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1. Mirtazapine to alleviate severe breathlessness in patients with COPD or interstitial lung diseases (BETTER-B): an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial

Author

Kelly, Emer, Lusuardi, Mirco, Gambassi, Giovanni, Jassem, Ewa, Kahnert, Kathrin, Sheehan, Caitlin, Eastman, Peter, Epton, Michael, Coleman, Courtney, Fazakas, Belinda S, Smith, Debs, Higginson, Irene J, Brown, Sarah T, Oluyase, Adejoke O, May, Peter, Maddocks, Matthew, Costantini, Massimo, Bajwah, Sabrina, Normand, Charles, Bausewein, Claudia, Simon, Steffen T, Ryan, Karen, Currow, David C, Johnson, Miriam J, Hart, Simon P, Mather, Hannah, Krajnik, Malgorzata, Tanzi, Silvia, Ghirotto, Luca, Bolton, Charlotte E, Janowiak, Piotr, Turola, Elena, Jolley, Caroline J, Murden, Geraldine, Wilcock, Andrew, Farsides, Bobbie, and Brown, Julia M

Published
2024
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2. Preparedness and Capacity of Indian Palliative Care Services to Respond to the COVID-19 Pandemic: An Online Rapid Assessment Survey.

Author

Lin, Cheng-Pei, Boufkhed, Sabah, Pai, Asha, Namisango, Eve, Luyirika, Emmanuel, Sleeman, Katherine, Costantini, Massimo, Peruselli, Carlo, Higginson, Irene, Ekstrand, Maria, Harding, Richard, Salins, Naveen, and Bhatnagar, Sushma

Subjects
COVID-19, India, palliative care, pandemic, preparedness
Abstract

BACKGROUND: COVID-19 has been causing a high burden of suffering for patients and families. There is limited evidence on the preparedness of Indian palliative care services for the pandemic. AIM: This study aimed to assess the preparedness and capacity of Indian palliative care services in response to the COVID-19 pandemic. METHODS: A cross-sectional online survey was developed based on prior evidence and international health regulations. It was emailed to the Indian Palliative Care Association members and investigators professional networks in India. One participant per palliative care service was requested. Descriptive analysis was used. RESULTS: Representatives of 78 palliative care services completed the survey. Three in four services had COVID-19 case definition and adapted their protocols for infection control (75%). About half of the services (55%) reported concerns about achieving appropriate hand hygiene in the community. More than half of the services (59%) had capacity to train nonspecialists for symptom control and psychological support. About half of the services reported that they had plans to redeploy staff (56%) and resources (53%) in the case of outbreaks. Two-fifths of the services used paper records to store an updated contact list of staff (40%) and did not have designated focal contacts for information update (40%). Staff anxiety related to personal infection risk and family care was relatively high (median score = 7 on a 1-10 scale). CONCLUSION: We recommend the following resource allocation to enable palliative care services to support the Indian health system in delivering essential care in this and future pandemics: (1) infection control, especially in the community; (2) training using existing clinical protocols to strengthen palliative care across the health system; and (3) redeployment plans.

Published
2021

5. Mirtazapine to alleviate severe breathlessness in patients with COPD or interstitial lung diseases (BETTER-B): an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial.

Author

Higginson, Irene J, Brown, Sarah T, Oluyase, Adejoke O, May, Peter, Maddocks, Matthew, Costantini, Massimo, Bajwah, Sabrina, Normand, Charles, Bausewein, Claudia, Simon, Steffen T, Ryan, Karen, Currow, David C, Johnson, Miriam J, Hart, Simon P, Mather, Hannah, Krajnik, Malgorzata, Tanzi, Silvia, Ghirotto, Luca, Bolton, Charlotte E, and Janowiak, Piotr

Subjects
INTERSTITIAL lung diseases, CHRONIC obstructive pulmonary disease, CLINICAL trials, MIRTAZAPINE, MEDICAL research
Abstract

Breathlessness frequently becomes severe among people with respiratory disease. Mirtazapine, a widely used antidepressant, has shown promise in the modulation of respiratory sensation and the response to it, as well as reducing feelings of panic, which often accompanies breathlessness. We aimed to determine the effectiveness of mirtazapine to alleviate severe persisting breathlessness. This international, multicentre, phase 3, parallel-group, double-blind, randomised, placebo-controlled trial across 16 centres in seven countries (Australia, Germany, Ireland, Italy, New Zealand, Poland, and the UK), recruited adults with chronic obstructive pulmonary disease (COPD), interstitial lung diseases, or both, and grade 3 or 4 of the modified Medical Research Council breathlessness scale. Consenting participants were randomly assigned (1:1) to receive oral mirtazapine or matching placebo for 56 days. Randomisation was by minimisation. The initial mirtazapine dose was 15 mg, escalating to a maximum of 45 mg per day, tapered at treatment end. Participants, caregivers, assessors, and investigators were masked to group assignment. The primary outcome was worst breathlessness in the preceding 24 h measured on a 0–10 numerical rating scale (NRS), at 56 days post-treatment start, with follow-up to 180 days. The primary analysis was performed in the modified intention-to-treat population using multivariable multi-level repeated measures model. This trial was registered with ISRCTN (ISRCTN10487976 and ISRCTN15751764 [Australia and New Zealand]) and EudraCT (2019–002001–21) and is complete. Between Feb 4, 2021 and March 28, 2023, we enrolled 225 eligible participants (148 men and 77 women, 113 to the mirtazapine group and 112 to the placebo group). The median age was 74 years (IQR 67–78). No evidence of a difference was found in worst breathlessness at day 56 between mirtazapine and placebo (difference in adjusted mean NRS score was 0·105 [95% CI –0·407 to 0·618]; p=0·69). Although the study was underpowered, the primary endpoint effect did not reach the pre-specified treatment effect of 0·55 for worst breathlessness score reduction that the study was powered to detect for the primary analysis. There were 215 adverse reactions in 72 (64%) of 113 participants in the mirtazapine group versus 116 in 44 (40%) of 110 participants in the placebo group; 11 serious adverse events in six (5%) participants in the mirtazapine group versus eight in seven (6%) participants in the placebo group; and one (1%) suspected unexpected serious adverse reaction in the mirtazapine group. At day 56, there were three deaths in the mirtazapine group and two deaths in the placebo group. At day 180, there were seven deaths in the mirtazapine group and 11 deaths in the placebo group. Our findings suggested that mirtazapine of doses 15 to 45 mg daily over 56 days does not improve severe breathlessness among patients with COPD or interstitial lung diseases and might cause adverse reactions. Based on these findings, we do not recommend mirtazapine as a treatment to alleviate severe breathlessness. EU Horizon 2020 (grant agreement No. 825319); Cicely Saunders International Breathlessness Programme; National Institute for Health and Care Research Applied Research Collaboration South London; Australian National Health and Medical Research Council—EU (application ID: APP1170731). [ABSTRACT FROM AUTHOR]

Published
2024
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6. Promoting post-traumatic growth in cancer patients: a randomized controlled trial of guided written disclosure

Author

Cafaro, Valentina, primary, Rabitti, Elisa, additional, Artioli, Giovanna, additional, Costantini, Massimo, additional, De Vincenzo, Francesco, additional, Franzoni, Francesca, additional, Cavuto, Silvio, additional, Bertelli, Tatiana, additional, Deledda, Giuseppe, additional, Piattelli, Angela, additional, Cardinali, Lisa, additional, De Padova, Silvia, additional, Poli, Sara, additional, Iuvaro, Maria Domenica, additional, Fantoni, Giovanna, additional, and Di Leo, Silvia, additional

Published
2024
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10. Correction to: Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

Author

Perrone, Francesco, Piccirillo, Maria Carmela, Ascierto, Paolo Antonio, Salvarani, Carlo, Parrella, Roberto, Marata, Anna Maria, Popoli, Patrizia, Ferraris, Laurenzia, Marrocco-Trischitta, Massimiliano M., Ripamonti, Diego, Binda, Francesca, Bonfanti, Paolo, Squillace, Nicola, Castelli, Francesco, Muiesan, Maria Lorenza, Lichtner, Miriam, Calzetti, Carlo, Salerno, Nicola Duccio, Atripaldi, Luigi, Cascella, Marco, Costantini, Massimo, Dolci, Giovanni, Facciolongo, Nicola Cosimo, Fraganza, Fiorentino, Massari, Marco, Montesarchio, Vincenzo, Mussini, Cristina, Negri, Emanuele Alberto, Botti, Gerardo, Cardone, Claudia, Gargiulo, Piera, Gravina, Adriano, Schettino, Clorinda, Arenare, Laura, Chiodini, Paolo, and Gallo, Ciro

Published
2021
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12. Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial

Author

Matthys, Orphé, De Vleminck, Aline, Dierickx, Sigrid, Deliens, Luc, Van Goethem, Vincent, Lapeire, Lore, Groenvold, Mogens, Lund, Line, Arnfeldt, Caroline Moeller, Sengeloev, Lisa, Pappot, Helle, Johnsen, Anna Thit, Guerin, Suzanne, Larkin, Philip J., Jordan, Catherine, Connolly, Michael, D’Alton, Paul, Costantini, Massimo, Di Leo, Silvia, Guberti, Monica, Turola, Elena, van der Heide, Agnes, Witkamp, Erika, Rietjens, Judith, van der Wel, Maaike, Brazil, Kevin, Prue, Gillian, Reid, Joanne, Scott, David, Bristowe, Katherine, Harding, Richard, Normand, Charles, May, Peter, Cronin, Catherine, Northouse, Laurel, Hudson, Peter, and Cohen, Joachim

Published
2021
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13. Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

Author

Perrone, Francesco, Piccirillo, Maria Carmela, Ascierto, Paolo Antonio, Salvarani, Carlo, Parrella, Roberto, Marata, Anna Maria, Popoli, Patrizia, Ferraris, Laurenzia, Marrocco-Trischitta, Massimiliano M., Ripamonti, Diego, Binda, Francesca, Bonfanti, Paolo, Squillace, Nicola, Castelli, Francesco, Muiesan, Maria Lorenza, Lichtner, Miriam, Calzetti, Carlo, Salerno, Nicola Duccio, Atripaldi, Luigi, Cascella, Marco, Costantini, Massimo, Dolci, Giovanni, Facciolongo, Nicola Cosimo, Fraganza, Fiorentino, Massari, Marco, Montesarchio, Vincenzo, Mussini, Cristina, Negri, Emanuele Alberto, Botti, Gerardo, Cardone, Claudia, Gargiulo, Piera, Gravina, Adriano, Schettino, Clorinda, Arenare, Laura, Chiodini, Paolo, and Gallo, Ciro

Published
2020
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17. A moonshot approach toward the management of cancer patients in the COVID-19 time: what have we learned and what could the Italian network of cancer centers (Alliance Against Cancer, ACC) do after the pandemic wave?

Author

Silvestris, Nicola, Apolone, Giovanni, Botti, Gerardo, Ciliberto, Gennaro, Costantini, Massimo, De Paoli, Paolo, Franceschi, Silvia, Opocher, Giuseppe, Paradiso, Angelo, Pronzato, Paolo, Sgambato, Alessandro, and De Maria, Ruggero

Published
2020
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20. Treatment of giant cell arteritis with ultra-short glucocorticoids and tocilizumab: the role of imaging in a prospective observational study.

Author

Muratore, Francesco, Marvisi, Chiara, Cassone, Giulia, Boiardi, Luigi, Mancuso, Pamela, Besutti, Giulia, Spaggiari, Lucia, Casali, Massimiliano, Croci, Stefania, Versari, Annibale, Rossi, Paolo Giorgi, Catanoso, Mariagrazia, Costantini, Massimo, Galli, Elena, and Salvarani, Carlo

Subjects
GLUCOCORTICOIDS, METHYLPREDNISOLONE, INJECTIONS, SCIENTIFIC observation, INTRAVENOUS therapy, CONFIDENCE intervals, TOCILIZUMAB, GIANT cell arteritis, POSITRON emission tomography computed tomography, TREATMENT effectiveness, LONGITUDINAL method
Abstract

Objectives To assess the impact of tocilizumab (TCZ) monotherapy after ultra-short-pulse glucocorticoids (GCs) on clinical manifestations, and vessel inflammation and damage in large vessel-GCA (LV-GCA). Methods In this prospective observational study, we enrolled patients with active LV-GCA. All patients received 500 mg per day i.v. methylprednisolone for three consecutive days and weekly s.c. TCZ injections from day 4 until week 52. PET/CT was performed on all patients at baseline and at weeks 24 and 52. The primary end points were the reduction in the PET vascular activity score (PETVAS) at weeks 24 and 52 compared with baseline, and the proportion of patients with relapse-free remission at weeks 24 and 52. The secondary end point was the proportion of patients with new aortic dilation at weeks 24 and 52. Results A total of 18 patients were included (72% female, mean age 68.5 years). Compared with the baseline value, a significant reduction in the PETVAS was observed at weeks 24 and 52, mean (95% CI) reductions –8.6 (–11.5 to –5.7) and –10.4 (–13.6 to –7.2), P  = 0.001 and 0.002, respectively. The proportion of patients with relapse-free remission at weeks 24 and 52 was 10/18 (56%, 95% CI 31–78) and 8/17 (47%, 95% CI 23–72), respectively. At weeks 24 and 52, no patient had shown new aortic dilation. However, 4 patients who had shown aortic dilation at baseline showed a significant increase in aortic diameter (≥5 mm) at week 52. Conclusion TCZ monotherapy after ultra-short-pulse GCs controlled the clinical symptoms of GCA and reduced vascular inflammation. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov , NCT05394909. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Treatment of giant cell arteritis with ultra-short glucocorticoids and tocilizumab: the role of imaging in a prospective observational study

Author

Muratore, Francesco, primary, Marvisi, Chiara, additional, Cassone, Giulia, additional, Boiardi, Luigi, additional, Mancuso, Pamela, additional, Besutti, Giulia, additional, Spaggiari, Lucia, additional, Casali, Massimiliano, additional, Croci, Stefania, additional, Versari, Annibale, additional, Giorgi Rossi, Paolo, additional, Catanoso, Mariagrazia, additional, Costantini, Massimo, additional, Galli, Elena, additional, and Salvarani, Carlo, additional

Published
2023
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22. Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial

Author

Frassineti, Giovanni Luca, Sansoni, Elisabetta, Ragazzini, Angela, Ruscelli, Silvia, Crivellari, Gino, Galiano, Antonella, Rodriquenz, Maria Grazia, Biasini, Claudia, Porzio, Rosa, Pittureri, Cristina, Amaducci, Elena, Faedi, Marina, Codecà, Carla, Crepaldi, Francesca, Pedrazzoli, Paolo, Bramanti, Alfina, Buonadonna, Angela, Garetto, Ferdinando, Comandone, Alessandro, Giordano, Monica, Luchena, Giovanna, Luzzani, Massimo, Cifatte, Chiara, Pino, Maria Simona, Zoccali, Sonia, Cattaneo, Maria Teresa, Dalu, Davide, Sozzi, Pietro, Gauna, Roberta, Alquati, Sara, Costantini, Massimo, Quadrini, Silvia, Narducci, Filomena, Mastromauro, Cataldo, Scognamiglio, Rodolfo, Degiovanni, Daniela, Negri, Federica, Caraceni, Augusto, Montanari, Luigi, Maltoni, Marco, Scarpi, Emanuela, Dall'Agata, Monia, Zagonel, Vittorina, Bertè, Raffaella, Ferrari, Daris, Broglia, Chiara Maria, Bortolussi, Roberto, Trentin, Leonardo, Valgiusti, Martina, Pini, Sara, Farolfi, Alberto, Casadei Gardini, Andrea, Nanni, Oriana, and Amadori, Dino

Published
2016
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25. Safety of third dose of COVID-19 vaccination in frail patients: Results from the prospective Italian VAX4FRAIL study

Author

Di Cosimo, Serena, primary, Lupo-Stanghellini, Maria Teresa, additional, Costantini, Massimo, additional, Mantegazza, Renato, additional, Ciceri, Fabio, additional, Salvarani, Carlo, additional, Zinzani, Pier Luigi, additional, Mantovani, Alberto, additional, Ciliberto, Gennaro, additional, Uccelli, Antonio, additional, Baldanti, Fausto, additional, Apolone, Giovanni, additional, Delcuratolo, Sabina, additional, Morrone, Aldo, additional, Locatelli, Franco, additional, Agrati, Chiara, additional, and Silvestris, Nicola, additional

Published
2022
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27. Are There Differences in the Prevalence of Palliative Care-Related Problems in People Living With Advanced Cancer and Eight Non-Cancer Conditions? A Systematic Review

Author

Brearley, Sarah, Caraceni, Augusto, Cohen, Joachim, Costantini, Massimo, Deliens, Luc, Francke, Anneke L., Kaasa, Stein, Linden, Karen, Meeussen, Koen, Miccinesi, Guido, Onwuteaka-Philipsen, Bregje, Pardon, Koen, Pasman, Roeline, Pautex, Sophie, Payne, Sheila, Van den Block, Lieve, Moens, Katrien, Higginson, Irene J., and Harding, Richard

Published
2014
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30. Humoral and T-cell immune response after three doses of mRNA SARS-CoV-2 vaccines in fragile patients: the Italian VAX4FRAIL study

Author

Corradini, Paolo, Agrati, Chiara, Apolone, Giovanni, Mantovani, Alberto, Giannarelli, Diana, Marasco, Vincenzo, Bordoni, Veronica, Sacchi, Alessandra, Matusali, Giulia, Salvarani, Carlo, Zinzani, Pier Luigi, Mantegazza, Renato, Tagliavini, Fabrizio, Lupo-Stanghellini, Maria Teresa, Ciceri, Fabio, Damian, Silvia, Uccelli, Antonio, Fenoglio, Daniela, Silvestris, Nicola, Baldanti, Fausto, Piaggio, Giulia, Ciliberto, Gennaro, Morrone, Aldo, Locatelli, Franco, Sinno, Valentina, Rescigno, Maria, Costantini, Massimo, Corradini, Paolo, Agrati, Chiara, Apolone, Giovanni, Mantovani, Alberto, Giannarelli, Diana, Marasco, Vincenzo, Bordoni, Veronica, Sacchi, Alessandra, Matusali, Giulia, Salvarani, Carlo, Zinzani, Pier Luigi, Mantegazza, Renato, Tagliavini, Fabrizio, Lupo-Stanghellini, Maria Teresa, Ciceri, Fabio, Damian, Silvia, Uccelli, Antonio, Fenoglio, Daniela, Silvestris, Nicola, Baldanti, Fausto, Piaggio, Giulia, Ciliberto, Gennaro, Morrone, Aldo, Locatelli, Franco, Sinno, Valentina, Rescigno, Maria, and Costantini, Massimo

Subjects
T-cell immunity, humoral immunity, SARS-CoV-2 mRNA vaccine, Fragile patient
Abstract

BackgroundPatients with solid or hematological tumors, neurological and immune-inflammatory disorders represent potentially fragile subjects with increased risk to experience severe COVID-19 and inadequate response to SARS-CoV2 vaccination.MethodsWe designed a prospective Italian multicentric study to assess humoral and T-cell response to SARS-CoV2 vaccination in patients (n=378) with solid tumors (ST), hematological malignancies (HM), neurological (ND) and immuno-rheumatological diseases (ID). The immunogenicity of primary vaccination schedule and of the booster dose were analyzed.ResultsOverall, patient seroconversion rate after two doses was 62.1%. A significant lower rate was observed in HM (52.4%) and ID (51.9%) patients compared to ST (95.6%) and ND (70.7%); a lower median level of antibodies was detected in HM and ID versus the others (pConclusionsImmunosuppressive treatment more than disease type per se is a risk factor for low humoral response after vaccination. The booster dose can improve both humoral and T-cell response.Article’s main point-Lower rate of seroconversion was observed in fragile patients as compared to healthy controls-The booster dose improves humoral and T-cell response in all fragile patient groups-Immunosuppressive treatment was associated with the worst humoral response to vaccination, but had no effects on T-cell responses.

Published
2022

33. Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19. The COMETA Italian Protocol

Author

Silvestris, Nicola, primary, Belleudi, Valeria, additional, Addis, Antonio, additional, Pimpinelli, Fulvia, additional, Morrone, Aldo, additional, Sciacchitano, Salvatore, additional, Mancini, Rita, additional, Garrisi, Vito Michele, additional, Costantini, Massimo, additional, Ciliberto, Gennaro, additional, Frisardi, Vincenza, additional, and Piaggio, Giulia, additional

Published
2022
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35. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial

Author

Salvarani, C, Massari, M, Costantini, M, Franco Merlo, D, Lucia Mariani, G, Viale, P, Nava, S, Guaraldi, G, Dolci, G, Boni, L, Savoldi, L, Bruzzi, P, Turrà, C, Catanoso, M, Maria Marata, A, Barbieri, C, Valcavi, A, Franzoni, F, Cavuto, S, Mazzi, G, Corsini, R, Trapani, F, Bartoloni, A, Barisione, E, Jole Burastero, G, Pan, A, Inojosa, W, Scala, R, Burattini, C, Luppi, F, Codeluppi, M, Eldin Tarek, K, Cenderello, G, Salio, M, Foti, G, Dongilli, R, Bajocchi, G, Alberto Negri, E, Ciusa, G, Fornaro, G, Bassi, I, Zammarchi, L, Aloè, T, Facciolongo, N, Salvarani, Carlo, Massari, Marco, Costantini, Massimo, Franco Merlo, Domenico, Lucia Mariani, Gabriella, Viale, Pierluigi, Nava, Stefano, Guaraldi, Giovanni, Dolci, Giovanni, Boni, Luca, Savoldi, Luisa, Bruzzi, Paolo, Turrà, Caterina, Catanoso, Mariagrazia, Maria Marata, Anna, Barbieri, Chiara, Valcavi, Annamaria, Franzoni, Francesca, Cavuto, Silvio, Mazzi, Giorgio, Corsini, Romina, Trapani, Fabio, Bartoloni, Alessandro, Barisione, Emanuela, Jole Burastero, Giulia, Pan, Angelo, Inojosa, Walter, Scala, Raffaele, Burattini, Cecilia, Luppi, Fabrizio, Codeluppi, Mauro, Eldin Tarek, Kamal, Cenderello, Giovanni, Salio, Mario, Foti, Giuseppe, Dongilli, Roberto, Bajocchi, Gianluigi, Alberto Negri, Emanuele, Ciusa, Giacomo, Fornaro, Giacomo, Bassi, Ilaria, Zammarchi, Lorenzo, Aloè, Teresita, Facciolongo, Nicola, Salvarani, C, Massari, M, Costantini, M, Franco Merlo, D, Lucia Mariani, G, Viale, P, Nava, S, Guaraldi, G, Dolci, G, Boni, L, Savoldi, L, Bruzzi, P, Turrà, C, Catanoso, M, Maria Marata, A, Barbieri, C, Valcavi, A, Franzoni, F, Cavuto, S, Mazzi, G, Corsini, R, Trapani, F, Bartoloni, A, Barisione, E, Jole Burastero, G, Pan, A, Inojosa, W, Scala, R, Burattini, C, Luppi, F, Codeluppi, M, Eldin Tarek, K, Cenderello, G, Salio, M, Foti, G, Dongilli, R, Bajocchi, G, Alberto Negri, E, Ciusa, G, Fornaro, G, Bassi, I, Zammarchi, L, Aloè, T, Facciolongo, N, Salvarani, Carlo, Massari, Marco, Costantini, Massimo, Franco Merlo, Domenico, Lucia Mariani, Gabriella, Viale, Pierluigi, Nava, Stefano, Guaraldi, Giovanni, Dolci, Giovanni, Boni, Luca, Savoldi, Luisa, Bruzzi, Paolo, Turrà, Caterina, Catanoso, Mariagrazia, Maria Marata, Anna, Barbieri, Chiara, Valcavi, Annamaria, Franzoni, Francesca, Cavuto, Silvio, Mazzi, Giorgio, Corsini, Romina, Trapani, Fabio, Bartoloni, Alessandro, Barisione, Emanuela, Jole Burastero, Giulia, Pan, Angelo, Inojosa, Walter, Scala, Raffaele, Burattini, Cecilia, Luppi, Fabrizio, Codeluppi, Mauro, Eldin Tarek, Kamal, Cenderello, Giovanni, Salio, Mario, Foti, Giuseppe, Dongilli, Roberto, Bajocchi, Gianluigi, Alberto Negri, Emanuele, Ciusa, Giacomo, Fornaro, Giacomo, Bassi, Ilaria, Zammarchi, Lorenzo, Aloè, Teresita, and Facciolongo, Nicola

Abstract

Rationale Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus disease 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia. Methods In this multicentre, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with COVID-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for three consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need for supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival. Results Overall, 112 (75.4%) out of 151 patients in the pulse methylprednisolone arm and 111 (75.2%) of 150 in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups (15 days, 95% CI 13.0–17.0 days and 16 days, 95% CI 13.8–18.2 days, respectively; hazard ratio (HR) 0.92, 95% CI 0.71–1.20; p=0.528). No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to intensive care unit with orotracheal intubation or death (20.0% versus 16.1%; HR 1.26, 95% CI 0.74–2.16; p=0.176) or overall mortality (10.0% versus 12.2%; HR 0.83, 95% CI 0.42–1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups. Conclusions Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.

Published
2022

36. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial

Author

Salvarani, Carlo, primary, Massari, Marco, additional, Costantini, Massimo, additional, Merlo, Domenico Franco, additional, Mariani, Gabriella Lucia, additional, Viale, Pierluigi, additional, Nava, Stefano, additional, Guaraldi, Giovanni, additional, Dolci, Giovanni, additional, Boni, Luca, additional, Savoldi, Luisa, additional, Bruzzi, Paolo, additional, Turrà, Caterina, additional, Catanoso, Mariagrazia, additional, Marata, Anna Maria, additional, Barbieri, Chiara, additional, Valcavi, Annamaria, additional, Franzoni, Francesca, additional, Cavuto, Silvio, additional, Mazzi, Giorgio, additional, Corsini, Romina, additional, Trapani, Fabio, additional, Bartoloni, Alessandro, additional, Barisione, Emanuela, additional, Burastero, Giulia Jole, additional, Pan, Angelo, additional, Inojosa, Walter, additional, Scala, Raffaele, additional, Burattini, Cecilia, additional, Luppi, Fabrizio, additional, Codeluppi, Mauro, additional, Tarek, Kamal Eldin, additional, Cenderello, Giovanni, additional, Salio, Mario, additional, Foti, Giuseppe, additional, Dongilli, Roberto, additional, Bajocchi, Gianluigi, additional, Negri, Emanuele Alberto, additional, Ciusa, Giacomo, additional, Fornaro, Giacomo, additional, Bassi, Ilaria, additional, Zammarchi, Lorenzo, additional, Aloè, Teresita, additional, and Facciolongo, Nicola, additional

Published
2022
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37. mRNA-COVID19 Vaccination Can Be Considered Safe and Tolerable for Frail Patients

Author

Lupo-Stanghellini, Maria Teresa, primary, Di Cosimo, Serena, additional, Costantini, Massimo, additional, Monti, Sara, additional, Mantegazza, Renato, additional, Mantovani, Alberto, additional, Salvarani, Carlo, additional, Zinzani, Pier Luigi, additional, Inglese, Matilde, additional, Ciceri, Fabio, additional, Apolone, Giovanni, additional, Ciliberto, Gennaro, additional, Baldanti, Fausto, additional, Morrone, Aldo, additional, Sinno, Valentina, additional, Locatelli, Franco, additional, Notari, Stefania, additional, Turola, Elena, additional, Giannarelli, Diana, additional, and Silvestris, Nicola, additional

Published
2022
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39. Predictive factors of clinical outcomes in patients with COVID-19 treated with tocilizumab: A monocentric retrospective analysis

Author

Cassone, Giulia, primary, Dolci, Giovanni, additional, Besutti, Giulia, additional, Braglia, Luca, additional, Pavone, Paolo, additional, Corsini, Romina, additional, Sampaolesi, Fabio, additional, Iotti, Valentina, additional, Teopompi, Elisabetta, additional, Massari, Marco, additional, Fontana, Matteo, additional, Ghidoni, Giulia, additional, Matei, Anaflorina, additional, Croci, Stefania, additional, Negri, Emanuele Alberto, additional, Costantini, Massimo, additional, Facciolongo, Nicola, additional, and Salvarani, Carlo, additional

Published
2022
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40. mRNA-COVID19 vaccination can be considered safe and tolerable for frail patients

Author

Stanghellini, Maria Teresa Lupo, primary, Cosimo, Serena Di, additional, Costantini, Massimo, additional, Monti, Sara, additional, Mantegazza, Renato, additional, Mantovani, Alberto, additional, Salvarani, Carlo, additional, Zinzani, Pier Luigi, additional, Inglese, Matilde, additional, Ciceri, Fabio, additional, Apolone, Giovanni, additional, Ciliberto, Gennaro, additional, Baldanti, Fausto, additional, Morrone, Aldo, additional, Sinno, Valentina, additional, Locatelli, Franco, additional, Notari, Stefania, additional, Turola, Elena, additional, Giannarelli, Diana, additional, and Silvestris, Nicola, additional

Published
2022
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41. Humoral and T-cell immune response after three doses of mRNA SARS-CoV-2 vaccines in fragile patients: the Italian VAX4FRAIL study

Author

Corradini, Paolo, primary, Agrati, Chiara, additional, Apolone, Giovanni, additional, Mantovani, Alberto, additional, Giannarelli, Diana, additional, Marasco, Vincenzo, additional, Bordoni, Veronica, additional, Sacchi, Alessandra, additional, Matusali, Giulia, additional, Salvarani, Carlo, additional, Zinzani, Pier Luigi, additional, Mantegazza, Renato, additional, Tagliavini, Fabrizio, additional, Lupo-Stanghellini, Maria Teresa, additional, Ciceri, Fabio, additional, Damian, Silvia, additional, Uccelli, Antonio, additional, Fenoglio, Daniela, additional, Silvestris, Nicola, additional, Baldanti, Fausto, additional, Piaggio, Giulia, additional, Ciliberto, Gennaro, additional, Morrone, Aldo, additional, Locatelli, Franco, additional, Sinno, Valentina, additional, Rescigno, Maria, additional, and Costantini, Massimo, additional

Published
2022
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44. EAPC White Paper on outcome measurement in palliative care: Improving practice, attaining outcomes and delivering quality services - Recommendations from the European Association for Palliative Care (EAPC) Task Force on Outcome Measurement

Author

Daveson, Barbara A, Bausewein, Claudia, Currow, David C, Downing, Julia, Deliens, Luc, Radbruch, Lukas, Defilippi, Kath, Ferreira, Pedro Lopes, Costantini, Massimo, Harding, Richard, and Higginson, Irene J

Published
2016
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45. Neutralizing antibodies to Omicron after the fourth SARS-CoV-2 mRNA vaccine dose in immunocompromised patients highlight the need of additional boosters.

Author

Rescigno, Maria, Agrati, Chiara, Salvarani, Carlo, Giannarelli, Diana, Costantini, Massimo, Mantovani, Alberto, Massafra, Raffaella, Zinzani, Pier Luigi, Morrone, Aldo, Notari, Stefania, Matusali, Giulia, Pinter, Giuseppe Lauria, Uccelli, Antonio, Ciliberto, Gennaro, Baldanti, Fausto, Locatelli, Franco, Silvestris, Nicola, Sinno, Valentina, Turola, Elena, and Lupo-Stanghellini, Maria Teresa

Abstract

Introduction: Immunocompromised patients have been shown to have an impaired immune response to COVID-19 vaccines. Methods: Here we compared the B-cell, T-cell and neutralizing antibody response to WT and Omicron BA.2 SARS-CoV-2 virus after the fourth dose of mRNA COVID19 vaccines in patients with hematological malignancies (HM, n=71), solid tumors (ST, n=39) and immune-rheumatological (IR, n=25) diseases. The humoral and Tcell responses to SARS-CoV-2 vaccination were analyzed by quantifying the antiRBD antibodies, their neutralization activity and the IFN-γ released after spike specific stimulation. Results: We show that the T-cell response is similarly boosted by the fourth dose across the different subgroups, while the antibody response is improved only in patients not receiving B-cell targeted therapies, independent on the pathology. However, 9% of patients with anti-RBD antibodies did not have neutralizing antibodies to either virus variants, while an additional 5.7% did not have neutralizing antibodies to Omicron BA.2, making these patients particularly vulnerable to SARS-CoV-2 infection. The increment of neutralizing antibodies was very similar towards Omicron BA.2 and WT virus after the third or fourth dose of vaccine, suggesting that there is no preferential skewing towards either virus variant with the booster dose. The only limited step is the amount of antibodies that are elicited after vaccination, thus increasing the probability of developing neutralizing antibodies to both variants of virus. Discussion: These data support the recommendation of additional booster doses in frail patients to enhance the development of a B-cell response directed against Omicron and/or to enhance the T-cell response in patients treated with antiCD20. [ABSTRACT FROM AUTHOR]

Published
2023
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46. Do guidelines influence breathlessness management in advanced lung diseases? A multinational survey of respiratory medicine and palliative care physicians

Author

Krajnik, Małgorzata, Hepgul, Nilay, Wilcock, Andrew, Jassem, Ewa, Bandurski, Tomasz, Tanzi, Silvia, Simon, Steffen T., Higginson, Irene J., Jolley, Caroline J., Arendt-Nowakowska, Agnieszka, Bajwah, Sabrina, Bausewein, Claudia, Bazata, Jeremias, Bolton, Charlotte, Bonelli, Candida, Brindle, Richard, Brown, Sarah, Costantini, Massimo, Currow, David, Dimbleby, Claire, Dix, Olivia, Doran, Peter, Eisenmann, Yvonne, Fellows, Alasdair, Fopka-Kowalczyk, Malgorzata, Gambassi, Giovanni, Higginson, Irene, Holton, Amy, Hussain, Rabia, Janowiak, Piotr, Jenkins, Gisli, Jiang, Jingjing, Johnson, Miriam, Jolley, Caroline, Katona, Eszter, Kelly, Emer, Kirjak, Mateusz, Krajnik, Malgorzata, Maddocks, Matthew, Malara, Anna, Merlo, Domenico, Mir, Hinna, Molloy, Brenda, Murden, Geraldine, Normand, Charles, Ogden, Margaret, Oluyase, Adejoke, Panfilak, Sabina, Powell, Pippa, Pralong, Anne, Pullen, Jackie, Regan, Faye, Ryan, Karen, Simon, Steffen, Smith, Samantha, Vaccaro, Valerie, Voltz, Raymond, and Walker, Fiona

Subjects
Pulmonary and Respiratory Medicine, Adult, Lung Diseases, Male, Health Knowledge, Attitudes, Practice, RC705-779, Research, Palliative Care, Guidelines as Topic, Middle Aged, Chronic obstructive, Europe, Diseases of the respiratory system, Dyspnea, Lung neoplasms, Health Care Surveys, Physicians, Surveys and Questionnaires, Pulmonary Medicine, Humans, Guideline Adherence, Practice Patterns, Physicians', Pulmonary disease, Interstitial, Breathlessness
Abstract

Background Respiratory medicine (RM) and palliative care (PC) physicians’ management of chronic breathlessness in advanced chronic obstructive pulmonary disease (COPD), fibrotic interstitial lung disease (fILD) and lung cancer (LC), and the influence of practice guidelines was explored via an online survey. Methods A voluntary, online survey was distributed to RM and PC physicians via society newsletter mailing lists. Results 450 evaluable questionnaires (348 (77%) RM and 102 (23%) PC) were analysed. Significantly more PC physicians indicated routine use (often/always) of opioids across conditions (COPD: 92% vs. 39%, fILD: 83% vs. 36%, LC: 95% vs. 76%; all p p p p χ2 = 13.8; p χ2 = 12.58, p χ2 = 6.41, p = 0.011) in COPD; use antidepressants (χ2 = 6.25; p = 0.044) and refer to PC (χ2 = 5.83; p = 0.016) in fILD; and use a handheld fan in COPD (χ2 = 8.75, p = 0.003), fILD (χ2 = 4.85, p = 0.028) and LC (χ2 = 5.63; p = 0.018). Conclusions These findings suggest a need for improved dissemination and uptake of jointly developed breathlessness management guidelines in order to encourage appropriate use of existing, evidence-based therapies. The lack of opioid use by RM, and continued benzodiazepine use in PC, suggest that a wider range of acceptable therapies need to be developed and trialled.

Published
2021

47. Giving Medicine A Fair Trial

Author

Allan, Laurie, Tooke, Lance, Rao, Jammi N., Bruzzi, Paolo, Costantini, Massimo, Szebik, Imre, Bydder, Sean, Slevin, Terry, and Katris, Paul

Published
2000

48. Managing Patients with Lung Cancer

Author

Costantini, Massimo, Higginson, Irene J., Farsides, Calliope C. S., Toscani, Franco, Wilkinson, Susie, Beynon, Teresa, Lidstone, Victoria, Sinnott, Claire, Richards, Michael, Watine, Joseph, Ardizzoni, Andrea, Grossi, Francesco, Salvati, Franco, Silvano, Giovanni, Santi, Leonardo, and Simmonds, Peter

Published
2000

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