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1. 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

2. 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

3. 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

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

Author

Benedetti, M, Pugliatti, M, Dalessandro, R, Beghi, E, 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, 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, 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, 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, Zoccolella, S, BEGHI, ETTORE, Borghi, AM, Bottacchi, EF, Cattaneo, SI, Clerici, AM, Curtò, NA, FERRARESE, CARLO, Papurello, DM, Penza, MT, Squintani, GM, Tola, MR, Zoccolella, S., Benedetti, M, Pugliatti, M, Dalessandro, R, Beghi, E, 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, 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, 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, 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, Zoccolella, S, BEGHI, ETTORE, Borghi, AM, Bottacchi, EF, Cattaneo, SI, Clerici, AM, Curtò, NA, FERRARESE, CARLO, Papurello, DM, Penza, MT, Squintani, GM, Tola, MR, and Zoccolella, S.

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

5. 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

6. 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

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, 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

8. 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

9. 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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10. 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

11. 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

12. 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

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