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2. Relationship between injection site reactions and different adalimumab formulations. Analysis of the adverse events reported in Italy in 2016-2019

Author

Pilunni, D., Santuccio, C., Sottosanti, Laura, Felicetti, P., Navarra, Pierluigi, Sottosanti L., Navarra P. (ORCID:0000-0002-4424-650X), Pilunni, D., Santuccio, C., Sottosanti, Laura, Felicetti, P., Navarra, Pierluigi, Sottosanti L., and Navarra P. (ORCID:0000-0002-4424-650X)

Abstract

OBJECTIVE: The adalimumab originator Humira® introduced a new citrate-free formulation in 2016, before the patent expiry that occurred in the European Union in October 2018. Some of the adalimumab biosimilars that were subsequently marketed are citrate-free, while others are not. Since citrate as an excipient is associated with pain at the injection site, recent anecdotical reporting in Italy raised the issue of possible prescription biases related to the differences in formulation existing among the various adalimumab products. In this study, we analyzed the data obtained from the ‘Rete Nazionale di Farmacovigilanza’ (Pharmacovigilance National Network) to investigate whether, and to what extent, the differences in the formulation of the various adalimumab versions had an impact on the rate of injection site reactions reported in Italy in the period 2016-2019. MATERIALS AND METHODS: A search was conducted based on 3 search criteria: (1) time frame; (2) suspected drugs, and (3) adverse reaction type. Reports classified in the System Organ Class “Administration site conditions” were analyzed by year, product, and type of adverse event (whether including or not ‘pain’). Data were reported both as absolute numbers, as well as signaling rates, considering the consumption data expressed as defined daily doses (DDD). RESULTS: We found that: (1) The change in Humira® formulation introduced in august 2016 was followed by a decrease in the reports of injection site reactions (from 45 in 2016 to 12, 12 and 8 in 2017, 2018, and 2019, respectively); (2) after the introduction of biosimilars during 2018, in 2019 a marked shift in reporting toward biosimilars was observed (52 out of 60; 87%). CONCLUSIONS: While the decrease in Humira® reports is consistent with the improved tolerability of the new formulation, the huge increase in biosimilar reporting may be only in part explained by the differences in formulation and cannot be accounted for by a parallel increase in exposure, si

Published
2021

3. Risk of Guillain-Barré syndrome after 2010–2011 influenza vaccination

Author

Galeotti F, Massari M, Beghi E, Chiò A, Logroscino G, Filippini G, Benedetti MD, Pugliatti M, Santuccio C, Raschetti R, The ITANG study Group [Clinical research assistants: Sara Marconi, Giorgia Giussani, Enrica Bersano, Umberto Manera, Stefano Zoccolella, Antonio Leo, Roberta Barki, Marco Turatti, Stefania Leoni, Steering committee of the study: Ettore Beghi, Maria Donata Benedetti, Andrea Calvo, Adriano Chiò, Roberto D’Alessandro, Fernanda Ferrazin, Graziella Filippini, Giancarlo Logroscino, Giampiero Mazzaglia, Maura Pugliatti, Roberto Raschetti, Carmela Santuccio, Loriana Tartaglia, Francesco Trotta, Clinical centers, co investigators: E. Romagna: Roberto MICHELUCCI, Patrizia RIGUZZI, Tommaso SACQUEGNA, Anna Maria BORGHI, Vittoria MUSSUTO, Patrizia DE MASSIS, Rita Rinaldi, Walter NERI, Carlo GUIDI, Maria Rosaria TOLA, Enrico GRANIERI, Valentina SIMIONI, Paolo NICHELLI, Jessica MANDRIOLI, Donata GUIDETTI, Emilio TERLIZZI, Mario Giovanni TERZANO, Giovanni PAVESI, Fabrizio RASI, Claudio CALLEGARINI, Norina MARCELLO, Massimo BONDAVALLI, Alessandro RAVASIO, Marco CURRÒ DOSSI, Annamaria MAURO, Chiara MINARDI, Gabriele GRECO, Stefano AMIDEI, Enrico MONTANARI, Doriana MEDICI, Lombardy: Tommaso RICCARDI, Elisabetta D’ADDA, Luigi BETTONI, Luciano ABRUZZI, Elio AGOSTONI, Francesco BASSO, Andrea MAGNONI, Vittorio CRESPI, Maria REPACI, Antonella CHELDI, Mariagrazia BELLOTTI, Carlo FERRARESE, Natale Augusto CURTÒ, Giovanni MEOLA, Giuseppe ROTONDO, Eduardo NOBILE ORAZIO, Fabrizia TERENGHI, Franco SASANELLI, Alessio GALBUSSERA, Marco MATTIOLI, Marco TIRITICCO, Caterina NASCIMBENE, Alessandra VANOTTI, Stefano JANN, Luisa DE TONI FRANCESCHINI, Vincenzo SILANI, Nicola TICOZZI, Giancarlo COMI, Raffaella FAZIO, Patrizia PERRONE, Andrea GIORGETTI, Alessandro ROMORINI, Pietro BASSI, Domenico SANTORO, Nereo BRESOLIN, Simone TONIETTI, Massimo SUARDELLI, Giacomo BEZZI, Daria BALDINI, Angelo Maurizio CLERICI, Giuseppina CAFASSO, Daniele PORAZZI, Isidoro LA SPINA, Giampiero GRAMPA, Davide ZARCONE, Michele PERINI, Marco POLONI, Emanuela AGAZZI, Massimiliano FILOSTO, Alessandro PADOVANI, Renato BESANA, Edoardo DONATI, Eugenio MAGNI, Marco ARNABOLDI, Vincenzo BELCASTRO, Mario GUIDOTTI, Raffaella CLERICI, Maurizio RIVA, Eugenio VITELLI, Paolo PREVIDI, Giuseppe MICIELI, Elisa CANDELORO, Carlo DALLOCCHIO, Carla ARBASINO, Piedmont: Andrea CALVO: Scdu Neurologia 4—AOU S. Giovanni Battista, Cristina MOGLIA: Scdu Neurologia 4—AOU S. Giovanni Battista, Marco VERCELLINO, Bruno FERRERO, Pietro PIGNATTA, Enrico ODDENINO, Daniele IMPERIALE, Daniela LEOTTA, Maurizio GIONCO, Carlo RAVETTI, Roberto CAVALLO, Nicoletta Di Vito, Claudio GEDA, Simona BORTOLOTTO, Emilio LUDA DI CORTEMIGLIA, Giovanna LIOTTA, Emilio URSINO, Mario PALERMO, Luca AMBROGIO, Piero MEINERI, Michele DOTTA, Paolo GHIGLIONE, Joseph MAISTRELLI, Susana ONORATO, Maurizio LEONE, Diego Maria PAPURELLO, Angelo VILLANI, Roberto CONTI, Franco COPPO, Fabiana TESSER, Lucia Testa, Silvia Isabella Cattaneo, Maria Teresa Penza, Graziano Gusmaroli, Katia Savio, Franco Perla, Fabrizio Pisano, Fabio Poglio, Luca Pradotto, Valle d’Aosta: Edo Fausto BOTTACCHI, Puglia: Paolo LIVREA, Francesco FEDERICO, Maria TROJANO, Vito COVELLI, Bruno MAGGIO, Vito SANTAMATO, Bruno PASSARELLA, Giovanni ZIMATORE, Giorgio TRIANNI, Gerardo CIARDO, Salvatore INTERNO’, Veneto: Corrado MARCHINI, Sandro ZAMBITO MARSALA, Giorgio MICHIELI, Carlo BORSATO, Giuseppe DIDONÈ, Emma FRASSON, Alberto POLO, Vincenza ARGENTIERO, Vincenzo ROMEO, Novenia PERLOTTO, Roberto L’ERARIO, Gianfranco MICAGLIO, Tiziana ROSSO, Sandro BRUNO, Bruno GIOMETTO, Mirco SERENA, Rocco QUATRALE, Ernesto GASTALDO, Francesco PERINI, Michele DILEONE, Alessandro CASANO, Lauretta SILVESTRI, Alessandro BURLINA, Virginia MUNERATI, Sebastiano D’Anna, Flavio SANSON, Valeria SARTORI, Giuseppe MORETTO, Giovanna SQUINTANI, Salvatore MONACO, Maria Donata BENEDETTI, Simone FUSINA, Claudio BIANCONI, Fabiana PIMAZZONI, Angela BONOMETTI, Giampietro ZANETTE, Marco TURATTI, Sardinia: Stefania LEONI, Giuseppe MURA, Anna TICCA, Piernicola MARCHI, Davide MANCA], D'ALESSANDRO, ROBERTO, CIRIGNOTTA, FABIO, Galeotti F, Massari M, D'Alessandro R, Beghi E, Chiò A, Logroscino G, Filippini G, Benedetti MD, Pugliatti M, Santuccio C, Raschetti R, The ITANG study Group [Clinical research assistants: Sara Marconi, Giorgia Giussani, Enrica Bersano and Umberto Manera, Stefano Zoccolella and Antonio Leo, Roberta Barki, Marco Turatti, Stefania Leoni, Steering committee of the study: Ettore Beghi, Maria Donata Benedetti, Andrea Calvo and Adriano Chiò, Roberto D’Alessandro, Fernanda Ferrazin, Graziella Filippini, Giancarlo Logroscino, Giampiero Mazzaglia, Maura Pugliatti, Roberto Raschetti, Carmela Santuccio, Loriana Tartaglia and Francesco Trotta, Clinical centers and co-investigators: E. Romagna: Roberto MICHELUCCI, Patrizia RIGUZZI, Tommaso SACQUEGNA, Anna Maria BORGHI, Vittoria MUSSUTO, Patrizia DE MASSIS, Fabio CIRIGNOTTA, Rita Rinaldi, Walter NERI, Carlo GUIDI, Maria Rosaria TOLA, Enrico GRANIERI, Valentina SIMIONI, Paolo NICHELLI, Jessica MANDRIOLI, Donata GUIDETTI, Emilio TERLIZZI, Mario Giovanni TERZANO, Giovanni PAVESI, Fabrizio RASI, Claudio CALLEGARINI, Norina MARCELLO, Massimo BONDAVALLI, Alessandro RAVASIO, Marco CURRÒ DOSSI, Annamaria MAURO, Chiara MINARDI, Gabriele GRECO, Stefano AMIDEI, Enrico MONTANARI, Doriana MEDICI, Lombardy: Tommaso RICCARDI, Elisabetta D’ADDA, Luigi BETTONI, Luciano ABRUZZI, Elio AGOSTONI, Francesco BASSO, Andrea MAGNONI, Vittorio CRESPI, Maria REPACI, Antonella CHELDI, Mariagrazia BELLOTTI, Carlo FERRARESE, Natale Augusto CURTÒ, Giovanni MEOLA, Giuseppe ROTONDO, Eduardo NOBILE-ORAZIO, Fabrizia TERENGHI, Franco SASANELLI, Alessio GALBUSSERA, Marco MATTIOLI, Marco TIRITICCO, Caterina NASCIMBENE, Alessandra VANOTTI, Stefano JANN, Luisa DE TONI FRANCESCHINI, Vincenzo SILANI, Nicola TICOZZI, Giancarlo COMI, Raffaella FAZIO, Patrizia PERRONE, Andrea GIORGETTI, Alessandro ROMORINI, Pietro BASSI, Domenico SANTORO, Nereo BRESOLIN, Simone TONIETTI, Massimo SUARDELLI, Giacomo BEZZI, Daria BALDINI, Angelo Maurizio CLERICI, Giuseppina CAFASSO, Daniele PORAZZI, Isidoro LA SPINA, Giampiero GRAMPA, Davide ZARCONE, Michele PERINI, Marco POLONI, Emanuela AGAZZI, Massimiliano FILOSTO, Alessandro PADOVANI, Renato BESANA, Edoardo DONATI, Eugenio MAGNI, Marco ARNABOLDI, Vincenzo BELCASTRO, Mario GUIDOTTI, Raffaella CLERICI, Maurizio RIVA, Eugenio VITELLI, Paolo PREVIDI, Giuseppe MICIELI, Elisa CANDELORO, Carlo DALLOCCHIO, Carla ARBASINO, Piedmont: Andrea CALVO: Scdu Neurologia 4—AOU S. Giovanni Battista, Cristina MOGLIA: Scdu Neurologia 4—AOU S. Giovanni Battista, Marco VERCELLINO, Bruno FERRERO, Pietro PIGNATTA, Enrico ODDENINO, Daniele IMPERIALE, Daniela LEOTTA, Maurizio GIONCO, Carlo RAVETTI, Roberto CAVALLO, Nicoletta Di Vito, Claudio GEDA, Simona BORTOLOTTO, Emilio LUDA DI CORTEMIGLIA, Giovanna LIOTTA, Emilio URSINO, Mario PALERMO, Luca AMBROGIO, Piero MEINERI, Michele DOTTA, Paolo GHIGLIONE, Joseph MAISTRELLI, Susana ONORATO, Maurizio LEONE, Diego Maria PAPURELLO, Angelo VILLANI, Roberto CONTI, Franco COPPO, Fabiana TESSER, Lucia Testa, Silvia Isabella Cattaneo, Maria Teresa Penza, Graziano Gusmaroli, Katia Savio, Franco Perla, Fabrizio Pisano, Fabio Poglio, Luca Pradotto, Valle d’Aosta: Edo Fausto BOTTACCHI, Puglia: Paolo LIVREA, Francesco FEDERICO, Maria TROJANO, Vito COVELLI, Bruno MAGGIO, Vito SANTAMATO, Bruno PASSARELLA, Giovanni ZIMATORE, Giorgio TRIANNI, Gerardo CIARDO, Salvatore INTERNO’, Veneto: Corrado MARCHINI, Sandro ZAMBITO MARSALA, Giorgio MICHIELI, Carlo BORSATO, Giuseppe DIDONÈ, Emma FRASSON, Alberto POLO, Vincenza ARGENTIERO, Vincenzo ROMEO, Novenia PERLOTTO, Roberto L’ERARIO, Gianfranco MICAGLIO, Tiziana ROSSO, Sandro BRUNO, Bruno GIOMETTO, Mirco SERENA, Rocco QUATRALE, Ernesto GASTALDO, Francesco PERINI, Michele DILEONE, Alessandro CASANO, Lauretta SILVESTRI, Alessandro BURLINA, Virginia MUNERATI, Sebastiano D’Anna, Flavio SANSON, Valeria SARTORI, Giuseppe MORETTO, Giovanna SQUINTANI, Salvatore MONACO, Maria Donata BENEDETTI, Simone FUSINA, Claudio BIANCONI, Fabiana PIMAZZONI, Angela BONOMETTI, Giampietro ZANETTE, Marco TURATTI, Sardinia: Stefania LEONI, Giuseppe MURA, Anna TICCA, Piernicola MARCHI, Davide MANCA], Galeotti, F, Massari, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Benedetti, M, Pugliatti, M, Santuccio, C, Raschetti, R, Ferrarese, C, Benedetti, Md, ITANG study, Group, and Giometto, B

Subjects
Male, Epidemiology, Pharmaco-Epidemiology, medicine.disease_cause, MED/26 Neurologia, Influenza A Virus, H1N1 Subtype, Risk Factors, Influenza A virus, Odds Ratio, influenza vaccination, Guillain-Barré Syndrome, Case–control study, self controlled case series, Prospective Studies, Case-control study, Guillain-Barrè Syndrome, Influenza vaccination, Self controlled case series, Aged, 80 and over, Guillain-Barre syndrome, Respiratory tract infections, Incidence (epidemiology), Incidence, Middle Aged, Vaccination, Guillain-Barrè, epidemic risk , gastrointestinal and respiratory infections, Italy, Influenza Vaccines, Population Surveillance, Regression Analysis, Female, Settore MED/26 - Neurologia, Adult, medicine.medical_specialty, Guillain-Barre Syndrome, Mass Vaccination, NO, Internal medicine, Influenza, Human, medicine, Humans, Pandemics, Aged, business.industry, Odds ratio, medicine.disease, Relative risk, Case-Control Studies, Immunology, Attributable risk, business
Abstract

Influenza vaccination has been implicated in Guillain Barre Syndrome (GBS) although the evidence for this link is controversial. A case–control study was conducted between October 2010 and May 2011 in seven Italian Regions to explore the relation between influenza vaccination and GBS. The study included 176 GBS incident cases aged ≥18 years from 86 neurological centers. Controls were selected among patients admitted for acute conditions to the Emergency Department of the same hospital as cases. Each control was matched to a case by sex, age, Region and admission date. Two different analyses were conducted: a matched case–control analysis and a self-controlled case series analysis (SCCS). Case–control analysis included 140 cases matched to 308 controls. The adjusted matched odds ratio (OR) for GBS occurrence within 6 weeks after influenza vaccination was 3.8 (95 % CI: 1.3, 10.5). A much stronger association with gastrointestinal infections (OR = 23.8; 95 % CI 7.3, 77.6) and influenza-like illness or upper respiratory tract infections (OR = 11.5; 95 % CI 5.6, 23.5) was highlighted. The SCCS analysis included all 176 GBS cases. Influenza vaccination was associated with GBS, with a relative risk of 2.1 (95 % CI 1.1, 3.9). According to these results the attributable risk in adults ranges from two to five GBS cases per 1,000,000 vaccinations.

Published
2013

4. A Multicentric Prospective Incidence Study of Guillain-Barré Syndrome in Italy. The ITANG Study

Author

Benedetti, M, Pugliatti, M, Dalessandro, R, BEGHI, ETTORE, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Raschetti, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, AM, Borsato, C, Bortolotto, S, Bottacchi, EF, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, SI, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, AM, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, NA, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, FERRARESE, CARLO, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Giometto, B, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, DM, Passarella, B, Pavesi, G, Penza, MT, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, GM, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, MR, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, Zoccolella, S., Benedetti, Md, Pugliatti, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Comi, Giancarlo, Raschetti, R, ITANG Study, Group, Giometto, B, Benedetti, M, Dalessandro, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, A, Borsato, C, Bortolotto, S, Bottacchi, E, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, S, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, A, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, N, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, Ferrarese, C, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, D, Passarella, B, Pavesi, G, Penza, M, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, G, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, M, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, and Zoccolella, S

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Epidemiology, Population, Guillain-Barre Syndrome, Rate ratio, NO, Young Adult, Axonal and demyelinating GBS, Guillain-Barré syndrome, Incidence, Prospective study, Trend, Neurology (clinical), Aged, Aged, 80 and over, Female, Humans, Italy, Middle Aged, 80 and over, medicine, Young adult, education, Prospective cohort study, education.field_of_study, Guillain-Barre syndrome, business.industry, Medicine (all), Incidence (epidemiology), medicine.disease, Vaccination, Settore MED/26 - NEUROLOGIA, business, Human
Abstract

Background: To assess Guillain-Barré syndrome (GBS) incidence we relied on the Italian Network for the study of GBS (ITANG) established in 2010 in 7 Italian regions to analyse the association between influenza vaccination and GBS. Methods: All individuals aged ≥18 years, presenting with clinical manifestations that suggested GBS according to the universally accepted Asbury's diagnostic criteria (1990) were prospectively notified to a centralised database by ITANG neurologists over the period October 1, 2010-September 30, 2011. Through a telephone survey, 9 trained interviewers followed up the cases to diagnosis and then for 1 year since hospital discharge. Validation of case reporting was performed with the support of administrative data in 5 regions. Results: We found 365 cases fulfilling the definition for GBS or one of its variants over 19,846,068 population ≥18 years of age, yielding an annual incidence rate of 1.84 per 100,000 (95% CI 1.65-2.03), 2.30 (95% CI 1.99-2.60) in men and 1.41 (95% CI 1.18-1.64) in women. A highly significant peak of incidence was observed in February 2011 as compared to reference month (September 2011, rate ratio 3.3:1, p < 0.01). Conclusions: In Italy, GBS incidence was among the highest reported in Europe and higher than previously observed in Italian studies.

Published
2015

5. Comparative safety evaluation of 7-valent and 13-valent pneumococcal vaccines in routine paediatric vaccinations in four Italian regions, 2009 to 2011

Author

Trotta F, Rizzo C, Santuccio C, Bella A, and Pharmacovigilance Study Group On Pneumococcal Vaccination In Children

Subjects
Male, Single administration, Pediatrics, medicine.medical_specialty, Heptavalent Pneumococcal Conjugate Vaccine, Epidemiology, Comparative safety, Rate ratio, Pneumococcal Infections, Pneumococcal Vaccines, Conjugate vaccine, Virology, Convulsion, medicine, Adverse Drug Reaction Reporting Systems, Humans, Adverse effect, Immunization Schedule, Immunization Programs, business.industry, Vaccination, Public Health, Environmental and Occupational Health, Infant, Antibodies, Bacterial, Confidence interval, Italy, Child, Preschool, Immunology, Female, medicine.symptom, business
Abstract

This study was aimed at estimating the risk of all types of adverse events following immunisation (AEFI), neurological events and convulsions following the co-administration of 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) with hexavalent vaccine. Paediatric spontaneous reports and exposure to vaccinations in four Italian regions were available. The estimated incidence rate ratio (IRR) for AEFI following co-administration of hexavalent vaccine with either PCV13 or PCV7 was 1.08 (95% confidence interval (CI): 0.91-1.28); the IRR for, respectively, neurological events and convulsion following co-administration of PCV13 with hexavalent vaccine were 1.27 (95% CI: 0.85-1.89) and 1.43 (95% CI: 0.70-2.91). Co-administration of PCV13 with hexavalent vaccine had a protective effect against AEFI (IRR?=?0.59; 95% CI: 0.49-0.72). This protective effect was not observed for neurological events or convulsions following co-administration of PCV13 with hexavalent vaccine compared with single administration (IRR?=?1.44; 95% CI: 0.77-2.67 and IRR?=?1.46; 95% CI: 0.50-4.25, respectively). We observed a trend of increased risk of neurological events or convulsions following PCV13 used in routine practice. Analysis of spontaneously reported data is a quick method to estimate associations between vaccines and less common adverse events. Given methodological limitations these findings cannot be conclusive and require further investigations. .

Published
2015
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6. Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases.

Author

Felicetti P., Chandler R., Girolomoni G., Hadden R.D.M., Kochar S., Kucuku M., Monaco G., Ozen S., Pahud B., Phuong L., Bachtiar N.S., Teeba A., Top K., Varricchio F., Wise R.P., Zanoni G., Zivkovic S., Bonhoeffer J., Burgner D., Brauchli Pernus Y., Santuccio C., Bonetto C., Trotta F., Felicetti P., Chandler R., Girolomoni G., Hadden R.D.M., Kochar S., Kucuku M., Monaco G., Ozen S., Pahud B., Phuong L., Bachtiar N.S., Teeba A., Top K., Varricchio F., Wise R.P., Zanoni G., Zivkovic S., Bonhoeffer J., Burgner D., Brauchli Pernus Y., Santuccio C., Bonetto C., and Trotta F.

Abstract

Background Vasculitides have been reported as adverse events following immunization (AEFI) following various vaccines. We describe reports of vasculitis to three international spontaneous reporting systems. Methods All spontaneous reports of vasculitis following immunization between January 2003 and June 2014 were retrieved from Eudravigilance (EV), the Vaccine Adverse Event Reporting System (VAERS), and VigiBase. A Standard MedDRA Query (SMQ) for vasculitis was used and vaccine types were categorized using the Anatomical Therapeutic Chemical classification system. We performed a descriptive analysis by source, sex, age, country, time to onset, vaccine, and type of vasculitis. Results We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase. Vasculitis was predominantly reported in children aged 1-17 years, and less frequently in the elderly (>65 years). The generic term "vasculitis" was the most frequently reported AEFI in this category across the three databases (range 21.9% to 27.5% of all reported vasculitis for vaccines). For the more specific terms, Henoch-Schoenlein Purpura (HSP) was most frequently reported, (19.1% on average), followed by Kawasaki disease (KD) (16.1% on average) and polymyalgia rheumatica (PMR) (9.2% on average). Less frequently reported subtypes were cutaneous vasculitis (CuV), vasculitis of the central nervous system (CNS-V), and Behcet's syndrome (BS). HSP, PMR and CuV were more frequently reported with influenza vaccines: on average in 29.3% for HSP reports, 61.5% for PMR reports and in 39.2% for CuV reports. KD was reported with pneumococcal vaccines in 32.0% of KD reports and with rotavirus vaccines in more than 20% of KD reports. BS was most frequently reported after hepatitis and HPV vaccines and CNS-V after HPV vaccines. Conclusion Similar reporting patterns of vasculitides were observed in different databases. Implementation of standardized case definitions for specific vasculitides could improve overall

Published
2016

7. Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy

Author

Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Felicetti, P, Tartaglia, L, Trotta, F, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, Pier Angelo, Gabiano, C, Urbino, A, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Manuela, O, Carlo, C, Mores, N, Romagnoli, C, Chiaretti, A, Compagnone, A, Riccardi, R, Delogu, G, Sali, M, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T, Sodano, G, Maccariello, A, Rafaniello, C, Fucà, F, Di Rosa, E, Altavilla, D, Mecchio, A, Arrigo, T, Italian Multicentre Study Group for Drug, Vaccine Safety in Children, Menniti Ippolito, Francesca, Da Cas, Roberto, Traversa, Giuseppe, Santuccio, Carmela, Felicetti, Patrizia, Tartaglia, Loriana, Trotta, Francesco, Di Pietro, Pasquale, Barabino, Paola, Renna, Salvatore, Riceputi, Laura, Tovo, Pier Angelo, Gabiano, Clara, Urbino, Antonio, Baroero, Luca, Le Serre, Daniele, Virano, Silvia, Perilongo, Giorgio, Daverio, Marco, Gnoato, Elisa, Maretti, Michela, Galeazzo, Beatrice, Rubin, Giulia, Scanferla, Stefania, Da Dalt, Liviana, Stefani, Chiara, Zerbinati, Claudia, Chiappini, Elena, Sollai, Sara, De Martino, Maurizio, Mannelli, Francesco, Becciani, Sabrina, Giacalone, Martina, Montano, Simona, Remaschi, Giulia, Stival, Alessia, Furbetta, Mario, Abate, Piera, Leonardi, Ilaria, Pirozzi, Nicola, Raucci, Umberto, Reale, Antonino, Rossi, Rossella, Russo, Cristina, Mancinelli, Livia, Manuela, Onori, Carlo, Concato, Mores, Nadia, Romagnoli, Costantino, Chiaretti, Antonio, Compagnone, Adele, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Prete, Valentina, Tipo, Vincenzo, Dinardo, Michele, Auricchio, Fabiana, Polimeno, Teodoro, Sodano, Giuseppe, Maccariello, Alessandra, Rafaniello, Concetta, Fucà, Fortunata, Di Rosa, Eleonora, Altavilla, Domenica, Mecchio, Anna, and Arrigo, Teresa

Subjects
Male, Pediatrics, Laboratory-confirmed case, Emergency Medical Services, Immunology and Microbiology (all), Laboratory-confirmed cases, Case-control study, Children, Influenza vaccine effectiveness, Seasonal influenza, Influenza vaccine effectivene, Emergency medical services, Medicine, Child, Vaccine effectiveness, Vaccination, Hospitalization, Systematic review, Infectious Diseases, Treatment Outcome, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Italy, Influenza Vaccines, Child, Preschool, Molecular Medicine, Veterinary (all), Female, Case-Control Studie, Influenza Vaccine, Settore BIO/19 - MICROBIOLOGIA GENERALE, Human, medicine.medical_specialty, Settore BIO/14 - FARMACOLOGIA, Adolescent, Settore MED/07 - MICROBIOLOGIA E MICROBIOLOGIA CLINICA, Immunology and Microbiology(all), Influenza, Human, Humans, Influenza-like illness, General Veterinary, General Immunology and Microbiology, business.industry, Emergency Medical Service, Public Health, Environmental and Occupational Health, Infant, Emergency department, veterinary(all), Confidence interval, Surgery, Case-Control Studies, Case-control study, Children, Influenza vaccine effectiveness, Laboratory-confirmed cases, influenza in children, business
Abstract

•Vaccine effectiveness in children visiting an Emergency Department for influenza.•Test negative case-control study in 11 paediatric centres in two influenza seasons.•Vaccine effectiveness in preventing ED visits: 38% (95% CI -52% to 75%).•Add information for recommendation for vaccination in children. Objective: To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children. Methods: We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children. Results: Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%). Discussion: This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children. © 2014 The Authors.

Published
2013

13. A Multicentric Prospective Incidence Study of Guillain-Barre Syndrome in Italy. the ITANG Study

Author

Benedetti, M. D., Pugliatti, M., Dalessandro, R., Beghi, E., Chio, A., Logroscino, G., Filippini, G., Galeotti, F., Massari, M., Santuccio, C., Raschetti R., Abruzzi L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, Am, Borsato, C, Bortolotto, S, Bottacchi, Ef, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, Si, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, Am, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, Na, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, Ferrarese, C, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Giometto, B, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, Eugenio, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile-Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, Dm, Passarella, B, Pavesi, G, Penza, Mt, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, Gm, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, Mg, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, Mr, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, Zoccolella, S., Magni E (ORCID:0000-0002-2235-2280), Benedetti, M. D., Pugliatti, M., Dalessandro, R., Beghi, E., Chio, A., Logroscino, G., Filippini, G., Galeotti, F., Massari, M., Santuccio, C., Raschetti R., Abruzzi L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, Am, Borsato, C, Bortolotto, S, Bottacchi, Ef, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, Si, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, Am, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, Na, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, Ferrarese, C, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Giometto, B, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, Eugenio, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile-Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, Dm, Passarella, B, Pavesi, G, Penza, Mt, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, Gm, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, Mg, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, Mr, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, Zoccolella, S., and Magni E (ORCID:0000-0002-2235-2280)

Abstract

To assess Guillain-Barre syndrome (GBS) incidence we relied on the Italian Network for the study of GBS (ITANG) established in 2010 in 7 Italian regions to analyse the association between influenza vaccination and GBS. Methods: All individuals aged ≥18 years, presenting with clinical manifestations that suggested GBS according to the universally accepted Asbury's diagnostic criteria (1990) were prospectively notified to a centralised database by ITANG neurologists over the period October 1, 2010-September 30, 2011. Through a telephone survey, 9 trained interviewers followed up the cases to diagnosis and then for 1 year since hospital discharge. Validation of case reporting was performed with the support of administrative data in 5 regions. Results: We found 365 cases fulfilling the definition for GBS or one of its variants over 19,846,068 population ≥18 years of age, yielding an annual incidence rate of 1.84 per 100,000 (95% CI 1.65-2.03), 2.30 (95% CI 1.99-2.60) in men and 1.41 (95% CI 1.18-1.64) in women. A highly significant peak of incidence was observed in February 2011 as compared to reference month (September 2011, rate ratio 3.3:1, p < 0.01). Conclusions: In Italy, GBS incidence was among the highest reported in Europe and higher than previously observed in Italian studies.

Published
2015

16. Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy.

Author

Mores, Nadia, Romagnoli, Costantino, Chiaretti, Antonio, Compagnone, Adele, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Trotta, F, Felicetti, P, Tartaglia, L, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, Pa, Gabiano, C, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Manuela, O, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Carlo, C, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Romagnoli, Costantino (ORCID:0000-0003-1176-2943), Chiaretti, Antonio (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), Sali, Michela (ORCID:0000-0003-3609-2990), Mores, Nadia, Romagnoli, Costantino, Chiaretti, Antonio, Compagnone, Adele, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Trotta, F, Felicetti, P, Tartaglia, L, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, Pa, Gabiano, C, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Manuela, O, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Carlo, C, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Romagnoli, Costantino (ORCID:0000-0003-1176-2943), Chiaretti, Antonio (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), and Sali, Michela (ORCID:0000-0003-3609-2990)

Abstract

OBJECTIVE: To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children. METHODS: We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children. RESULTS: Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%). DISCUSSION: This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children.

Published
2014

17. Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy

Author

Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Felicetti, P, Tartaglia, L, Trotta, F, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, P, Gabiano, C, Urbino, A, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Manuela, O, Carlo, C, Mores, Nadia, Romagnoli, C, Chiaretti, Antonio, Compagnone, A, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T, Sodano, G, Maccariello, A, Rafaniello, C, Fucà, F, Di Rosa, E, Altavilla, D, Mecchio, A, Arrigo, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Chiaretti, A (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), Sali, Michela (ORCID:0000-0003-3609-2990), Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Felicetti, P, Tartaglia, L, Trotta, F, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, P, Gabiano, C, Urbino, A, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Manuela, O, Carlo, C, Mores, Nadia, Romagnoli, C, Chiaretti, Antonio, Compagnone, A, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T, Sodano, G, Maccariello, A, Rafaniello, C, Fucà, F, Di Rosa, E, Altavilla, D, Mecchio, A, Arrigo, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Chiaretti, A (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), and Sali, Michela (ORCID:0000-0003-3609-2990)

Abstract

To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children.

Published
2014

18. The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

Author

Wijnans, L., Lecomte, C., Vries, C. de, Weibel, D., Sammon, C., Hviid, A., Svanstrom, H., Molgaard-Nielsen, D., Heijbel, H., Dahlstrom, L.A., Hallgren, J., Sparen, P., Jennum, P., Mosseveld, M., Schuemie, M., Maas, N. van der, Partinen, M., Romio, S., Trotta, F., Santuccio, C., Menna, A., Plazzi, G., Moghadam, K.K., Ferro, S., Lammers, G.J., Overeem, S., Johansen, K., Kramarz, P., Bonhoeffer, J., Sturkenboom, M.C., Wijnans, L., Lecomte, C., Vries, C. de, Weibel, D., Sammon, C., Hviid, A., Svanstrom, H., Molgaard-Nielsen, D., Heijbel, H., Dahlstrom, L.A., Hallgren, J., Sparen, P., Jennum, P., Mosseveld, M., Schuemie, M., Maas, N. van der, Partinen, M., Romio, S., Trotta, F., Santuccio, C., Menna, A., Plazzi, G., Moghadam, K.K., Ferro, S., Lammers, G.J., Overeem, S., Johansen, K., Kramarz, P., Bonhoeffer, J., and Sturkenboom, M.C.

Abstract

Contains fulltext : 117810.pdf (publisher's version ) (Closed access), BACKGROUND: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. METHODS: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. RESULTS: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women>men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. CONCLUSIONS: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

Published
2013

19. The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

Author

Wijnans, E.G. (Leonoor), Lecomte, C. (Coralie), Vries, C.S. (Corinne) de, Weibel, D.M. (Daniel), Sammon, C. (Cormac), Hviid, A. (Anders), Svanström, H. (Henrik), Mølgaard-Nielsen, D. (Ditte), Heijbel, H. (Harald), Dahlström, L.A. (Lisen Arnheim), Hallgren, J. (Jonas), Sparen, P. (Pär), Jennum, P. (Poul), Mosseveld, M. (Mees), Schuemie, M.J. (Martijn), Maas, N.A.T. (Nicoline) van der, Partinen, M. (Markku), Romio, S.A. (Silvana), Trotta, F. (Francesco), Santuccio, C. (Carmela), Menna, A. (Angelo), Plazzi, G. (Giuseppe), Moghadam, K.K. (Keivan Kaveh), Ferro, M.T. (María), Lammers, G.J. (Gert Jan), Overeem, S. (Sebastiaan), Johansen, K. (Kari), Kramarz, P (Piotr), Bonhoeffer, J. (Jan), Sturkenboom, M.C.J.M. (Miriam), Wijnans, E.G. (Leonoor), Lecomte, C. (Coralie), Vries, C.S. (Corinne) de, Weibel, D.M. (Daniel), Sammon, C. (Cormac), Hviid, A. (Anders), Svanström, H. (Henrik), Mølgaard-Nielsen, D. (Ditte), Heijbel, H. (Harald), Dahlström, L.A. (Lisen Arnheim), Hallgren, J. (Jonas), Sparen, P. (Pär), Jennum, P. (Poul), Mosseveld, M. (Mees), Schuemie, M.J. (Martijn), Maas, N.A.T. (Nicoline) van der, Partinen, M. (Markku), Romio, S.A. (Silvana), Trotta, F. (Francesco), Santuccio, C. (Carmela), Menna, A. (Angelo), Plazzi, G. (Giuseppe), Moghadam, K.K. (Keivan Kaveh), Ferro, M.T. (María), Lammers, G.J. (Gert Jan), Overeem, S. (Sebastiaan), Johansen, K. (Kari), Kramarz, P (Piotr), Bonhoeffer, J. (Jan), and Sturkenboom, M.C.J.M. (Miriam)

Abstract

Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

Published
2013
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20. Risk of Guillain-Barré syndrome after 2010-2011 influenza vaccination

Author

Galeotti, F, Massari, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Benedetti, M, Pugliatti, M, Santuccio, C, Raschetti, R, Ferrarese, C, Benedetti, MD, FERRARESE, CARLO, Galeotti, F, Massari, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Benedetti, M, Pugliatti, M, Santuccio, C, Raschetti, R, Ferrarese, C, Benedetti, MD, and FERRARESE, CARLO

Abstract

Influenza vaccination has been implicated in Guillain Barré Syndrome (GBS) although the evidence for this link is controversial. A case-control study was conducted between October 2010 and May 2011 in seven Italian Regions to explore the relation between influenza vaccination and GBS. The study included 176 GBS incident cases aged ≥18 years from 86 neurological centers. Controls were selected among patients admitted for acute conditions to the Emergency Department of the same hospital as cases. Each control was matched to a case by sex, age, Region and admission date. Two different analyses were conducted: a matched case-control analysis and a self-controlled case series analysis (SCCS). Case-control analysis included 140 cases matched to 308 controls. The adjusted matched odds ratio (OR) for GBS occurrence within 6 weeks after influenza vaccination was 3.8 (95 % CI: 1.3, 10.5). A much stronger association with gastrointestinal infections (OR = 23.8; 95 % CI 7.3, 77.6) and influenza-like illness or upper respiratory tract infections (OR = 11.5; 95 % CI 5.6, 23.5) was highlighted. The SCCS analysis included all 176 GBS cases. Influenza vaccination was associated with GBS, with a relative risk of 2.1 (95 % CI 1.1, 3.9). According to these results the attributable risk in adults ranges from two to five GBS cases per 1,000,000 vaccinations.

Published
2013

21. Sindrome di guillain-barré e vaccinazione antinfluenzale

Author

Galeotti, F, Massari, M, D’Alessandro, R, Beghi, B, Benedetti, M, Chiò, A, Filippini, G, Logroscino, G, Mazzaglia, G, Pugliatti, M, Santuccio, C, Trotta, F, Tartaglia, L, Raschetti, R, Logroscino G, MAZZAGLIA, GIAMPIERO, Galeotti, F, Massari, M, D’Alessandro, R, Beghi, B, Benedetti, M, Chiò, A, Filippini, G, Logroscino, G, Mazzaglia, G, Pugliatti, M, Santuccio, C, Trotta, F, Tartaglia, L, Raschetti, R, Logroscino G, and MAZZAGLIA, GIAMPIERO

Published
2011

22. Henoch-Schönlein purpura and drug and vaccine use in childhood: a case-control study

Author

Da Dalt, L, Zerbinati, C, Strafella, Ms, Renna, S, Riceputi, L, Di Pietro, P, Barabino, P, Scanferla, S, Raucci, U, Mores, N, Compagnone, A, Da Cas, R, Menniti Ippolito, F, Italian Multicenter Study Group for Drug, Vaccine Safety in Children including Menniti Ippolito, F, Traversa, G, Santuccio, C, Felicetti, P, Tartaglia, L, Trotta, F, Tovo, Pier Angelo, Gabiano, C, Urbino, A, Baroero, Luca, LE SERRE, Daniele, Virano, Silvia, Stefani, C, Perilongo, G, Daverio, M, Maretti, M, Galeazzo, B, Rubin, G, Chiappini, E, Sollai, S, De Martino, M, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Abate, P, Leonardi, I, Pirozzi, N, Reale, A, Rossi, R, Bersani, G, Chiaretti, A, Riccardi, R, Romagnoli, C, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T, Bonagura, M, Maccariello, A, Fucà, F, Di Rosa, E, Altavilla, D, Mecchio, A, and Arrigo, T.

Subjects
Male, Drug, Pediatrics, medicine.medical_specialty, Henoch-Schonlein purpura, Adolescent, Drug-Related Side Effects and Adverse Reactions, IgA Vasculitis, media_common.quotation_subject, Adverse drug reaction, Disease, MMR vaccine, Risk Assessment, Statistics, Nonparametric, 03 medical and health sciences, Age Distribution, 0302 clinical medicine, 030225 pediatrics, Confidence Intervals, medicine, Humans, Children, Henoch-Schönlein purpura, Vaccine, Pediatrics, Perinatology and Child Health, Sex Distribution, Child, media_common, 030203 arthritis & rheumatology, Chi-Square Distribution, business.industry, Incidence, Research, Case-control study, Reproducibility of Results, Perinatology and Child Health, medicine.disease, Italy, Pharmaceutical Preparations, Case-Control Studies, Child, Preschool, Etiology, Female, business, Vasculitis, Measles-Mumps-Rubella Vaccine, Follow-Up Studies
Abstract

Background Henoch-Schönlein purpura (HSP) is the most common vasculitis in childhood; nevertheless, its etiology and pathogenesis remain unknown despite the fact that a variety of factors, mainly infectious agents, drugs and vaccines have been suggested as triggers for the disease. The aim of this study was to estimate the association of HSP with drug and vaccine administration in a pediatric population. Methods An active surveillance on drug and vaccine safety in children is ongoing in 11 clinical centers in Italy. All children hospitalized through the local Paediatric Emergency Department for selected acute clinical conditions of interest were enrolled in the study. Data on drug and vaccine use in children before the onset of symptoms leading to hospitalization were collected by parents interview. A case-control design was applied for risk estimates: exposure in children with HSP, included as cases, was compared with similar exposure in children with gastroduodenal lesions, enrolled as controls. HSP cases were validated according to EULAR/PRINTO/PRES criteria. Validation was conducted retrieving data from individual patient clinical record. Results During the study period (November 1999–April 2013), 288 cases and 617 controls were included. No increased risk of HSP was estimated for any drug. Among vaccines, measles-mumps-rubella (MMR) vaccine showed an increased risk of HSP (OR 3.4; 95 % CI 1.2–10.0). Conclusions This study provides further evidence on the possible role of MMR vaccine in HSP occurrence.

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23. Intussusception hospitalizations incidence in the pediatric population in Italy: a nationwide cross-sectional study.

Author

Trotta F, Da Cas R, Bella A, Santuccio C, and Salmaso S

Abstract

Background: Study to investigate the intussusception incidence background in the pediatric population and its temporal trend in Italy., Methods: A cross-sectional study was conducted on the pediatric population aged 0 to 15 years, in the period 1 January 2002 to 31 December 2012. Intussusception cases were identified using the national hospital discharge database. The annual intussusception incidence, the incidence rate ratios (IRRs) and the related 95 % confidence Intervals (CI) were calculated., Results: The overall intussusception incidence rate was 21 per 100,000 children aged ≤15 years, and was higher among boys than girls. The highest intussusception incidence rate occurred in infants <1 year of age (39 per 100,000 infants). Among infants, incidence varied with the geographical area, with higher rates in the central Italy (50 per 100,000 infants). The annual incidence rates in infants were stable since 2004 and up to 2012, ranging from 40.1 and 33.0 per 100,000 infants. Similar stable patterns were observed when conducting the analysis on children over 1 year of age., Conclusions: This study provided the intussusception incidence background in Italy in different pediatric ages, including infants, over an 11-year period. This information is essential in post-marketing safety surveillance, to continuously monitor the benefit/risk profile of rotavirus vaccinations.

Published
2016
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24. Hypovolemic shock due to severe gastrointestinal bleeding in a child taking an herbal syrup.

Author

Moro PA, Flacco V, Cassetti F, Clementi V, Colombo ML, Chiesa GM, Menniti-Ippolito F, Raschetti R, and Santuccio C

Subjects
Child, Preschool, Chromatography, High Pressure Liquid, Common Cold complications, Common Cold drug therapy, Critical Care, Drug Recalls, Endoscopy, Digestive System, Hernia, Hiatal complications, Hernia, Hiatal pathology, Humans, Italy, Male, Reference Standards, Salicylates adverse effects, Salicylates analysis, Shock pathology, Gastrointestinal Hemorrhage chemically induced, Gastrointestinal Hemorrhage complications, Plant Preparations adverse effects, Shock etiology
Abstract

We report the case of a 4-years-old boy who was admitted with hypovolemic shock due to a severe gastrointestinal bleeding. The esophagogastroduodenoscopy (EGDS) showed hiatus hernia, erosions and ulcerations of the lower esophagus, possibly due to a gastroesophageal reflux, and a small duodenal erosion. The child was previously healthy and he had never shown any symptoms related to this condition. The only product taken by the child in the previous days was a syrup containing several herbs, among which Filipendula ulmaria (L.) Maxim. and Salix spp. (known to contain salicylates), marketed as food and prescribed by his paediatrician to treat a mild cold accompanied by fever. Quali-quantitative analysis confirmed the presence of salicylates in the syrup. Naranjo algorithm showed a probable correlation between the onset of symptoms and the consumption of the herbal remedy. The child recovered after receiving intensive care. The product was withdrawn from Italian market.

Published
2011
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