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1. The diagnostic role of pathergy test in patients with Behçet's disease from the Western Europe

Author

Vitale Antonio, Virginia Berlengiero, Valeria Caggiano, Sara Barneschi, Mariam Mourabi, Jurgen Sota, Stefano Gentileschi, Maria Cristina Maggio, Carla Gaggiano, Maria Tarsia, Gian Marco Tosi, Giuseppe Lopalco, Claudia Fabiani, Bruno Frediani, Luca Cantarini, Antonio, Vitale, Berlengiero, Virginia, Caggiano, Valeria, Barneschi, Sara, Mourabi, Mariam, Sota, Jurgen, Gentileschi, Stefano, Maggio, Maria Cristina, Gaggiano, Carla, Tarsia, Maria, Tosi, Gian Marco, Lopalco, Giuseppe, Fabiani, Claudia, Frediani, Bruno, and Cantarini, Luca

Subjects
Autoinflammatory diseases, Diagnosis, Diagnostic accuracy, Diagnostic test, Geographical differences, Management, Settore MED/38 - Pediatria Generale E Specialistica, Emergency Medicine, Internal Medicine
Abstract

The aim of the study is to evaluate the frequency and features of positive pathergy test (PPT) in Italy, its role in the diagnosis of Behçet's disease (BD), and any association with other BD-related manifestations. 52 BD patients, 52 patients with axial spondyloarthritis (ax-SpA), and 26 healthy controls (HCs) underwent intradermal injection of normal saline and intradermal needle soaked with fresh self-saliva. The results of pathergy tests were statistically analysed in the light of demographic, clinical, and therapeutic features of subjects enrolled. Pathergy test performed with saline resulted always negative in all groups. Skin prick test using self-saliva resulted in the occurrence of a papule in 3 (5.8%) BD patients and in 1 (1.9%) patient with ax-SpA. A ≥ 15mm erythematous area surrounding the needle prick site was observed in 22 (42.3%) BD patients, 5 (9.6%) patients with ax-SpA, and 2 (7.7%) HCs (p = 0.00002). The frequency of skin erythema was significantly more frequent in patients with BD than those with ax-SpA (p

Published
2022

2. 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

3. Development and Implementation of the AIDA International Registry for Patients With Undifferentiated Systemic AutoInflammatory Diseases

Author

Francesca Della Casa, Antonio Vitale, Giuseppe Lopalco, Piero Ruscitti, Francesco Ciccia, Giacomo Emmi, Marco Cattalini, Ewa Wiesik-Szewczyk, Maria Cristina Maggio, Benson Ogunjimi, Petros P. Sfikakis, Abdurrahman Tufan, Sulaiman M. Al-Mayouf, Emanuela Del Giudice, Emma Aragona, Francesco La Torre, Jurgen Sota, Sergio Colella, Ilenia Di Cola, Daniela Iacono, Irene Mattioli, Karina Jahnz-Rózyk, Rik Joos, Katerina Laskari, Carla Gaggiano, Anna Abbruzzese, Paola Cipriani, Gelsomina Rozza, Alhanouf AlSaleem, Derya Yildirim, Maria Tarsia, Gaafar Ragab, Francesca Ricci, Fabio Cardinale, Marcelina Korzeniowska, Micol Frassi, Valeria Caggiano, Moustafa Ali Saad, Rosa Maria Pereira, Virginia Berlengiero, Stefano Gentileschi, Silvana Guerriero, Teresa Giani, Viviana Gelardi, Florenzo Iannone, Henrique Ayres Mayrink Giardini, Ibrahim A. Almaghlouth, Riza Can Kardas, Djouher Ait-Idir, Bruno Frediani, Alberto Balistreri, Claudia Fabiani, Donato Rigante, Luca Cantarini, Della Casa, Francesca, Vitale, Antonio, Lopalco, Giuseppe, Ruscitti, Piero, Ciccia, Francesco, Emmi, Giacomo, Cattalini, Marco, Wiesik-Szewczyk, Ewa, Maggio, Maria Cristina, Ogunjimi, Benson, Sfikakis, Petros P, Tufan, Abdurrahman, Al-Mayouf, Sulaiman M, Del Giudice, Emanuela, Aragona, Emma, La Torre, Francesco, Sota, Jurgen, Colella, Sergio, Di Cola, Ilenia, Iacono, Daniela, Mattioli, Irene, Jahnz-Rózyk, Karina, Joos, Rik, Laskari, Katerina, Gaggiano, Carla, Abbruzzese, Anna, Cipriani, Paola, Rozza, Gelsomina, Alsaleem, Alhanouf, Yildirim, Derya, Tarsia, Maria, Ragab, Gaafar, Ricci, Francesca, Cardinale, Fabio, Korzeniowska, Marcelina, Frassi, Micol, Caggiano, Valeria, Saad, Moustafa Ali, Pereira, Rosa Maria, Berlengiero, Virginia, Gentileschi, Stefano, Guerriero, Silvana, Giani, Teresa, Gelardi, Viviana, Iannone, Florenzo, Giardini, Henrique Ayres Mayrink, Almaghlouth, Ibrahim A, Kardas, Riza Can, Ait-Idir, Djouher, Frediani, Bruno, Balistreri, Alberto, Fabiani, Claudia, Rigante, Donato, Cantarini, Luca, and AlSaleem, Alhanouf

Subjects
Registry, Settore MED/16 - REUMATOLOGIA, precision medicine, rare diseases, General Medicine, personalized medicine, autoinflammatory diseases, International Registry, Settore MED/38 - Pediatria Generale E Specialistica, autoinflammatory disease, Autoinflammation, Human medicine
Abstract

ObjectiveThis paper points out the design, development and deployment of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to pediatric and adult patients affected by Undifferentiated Systemic AutoInflammatory Diseases (USAIDs).MethodsThis is an electronic registry employed for real-world data collection about demographics, clinical, laboratory, instrumental and socioeconomic data of USAIDs patients. Data recruitment, based on the Research Electronic Data Capture (REDCap) tool, is designed to obtain standardized information for real-life research. The instrument is endowed with flexibility, and it could change over time according to the scientific acquisitions and potentially communicate with other similar tools; this platform ensures security, data quality and data governance.ResultsThe focus of the AIDA project is connecting physicians and researchers from all over the world to shed a new light on heterogeneous rare diseases. Since its birth, 110 centers from 23 countries and 4 continents have joined the AIDA project. Fifty-four centers have already obtained the approval from their local Ethics Committees. Currently, the platform counts 290 users (111 Principal Investigators, 179 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry is collecting baseline and follow-up data using 3,769 fields organized into 23 instruments, which include demographics, history, symptoms, trigger/risk factors, therapies, and healthcare information access for USAIDs patients.ConclusionsThe development of the AIDA International Registry for USAIDs patients will facilitate the online collection of real standardized data, connecting a worldwide group of researchers: the Registry constitutes an international multicentre observational groundwork aimed at increasing the patient cohort of USAIDs in order to improve our knowledge of this peculiar cluster of autoinflammatory diseases. NCT 05200715 available at https://clinicaltrials.gov/.

Published
2022

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