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2. The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Author

Fusaroli, Michele, Salvo, Francesco, Begaud, Bernard, AlShammari, Thamir M., Bate, Andrew, Battini, Vera, Brueckner, Andreas, Candore, Gianmario, Carnovale, Carla, Crisafulli, Salvatore, Cutroneo, Paola Maria, Dolladille, Charles, Drici, Milou-Daniel, Faillie, Jean-Luc, Goldman, Adam, Hauben, Manfred, Herdeiro, Maria Teresa, Mahaux, Olivia, Manlik, Katrin, Montastruc, François, Noguchi, Yoshihiro, Norén, G. Niklas, Noseda, Roberta, Onakpoya, Igho J., Pariente, Antoine, Poluzzi, Elisabetta, Salem, Myriam, Sartori, Daniele, Trinh, Nhung T. H., Tuccori, Marco, van Hunsel, Florence, van Puijenbroek, Eugène, Raschi, Emanuel, and Khouri, Charles

Published
2024
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3. The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement

Author

Fusaroli, Michele, Salvo, Francesco, Begaud, Bernard, AlShammari, Thamir M., Bate, Andrew, Battini, Vera, Brueckner, Andreas, Candore, Gianmario, Carnovale, Carla, Crisafulli, Salvatore, Cutroneo, Paola Maria, Dolladille, Charles, Drici, Milou-Daniel, Faillie, Jean-Luc, Goldman, Adam, Hauben, Manfred, Herdeiro, Maria Teresa, Mahaux, Olivia, Manlik, Katrin, Montastruc, François, Noguchi, Yoshihiro, Norén, G. Niklas, Noseda, Roberta, Onakpoya, Igho J., Pariente, Antoine, Poluzzi, Elisabetta, Salem, Myriam, Sartori, Daniele, Trinh, Nhung T. H., Tuccori, Marco, van Hunsel, Florence, van Puijenbroek, Eugène, Raschi, Emanuel, and Khouri, Charles

Published
2024
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5. Communicating Drug Safety

Author

Tuccori, Marco, Convertino, Irma, Ferraro, Sara, Bonaso, Marco, Valdiserra, Giulia, Cappello, Emiliano, Jose, Jimmy, editor, Cox, Anthony R., editor, and Paudyal, Vibhu, editor

Published
2024
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6. Comparing clinical trial population representativeness to real-world users of 17 biologics approved for immune-mediated inflammatory diseases: An external validity analysis of 66,639 biologic users from the Italian VALORE project

Author

Ingrasciotta, Ylenia, Spini, Andrea, L'Abbate, Luca, Fiore, Elena Sofia, Carollo, Massimo, Ientile, Valentina, Isgrò, Valentina, Cavazzana, Anna, Biasi, Valeria, Rossi, Paola, Ejlli, Lucian, Belleudi, Valeria, Poggi, Francesca, Sapigni, Ester, Puccini, Aurora, Ancona, Domenica, Stella, Paolo, Pollina Addario, Sebastiano, Allotta, Alessandra, Leoni, Olivia, Zanforlini, Martina, Tuccori, Marco, Gini, Rosa, and Trifirò, Gianluca

Published
2024
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7. Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison

Author

Machado, Fernanda Lacerda da Silva, Cañás, Martín, Doubova, Svetlana V., Urtasun, Martín A., Marín, Gustavo H., Osorio-de-Castro, Claudia Garcia Serpa, Albuquerque, Flavia Caixeta, Ribeiro, Tatiane Bonfim, Pont, Lisa, Crisóstomo Landeros, José, Roldán Saelzer, Juan, Sepúlveda Viveros, Dino, Acosta, Angela, Machado Beltrán, Manuel A., Gordillo Alas, Lily Iracema, Orellana Tablas, Lourdes Abigail, Benko, Ria, Convertino, Irma, Bonaso, Marco, Tuccori, Marco, Kirchmayer, Ursula, Contreras Sánchez, Saúl E., Rodríguez-Tanta, L. Yesenia, Gutierrez Aures, Ysabel, Lin, Boya, Alipour-Haris, Golnoosh, Eworuke, Efe, and Lopes, Luciane Cruz

Published
2023
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13. Drug Use Patterns in Myasthenia Gravis: A Real-World Population-Based Cohort Study in Italy.

Author

Finocchietti, Marco, Crescioli, Giada, Paoletti, Olga, Brunori, Paola, Sciancalepore, Francesco, Tuccori, Marco, Addis, Antonio, Vannacci, Alfredo, Lombardi, Niccolò, and Kirchmayer, Ursula

Subjects
DRUG utilization, MYASTHENIA gravis, COHORT analysis, NEUROMUSCULAR diseases, DRUG efficacy, VITAMIN D
Abstract

Background: In the context of a comparative study of efficacy and safety of drugs used in rare neuromuscular and neurodegenerative diseases (CAESAR—call AIFA_FV_2012-13-14), we assessed the use patterns of drugs indicated for myasthenia gravis (MG). Methods: A retrospective cohort study was conducted based on administrative healthcare data. For a cohort of MG patients, prevalent and incident use of pyridostigmine (Py) and other indicated drugs in the first year after case identification was evaluated. Prevalent combined use of major therapies (azathioprine (Az), prednisone (Pr), vitamin D (Vd)) stratified by Py use was assessed, and a comparison between therapies at the time of MG identification and during the first year of follow-up was performed. Results: We included 2369 MG patients between 2013 and 2019. Among them, prevalent and incident Py users were 38.4% and 22.0%, respectively. In the first year of follow-up, the use of Pr was observed in 74.5% of Py prevalent users and in 82.0% of Py incident users, respectively; the use of Az was observed in 24.9% and 23.0%, respectively; and the use of Vd was observed in 53.3% and 48.2%, respectively. Among 910 Py prevalent users, 13.1% also used Az, Pr, and Vd, while 15.3% used none of these. Among 938 non-Py users, 2.7% used Az, Pr, and Vd, while 53.8% used none of these. During the first year, an increase in combined therapies was evident in incident Py users. Conclusions: Our results suggest that, for some MG patients, there may be a need for treatments that combine a rapid onset of benefit with long-term and consistent disease control. These issues may be addressed by the new treatments currently being developed. To date, more studies are needed to address the heterogeneity, quality, and generalizability of the existing data and to evaluate patterns of use, efficacy, and safety of new or emerging therapies for MG. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Validation of algorithms for selecting rheumatoid arthritis patients in the Tuscan healthcare administrative databases

Author

Convertino, Irma, Cazzato, Massimiliano, Giometto, Sabrina, Gini, Rosa, Valdiserra, Giulia, Cappello, Emiliano, Ferraro, Sara, Tillati, Silvia, Bartolini, Claudia, Paoletti, Olga, Lorenzoni, Valentina, Trieste, Leopoldo, Filippi, Matteo, Turchetti, Giuseppe, Cristofano, Michele, Blandizzi, Corrado, Mosca, Marta, Lucenteforte, Ersilia, and Tuccori, Marco

Published
2021
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18. Assessing disease activity of rheumatoid arthritis patients and drug-utilization patterns of biologic disease-modifying antirheumatic drugs in the Tuscany region, Italy

Author

Convertino, Irma, primary, Cazzato, Massimiliano, additional, Tillati, Silvia, additional, Giometto, Sabrina, additional, Gini, Rosa, additional, Valdiserra, Giulia, additional, Cappello, Emiliano, additional, Ferraro, Sara, additional, Bonaso, Marco, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Lorenzoni, Valentina, additional, Trieste, Leopoldo, additional, Filippi, Matteo, additional, Turchetti, Giuseppe, additional, Cristofano, Michele, additional, Blandizzi, Corrado, additional, Mosca, Marta, additional, Lucenteforte, Ersilia, additional, and Tuccori, Marco, additional

Published
2023
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19. Potential missed diagnoses of Crohn’s disease in tertiary care: impact on drug utilization and healthcare facilities use

Author

Ferraro, Sara, primary, Cappello, Emiliano, additional, Bartolini, Claudia, additional, Convertino, Irma, additional, Bertani, Lorenzo, additional, Lucenteforte, Ersilia, additional, Costa, Francesco, additional, Paoletti, Olga, additional, Giometto, Sabrina, additional, Gini, Rosa, additional, and Tuccori, Marco, additional

Published
2023
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23. Signal management and risk minimization strategy: a case study on obinutuzumab and non-overt disseminated intravascular coagulation

Author

Valdiserra, Giulia, primary, Mores, Nadia, additional, Rocchi, Rosalba Elisabetta, additional, Sottosanti, Laura, additional, Felicetti, Patrizia, additional, Marchione, Pasquale, additional, Laurenti, Luca, additional, Fresa, Alberto, additional, Bucaneve, Giampaolo, additional, Cappello, Emiliano, additional, Bonaso, Marco, additional, Ferraro, Sara, additional, Convertino, Irma, additional, and Tuccori, Marco, additional

Published
2023
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24. Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.

Author

Cutroneo, Paola Maria, Sartori, Daniele, Tuccori, Marco, Crisafulli, Salvatore, Battini, Vera, Carnovale, Carla, Rafaniello, Concetta, Capuano, Annalisa, Poluzzi, Elisabetta, Moretti, Ugo, and Raschi, Emanuel

Subjects
DRUG side effects, SIGNAL detection, JUDGMENT (Psychology)
Abstract

Spontaneous reporting systems remain pivotal for post-marketing surveillance and disproportionality analysis (DA) represents a recognized approach for early signal detection. Although DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient, their role remain irreplaceable for rapid detection of rare and unpredictable adverse drug reactions with strong drug-attributable component (e.g., designated medical events), especially when developed by a multidisciplinary team and combined with a careful case-by-case analysis (individual inspection of reports for causality assessment or to uncover reporting patterns and clinical features). In the recent past, a remarkable increase in publications of pharmacovigilance studies using DAs was observed, albeit the quality was debated: several publications contained "spin", namely, misinterpretation of results to infer causality, calculate incidence, or provide risk stratification, which may ultimately result in unjustified alarm. The development of dedicated Guidelines by the international READUS-PV project (https://readusstatement. org/) will allow reproducible and transparent publication of accurate DAs, thus supporting their real transferability and exploitation by regulators and clinicians. This review offered a perspective on methodological aspects (and understanding) of DAs, their rationale, design, reporting, and interpretation. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Potentially inappropriate drug use in myasthenia gravis: a real-world population-based cohort study in Italy.

Author

Crescioli, Giada, Finocchietti, Marco, Paoletti, Olga, Brunori, Paola, Sciancalepore, Francesco, Tuccori, Marco, Addis, Antonio, Vannacci, Alfredo, Lombardi, Niccolò, and Kirchmayer, Ursula

Subjects
DRUG utilization, COHORT analysis, ODDS ratio, LOGISTIC regression analysis, MYASTHENIA gravis, KIDNEY diseases
Abstract

Introduction: To evaluate the use of pyridostigmine in presence of contraindications, and the use of concomitant potentially contraindicated drugs in a cohort of patients affected by Myasthenia Gravis (MG) in the Italian Regions of Lazio, Tuscany, and Umbria. Methods: This is a retrospective cohort study. A multivariate logistic regression model was used to evaluate the determinants of pyridostigmine and of potentially contraindicated drugs use in MG patients. Results: Among 591 incident pyridostigmine users affected by MG, 91 (15.4%) had at least one of the contraindications considered at the first prescription of pyridostigmine. Patients prescribed with pyridostigmine in presence of contraindications were more frequently affected by diabetes, obesity, and renal diseases. Age 75+ years (odds ratio, OR 4.94, 95% confidence interval, CI 1.60-15.22 for Latium; OR 3.78, 95%CI: 1.26-11.34 for Tuscany; OR 5.83, 95%CI 1.19-28.52 for Umbria), the presence of at least one specific comorbidity (OR 3.93; 95%CI 1.68-9.17 for Latium), and polytherapy (6+ drugs, OR 4.90, 95%CI: 1.35-17.85 for Tuscany) were found to be significantly associated with pyridostigmine use in presence of contraindications. Among patients affected by MG, 1,483 (62.6%) were treated with potentially contraindicated drugs in the first year of follow-up (67.06.9% in Latium; 59% in Tuscany; 57.6% in Umbria). Patients aged 75+ years, those with at least one specific complication or comorbidity, and those exposed to polytherapy were more likely to be treated with a potential contraindicated drug. Conclusion: Among incident users of pyridostigmine, more than 15% of patients have at least one of the contraindications considered, and among patients diagnosed with MG, in the first year of follow-up >60% of subjects were treated with potentially contraindicated drugs. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Drug-Utilization, Healthcare Facilities Accesses and Costs of the First Generation of JAK Inhibitors in Rheumatoid Arthritis

Author

Convertino, Irma, primary, Lorenzoni, Valentina, additional, Gini, Rosa, additional, Turchetti, Giuseppe, additional, Fini, Elisabetta, additional, Giometto, Sabrina, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Ferraro, Sara, additional, Cappello, Emiliano, additional, Valdiserra, Giulia, additional, Bonaso, Marco, additional, Blandizzi, Corrado, additional, Tuccori, Marco, additional, and Lucenteforte, Ersilia, additional

Published
2023
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29. Lessons learnt from the preclinical discovery and development of ensitrelvir as a COVID-19 therapeutic option

Author

Ferraro, Sara, Convertino, Irma, Cappello, Emiliano, Valdiserra, Giulia, Bonaso, Marco, and Tuccori, Marco

Abstract

ABSTRACTIntroductionThe COVID-19 pandemic stimulated the development of several therapeutic tools with several degrees of success. Ensitrelvir, a protease inhibitor that blocks the replication of SARS-CoV-2, can reduce the viral load and the severity of symptoms in infected patients and become available for emergency use in Japan. Clinical trials showed a good tolerability profile although the potential for interactions with substrates, inhibitors, and inducers of CYP3A must be considered. The occurrence of resistance is also a matter of investigation.Areas coveredIn this article, the authors describe the development of ensitrelvir starting from the identification of the molecule to the pre-clinical and clinical trials up to the post-authorization phase.Expert opinionEnsitrelvir was developed in a late phase of the pandemic when the availability of patients that can be candidate to enter the clinical trial was limited with consequences for the possibility of assessing certain outcomes and for the robustness of results. Although the evidence about the benefits of ensitrelvir in COVID-19 is not questionable, the problems of interactions with other drugs, emerging resistant variants, the availability of alternative therapeutic options, costs, and accessibility will concur to its probable limited clinical use in the future.

Published
2024
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34. Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the CAESAR project)

Author

Crescioli, Giada, Finocchietti, Marco, Cascini, Silvia, Paoletti, Olga, Franchini, David, Cappello, Emiliano, Valdiserra, Giulia, Sciancalepore, Francesco, Celani, Maria Grazia, Tuccori, Marco, Vannacci, Alfredo, Lombardi, Niccolò, and Kirchmayer, Ursula

Abstract

Background: This analysis describes the use of riluzole in amyotrophic lateral sclerosis (ALS) individuals with contraindications and off-label use for subjects with other motor neuron diseases (o-MND) in the Italian regions of Latium, Tuscany and Umbria.Methods: A cohort of adults with ALS prescribed with riluzole during the years 2016–2019 was enrolled from administrative healthcare databases, excluding subjects with o-MND in the preceding 5 years. Being affected by ALS for more than 5 years, presence of tracheostomy, renal or hepatic failure were considered as contraindications to the use of riluzole. A cohort of adults with o-MND was enrolled in 2016–2019 for whom off-label use of riluzole was retrieved up to 4 years, analysing over the time differences related to sex.Results: Among 206 ALS individuals prescribed with riluzole in Latium, 336 in Tuscany and 60 in Umbria, less than 1% were diagnosed with ALS for more than 5 years. Less than 2% were tracheotomised or affected by hepatic failure. Renal failure was documented for 1.9%, 2.7%, and 5.0% of ALS individuals in Latium, Tuscany and Umbria. The o-MND cohort comprised 264 subjects in Latium, 222 in Tuscany, and 66 in Umbria. Non-negligible off-label riluzole use was observed: 8.5%, 33.0%, and 4.2% in females, and 19.9%, 26.5% and 2.4% in males in Latium, Tuscany and Umbria.Discussion: Riluzole use in ALS individuals in the presence of contraindications is rare, with slightly higher numbers in presence of renal failure. Off-label use in o-MND was found to be non-negligible, with variations between sexes.

Published
2022

49. Trajectories of Adherence to Biologic Disease-Modifying Anti-Rheumatic Drugs in Tuscan Administrative Databases: The Pathfinder Study

Author

Convertino, Irma, primary, Giometto, Sabrina, additional, Gini, Rosa, additional, Cazzato, Massimiliano, additional, Fornili, Marco, additional, Valdiserra, Giulia, additional, Cappello, Emiliano, additional, Ferraro, Sara, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Tillati, Silvia, additional, Baglietto, Laura, additional, Turchetti, Giuseppe, additional, Trieste, Leopoldo, additional, Lorenzoni, Valentina, additional, Blandizzi, Corrado, additional, Mosca, Marta, additional, Tuccori, Marco, additional, and Lucenteforte, Ersilia, additional

Published
2021
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