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1. Comorbidities, cardiovascular therapies, and COVID-19 mortality: A nationwide, italian observational study (ItaliCO)

Author

Polverino, F, Stern, D, Ruocco, G, Balestro, E, Bassetti, M, Candelli, M, Cirillo, B, Contoli, M, Corsico, A, D'Amico, F, D'Elia, E, Falco, G, Gasparini, S, Guerra, S, Harari, S, Kraft, M, Mennella, L, Papi, A, Parrella, R, Pelosi, P, Poletti, V, Polverino, M, Tana, C, Terribile, R, Woods, J, Di Marco, F, Martinez, F, Zhang, S, Geelhoed, B, Sinning, C, Agarossi, A, Agati, S, Agosteo, E, Ando', F, Andreoni, M, Angelillo, I, Arcoleo, G, Arena, C, Baiamonte, P, Ball, L, Banfi, P, Bartoletti, G, Bartolotta, R, Battaglini, D, Bellan, M, Benzoni, I, Bertolini, R, Bevilacqua, M, Bezzi, M, Bianco, A, Bisbano, A, Bobbio, F, Bocchialini, G, Bonetti, F, Boni, F, Bonifazi, M, Borgonovo, G, Borre', S, Bosio, M, Brachini, G, Brunetti, I, Calagna, L, Calo, F, Capuozzo, A, Carr, T, Castellani, A, Catalano, F, Catania, G, Catena, E, Cattaneo, M, Cattelan, A, Ceruti, V, Chiumiento, F, Cicchitto, G, Confalonieri, M, Confalonieri, P, Coppola, N, Cosentina, R, Costantino, R, Crimi, C, Curra, A, D'Abbraccio, M, Dalbeni, A, Daleffe, F, Davide, R, Del Donno, M, Di Pastena, F, Di Perna, F, Di Rosa, Z, Di Sabatino, A, Elesbani, O, Elia, D, Esposito, V, Fabiani, L, Falo, G, Fanelli, C, Fantin, A, Ferrigno, F, Fiorentino, G, Franceschi, F, Fronza, M, Gardenghi, G, Giacobbe, D, Giannotti, C, Giannotti, G, Gidari, A, Giovanardi, F, Gnerre, P, Gonnelli, F, Graziano, M, Greco, S, Grosso, A, Guarino, S, Iannarelli, A, Imitazione, P, Inglese, F, Iodice, V, Izzo, A, La Greca, C, Lax, A, Legittimo, F, Leo, A, Leone, S, Lepidini, V, Leto, M, Licata, F, Locati, F, Lorini, L, Lucchetti, B, Maida, I, Macera, M, Manzillo, E, March, A, Mascheroni, D, Mastroianni, A, Mauro, I, Mazzitelli, M, Mazzuca, E, Micheletto, C, Mingoli, A, Minuz, P, Moioli, M, Monti, L, Morgagni, R, Mucci, L, Muselli, M, Negri, S, Nobile, C, Oldani, S, Olivieri, C, Parati, G, Parodi, L, Pastorelli, E, Patruno, V, Pellegrino, F, Pengo, M, Pepe, D, Perotti, A, Petrino, R, Petrucci, M, Piane, R, Pignataro, G, Pino, M, Pirisi, M, Porru, F, Pugliese, F, Punzi, R, Ramaroli, D, Robba, C, Rostagno, R, Sabatini, U, Sainaghi, P, Salton, F, Salzano, C, Sanduzzi, A, Zamparelli, S, Sangiovanni, V, Santopuoli, D, Sapienza, P, Sarmati, L, Schiaroli, E, Scienza, F, Senni, M, Serchisu, L, Sgherzi, S, Soddu, D, Soranna, D, Sorino, C, Spadaro, S, Stirpe, E, Tardivo, S, Tartaglia, S, Teopompi, E, Tomchaney, M, Torelli, E, Torlasco, C, Torti, C, Tupputi, E, Ugolinelli, C, Vatrella, A, Versace, A, Villani, M, Vincenzo, L, Volta, C, Voraphani, N, Zekaj, E, Zoppellari, R, Polverino F., Stern D. A., Ruocco G., Balestro E., Bassetti M., Candelli M., Cirillo B., Contoli M., Corsico A., D'Amico F., D'Elia E., Falco G., Gasparini S., Guerra S., Harari S., Kraft M., Mennella L., Papi A., Parrella R., Pelosi P., Poletti V., Polverino M., Tana C., Terribile R., Woods J. C., Di Marco F., Martinez F. D., Zhang S., Geelhoed B., Sinning C., Agarossi A., Agati S., Agosteo E., Ando' F., Andreoni M., Angelillo I. F., Arcoleo G., Arena C., Baiamonte P., Ball L., Banfi P., Bartoletti G., Bartolotta R., Battaglini D., Bellan M., Benzoni I., Bertolini R., Bevilacqua M., Bezzi M., Bianco A., Bisbano A., Bobbio F., Bocchialini G., Bonetti F., Boni F., Bonifazi M., Borgonovo G., Borre' S., Bosio M., Brachini G., Brunetti I., Calagna L., Calo F., Capuozzo A., Carr T., Castellani A., Catalano F., Catania G., Catena E., Cattaneo M., Cattelan A., Ceruti V., Chiumiento F., Cicchitto G., Confalonieri M., Confalonieri P., Coppola N., Cosentina R., Costantino R., Crimi C., Curra A., D'Abbraccio M., Dalbeni A., Daleffe F., Davide R., Del Donno M., Di Pastena F., Di Perna F., Di Rosa Z., Di Sabatino A., Elesbani O., Elia D., Esposito V., Fabiani L., Falo G., Fanelli C., Fantin A., Ferrigno F., Fiorentino G., Franceschi F., Fronza M., Gardenghi G. G., Giacobbe D. R., Giannotti C., Giannotti G., Gidari A., Giovanardi F., Gnerre P., Gonnelli F., Graziano M., Greco S., Grosso A., Guarino S., Iannarelli A., Imitazione P., Inglese F., Iodice V., Izzo A., La Greca C., Lax A., Legittimo F., Leo A., Leone S., Lepidini V., Leto M., Licata F., Locati F., Lorini L., Lucchetti B., Maida I., Macera M., Manzillo E., March A., Mascheroni D., Mastroianni A., Mauro I., Mazzitelli M., Mazzuca E., Micheletto C., Mingoli A., Minuz P., Moioli M., Monti L., Morgagni R., Mucci L., Muselli M., Negri S., Nobile C. G. A., Oldani S., Olivieri C., Parati G., Parodi L., Pastorelli E., Patruno V., Pellegrino F., Pengo M. F., Pepe D., Perotti A., Petrino R., Petrucci M., Piane R. M., Pignataro G., Pino M., Pirisi M., Porru F., Pugliese F., Punzi R., Ramaroli D. A., Robba C., Rostagno R., Sabatini U., Sainaghi P. P., Salton F., Salzano C., Sanduzzi A., Zamparelli S. S., Sangiovanni V., Santopuoli D., Sapienza P., Sarmati L., Schiaroli E., Scienza F., Senni M., Serchisu L., Sgherzi S., Soddu D., Soranna D., Sorino C., Spadaro S., Stirpe E., Tardivo S., Tartaglia S., Teopompi E., Tomchaney M., Torelli E., Torlasco C., Torti C., Tupputi E., Ugolinelli C., Vatrella A., Versace A. G., Villani M., Vincenzo L., Volta C. A., Voraphani N., Zekaj E., Zoppellari R., Polverino, F, Stern, D, Ruocco, G, Balestro, E, Bassetti, M, Candelli, M, Cirillo, B, Contoli, M, Corsico, A, D'Amico, F, D'Elia, E, Falco, G, Gasparini, S, Guerra, S, Harari, S, Kraft, M, Mennella, L, Papi, A, Parrella, R, Pelosi, P, Poletti, V, Polverino, M, Tana, C, Terribile, R, Woods, J, Di Marco, F, Martinez, F, Zhang, S, Geelhoed, B, Sinning, C, Agarossi, A, Agati, S, Agosteo, E, Ando', F, Andreoni, M, Angelillo, I, Arcoleo, G, Arena, C, Baiamonte, P, Ball, L, Banfi, P, Bartoletti, G, Bartolotta, R, Battaglini, D, Bellan, M, Benzoni, I, Bertolini, R, Bevilacqua, M, Bezzi, M, Bianco, A, Bisbano, A, Bobbio, F, Bocchialini, G, Bonetti, F, Boni, F, Bonifazi, M, Borgonovo, G, Borre', S, Bosio, M, Brachini, G, Brunetti, I, Calagna, L, Calo, F, Capuozzo, A, Carr, T, Castellani, A, Catalano, F, Catania, G, Catena, E, Cattaneo, M, Cattelan, A, Ceruti, V, Chiumiento, F, Cicchitto, G, Confalonieri, M, Confalonieri, P, Coppola, N, Cosentina, R, Costantino, R, Crimi, C, Curra, A, D'Abbraccio, M, Dalbeni, A, Daleffe, F, Davide, R, Del Donno, M, Di Pastena, F, Di Perna, F, Di Rosa, Z, Di Sabatino, A, Elesbani, O, Elia, D, Esposito, V, Fabiani, L, Falo, G, Fanelli, C, Fantin, A, Ferrigno, F, Fiorentino, G, Franceschi, F, Fronza, M, Gardenghi, G, Giacobbe, D, Giannotti, C, Giannotti, G, Gidari, A, Giovanardi, F, Gnerre, P, Gonnelli, F, Graziano, M, Greco, S, Grosso, A, Guarino, S, Iannarelli, A, Imitazione, P, Inglese, F, Iodice, V, Izzo, A, La Greca, C, Lax, A, Legittimo, F, Leo, A, Leone, S, Lepidini, V, Leto, M, Licata, F, Locati, F, Lorini, L, Lucchetti, B, Maida, I, Macera, M, Manzillo, E, March, A, Mascheroni, D, Mastroianni, A, Mauro, I, Mazzitelli, M, Mazzuca, E, Micheletto, C, Mingoli, A, Minuz, P, Moioli, M, Monti, L, Morgagni, R, Mucci, L, Muselli, M, Negri, S, Nobile, C, Oldani, S, Olivieri, C, Parati, G, Parodi, L, Pastorelli, E, Patruno, V, Pellegrino, F, Pengo, M, Pepe, D, Perotti, A, Petrino, R, Petrucci, M, Piane, R, Pignataro, G, Pino, M, Pirisi, M, Porru, F, Pugliese, F, Punzi, R, Ramaroli, D, Robba, C, Rostagno, R, Sabatini, U, Sainaghi, P, Salton, F, Salzano, C, Sanduzzi, A, Zamparelli, S, Sangiovanni, V, Santopuoli, D, Sapienza, P, Sarmati, L, Schiaroli, E, Scienza, F, Senni, M, Serchisu, L, Sgherzi, S, Soddu, D, Soranna, D, Sorino, C, Spadaro, S, Stirpe, E, Tardivo, S, Tartaglia, S, Teopompi, E, Tomchaney, M, Torelli, E, Torlasco, C, Torti, C, Tupputi, E, Ugolinelli, C, Vatrella, A, Versace, A, Villani, M, Vincenzo, L, Volta, C, Voraphani, N, Zekaj, E, Zoppellari, R, Polverino F., Stern D. A., Ruocco G., Balestro E., Bassetti M., Candelli M., Cirillo B., Contoli M., Corsico A., D'Amico F., D'Elia E., Falco G., Gasparini S., Guerra S., Harari S., Kraft M., Mennella L., Papi A., Parrella R., Pelosi P., Poletti V., Polverino M., Tana C., Terribile R., Woods J. C., Di Marco F., Martinez F. D., Zhang S., Geelhoed B., Sinning C., Agarossi A., Agati S., Agosteo E., Ando' F., Andreoni M., Angelillo I. F., Arcoleo G., Arena C., Baiamonte P., Ball L., Banfi P., Bartoletti G., Bartolotta R., Battaglini D., Bellan M., Benzoni I., Bertolini R., Bevilacqua M., Bezzi M., Bianco A., Bisbano A., Bobbio F., Bocchialini G., Bonetti F., Boni F., Bonifazi M., Borgonovo G., Borre' S., Bosio M., Brachini G., Brunetti I., Calagna L., Calo F., Capuozzo A., Carr T., Castellani A., Catalano F., Catania G., Catena E., Cattaneo M., Cattelan A., Ceruti V., Chiumiento F., Cicchitto G., Confalonieri M., Confalonieri P., Coppola N., Cosentina R., Costantino R., Crimi C., Curra A., D'Abbraccio M., Dalbeni A., Daleffe F., Davide R., Del Donno M., Di Pastena F., Di Perna F., Di Rosa Z., Di Sabatino A., Elesbani O., Elia D., Esposito V., Fabiani L., Falo G., Fanelli C., Fantin A., Ferrigno F., Fiorentino G., Franceschi F., Fronza M., Gardenghi G. G., Giacobbe D. R., Giannotti C., Giannotti G., Gidari A., Giovanardi F., Gnerre P., Gonnelli F., Graziano M., Greco S., Grosso A., Guarino S., Iannarelli A., Imitazione P., Inglese F., Iodice V., Izzo A., La Greca C., Lax A., Legittimo F., Leo A., Leone S., Lepidini V., Leto M., Licata F., Locati F., Lorini L., Lucchetti B., Maida I., Macera M., Manzillo E., March A., Mascheroni D., Mastroianni A., Mauro I., Mazzitelli M., Mazzuca E., Micheletto C., Mingoli A., Minuz P., Moioli M., Monti L., Morgagni R., Mucci L., Muselli M., Negri S., Nobile C. G. A., Oldani S., Olivieri C., Parati G., Parodi L., Pastorelli E., Patruno V., Pellegrino F., Pengo M. F., Pepe D., Perotti A., Petrino R., Petrucci M., Piane R. M., Pignataro G., Pino M., Pirisi M., Porru F., Pugliese F., Punzi R., Ramaroli D. A., Robba C., Rostagno R., Sabatini U., Sainaghi P. P., Salton F., Salzano C., Sanduzzi A., Zamparelli S. S., Sangiovanni V., Santopuoli D., Sapienza P., Sarmati L., Schiaroli E., Scienza F., Senni M., Serchisu L., Sgherzi S., Soddu D., Soranna D., Sorino C., Spadaro S., Stirpe E., Tardivo S., Tartaglia S., Teopompi E., Tomchaney M., Torelli E., Torlasco C., Torti C., Tupputi E., Ugolinelli C., Vatrella A., Versace A. G., Villani M., Vincenzo L., Volta C. A., Voraphani N., Zekaj E., and Zoppellari R.

Abstract

Background: Italy has one of the world’s oldest populations, and suffered one the highest death tolls from Coronavirus disease 2019 (COVID-19) worldwide. Older people with cardiovascular diseases (CVDs), and in particular hypertension, are at higher risk of hospitalization and death for COVID-19. Whether hypertensionmedicationsmay increase the risk for death in older COVID 19 inpatients at the highest risk for the disease is currently unknown. Methods: Data from 5,625 COVID-19 inpatients were manually extracted from medical charts from 61 hospitals across Italy. From the initial 5,625 patients, 3,179 were included in the study as they were either discharged or deceased at the time of the data analysis. Primary outcome was inpatient death or recovery. Mixed effects logistic regression models were adjusted for sex, age, and number of comorbidities, with a random effect for site. Results: A large proportion of participating inpatients were ≥65 years old (58%), male (68%), non-smokers (93%) with comorbidities (66%). Each additional comorbidity increased the risk of death by 35% [adjOR = 1.35 (1.2, 1.5) p < 0.001]. Use of ACE inhibitors, ARBs, beta-blockers or Ca-antagonists was not associated with significantly increased risk of death. There was a marginal negative association between ARB use and death, and a marginal positive association between diuretic use and death. Conclusions: This Italian nationwide observational study of COVID-19 inpatients, the majority of which ≥65 years old, indicates that there is a linear direct relationship between the number of comorbidities and the risk of death. Among CVDs, hypertension and pre-existing cardiomyopathy were significantly associated with risk of death. The use of hypertension medications reported to be safe in younger cohorts, do not contribute significantly to increased COVID-19 related deaths in an older population that suffered one of the highest death tolls worldwide.

Published
2020

2. Patient-reported outcomes and patient-reported outcome measures in interstitial lung disease: where to go from here?

Author

Kalluri, M, Luppi, F, Vancheri, A, Vancheri, C, Balestro, E, Varone, F, Mogulkoc, N, Cacopardo, G, Bargagli, E, Renzoni, E, Torrisi, S, Calvello, M, Libra, A, Pavone, M, Bonella, F, Cottin, V, Valenzuela, C, Wijsenbeek, M, Bendstrup, E, Kalluri, Meena, Luppi, Fabrizio, Vancheri, Ada, Vancheri, Carlo, Balestro, Elisabetta, Varone, Francesco, Mogulkoc, Nesrin, Cacopardo, Giulia, Bargagli, Elena, Renzoni, Elizabeth, Torrisi, Sebastiano, Calvello, Mariarosaria, Libra, Alessandro, Pavone, Mauro, Bonella, Francesco, Cottin, Vincent, Valenzuela, Claudia, Wijsenbeek, Marlies, Bendstrup, Elisabeth, Kalluri, M, Luppi, F, Vancheri, A, Vancheri, C, Balestro, E, Varone, F, Mogulkoc, N, Cacopardo, G, Bargagli, E, Renzoni, E, Torrisi, S, Calvello, M, Libra, A, Pavone, M, Bonella, F, Cottin, V, Valenzuela, C, Wijsenbeek, M, Bendstrup, E, Kalluri, Meena, Luppi, Fabrizio, Vancheri, Ada, Vancheri, Carlo, Balestro, Elisabetta, Varone, Francesco, Mogulkoc, Nesrin, Cacopardo, Giulia, Bargagli, Elena, Renzoni, Elizabeth, Torrisi, Sebastiano, Calvello, Mariarosaria, Libra, Alessandro, Pavone, Mauro, Bonella, Francesco, Cottin, Vincent, Valenzuela, Claudia, Wijsenbeek, Marlies, and Bendstrup, Elisabeth

Abstract

Patient-reported outcome measures (PROMs), tools to assess patient self-report of health status, are now increasingly used in research, care and policymaking. While there are two well-developed disease-specific PROMs for interstitial lung diseases (ILD) and idiopathic pulmonary fibrosis (IPF), many unmet and urgent needs remain. In December 2019, 64 international ILD experts convened in Erice, Italy to deliberate on many topics, including PROMs in ILD. This review summarises the history of PROMs in ILD, shortcomings of the existing tools, challenges of development, validation and implementation of their use in clinical trials, and the discussion held during the meeting. Development of disease-specific PROMs for ILD including IPF with robust methodology and validation in concordance with guidance from regulatory authorities have increased user confidence in PROMs. Minimal clinically important difference for bidirectional changes may need to be developed. Cross-cultural validation and linguistic adaptations are necessary in addition to robust psychometric properties for effective PROM use in multinational clinical trials. PROM burden of use should be reduced through appropriate use of digital technologies and computerised adaptive testing. Active patient engagement in all stages from development, testing, choosing and implementation of PROMs can help improve probability of success and further growth.

Published
2021

3. Subclinical liver fibrosis in patients with idiopathic pulmonary fibrosis

Author

Cocconcelli, E, Tonelli, R, Abbati, G, Marchioni, A, Castaniere, I, Pelizzaro, F, Russo, F, Vegetti, A, Balestro, E, Pietrangelo, A, Richeldi, L, Luppi, F, Spagnolo, P, Clini, E, Cerri, S, Cocconcelli, Elisabetta, Tonelli, Roberto, Abbati, Gianluca, Marchioni, Alessandro, Castaniere, Ivana, Pelizzaro, Filippo, Russo, Francesco Paolo, Vegetti, Alberto, Balestro, Elisabetta, Pietrangelo, Antonello, Richeldi, Luca, Luppi, Fabrizio, Spagnolo, Paolo, Clini, Enrico, Cerri, Stefania, Cocconcelli, E, Tonelli, R, Abbati, G, Marchioni, A, Castaniere, I, Pelizzaro, F, Russo, F, Vegetti, A, Balestro, E, Pietrangelo, A, Richeldi, L, Luppi, F, Spagnolo, P, Clini, E, Cerri, S, Cocconcelli, Elisabetta, Tonelli, Roberto, Abbati, Gianluca, Marchioni, Alessandro, Castaniere, Ivana, Pelizzaro, Filippo, Russo, Francesco Paolo, Vegetti, Alberto, Balestro, Elisabetta, Pietrangelo, Antonello, Richeldi, Luca, Luppi, Fabrizio, Spagnolo, Paolo, Clini, Enrico, and Cerri, Stefania

Abstract

Data on the presence of subclinical fibrosis across multiple organs in patients with idiopathic lung fibrosis (IPF) are lacking. Our study aimed at investigating through hepatic transient elastography (HTE) the prevalence and clinical impact of subclinical liver fibrosis in a cohort of patients with IPF. Patients referred to the Centre for Rare Lung Disease of the University Hospital of Modena (Italy) from March 2012 to February 2013 with established diagnosis of IPF and without a documented history of liver diseases were consecutively enrolled and underwent HTE. Based on hepatic stiffness status as assessed through METAVIR score patients were categorized as "with liver fibrosis" (corresponding to a METAVIR score of F1-F4) and "without liver fibrosis" (METAVIR F0). Potential predictors of liver fibrosis were investigated through logistic regression model among clinical and serological variables. The overall survival (OS) was assessed according to liver fibrosis and multivariate Cox regression analysis was used to identify independent predictors. In 13 out of 37 patients (35%) with IPF, a certain degree of liver fibrosis was documented. No correlation was found between liver stiffness and clinical-functional parameters. OS was lower in patients 'with liver fibrosis' than in patients 'without liver fibrosis' (median months 33 [23-55] vs. 63 [26-94], p = 0.038). Patients 'with liver fibrosis' presented a higher risk of death at seven years as compared to patients 'without liver fibrosis' (HR = 2.6, 95% CI [1.003-6.7], p = 0.049). Higher level of AST to platelet ratio index (APRI) was an independent predictor of survival (HR = 4.52 95% CI [1.3-15.6], p = 0.02). In our cohort, more than one-third of IPF patients had concomitant subclinical liver fibrosis that negatively affected OS. These preliminary claims further investigation aimed at clarifying the mechanisms beyond multiorgan fibrosis and its clinical implication in patients with IPF.

Published
2021

4. Subclinical liver fibrosis in patients with idiopathic pulmonary fibrosis

Author

Cocconcelli, E., Tonelli, R., Abbati, G., Marchioni, A., Castaniere, I., Pelizzaro, F., Russo, F. P., Vegetti, A., Balestro, E., Pietrangelo, A., Richeldi, Luca, Luppi, F., Spagnolo, P., Clini, E., Cerri, S., Richeldi L. (ORCID:0000-0001-8594-1448), Cocconcelli, E., Tonelli, R., Abbati, G., Marchioni, A., Castaniere, I., Pelizzaro, F., Russo, F. P., Vegetti, A., Balestro, E., Pietrangelo, A., Richeldi, Luca, Luppi, F., Spagnolo, P., Clini, E., Cerri, S., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Data on the presence of subclinical fibrosis across multiple organs in patients with idiopathic lung fibrosis (IPF) are lacking. Our study aimed at investigating through hepatic transient elastography (HTE) the prevalence and clinical impact of subclinical liver fibrosis in a cohort of patients with IPF. Patients referred to the Centre for Rare Lung Disease of the University Hospital of Modena (Italy) from March 2012 to February 2013 with established diagnosis of IPF and without a documented history of liver diseases were consecutively enrolled and underwent HTE. Based on hepatic stiffness status as assessed through METAVIR score patients were categorized as “with liver fibrosis” (corresponding to a METAVIR score of F1–F4) and “without liver fibrosis” (METAVIR F0). Potential predictors of liver fibrosis were investigated through logistic regression model among clinical and serological variables. The overall survival (OS) was assessed according to liver fibrosis and multivariate Cox regression analysis was used to identify independent predictors. In 13 out of 37 patients (35%) with IPF, a certain degree of liver fibrosis was documented. No correlation was found between liver stiffness and clinical–functional parameters. OS was lower in patients ‘with liver fibrosis’ than in patients ‘without liver fibrosis’ (median months 33 [23–55] vs. 63 [26–94], p = 0.038). Patients ‘with liver fibrosis’ presented a higher risk of death at seven years as compared to patients ‘without liver fibrosis’ (HR = 2.6, 95% CI [1.003–6.7], p = 0.049). Higher level of AST to platelet ratio index (APRI) was an independent predictor of survival (HR = 4.52 95% CI [1.3–15.6], p = 0.02). In our cohort, more than one-third of IPF patients had concomitant subclinical liver fibrosis that negatively affected OS. These preliminary claims further investigation aimed at clarifying the mechanisms beyond multiorgan fibrosis and its clinical implication in patients with IPF.

Published
2020

5. Gaps in care of patients living with pulmonary fibrosis

Author

Moor, C.C. (Karen), Wijsenbeek-Lourens, M.S. (Marlies), Balestro, E. (Elisabetta), Biondini, D. (Davide), Bondue, B. (Benjamin), Cottin, V. (Vincent), Kreuter, M. (Michael), Bonella, F. (Francesco), Moor, C.C. (Karen), Wijsenbeek-Lourens, M.S. (Marlies), Balestro, E. (Elisabetta), Biondini, D. (Davide), Bondue, B. (Benjamin), Cottin, V. (Vincent), Kreuter, M. (Michael), and Bonella, F. (Francesco)

Abstract

Introduction: Pulmonary fibrosis (PF) and its most common form, idiopathic pulmonary fibrosis (IPF), are chronic, progressive diseases resulting in increasing loss of lung function and impaired quality of life and survival. The aim of this joint expert and patient statement was to highlight the most pressing common unmet needs of patients with PF/IPF, putting forward recommendations to improve the quality of life and health outcomes throughout the patient journey. Methods: Two online surveys for patients and healthcare professionals (HCPs) were conducted by the European Idiopathic Pulmonary Fibrosis and Related Disorders Federation (EU-IPFF) in 14 European countries. Results: The surveys were answered by 286 patients and 69 HCPs, including physicians and nurses. Delays in diagnosis and timely access to interstitial lung disease specialists and pharmacological treatment have been identified as important gaps in care. Additionally, patients and HCPs reported that a greater focus on symptomcentred management, adequate information, trial information and increasing awareness of PF/IPF is required. Conclusions: The surveys offer important insights into the current unmet needs of PF/IPF patients. Interventions at different points of the care pathway are needed to improve patient experience.

Published
2019
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7. Pretreatment rate of decay in forced vital capacity predicts long-term response to pirfenidone in patients with idiopathic pulmonary fibrosis

Author

Biondini, D, Balestro, E, Lacedonia, D, Cerri, S, Milaneschi, R, Luppi, F, Cocconcelli, E, Bazzan, E, Clini, E, Foschino Barbaro, M, Gregori, D, Cosio, M, Saetta, M, Spagnolo, P, Foschino Barbaro, MP, Cosio, MG, Biondini, D, Balestro, E, Lacedonia, D, Cerri, S, Milaneschi, R, Luppi, F, Cocconcelli, E, Bazzan, E, Clini, E, Foschino Barbaro, M, Gregori, D, Cosio, M, Saetta, M, Spagnolo, P, Foschino Barbaro, MP, and Cosio, MG

Abstract

Pirfenidone reduces functional decline in patients with Idiopathic Pulmonary Fibrosis (IPF). However, response to treatment is highly heterogeneous. We sought to evaluate whether response to pirfenidone is influenced by the pretreatment rate of forced vital capacity (FVC) decline. Fifty-six IPF patients were categorized as rapid (RP) or slow progressors (SP) based on whether their FVC decline in the year preceding pirfenidone treatment was > or ≤ 10% predicted. Following pirfenidone treatment patients were followed-up every 6 months and up to 24 months. In the entire population, pirfenidone reduced significantly FVC decline from 231 to 49 ml/year at 6 months (T6) (p = 0.003) and this effect was maintained at the 12-, 18- and 24-month time points (p value for trend n.s.). In RP, the reduction of FVC decline was evident at 6 months (36 vs 706 ml/year pretreatment; p = 0.002) and maintained, though to a lesser degree, at 12 (106 ml/year), 18 (176 ml/year) and 24 months (162 ml/year; p value for trend n.s). Among SP, the reduction in FVC decline was not significant at any of the time points analyzed. In conclusion, pirfenidone reduces FVC decline in IPF patients. However, its beneficial effect is more pronounced in patients with rapidly progressive disease.

Published
2018

8. A Real-Life Multicenter National Study on Nintedanib in Severe Idiopathic Pulmonary Fibrosis

Author

Harari, S, Caminati, A, Poletti, V, Confalonieri, M, Gasparini, S, Lacedonia, D, Luppi, F, Pesci, A, Sebastiani, A, Spagnolo, P, Vancheri, C, Balestro, E, Bonifazi, M, Cerri, S, De Giacomi, F, Della Porta, R, Foschino Barbaro, M, Fui, A, Pasquinelli, P, Rosso, R, Tomassetti, S, Specchia, C, Rottoli, P, Harari, Sergio, Caminati, Antonella, Poletti, Venerino, Confalonieri, Marco, Gasparini, Stefano, Lacedonia, Donato, Luppi, Fabrizio, Pesci, Alberto, Sebastiani, Alfredo, Spagnolo, Paolo, Vancheri, Carlo, Balestro, Elisabetta, Bonifazi, Martina, Cerri, Stefania, De Giacomi, Federica, Della Porta, Rossana, Foschino Barbaro, Maria Pia, Fui, Annalisa, Pasquinelli, Patrizio, Rosso, Roberta, Tomassetti, Sara, Specchia, Claudia, Rottoli, Paola, Harari, S, Caminati, A, Poletti, V, Confalonieri, M, Gasparini, S, Lacedonia, D, Luppi, F, Pesci, A, Sebastiani, A, Spagnolo, P, Vancheri, C, Balestro, E, Bonifazi, M, Cerri, S, De Giacomi, F, Della Porta, R, Foschino Barbaro, M, Fui, A, Pasquinelli, P, Rosso, R, Tomassetti, S, Specchia, C, Rottoli, P, Harari, Sergio, Caminati, Antonella, Poletti, Venerino, Confalonieri, Marco, Gasparini, Stefano, Lacedonia, Donato, Luppi, Fabrizio, Pesci, Alberto, Sebastiani, Alfredo, Spagnolo, Paolo, Vancheri, Carlo, Balestro, Elisabetta, Bonifazi, Martina, Cerri, Stefania, De Giacomi, Federica, Della Porta, Rossana, Foschino Barbaro, Maria Pia, Fui, Annalisa, Pasquinelli, Patrizio, Rosso, Roberta, Tomassetti, Sara, Specchia, Claudia, and Rottoli, Paola

Abstract

Background: Two therapeutic options are currently available for patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib. To date, there is still insufficient data on the efficacy of these 2 agents in patients with more severe disease. Objectives: This national, multicenter, retrospective real-life study was intended to determine the impact of nintedanib on the treatment of patients with severe IPF. Methods: All patients included had severe IPF and had to have at least 6 months of follow-up before and at least 6 months of follow-up after starting nintedanib. The aim of the study was to compare the decline in lung function before and after treatment. Patient survival after 6 months of therapy with nintedanib was assessed. Results: Forty-one patients with a forced vital capacity (FVC) ≤50% and/or a diffusing capacity of the lung for carbon monoxide (DLCO) ≤35% predicted at the start of nintedanib treatment were enrolled. At the 6-month follow-up, the decline of DLCO (both absolute and % predicted) was significantly reduced compared to the pretreatment period (absolute DLCO at the -6-month, T0, and +6-month time points (5.48, 4.50, and 5.03 mmol/min/kPa, respectively, p = 0.03; DLCO% predicted was 32.73, 26.54, and 29.23%, respectively, p = 0.04). No significant beneficial effect was observed in the other functional parameters analyzed. The 1-year survival in this population was 79%, calculated from month 6 of therapy with nintedanib. Conclusions: This nationwide multicenter experience in patients with severe IPF shows that nintedanib slows down the rate of decline of absolute and % predicted DLCO but does not have significant impact on FVC or other lung parameters.

Published
2018

9. Pretreatment rate of decay in forced vital capacity predicts long-term response to pirfenidone in patients with idiopathic pulmonary fibrosis

Author

Biondini, D, Balestro, E, Lacedonia, D, Cerri, S, Milaneschi, R, Luppi, F, Cocconcelli, E, Bazzan, E, Clini, E, Foschino Barbaro, M, Gregori, D, Cosio, M, Saetta, M, Spagnolo, P, Foschino Barbaro, MP, Cosio, MG, Biondini, D, Balestro, E, Lacedonia, D, Cerri, S, Milaneschi, R, Luppi, F, Cocconcelli, E, Bazzan, E, Clini, E, Foschino Barbaro, M, Gregori, D, Cosio, M, Saetta, M, Spagnolo, P, Foschino Barbaro, MP, and Cosio, MG

Abstract

Pirfenidone reduces functional decline in patients with Idiopathic Pulmonary Fibrosis (IPF). However, response to treatment is highly heterogeneous. We sought to evaluate whether response to pirfenidone is influenced by the pretreatment rate of forced vital capacity (FVC) decline. Fifty-six IPF patients were categorized as rapid (RP) or slow progressors (SP) based on whether their FVC decline in the year preceding pirfenidone treatment was > or ≤ 10% predicted. Following pirfenidone treatment patients were followed-up every 6 months and up to 24 months. In the entire population, pirfenidone reduced significantly FVC decline from 231 to 49 ml/year at 6 months (T6) (p = 0.003) and this effect was maintained at the 12-, 18- and 24-month time points (p value for trend n.s.). In RP, the reduction of FVC decline was evident at 6 months (36 vs 706 ml/year pretreatment; p = 0.002) and maintained, though to a lesser degree, at 12 (106 ml/year), 18 (176 ml/year) and 24 months (162 ml/year; p value for trend n.s). Among SP, the reduction in FVC decline was not significant at any of the time points analyzed. In conclusion, pirfenidone reduces FVC decline in IPF patients. However, its beneficial effect is more pronounced in patients with rapidly progressive disease.

Published
2018

10. A Real-Life Multicenter National Study on Nintedanib in Severe Idiopathic Pulmonary Fibrosis

Author

Harari, S, Caminati, A, Poletti, V, Confalonieri, M, Gasparini, S, Lacedonia, D, Luppi, F, Pesci, A, Sebastiani, A, Spagnolo, P, Vancheri, C, Balestro, E, Bonifazi, M, Cerri, S, De Giacomi, F, Della Porta, R, Foschino Barbaro, M, Fui, A, Pasquinelli, P, Rosso, R, Tomassetti, S, Specchia, C, Rottoli, P, Harari, Sergio, Caminati, Antonella, Poletti, Venerino, Confalonieri, Marco, Gasparini, Stefano, Lacedonia, Donato, Luppi, Fabrizio, Pesci, Alberto, Sebastiani, Alfredo, Spagnolo, Paolo, Vancheri, Carlo, Balestro, Elisabetta, Bonifazi, Martina, Cerri, Stefania, De Giacomi, Federica, Della Porta, Rossana, Foschino Barbaro, Maria Pia, Fui, Annalisa, Pasquinelli, Patrizio, Rosso, Roberta, Tomassetti, Sara, Specchia, Claudia, Rottoli, Paola, Harari, S, Caminati, A, Poletti, V, Confalonieri, M, Gasparini, S, Lacedonia, D, Luppi, F, Pesci, A, Sebastiani, A, Spagnolo, P, Vancheri, C, Balestro, E, Bonifazi, M, Cerri, S, De Giacomi, F, Della Porta, R, Foschino Barbaro, M, Fui, A, Pasquinelli, P, Rosso, R, Tomassetti, S, Specchia, C, Rottoli, P, Harari, Sergio, Caminati, Antonella, Poletti, Venerino, Confalonieri, Marco, Gasparini, Stefano, Lacedonia, Donato, Luppi, Fabrizio, Pesci, Alberto, Sebastiani, Alfredo, Spagnolo, Paolo, Vancheri, Carlo, Balestro, Elisabetta, Bonifazi, Martina, Cerri, Stefania, De Giacomi, Federica, Della Porta, Rossana, Foschino Barbaro, Maria Pia, Fui, Annalisa, Pasquinelli, Patrizio, Rosso, Roberta, Tomassetti, Sara, Specchia, Claudia, and Rottoli, Paola

Abstract

Background: Two therapeutic options are currently available for patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib. To date, there is still insufficient data on the efficacy of these 2 agents in patients with more severe disease. Objectives: This national, multicenter, retrospective real-life study was intended to determine the impact of nintedanib on the treatment of patients with severe IPF. Methods: All patients included had severe IPF and had to have at least 6 months of follow-up before and at least 6 months of follow-up after starting nintedanib. The aim of the study was to compare the decline in lung function before and after treatment. Patient survival after 6 months of therapy with nintedanib was assessed. Results: Forty-one patients with a forced vital capacity (FVC) ≤50% and/or a diffusing capacity of the lung for carbon monoxide (DLCO) ≤35% predicted at the start of nintedanib treatment were enrolled. At the 6-month follow-up, the decline of DLCO (both absolute and % predicted) was significantly reduced compared to the pretreatment period (absolute DLCO at the -6-month, T0, and +6-month time points (5.48, 4.50, and 5.03 mmol/min/kPa, respectively, p = 0.03; DLCO% predicted was 32.73, 26.54, and 29.23%, respectively, p = 0.04). No significant beneficial effect was observed in the other functional parameters analyzed. The 1-year survival in this population was 79%, calculated from month 6 of therapy with nintedanib. Conclusions: This nationwide multicenter experience in patients with severe IPF shows that nintedanib slows down the rate of decline of absolute and % predicted DLCO but does not have significant impact on FVC or other lung parameters.

Published
2018

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