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1. Preliminary data revealing efficacy of Streptococcus salivarius K12 (SSK12) in Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis (PFAPA) syndrome : a multicenter study from the AIDA Network PFAPA syndrome registry

Author

La Torre, F, Sota, J, Insalaco, A, Conti, G, Del Giudice, E, Lubrano, R, Breda, L, Maggio, Mc, Civino, A, Mastrorilli, V, Loconte, R, Natale, Mf, Celani, C, Romeo, M, Patroniti, S, Gentile, C, Vitale, A, Caggiano, V, Gaggiano, C, Diomeda, F, Cattalini, M, Lopalco, G, Emmi, G, Parronchi, P, Gentileschi, S, Cardinale, F, Aragona, E, Shahram, F, Marino, A, Barone, P, Moscheo, C, Ozkiziltas, B, Carubbi, F, Alahmed, O, Iezzi, Ludovica, Ogunjimi, B, Mauro, A, Tarsia, M, Mahmoud, Aaa, Mayrink Giardini HAM, Sfikakis, Pp, Laskari, K, Więsik-Szewczyk, E, Hernàndez-Rodriguez, J, Frediani, B, Gòmez-Caverzaschi, V, Tufan, A, Almaghlouth, Ia, Balistreri, A, Ragab, G, Fabiani, C, Cantarini, L, Rigante, Donato, AIDA Network, La Torre, Francesco, Sota, Jurgen, Insalaco, Antonella, Conti, Giovanni, Del Giudice, Emanuela, Lubrano, Riccardo, Breda, Luciana, Maggio, Maria Cristina, Civino, Adele, Mastrorilli, Violetta, Loconte, Roberta, Natale, Marco Francesco, Celani, Camilla, Romeo, Mery, Patroniti, Serena, Gentile, Cristina, Vitale, Antonio, Caggiano, Valeria, Gaggiano, Carla, Diomeda, Federico, Cattalini, Marco, Lopalco, Giuseppe, Emmi, Giacomo, Parronchi, Paola, Gentileschi, Stefano, Cardinale, Fabio, Aragona, Emma, Shahram, Farhad, Marino, Achille, Barone, Patrizia, Moscheo, Carla, Ozkiziltas, Burcugul, Carubbi, Francesco, Alahmed, Ohoud, Iezzi, Ludovica, Ogunjimi, Benson, Mauro, Angela, Tarsia, Maria, Mahmoud, Ayman Abdel-Monem Ahmed, Giardini, Henrique Ayres Mayrink, Sfikakis, Petros P, Laskari, Katerina, Więsik-Szewczyk, Ewa, Hernández-Rodríguez, José, Frediani, Bruno, Gómez-Caverzaschi, Verónica, Tufan, Abdurrahman, Almaghlouth, Ibrahim A, Balistreri, Alberto, Ragab, Gaafar, Fabiani, Claudia, Cantarini, Luca, and Rigante, Donato

Subjects
International Registry, PFAPA syndrome, Streptococcus salivarius K12, autoinflammatory disease, probiotic, prophylaxis, tonsillitis, Settore MED/38 - Pediatria Generale E Specialistica, Autoinflammation, General Medicine, Human medicine, PFAPA syndrome
Abstract

ObjectiveTo evaluate the potential role of Streptococcus salivarius K12 (SSK12) in controlling febrile flares in patients with Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis (PFAPA) syndrome. Further aims were to assess the impact of SSK12 on (i) flare duration, (ii) variation in the degree of the highest body temperature during flares, (iii) steroid-sparing effect, and (iv) change of PFAPA accompanying symptoms before and after SSK12 introduction.Patients and methodsThe medical charts from 85 pediatric patients with PFAPA syndrome (49 males and 36 females) enrolled in the AIDA registry and treated with SSK12 for a median period of 6.00 ± 7.00 months in the period between September 2017 and May 2022 were examined. Children recruited had a median time of disease duration of 19.00 ± 28.00 months.ResultsThe number of febrile flares significantly decreased comparing the 12 months before [median (IQR), 13.00 (6.00)] and after SSK12 initiation [median (IQR), 5.50 (8.00), p < 0.001]. The duration of fever was significantly reduced from 4.00 (2.00) days to 2.00 (2.00) days [p < 0.001]. Similarly, the highest temperature in°C was found significantly lower in the last follow-up assessment [median (IQR), 39.00 (1.00)] compared to the period prior to SSK12 start [median (IQR), 40.00 (1.00), p < 0.001]. Steroid load (mg/year) of betamethasone (or any equivalent steroid) significantly decreased between 12 months before treatment with SSK12 [median (IQR), 5.00 (8.00) mg/year] and the last follow-up visit [median (IQR), 2.00 (4.00) mg/year, p < 0.001]. The number of patients experiencing symptoms including pharyngitis/tonsillitis (p < 0.001), oral aphthae (p < 0.001) and cervical lymphadenopathy (p < 0.001) significantly decreased following SSK12.ConclusionSSK12 prophylaxis given for at least 6.00 months was found to reduce febrile flares of PFAPA syndrome: in particular, it halved the total number per year of fever flares, shortened the duration of the single febrile episode, lowered body temperature by 1°C in the febrile flare, provided a steroid-sparing effect, and significantly reduced the accompanying symptoms related to the syndrome.

Published
2023

3. Development and implementation of the AIDA International Registry for patients with Behçet's disease

Author

Vitale, A, Della Casa, F, Ragab, G, Almaghlouth, Ia, Lopalco, G, Pereira, Rm, Guerriero, S, Govoni, M, Sfikakis, Pp, Giacomelli, R, Ciccia, F, Monti, S, Ruscitti, P, Piga, M, Lomater, C, Tufan, A, Opris-Belinski, D, Emmi, G, Hernández-Rodríguez, J, Şahin, A, Sebastiani, Gd, Bartoloni, E, Akkoç, N, Gündüz, Ös, Cattalini, M, Conti, Giorgio, Hatemi, G, Maier, A, Parronchi, P, Del Giudice, E, Erten, S, Insalaco, A, Li Gobbi, F, Maggio, Mc, Shahram, F, Caggiano, V, Hegazy, Mt, Asfina, Kn, Morrone, M, Prado, Ll, Dammacco, R, Ruffilli, F, Arida, A, Navarini, L, Pantano, I, Cavagna, L, Conforti, A, Cauli, A, Marucco, Em, Kucuk, H, Ionescu, R, Mattioli, I, Espinosa, G, Araújo, O, Karkaş, B, Canofari, C, Sota, J, Laymouna, Ah, Bedaiwi, Aa, Colella, S, Giardini, Ham, Albano, V, Lo Monaco, A, Fragoulis, Ge, Kardas, Rc, Berlengiero, V, Hussein, Ma, Ricci, F, La Torre, F, Rigante, Donato, Więsik-Szewczyk, E, Frassi, M, Gentileschi, S, Tosi, Gm, Dagostin, Ma, Mahmoud, Aaa, Tarsia, M, Alessio, G, Cimaz, R, Giani, T, Gaggiano, C, Iannone, F, Cipriani, P, Mourabi, M, Spedicato, V, Barneschi, S, Aragona, E, Balistreri, A, Frediani, B, Fabiani, C, Cantarini, L, Autoinflammatory Diseases Alliance (AIDA) Network, Vitale, Antonio, Della Casa, Francesca, Ragab, Gaafar, Almaghlouth, Ibrahim A, Lopalco, Giuseppe, Pereira, Rosa Maria, Guerriero, Silvana, Govoni, Marcello, Sfikakis, Petros P, Giacomelli, Roberto, Ciccia, Francesco, Monti, Sara, Ruscitti, Piero, Piga, Matteo, Lomater, Claudia, Tufan, Abdurrahman, Opris-Belinski, Daniela, Emmi, Giacomo, Hernández-Rodríguez, José, Şahin, Ali, Sebastiani, Gian Domenico, Bartoloni, Elena, Akkoç, Nurullah, Gündüz, Özgül Soysal, Cattalini, Marco, Conti, Giovanni, Hatemi, Gulen, Maier, Armin, Parronchi, Paola, Del Giudice, Emanuela, Erten, Sukran, Insalaco, Antonella, Li Gobbi, Francesca, Maggio, Maria Cristina, Shahram, Farhad, Caggiano, Valeria, Hegazy, Mohamed Tharwat, Asfina, Kazi Nur, Morrone, Maria, Prado, Leandro L, Dammacco, Rosanna, Ruffilli, Francesca, Arida, Aikaterini, Navarini, Luca, Pantano, Ilenia, Cavagna, Lorenzo, Conforti, Alessandro, Cauli, Alberto, Marucco, Elena Maria, Kucuk, Hamit, Ionescu, Ruxandra, Mattioli, Irene, Espinosa, Gerard, Araújo, Olga, Karkaş, Burak, Canofari, Claudia, Sota, Jurgen, Laymouna, Ahmed Hatem, Bedaiwi, Asma A, Colella, Sergio, Giardini, Henrique Ayres M, Albano, Valeria, Lo Monaco, Andrea, Fragoulis, George E, Kardas, Riza Can, Berlengiero, Virginia, Hussein, Mohamed A, Ricci, Francesca, La Torre, Francesco, Rigante, Donato, Więsik-Szewczyk, Ewa, Frassi, Micol, Gentileschi, Stefano, Tosi, Gian Marco, Dagostin, Marilia Ambiel, Mahmoud, Ayman Abdel-Monem Ahmed, Tarsia, Maria, Alessio, Giovanni, Cimaz, Rolando, Giani, Teresa, Gaggiano, Carla, Iannone, Florenzo, Cipriani, Paola, Mourabi, Mariam, Spedicato, Veronica, Barneschi, Sara, Aragona, Emma, Balistreri, Alberto, Frediani, Bruno, Fabiani, Claudia, and Cantarini, Luca

Subjects
Adult, Registrie, Autoinflammatory disease, Registry, Settore MED/16 - REUMATOLOGIA, precision medicine, behçet’s disease, Settore MED/38 - Pediatria Generale E Specialistica, Retrospective Studie, Internal Medicine, Humans, Prospective Studies, Registries, Child, international registry, Retrospective Studies, Behçet's disease, autoinflammatory diseases, rare diseases, uveitis, Behcet Syndrome, Prospective Studie, Uveiti, Emergency Medicine, Rare disease, Human
Abstract

Purpose of the present paper is to point out the design, development and deployment of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to pediatric and adult patients with Behçet’s disease (BD). The Registry is a clinical physician-driven non-population- and electronic-based instrument implemented for the retrospective and prospective collection of real-life data about demographics, clinical, therapeutic, laboratory, instrumental and socioeconomic information from BD patients; the Registry is based on the Research Electronic Data Capture (REDCap) tool, which is thought to collect standardised information for clinical real-life research, and has been realised to change over time according to future scientific acquisitions and potentially communicate with other existing and future Registries dedicated to BD. Starting from January 31st, 2021, to February 7th, 2022, 110 centres from 23 countries in 4 continents have been involved. Fifty-four of these have already obtained the approval from their local Ethics Committees. Currently, the platform counts 290 users (111 Principal Investigators, 175 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry collects baseline and follow-up data using 5993 fields organised into 16 instruments, including patient’s demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access. The development of the AIDA International Registry for BD patients will facilitate the collection of standardised data leading to real-world evidence, enabling international multicentre collaborative research through data sharing, international consultation, dissemination of knowledge, inclusion of patients and families, and ultimately optimisation of scientific efforts and implementation of standardised care.Trial registration NCT05200715 in 21/01/2022.

Published
2022

4. Development and Implementation of the AIDA International Registry for Patients With VEXAS Syndrome

Author

Antonio Vitale, Valeria Caggiano, Francesca Della Casa, José Hernández-Rodríguez, Micol Frassi, Sara Monti, Abdurrahman Tufan, Salvatore Telesca, Edoardo Conticini, Gaafar Ragab, Giuseppe Lopalco, Ibrahim Almaghlouth, Rosa Maria R. Pereira, Derya Yildirim, Marco Cattalini, Achille Marino, Teresa Giani, Francesco La Torre, Piero Ruscitti, Emma Aragona, Ewa Wiesik-Szewczyk, Emanuela Del Giudice, Petros P. Sfikakis, Marcello Govoni, Giacomo Emmi, Maria Cristina Maggio, Roberto Giacomelli, Francesco Ciccia, Giovanni Conti, Djouher Ait-Idir, Claudia Lomater, Vito Sabato, Matteo Piga, Ali Sahin, Daniela Opris-Belinski, Ruxandra Ionescu, Elena Bartoloni, Franco Franceschini, Paola Parronchi, Amato de Paulis, Gerard Espinosa, Armin Maier, Gian Domenico Sebastiani, Antonella Insalaco, Farhad Shahram, Paolo Sfriso, Francesca Minoia, Maria Alessio, Joanna Makowska, Gülen Hatemi, Nurullah Akkoç, Francesca Li Gobbi, Antonio Gidaro, Alma Nunzia Olivieri, Sulaiman M. Al-Mayouf, Sükran Erten, Stefano Gentileschi, Ibrahim Vasi, Maria Tarsia, Ayman Abdel-Monem Ahmed Mahmoud, Bruno Frediani, Musa Fares Alzahrani, Ahmed Hatem Laymouna, Francesca Ricci, Fabio Cardinale, Karina Jahnz-Rózyk, Gian Marco Tosi, Francesca Crisafulli, Alberto Balistreri, Marília A. Dagostin, Mahmoud Ghanema, Carla Gaggiano, Jurgen Sota, Ilenia Di Cola, Claudia Fabiani, Henrique A. Mayrink Giardini, Alessandra Renieri, Alessandra Fabbiani, Anna Carrer, Monica Bocchia, Federico Caroni, Donato Rigante, Luca Cantarini, Vitale, Antonio, Caggiano, Valeria, Della Casa, Francesca, Hernández-Rodríguez, José, Frassi, Micol, Monti, Sara, Tufan, Abdurrahman, Telesca, Salvatore, Conticini, Edoardo, Ragab, Gaafar, Lopalco, Giuseppe, Almaghlouth, Ibrahim, Pereira, Rosa Maria R, Yildirim, Derya, Cattalini, Marco, Marino, Achille, Giani, Teresa, La Torre, Francesco, Ruscitti, Piero, Aragona, Emma, Wiesik-Szewczyk, Ewa, Del Giudice, Emanuela, Sfikakis, Petros P, Govoni, Marcello, Emmi, Giacomo, Maggio, Maria Cristina, Giacomelli, Roberto, Ciccia, Francesco, Conti, Giovanni, Ait-Idir, Djouher, Lomater, Claudia, Sabato, Vito, Piga, Matteo, Sahin, Ali, Opris-Belinski, Daniela, Ionescu, Ruxandra, Bartoloni, Elena, Franceschini, Franco, Parronchi, Paola, de Paulis, Amato, Espinosa, Gerard, Maier, Armin, Sebastiani, Gian Domenico, Insalaco, Antonella, Shahram, Farhad, Sfriso, Paolo, Minoia, Francesca, Alessio, Maria, Makowska, Joanna, Hatemi, Gülen, Akkoç, Nurullah, Li Gobbi, Francesca, Gidaro, Antonio, Olivieri, Alma Nunzia, Al-Mayouf, Sulaiman M, Erten, Sükran, Gentileschi, Stefano, Vasi, Ibrahim, Tarsia, Maria, Mahmoud, Ayman Abdel-Monem Ahmed, Frediani, Bruno, Fares Alzahrani, Musa, Laymouna, Ahmed Hatem, Ricci, Francesca, Cardinale, Fabio, Jahnz-Rózyk, Karina, Tosi, Gian Marco, Crisafulli, Francesca, Balistreri, Alberto, Dagostin, Marília A, Ghanema, Mahmoud, Gaggiano, Carla, Sota, Jurgen, Di Cola, Ilenia, Fabiani, Claudia, Giardini, Henrique A Mayrink, Renieri, Alessandra, Fabbiani, Alessandra, Carrer, Anna, Bocchia, Monica, Caroni, Federico, Rigante, Donato, Cantarini, Luca, Vitale, A, Caggiano, V, Della Casa, F, Hernández-Rodríguez, J, Frassi, M, Monti, S, Tufan, A, Telesca, S, Conticini, E, Ragab, G, Lopalco, G, Almaghlouth, I, Pereira, Rmr, Yildirim, D, Cattalini, M, Marino, A, Giani, T, La Torre, F, Ruscitti, P, Aragona, E, Wiesik-Szewczyk, E, Del Giudice, E, Sfikakis, Pp, Govoni, M, Emmi, G, Maggio, Mc, Giacomelli, R, Ciccia, F, Conti, G, Ait-Idir, D, Lomater, C, Sabato, V, Piga, M, Sahin, A, Opris-Belinski, D, Ionescu, R, Bartoloni, E, Franceschini, F, Parronchi, P, de Paulis, A, Espinosa, G, Maier, A, Sebastiani, Gd, Insalaco, A, Shahram, F, Sfriso, P, Minoia, F, Alessio, M, Makowska, J, Hatemi, G, Akkoç, N, Li Gobbi, F, Gidaro, A, Olivieri, An, Al-Mayouf, Sm, Erten, S, Gentileschi, S, Vasi, I, Tarsia, M, Mahmoud, Aaa, Frediani, B, Fares Alzahrani, M, Laymouna, Ah, Ricci, F, Cardinale, F, Jahnz-Rózyk, K, Tosi, Gm, Crisafulli, F, Balistreri, A, Dagostin, Ma, Ghanema, M, Gaggiano, C, Sota, J, Di Cola, I, Fabiani, C, Giardini, Ham, Renieri, A, Fabbiani, A, Carrer, A, Bocchia, M, Caroni, F, Rigante, D, and Cantarini, L.

Subjects
Registry, Keywords: autoinflammatory diseases, clinical management, precision medicine, rare diseases, research, treatment, Settore MED/16 - REUMATOLOGIA, rare disease, General Medicine, autoinflammatory diseases, Settore MED/38 - Pediatria Generale E Specialistica, autoinflammatory disease, VEXAS syndrome, Human medicine
Abstract

ObjectiveThe aim of this paper is to present the AutoInflammatory Disease Alliance (AIDA) international Registry dedicated to Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome, describing its design, construction, and modalities of dissemination.MethodsThis Registry is a clinical, physician-driven, population- and electronic-based instrument designed for the retrospective and prospective collection of real-life data. Data gathering is based on the Research Electronic Data Capture (REDCap) tool and is intended to obtain real-world evidence for daily patients' management. The Registry may potentially communicate with other on-line tools dedicated to VEXAS syndrome, thus enhancing international collaboration and data sharing for research purposes. The Registry is practical enough to be easily modified to meet future needs regarding VEXAS syndrome.ResultsTo date (April 22nd, 2022), 113 Centers from 23 Countries in 4 continents have been involved; 324 users (114 Principal Investigators, 205 Site Investigators, 2 Lead Investigators, and 3 data managers) are currently able to access the registry for data entry (or data sharing) and collection. The Registry includes 4,952 fields organized into 18 instruments designed to fully describe patient's details about demographics, clinical manifestations, symptoms, histologic details about skin and bone marrow biopsies and aspirate, laboratory features, complications, comorbidities, therapies, and healthcare access.ConclusionThis international Registry for patients with VEXAS syndrome will allow the achievement of a comprehensive knowledge about this new disease, with the final goal to obtain real-world evidence for daily clinical practice, especially in relation to the comprehension of this disease about the natural history and the possible therapeutic approaches. This Project can be found on https://clinicaltrials.gov NCT05200715.

Published
2022

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