, Salvi, GP, Saviotti, FM, and Alberici, A.

Abstract

Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drugs effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimers disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke Alzheimers Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (meanage 77 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (no deterioration and improvement), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) w

Published
2009

18. Memantine effects on behaviour in moderately severe to severe Alzheimer's disease: a post-marketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila-Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, Pl, Magnani, G, Schiatti, E, Marcone, A, Giusti, Mc, Margarito, Fp, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Negri Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petrò, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, Gp, Manzoni, L, Saviotti, Fm, Scarpini, E, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Marcon, Gabriella, and Appollonio, I

Subjects
Male, medicine.medical_specialty, Psychosis, Hallucinations, Behavioural and psychological symptoms of dementia, Apathy, Dopamine Agents, Postmarketing surveillance, Dermatology, Anxiety, Neuropsychological Tests, Logistic regression, Disease cluster, Severity of Illness Index, Alzheimer's disease, Memantine, Post-marketing surveillance study, Alzheimer Disease, Internal medicine, Severity of illness, Product Surveillance, Postmarketing, medicine, Humans, Dementia, Psychiatry, BIO/14 - FARMACOLOGIA, Aged, Aged, 80 and over, MED/26 - NEUROLOGIA, treatment, Depression, Feeding Behavior, General Medicine, medicine.disease, Psychiatry and Mental health, Treatment Outcome, Hypomania, Female, Neurology (clinical), medicine.symptom, Psychology, Follow-Up Studies, dementia, medicine.drug
Abstract

The aim of this study is to evaluate memantine effectiveness on behavioural and psychological symptoms of dementia (BPSD) in clinical practice and to identify variables that may predict the therapy effects. The effects of memantine on behaviour were analysed in the database of a post-marketing surveillance study promoted by the Lombardy Region Health Office and involving 43 Alzheimer's disease (AD) Units. From July to December 2005, 399 moderately severe-to-severe AD patients free of cholinergic medications were enrolled, treated with memantine and followed-up for 6 months. BPSD were assessed in a subgroup of 297 patients [mean age 77 ± 8 years; 73% females; mean neuropsychiatric inventory (NPI) score 28 ± 24] for whom the 12-item NPI subscores at baseline, and at 3 and 6 months were available. The 12 BPSD were clustered as follows: affect, physical behaviour, psychosis and hypomania. The main outcome measure was the proportion of individual cluster responders at 6 months of therapy. The proportion of individual cluster responders was 30% affect, 24% physical behaviour, 29% psychosis, 27% hypomania. Patients taking 20 mg memantine daily during the study period had a statistically significant higher probability to experience behavioural improvement than those who discontinued treatment or did not complete memantine titration (affect OR 9.0; 95% CI 3.8-21.6; physical behaviour OR 17.8; 95% CI 5.9-53.6; psychosis OR 23.6; 95% CI 5.1-110.8). The logistic regression analysis was not applicable to the hypomania subsyndrome because of the low cluster prevalence. The standard 20 mg daily memantine treatment regimen was found to be associated with a modest 6-month behavioural improvement in the affect, physical behaviour and psychosis domains in 24-30% of patients.

Published
2012

19. Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study

Author

Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, Altavilla, R, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, Avanzi, S, Bargnani, C, Bascelli, C, BELLELLI, GIUSEPPE, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, PL, Magnani, G, Schiatti, E, Marcone, A, Giusti, MC, Margarito, FP, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, CN, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, GP, Manzoni, L, Saviotti, FM, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, and Alberici, A

Subjects
Male, medicine.medical_specialty, Postmarketing surveillance, Severity of Illness Index, law.invention, Demenza, malattia di Alzheimer, Randomized controlled trial, law, Alzheimer Disease, Memantine, Internal medicine, medicine, Product Surveillance, Postmarketing, Dementia, Humans, Pharmacology (medical), Adverse effect, Aged, MED/26 - NEUROLOGIA, Aged, 80 and over, Psychiatric Status Rating Scales, business.industry, Odds ratio, medicine.disease, Surgery, Treatment Outcome, Tolerability, Italy, Clinical Global Impression, Female, Geriatrics and Gerontology, business, Excitatory Amino Acid Antagonists, memantina, medicine.drug
Abstract

Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drug’s effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimer’s disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke — Alzheimer’s Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (mean age 77 ± 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (‘no deterioration’ and ‘improvement’), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) was similar to that reported in two previous randomized clinical trials (10% and 12.4%). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.

Published
2009

22. Mortalita' nei primi due anni di vita in Italia: Sudden Infant Death Syndrome e altre morti inattese

Author

Raschetti, R, Salmaso, S, Traversa, G, Bianchi, C, Caffari, B, Ciofi degli Atti, M, Fagiolo, L, Maggini, M, Menniti Ippolito, F, Pastore Celentano, L, Ruggeri, P, Spila Alegiani, S, Frova, L, Pappagallo, M, Santuccio, C, Severi, V, Montomoli, C, and SCALIA TOMBA, G

Subjects
SIDS, Infant mortality, SIDS, Infant mortality, Mortality studies, Mortality studies, Settore MAT/06 - Probabilita' e Statistica Matematica
Published
2005

25. The Unconventional Di Bella Cancer Treatment. A Reflection on the Italian Experience

Author

Traversa, G, Maggini, M, Menniti Ippolito, F, Bruzzi, P, Chiarotti, F, Greco, D, Spila Alegiani, S, Raschetti, R, Benagiano, G, Caffari, B, Da Cas, R, De Mei, B, Di Giovambattista, G, Modigliani, S, Popoli, P, Ruggeri, P, Tomino, C, Gamucci, T, Amadori, D, Buiatti, E, Ciranni, E, Cognetti, F, Colucci, G, Conte, Pf, Di Bella, G, Iacobelli, S, Mandelli, F, Marubini, E, Massotti, M, Monfardini, S, Oleari, F, Sannazzari, Gl, Tomatis, L, Veronesi, U, Cellerino, R, Antognoli, S, Berardi, R, Bracci, R, Lippe, P, Pulita, F, Di Vito, F, Martinod, D, Musi, M, Veronesi, A, Lazzarini, R, Attolico, V, Giotta, F, Longo, M, Maiello, E, Tura, S, Gherlinzoni, F, Tani, M, Amor, H, Borona, P, Giradi, F, Graiff, C, Broccia, G, Corona, Mg, Desogus, A, Mascia, V, Pasqualucci, S, Failla, G, Aiello, Rm, Cordio, S, Finocchiaro, P, Melena, E, Tursi, De, Scognamiglio, Mt, Tinati, N, Maltoni, M, Nanni, O, Scardovi, F, Serra, P, Rosso, R, Boccardo, F, Bapr, A, Coli, T, Grimaldi, M, Cascinalli, N, Ascani, L, Bajetta, E, Bidoli, P, Cassata, A, De Candis, D, Giannessi, W, Procopio, G, Di Donato, S, Boiardi, A, Cerri, D, Eoli, M, Silvani, A, Colleoni, M, Rotmensz, N, Morfadini, S, Comella, G, De Matteis, A, Gravina, A, Gridelli, C, Perrone, F, Salzano, Mr, Sandomenico, C, Battista, C, Iodice, G, Fico, R, Nicchia, A, Lise, M, De Salvo GL, Di lenardo, E, Iadicicco, F, Agostara, Bb, Cafarelli, I, Tonato, M, Radicchi, F, Sorbolini, S, Taschini, O, Carmignani, A, Del Mastro, L, Gennari, A, Orlandini, C, Manzione, L, Dinota, A, Lombardi, G, Gasparini, G, Arena, Mg, Fanelli, M, Modafferi, F, Fazi, P, Mauro, F, Martelli, M, Ricci, C, Vignetti, M, D’Alessio, A, Giannarelli, D, Magnani, E, Rellecati, P, Ruggeri, Em, Zeuli, Borgognone, M, Chio', Adriano, Gasco, A, Ragona, R, Sacco, M, Soffietti, Riccardo, Tessa, M, Pileri, A, Galligioni, E, Lucenti, A, Moltreer, F, Paolazzi, F, Bianco, Ar, Labianca, R, Rossi Ferrini PL, Simonetti, G, and Sobrero, A.

Published
1999

26. Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy

Author

Raschetti, R, Bruzzi, P, Greco, D, Maggini, M, Menniti Ippolito, F, Spila Alegiani, S, Traversa, G, Benagiano, G, Caffari, B, Chiarotti, F, Da Cas, R, De Mei, B, Di Giovambattista, G, Modigliani, S, Popoli, P, Ruggeri, P, Tomino, C, Gamucci, T, Amadori, D, Buiatti, E, Ciranni, E, Cognetti, F, Colucci, G, Conte, Pf, Di Bella, G, Iacobelli, S, Mandelli, F, Marubini, E, Massotti, M, Monfardini, S, Oleari, F, Sannazzari, Gl, Tomatis, L, Veronesi, U, Cellerino, R, Antognoli, S, Berardi, R, Bracci, R, Lippe, P, Pulita, F, Di Vito, F, Martinod, D, Musi, M, Veronesi, A, Lazzarini, R, Attolico, V, Giotta, F, Longo, M, Maiello, E, Tura, S, Gherlinzoni, F, Tani, M, Amor, H, Borona, P, Giradi, F, Graiff, C, Broccia, G, Corona, Mg, Desogus, A, Mascia, V, Pasqualucci, S, Failla, G, Aiello, Rm, Cordio, S, Finocchiaro, P, Melena, E, Tursi, De, Scognamiglio, Mt, Tinati, N, Maltoni, M, Nanni, O, Scardovi, F, Serra, P, Rosso, R, Boccardo, F, Bapr, A, Coli, T, Grimaldi, M, Cascinalli, N, Ascani, L, Bajetta, E, Bidoli, P, Cassata, A, De Candis, D, Giannessi, W, Procopio, G, Di Donato, S, Boiardi, A, Cerri, D, Eoli, M, Silvani, A, Colleoni, M, Rotmensz, N, Morfadini, S, Comella, G, De Matteis, A, Gravina, A, Gridelli, C, Perrone, F, Salzano, Mr, Sandomenico, C, Battista, C, Iodice, G, Fico, R, Nicchia, A, Lise, M, De Salvo GL, Di lenardo, E, Iadicicco, F, Agostara, Bb, Cafarelli, I, Tonato, M, Radicchi, F, Sorbolini, S, Taschini, O, Carmignani, A, Del Mastro, L, Gennari, A, Orlandini, C, Manzione, L, Dinota, A, Lombardi, G, Gasparini, G, Arena, Mg, Fanelli, M, Modafferi, F, Fazi, P, Mauro, F, Martelli, M, Ricci, C, Vignetti, M, D’Alessio, A, Giannarelli, D, Magnani, E, Rellecati, P, Ruggeri, Em, Zeuli, Borgognone, M, Chio', Adriano, Gasco, A, Ragona, R, Sacco, M, Soffietti, Riccardo, Tessa, M, Pileri, A, Galligoini, E, Lucenti, A, Moltreer, F, Paolazzi, F, Bianco, Ar, Labianca, R, Rossi Ferrini PL, Simonetti, G, and Sobrero, A.

Subjects
Papers
Published
1999

37. Gangliosides and Guillain-Barré syndrome

Author

Raschetti, R., primary, Maggini, M., additional, Popoli, P., additional, Caffari, B., additional, Da Cas, R., additional, Menniti-Ippolito, F., additional, Spila-Alegiani, S., additional, and Traversa, G., additional

Published
1995
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38. Incidence of coronary heart disease in type 2 diabetic men and women: impact of microvascular complications, treatment, and geographic location.

Author

Avogaro A, Giorda C, Maggini M, Mannucci E, Raschetti R, Lombardo F, Spila-Alegiani S, Turco S, Velussi M, Ferrannini E, and Istituto Superiore di Sanita. Association of Clinical Diabetologists. Diabetes and Informatics Study Group

Abstract

OBJECTIVE: Cardiovascular disease (CVD) is the main cause of morbidity/mortality in diabetes. We set forth to determine incidence and identify predictors (including microvascular complications and treatment) of first coronary heart disease (CHD) event in CVD-free type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A cohort of 6,032 women and 5,612 men, sampled from a nationwide network of hospital-based diabetes clinics, was followed up for 4 years. Baseline assessment included retinopathy, nephropathy, and foot ulcers. First CHD events (myocardial infarction, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and electrocardiogram-proven angina) were analyzed for 29,069 person-years. RESULTS: The age-standardized incidence rate (per 1,000 person-years) of first CHD event (n = 881) was 28.8 (95% CI 5.4-32.2) in men and 23.3 (20.2-26.4) in women. Major CHD (myocardial infarction, coronary artery bypass grafting, and percutaneous transluminal coronary angioplasty) was less frequent in women (5.8 [4.3-7.2]) than in men (13.1 [10.9-15.4]; a sex ratio of 0.5 [0.4-0.6]). Incidence rates of all outcomes were higher in patients with microvascular complications (for major CHD, age-adjusted rate ratios were 1.6 [1.2-2.21] in men and 1.5 [1.0-2.2] in women). By multivariate Cox analysis, age and diabetes duration were risk predictors common in both sexes. In men, glycemic control and treated hypertension were additional independent risk factors, but residing in the south was associated with a significant 29% risk reduction. In women, higher triglycerides/lower HDL cholesterol and microvascular complications were independent risk factors. CONCLUSIONS: In CVD-free patients with type 2 diabetes, risk of first CHD event depends on sex, geographic location, and presence of microvascular disease. Hyperglycemia and hypertension, particularly in men, and diabetic dyslipidemia, especially in women, are risk factors amenable to more aggressive treatment. [ABSTRACT FROM AUTHOR]

Published
2007
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43. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients with COVID-19 Pneumonia: A Randomized Clinical Trial

Author

Menichetti, F., Popoli, P., Puopolo, M., Alegiani, S. S., Tiseo, G., Bartoloni, A., De Socio, G., Luchi, S., Blanc, P., Puoti, M., Toschi, E., Massari, M., Palmisano, L., Marano, G., Chiamenti, M., Martinelli, L., Franchi, S., Pallotto, C., Suardi, L. R., Pasqua, B. L., Merli, M., Fabiani, P., Bertolucci, L., Borchi, B., Modica, S., Moneta, S., Marchetti, G., d'Arminio Monforte, A., Stoppini, L., Ferracchiato, N., Piconi, S., Fabbri, C., Beccastrini, E., Saccardi, R., Giacometti, A., Esperti, S., Pierotti, P., Bernini, L., Bianco, C., Benedetti, S., Lanzi, A., Bonfanti, P., Sani, S., Saracino, A., Castagna, A., Trabace, L., Lanza, M., Focosi, D., Mazzoni, A., Pistello, M., Falcone, M., Locatelli, F., Ippolito, G., Magrini, N., Bernardini, R., Brusaferro, S., De Angelis, V., Perotti, C., Remuzzi, G., De Silvestro, G., Costantini, M., Bocchino, M., De Donno, G., Francisci, D., Menichetti, F., Popoli, P., Puopolo, M., Spila Alegiani, S., Tiseo, G., Bartoloni, A., De Socio, G. V., Luchi, S., Blanc, P., Puoti, M., Toschi, E., Massari, M., Palmisano, L., Marano, G., Chiamenti, M., Martinelli, L., Franchi, S., Pallotto, C., Suardi, L. R., Luciani Pasqua, B., Merli, M., Fabiani, P., Bertolucci, L., Borchi, B., Modica, S., Moneta, S., Marchetti, G., D'Arminio Monforte, A., Stoppini, L., Ferracchiato, N., Piconi, S., Fabbri, C., Beccastrini, E., Saccardi, R., Giacometti, A., Esperti, S., Pierotti, P., Bernini, L., Bianco, C., Benedetti, S., Lanzi, A., Bonfanti, P., Sani, S., Saracino, A., Castagna, A., Trabace, L., Lanza, M., Focosi, D., Mazzoni, A., Pistello, M., Falcone, M., Menichetti, F, Popoli, P, Puopolo, M, Spila Alegiani, S, Tiseo, G, Bartoloni, A, De Socio, G, Luchi, S, Blanc, P, Puoti, M, Toschi, E, Massari, M, Palmisano, L, Marano, G, Chiamenti, M, Martinelli, L, Franchi, S, Pallotto, C, Suardi, L, Luciani Pasqua, B, Merli, M, Fabiani, P, Bertolucci, L, Borchi, B, Modica, S, Moneta, S, Marchetti, G, d'Arminio Monforte, A, Stoppini, L, Ferracchiato, N, Piconi, S, Fabbri, C, Beccastrini, E, Saccardi, R, Giacometti, A, Esperti, S, Pierotti, P, Bernini, L, Bianco, C, Benedetti, S, Lanzi, A, Bonfanti, P, Sani, S, Saracino, A, Castagna, A, Trabace, L, Lanza, M, Focosi, D, Mazzoni, A, Pistello, M, and Falcone, M

Subjects
Male, medicine.medical_specialty, Randomization, Settore MED/17 - Malattie Infettive, Population, Aged, COVID-19, Disease Progression, Female, Humans, Italy, Middle Aged, Prospective Studies, SARS-CoV-2, Severity of Illness Index, Standard of Care, Hospital Mortality, Hospitalization, Immunization, Passive, Plasma, Respiratory Insufficiency, Passive, law.invention, Randomized controlled trial, law, Internal medicine, Clinical endpoint, medicine, education, Adverse effect, education.field_of_study, business.industry, General Medicine, Odds ratio, medicine.disease, Pneumonia, Respiratory failure, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Immunization, business
Abstract

Importance: Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. Objective: To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia. Design, setting, and participants: This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible. Interventions: Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations. Main outcomes and measures: The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio

Published
2021

44. Time to Treatment Intensification in Patients Receiving DPP4 Inhibitors Versus Sulfonylureas as the First Add-On to Metformin Monotherapy: A Retrospective Cohort Study

Author

Giuseppe Roberto, Anna Girardi, Francesco Barone-Adesi, Alessandro Pecere, Valentina Ientile, Claudia Bartolini, Roberto Da Cas, Stefania Spila-Alegiani, Carmen Ferrajolo, Paolo Francesconi, Gianluca Trifirò, Elisabetta Poluzzi, Fabio Baccetti, Rosa Gini, Roberto G., Girardi A., Barone-Adesi F., Pecere A., Ientile V., Bartolini C., Da Cas R., Spila-Alegiani S., Ferrajolo C., Francesconi P., Trifiro G., Poluzzi E., Baccetti F., and Gini R.

Subjects
Pharmacology, DPP4i, secondary failure, durability, sulfonylurea, observational study, Pharmacology (medical), type 2 diabetes, metformin, treatment intensification
Abstract

Background: To verify whether, in patients on metformin (MET) monotherapy for type 2 diabetes (T2D), the add-on of a dipeptidyl peptidase inhibitor (DPP4i) compared to a sulfonylurea (SU) can delay the time to the subsequent treatment intensification (TI).Methods: Population-based administrative data banks from four Italian geographic areas were used. Patients aged ≥18 years on MET monotherapy receiving first DPP4i or SU dispensing between 2008 and 2015 (cohort entry) were followed up to the occurrence of TI (insulin dispensing or add-on of a third non-insulin hypoglicemic >180 days after cohort entry), treatment discontinuation, switch, cancer, death, TI occurrence within, end of data availability, end of study period (31 December 2016), whichever came first. Patients on MET + DPP4i were matched 1:1 with those on MET + SU by sex, age, year of cohort entry, and data bank. Hazard Ratio (HR) and 95% confidence intervals (95%CI) were estimated using multivariable Cox regression model including matching variables and potential confounders measured at baseline. Different sensitivity analyses were performed: i) matching at 180 days after cohort entry, ii) intent to treat (ITT) analysis, iii) matching by duration of MET monotherapy, iv) matching by propensity score.Results: The matched study cohort included 10,600 patients. Overall, 763 TI were observed (4.5/100 person-years; mean follow-up = 1.6 years). The primary analysis showed no difference in time to TI between the two groups (HR = 1.02; 95% CI = 0.88–1.19). Sensitivity analyses confirmed this result, except from the ITT analysis (HR = 1.27; 1.13–1.43).Conclusion: The use of a DPP4i rather than a SU as add-on to MET monotherapy was not associated with a delay in treatment intensification.

Published
2022

45. Patterns and trends of utilization of incretin-based medicines between 2008 and 2014 in three Italian geographic areas

Author

Giuseppe Roberto, Gianluca Trifirò, Valeria Pizzimenti, Francesco Barone-Adesi, Francesco Giorgianni, Paolo Francesconi, Elisabetta Poluzzi, Carmen Ferrajolo, Rosa Gini, Roberto Da Cas, Marina Maggini, Claudia Bartolini, Stefania Spila-Alegiani, Michele Tari, Fabio Baccetti, Roberto, Giuseppe, Barone-Adesi, Francesco, Giorgianni, Francesco, Pizzimenti, Valeria, Ferrajolo, Carmen, Tari, Michele, Bartolini, Claudia, Da Cas, Roberto, Maggini, Marina, Spila-Alegiani, Stefania, Francesconi, Paolo, Trifirò, Gianluca, Poluzzi, Elisabetta, Baccetti, Fabio, Gini, Rosa, Medical Informatics, Roberto G., Barone-Adesi F., Giorgianni F., Pizzimenti V., Ferrajolo C., Tari M., Bartolini C., Da Cas R., Maggini M., Spila-Alegiani S., Francesconi P., Trifiro G., Poluzzi E., Baccetti F., and Gini R.

Subjects
Male, Time Factors, Databases, Factual, Endocrinology, Diabetes and Metabolism, lcsh:Diseases of the endocrine glands. Clinical endocrinology, Cohort Studies, Endocrinology, 0302 clinical medicine, Database network, Dipeptidyl peptidase-4 inhibitors, Drug utilization, Glucagon-like peptide-1 analogues, Endocrinology, Diabetes and Metabolism, 030212 general & internal medicine, Aged, 80 and over, Incidence (epidemiology), General Medicine, Middle Aged, Prognosis, Diabetes and Metabolism, Italy, Population study, Female, Human, medicine.drug, Cohort study, Research Article, Adult, Glucagon-like peptide-1 analogues, medicine.medical_specialty, Time Factor, Adolescent, Prognosi, Incretin, 030209 endocrinology & metabolism, Dipeptidyl peptidase-4 inhibitor, Follow-Up Studie, 03 medical and health sciences, Young Adult, Pharmacotherapy, Glucagon-like peptide-1 analogue, Internal medicine, Dipeptidyl peptidase-4 inhibitors, medicine, Drug utilization, Humans, Medical prescription, Aged, Dipeptidyl-Peptidase IV Inhibitors, lcsh:RC648-665, business.industry, Liraglutide, Diabetes Mellitus, Type 2, Dipeptidyl-Peptidase IV Inhibitor, Database network, Cohort Studie, business, Exenatide, Follow-Up Studies
Abstract

Background The incretin-based medicines GLP1 analogues (GLP1a) and dipeptidyl peptidase-4 inhibitors (DPP4i) are hypoglycaemic agents licensed for the treatment of type 2 diabetes mellitus (T2DM). Although these drugs possess comparable efficacy and low risk of hypoglycaemia, differences in terms of route of administration (subcutaneous versus oral), effect on body weight and gastrointestinal tolerabily can impact their actual use in clinical practice. This study aimed to describe the real-world utilization of incretin-based medicines in the Italian clinical practice. Methods A multi-database, population-based, descriptive, cohort study was performed using administrative data collected between 2008 and 2014 from three Italian geographic areas. Subjects aged ≥18 were selected. New users were defined as those with ≥1 dispensing of GLP1a or DPP4i during the year of interest and none in the past. Trends of cumulative annual incidence of use in the general adult population were observed. New users of GLP1a or DPP4i were respectively described in terms of demographic characteristics and use of antidiabetic drugs during 1 year before and after the first incretin dispensing. Results The overall study population included 4,943,952 subjects. A total of 7357 new users of GLP1a and 41,907 of DPP4i were identified during the study period. Incidence of use increased between 2008 (0.2‰ for both GLP1a and DPP4i) and 2011 (GLP1a = 0.6‰; DPP4i = 2.5‰) and slightly decreased thereafter. In 2014, 61% of new GLP1a users received once-daily liraglutide while 52% of new DPP4i users received metformin/DPP4i in fixed-dose. The percentage of new DPP4i users older than 65 years of age increased from 30.9 to 62.6% during the study period. Around 12% of new users had not received any antidiabetic before starting an incretin. Conclusions During the study period, DPP4i rapidly became the most prescribed incretin-based medicine, particularly among older new user. The choice of the specific incretin-based medicine at first prescription appeared to be directed towards those with higher convenience of use (e.g. oral DPP4i rather than subcutaneous GLP1a, once-daily liraglutide rather than twice-daily exenatide). The non-negligibile use of incretin-based medicines as first-line pharmacotherapy for T2DM warrants further effectiveness and safety evaluations to better define their place in therapy. Electronic supplementary material The online version of this article (10.1186/s12902-019-0334-y) contains supplementary material, which is available to authorized users.

Published
2019

47. Salvate Eva in Sicilia: indagine conoscitiva 2016 sull’adesione allo screening organizzato del cervicocarcinoma

Author

Giusti, Angela, Colaceci, Sofia, Mallone, Sandra, Perra, Alberto, Scardetta, Paola, Spila Alegiani, Stefania, Casuccio, Alessandra, Mazzucco, Walter, Vitale, Francesco, Scondotto, Salvatore, Cernigliaro, Achille, Dardanoni, Gabriella, Milici, Silvana, Caltabiano, Pier Sergio, Drogo, Letizia, Falconeri, Daniela, Zoda, Luisa, Anzalone, Concetta, Belbruno, Franco, Bella, Francesca, Bellina, Luigia, Di Giorgi, Monica, Ferro, Maria Paola, Ficano, Provvidenza, Gambino, Carlo Roberto, Lo Gerfo, Rosalia, Madonia, Salvatore, Marras, Antonello, Ottaviani, Maria Barbara, Pesce, Paola Nunzia Rita, Randazzo, Maria Angela, Ripoli, Giovanna, Rudisi, Giuseppa, SALVIATO, NICOLETTA, Scelfo, Sabrina, Scuderi, Tiziana, Tavormina, Elisa Eleonora, Usticano, Antonella, Varvarà, Massimo, Bono, Stefania, Costantino, Claudio, Graziano, Giorgio, Maniglia, Maria Luisa, Marchese, Valentina, Marotta, Claudia, NAPOLI, Giuseppe, Palmeri, Sara, Provenzano, Sandro, Raia, Daniele Domenico, Restivo, Vincenzo, Fiorino, Giusy Russo, SANTANGELO, Omar Enzo, Saporito, Laura, Ventura, GIANMARCO, Giusti, A., Colaceci, S., Mallone, S., Perra, A., Scardetta, P., Spila Alegiani, S., Casuccio, A., Mazzucco, W., Vitale, F., Scondotto, S., Cernigliaro, A., Dardanoni, G., Milici, S., Caltabiano, P., Drogo, L., Falconeri, D., Zoda, L., Anzalone, C., Belbruno, F., Bella, F., Bellina, L., Di Giorgi, M., Ferro, M., Ficano, P., Gambino, C., Lo Gerfo, R., Madonia, S., Marras, A., Ottaviani, M., Pesce, P., Randazzo, M., Ripoli, G., Rudisi, G., Salviato, N., Scelfo, S., Scuderi, T., Tavormina, E., Usticano, A., Varvarà, M., Bono, S., Costantino, C., Graziano, G., Maniglia, M., Marchese, V., Marotta, C., Napoli, G., Palmeri, S., Provenzano, S., Raia, D., Restivo, V., Fiorino, G., Santangelo, O., Saporito, L., and Ventura, G.

Subjects
cervicocarcinoma, tumore cervice uterina, Screening, prevenzione secondaria, Settore MED/42 - Igiene Generale E Applicata
Abstract

In Sicilia, a fronte di un incremento dell’estensione dello screening organizzato del cervicocarcinoma, non corrisponde un aumento dell’adesione. Nei mesi di gennaio-giugno 2016 è stata condotta un’indagine trasversale somministrando un questionario standardizzato a un campione di 365 donne, per descrivere le ragioni del fenomeno e promuovere interventi mirati. Per le variabili di atteggiamento e conoscenza è stato utilizzato l’Health Belief Model, che ha esplorato la percezione della donna della suscettibilità (rischio di sviluppare il cancro), della gravità della patologia e dei benefici derivanti dal pap-test. Dai risultati emerge che il 66,6% delle intervistate ha effettuato un pap- test nell’ultimo triennio (valore nazionale 79,2%); il consiglio da parte di un operatore sanitario e la suscettibilità percepita sono associati a una maggiore adesione allo screening. Il potenziamento dei programmi organizzati di screening e l’intervento attivo del medico di medicina generale rappresentano strategie efficaci di promozione dello screening.

Published
2017

48. Farmaci e giovani: indagine tra studenti universitari

Author

BERGAMASCHI, ANNA, LEONI, ERICA, SACCHETTI, ROSSELLA, ZANETTI, FRANCA, Aloi M. G., MAGGINI M, RUGGERI P, SPILA ALEGIANI S., Bergamaschi A., Aloi M G., Leoni E., Sacchetti R., and Zanetti F.

Published
2006

49. Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study.

Author

Morciano C, Massari M, Cutillo M, Belleudi V, Trifirò G, Mores N, Sapigni E, Puccini A, Zanoni G, Zorzi M, Monaco G, Leoni O, Del Zotto S, Samez S, Mayer F, Marano G, Menniti Ippolito F, Da Cas R, Traversa G, and Spila Alegiani S

Subjects
Humans, Male, Italy epidemiology, Female, Adult, Middle Aged, Young Adult, Adolescent, Aged, ChAdOx1 nCoV-19 adverse effects, Child, Acute Disease, SARS-CoV-2, Ad26COVS1 adverse effects, Appendicitis epidemiology, BNT162 Vaccine adverse effects, 2019-nCoV Vaccine mRNA-1273 adverse effects, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage, COVID-19 prevention & control, COVID-19 epidemiology
Abstract

Background and Objective: Cases of appendicitis were identified in the pivotal randomized clinical trial on BNT162b2 mRNA vaccine and reported from coronavirus disease 2019 (COVID-19) vaccine pharmacovigilance systems. Three cohort studies and two self-controlled case series (SCCS) studies evaluating the association between mRNA vaccines and appendicitis reported discordant results. To address this uncertainty, the present study examines in a large population, with a SCCS design, the association between mRNA (BNT162b2 and mRNA-1273) and, for the first time, viral vector (ChAdOx1-S and Ad26.COV2-S) COVID-19 vaccines and acute appendicitis., Methods: The SCCS study design was used to evaluate the association between COVID-19 vaccination and subsequent onset of acute appendicitis. The study was based on record linkage of health archives through TheShinISS application, a statistical tool that locally processes data from regional health care databases according to ad hoc, study-tailored and common data model. The study population included all vaccinated subjects ≥ 12 years old between 27 December 2020 and 30 September 2021. The acute appendicitis was identified through discharge diagnoses of hospital admissions or emergency department visits. Incident cases were defined as those who experienced a first event of acute appendicitis in the study period, excluding subjects with a diagnosis of appendicitis in the previous 5 years. Exposure was defined as the first or second dose of BNT162b2, mRNA-1273 and ChAdOx1-S and the single dose of Ad26.COV2-S. The risk interval was defined as 42 days from the first or second vaccination dose and divided into pre-specified risk subperiods; the reference period was the observation time outside the risk interval. Relative incidences (RI) and 95% confidence intervals (95% CI) were estimated with the SCCS method 'modified for event-dependent exposures', through unbiased estimating equations. The seasonal component was considered as a time-dependent covariate., Results: In the 42-day risk interval 1285 incident cases of acute appendicitis occurred: 727 cases after the first dose and 558 cases after the second dose. In the main analysis, no increased risks of acute appendicitis were observed in subjects vaccinated with BNT162b, mRNA-1273, ChAdOx1-S and Ad26.COV2-S. The subgroup analyses by sex showed an increased risk in the 14-27 day risk interval, in males after the first dose of mRNA-1273 (RI of 1.71; 95% CI 1.08-2.70, p = 0.02) and in females after the single dose of Ad26.COV2-S (RI of 4.40; 95% CI 1.29-15.01, p = 0.02)., Conclusions: There was no evidence of association of BNT162b, ChAdOx1-S, mRNA-1273 and Ad26.COV2-S with acute appendicitis in the general population. The results of the subgroup analyses by sex needs to be considered with caution. The multiplicity issue cannot be excluded being these hypotheses two of several hypotheses tested. In addition, relevant literature on the biological mechanism of the disease and evidence of similar effects with other vaccines or with the same vaccines are still lacking to provide strong support for a conclusion that there is an harmful effect in males and females with mRNA-1273 and Ad26.COV2-S., (© 2024. The Author(s).)

Published
2024
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50. The Importance of Real-World Data in Evaluating the Safety of Biosimilars: A Descriptive Study of Clinical Practice in an Oncohematological Italian Population.

Author

Urru SAM, Mayer F, Spila Alegiani S, Paoloni F, Guella A, Murru R, Bucaneve G, Formoso G, Racanelli V, Ferrarini I, Fozza C, Longo G, Musicco F, and Campomori A

Abstract

The clinical safety and efficacy of rituximab biosimilars compared to the reference rituximab (Mabthera) have been well established in randomized trials. However, concerns persist regarding the safety of changing from the reference product to biosimilars, and particularly between different biosimilars. This prospective multicenter observational study was conducted in 13 oncohematology units of eight Italian regions. The study included 800 patients with non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who received rituximab between March 2018 and June 2022. To minimize survivorship bias, only newly diagnosed patients (i.e., those without prior rituximab treatment) were included in the analysis of adverse drug reactions (ADRs). Thus, this study focused on 505 incident cases (79.8% of the initial cohort) from 13 centers. A total of 3681 rituximab infusions were administered, and 16.8% of the patients experienced at least one ADR. These were observed most frequently during the first infusion (44 patients, 52%) and the second infusion (17 patients, 20%). The most frequent reactions were general disorders and administration site conditions (n. 50, 8% serious). These findings support the clinical safety of rituximab biosimilars and suggest that switching between biosimilars does not increase the risk of adverse events. This evidence may alleviate concerns about biosimilar use, potentially leading to broader acceptance and reduced healthcare costs.

Published
2024
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