The Autoinflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases

Carla Gaggiano¹, Antonio Vitale¹, Abdurrahman Tufan², Gaafar Ragab^{3

4}, Emma Aragona⁵, Ewa Wiesik-Szewczyk⁶, Djouher Ait-Idir⁷, Giovanni Conti⁸, Ludovica Iezzi⁹, Maria Cristina Maggio¹⁰, Marco Cattalini¹¹, Francesco La Torre¹², Giuseppe Lopalco¹³, Elena Verrecchia^{14

15}, Amato de Paulis^{16

17}, Ali Sahin¹⁸, Antonella Insalaco¹⁹, Petros P Sfikakis²⁰, Achille Marino²¹, Micol Frassi²², Benson Ogunjimi^{23

24

25

26}, Daniela Opris-Belinski²⁷, Paola Parronchi²⁸, Giacomo Emmi²⁸, Farhad Shahram²⁹, Francesco Ciccia³⁰, Matteo Piga³¹, José Hernández-Rodríguez³², Rosa Maria R Pereira³³, Maria Alessio³⁴, Roberta Naddei³⁴, Alma Nunzia Olivieri³⁵, Emanuela Del Giudice³⁶, Paolo Sfriso³⁷, Piero Ruscitti³⁸, Francesca Li Gobbi³⁹, Hamit Kucuk², Jurgen Sota¹, Mohamed A Hussein³, Giuseppe Malizia⁵, Karina Jahnz-Różyk⁶, Rawda Sari-Hamidou⁴⁰, Mery Romeo⁸, Francesca Ricci¹¹, Fabio Cardinale¹², Florenzo Iannone¹³, Francesca Della Casa¹⁶, Marco Francesco Natale¹⁹, Katerina Laskari²⁰, Teresa Giani²¹, Franco Franceschini²², Vito Sabato⁴¹, Derya Yildirim², Valeria Caggiano¹, Mohamed Tharwat Hegazy^{3

4}, Rosalba Di Marzo⁴², Aleksandra Kucharczyk⁶, Ghalia Khellaf⁴³, Maria Tarsia¹, Ibrahim A Almaghlouth^{44

45}, Ahmed Hatem Laymouna³, Violetta Mastrorilli¹², Laura Dotta¹¹, Luca Benacquista⁹, Salvatore Grosso⁴⁶, Francesca Crisafulli²², Veronica Parretti¹, Heitor F Giordano³³, Ayman Abdel-Monem Ahmed Mahmoud³, Rossana Nuzzolese¹, Marta De Musso¹, Cecilia Beatrice Chighizola^{47

48}, Stefano Gentileschi⁴⁹, Mirella Morrone¹³, Ilenia Di Cola³⁸, Veronica Spedicato¹³, Henrique A Mayrink Giardini³³, Ibrahim Vasi², Alessandra Renieri^{50

51

52}, Alessandra Fabbiani^{50

51

52}, Maria Antonietta Mencarelli⁵², Bruno Frediani⁴⁹, Alberto Balistreri⁵³, Gian Marco Tosi⁵⁴, Claudia Fabiani⁵⁴, Merav Lidar^{55

56

57}, Donato Rigante^{9

14}, Luca Cantarini¹

Affiliations

¹ Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
² Division of Rheumatology, Department of Internal Medicine, Gazi University Faculty of Medicine, Ankara, Turkey.
³ Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt.
⁴ Faculty of Medicine, Newgiza University, 6th of October City, Egypt.
⁵ Division of Gastroenterology, Ospedali Riuniti Villa Sofia-Vincenzo Cervello, Palermo, Italy.
⁶ Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland.
⁷ Research Laboratory, Biodiversity, Biotechnology, Environment and Sustainable Development, Department of Biology, Faculty of Sciences, M'Hamed Bougara University, Boumerdes, Algeria.
⁸ Pediatric Nephrology and Rheumatology Unit, Azienda Ospedaliero Universitaria (AOU) G Martino, Messina, Italy.
⁹ Department of Life Sciences and Global Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
¹⁰ University Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE) "G. D'Alessandro", University of Palermo, Palermo, Italy.
¹¹ Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy.
¹² Department of Pediatrics, Pediatric Rheumatology Center, Giovanni XXIII Pediatric Hospital, University of Bari, Bari, Italy.
¹³ Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
¹⁴ Rare Diseases and Periodic Fevers Research Centre, Università Cattolica del Sacro Cuore, Rome, Italy.
¹⁵ Department of Aging, Neurological, Orthopedic and Head and Neck Sciences, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
¹⁶ Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy.
¹⁷ Center for Basic and Clinical Immunology Research (CISI), World Allergy Organization (WAO) Center of Excellence, University of Naples Federico II, Naples, Italy.
¹⁸ Division of Rheumatology, Department of Internal Medicine, Medical Faculty, Sivas Cumhuriyet University, Sivas, Turkey.
¹⁹ Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, IRCCS [European Reference Network (ERN) for Rare Immunodeficiency, Autoinflammatory and Autoimmune Diseases (RITA) Center], Rome, Italy.
²⁰ Joint Academic Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
²¹ Unit of Pediatric Rheumatology, Azienda Socio-Sanitaria Territoriale (ASST) Gaetano Pini-Centro Specialistico Ortopedico Traumatologico (CTO), Milan, Italy.
²² Rheumatology and Clinical Immunology, Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
²³ Departement of Pediatrics, Antwerp University Hospital, Edegem, Belgium.
²⁴ Center for Health Economics Research and Modeling Infectious Diseases, Vaccine and Infectious Diseases Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.
²⁵ Department of Rheumatology, Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium.
²⁶ KidZ Health Castle, Universitair Ziekenhuis Brussel, Jette, Belgium.
²⁷ Rheumatology and Internal Medicine Department, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
²⁸ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
²⁹ Behcet's Disease Unit, Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
³⁰ Department of Precision Medicine, Università Degli Studi Della Campania Luigi Vanvitelli, Naples, Italy.
³¹ Rheumatology Unit, Department of Medical Sciences, University and AOU of Cagliari, Cagliari, Italy.
³² Vasculitis Research Unit, Autoinflammatory Diseases Clinical Unit, Department of Autoimmune Diseases, Hospital Clinic of Barcelona, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), University of Barcelona, Barcelona, Spain.
³³ Rheumatology Division, Faculdade de Medicina, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Universidade de São Paulo, São Paulo, Brazil.
³⁴ Pediatric Rheumatology Unit, Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy.
³⁵ Department of Woman, Child and of General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.
³⁶ Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Rome, Italy.
³⁷ Rheumatology Unit, Department of Medicine (DIMED), University of Padova, Padova, Italy.
³⁸ Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
³⁹ Rheumatology Unit, San Giovanni di Dio Hospital, Firenze, Italy.
⁴⁰ Research Laboratory Toxicomed, Faculty of Medicine, Abou Bekr Belkaid University, Tlemcen, Algeria.
⁴¹ Department of Immunology, Allergology, Rheumatology, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium.
⁴² Division of Ematology II, Ospedali Riuniti Villa Sofia-Vincenzo Cervello, Palermo, Italy.
⁴³ Faculté de Médecine, Service de Néphrologie, Centre Hospitalo-Universitaire Lamine Debaghine, Université Alger 1 Benyoucef Benkhedda, Alger, Algeria.
⁴⁴ Rheumatology Unit, Department of Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
⁴⁵ College of Medicine Research Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
⁴⁶ Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy.
⁴⁷ Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy.
⁴⁸ Pediatric Rheumatology Unit, Azienda Socio-Sanitaria Territoriale (ASST) Gaetano Pini Centro Specialistico Ortopedico Traumatologico (CTO), Milan, Italy.
⁴⁹ Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
⁵⁰ Medical Genetics, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
⁵¹ Department of Medical Biotechnologies, Med Biotech Hub and Competence Center, University of Siena, Siena, Italy.
⁵² Genetica Medica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
⁵³ Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
⁵⁴ Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
⁵⁵ Familial Mediterranean Fever (FMF) Clinic, The Chaim Sheba Medical Center, Ramat-Gan, Israel.
⁵⁶ Rheumatology Unit, The Chaim Sheba Medical Center, Ramat-Gan, Israel.
⁵⁷ The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

PMID: 36160138
PMCID: PMC9500177
DOI: 10.3389/fmed.2022.980679

The Autoinflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases

Carla Gaggiano et al. Front Med (Lausanne). 2022.

. 2022 Sep 9:9:980679.

doi: 10.3389/fmed.2022.980679. eCollection 2022.

Authors

Affiliations

¹ Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
² Division of Rheumatology, Department of Internal Medicine, Gazi University Faculty of Medicine, Ankara, Turkey.
³ Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt.
⁴ Faculty of Medicine, Newgiza University, 6th of October City, Egypt.
⁵ Division of Gastroenterology, Ospedali Riuniti Villa Sofia-Vincenzo Cervello, Palermo, Italy.
⁶ Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland.
⁷ Research Laboratory, Biodiversity, Biotechnology, Environment and Sustainable Development, Department of Biology, Faculty of Sciences, M'Hamed Bougara University, Boumerdes, Algeria.
⁸ Pediatric Nephrology and Rheumatology Unit, Azienda Ospedaliero Universitaria (AOU) G Martino, Messina, Italy.
⁹ Department of Life Sciences and Global Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
¹⁰ University Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE) "G. D'Alessandro", University of Palermo, Palermo, Italy.
¹¹ Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy.
¹² Department of Pediatrics, Pediatric Rheumatology Center, Giovanni XXIII Pediatric Hospital, University of Bari, Bari, Italy.
¹³ Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
¹⁴ Rare Diseases and Periodic Fevers Research Centre, Università Cattolica del Sacro Cuore, Rome, Italy.
¹⁵ Department of Aging, Neurological, Orthopedic and Head and Neck Sciences, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
¹⁶ Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy.
¹⁷ Center for Basic and Clinical Immunology Research (CISI), World Allergy Organization (WAO) Center of Excellence, University of Naples Federico II, Naples, Italy.
¹⁸ Division of Rheumatology, Department of Internal Medicine, Medical Faculty, Sivas Cumhuriyet University, Sivas, Turkey.
¹⁹ Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, IRCCS [European Reference Network (ERN) for Rare Immunodeficiency, Autoinflammatory and Autoimmune Diseases (RITA) Center], Rome, Italy.
²⁰ Joint Academic Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
²¹ Unit of Pediatric Rheumatology, Azienda Socio-Sanitaria Territoriale (ASST) Gaetano Pini-Centro Specialistico Ortopedico Traumatologico (CTO), Milan, Italy.
²² Rheumatology and Clinical Immunology, Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
²³ Departement of Pediatrics, Antwerp University Hospital, Edegem, Belgium.
²⁴ Center for Health Economics Research and Modeling Infectious Diseases, Vaccine and Infectious Diseases Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.
²⁵ Department of Rheumatology, Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium.
²⁶ KidZ Health Castle, Universitair Ziekenhuis Brussel, Jette, Belgium.
²⁷ Rheumatology and Internal Medicine Department, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
²⁸ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
²⁹ Behcet's Disease Unit, Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
³⁰ Department of Precision Medicine, Università Degli Studi Della Campania Luigi Vanvitelli, Naples, Italy.
³¹ Rheumatology Unit, Department of Medical Sciences, University and AOU of Cagliari, Cagliari, Italy.
³² Vasculitis Research Unit, Autoinflammatory Diseases Clinical Unit, Department of Autoimmune Diseases, Hospital Clinic of Barcelona, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), University of Barcelona, Barcelona, Spain.
³³ Rheumatology Division, Faculdade de Medicina, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Universidade de São Paulo, São Paulo, Brazil.
³⁴ Pediatric Rheumatology Unit, Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy.
³⁵ Department of Woman, Child and of General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.
³⁶ Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Rome, Italy.
³⁷ Rheumatology Unit, Department of Medicine (DIMED), University of Padova, Padova, Italy.
³⁸ Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
³⁹ Rheumatology Unit, San Giovanni di Dio Hospital, Firenze, Italy.
⁴⁰ Research Laboratory Toxicomed, Faculty of Medicine, Abou Bekr Belkaid University, Tlemcen, Algeria.
⁴¹ Department of Immunology, Allergology, Rheumatology, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium.
⁴² Division of Ematology II, Ospedali Riuniti Villa Sofia-Vincenzo Cervello, Palermo, Italy.
⁴³ Faculté de Médecine, Service de Néphrologie, Centre Hospitalo-Universitaire Lamine Debaghine, Université Alger 1 Benyoucef Benkhedda, Alger, Algeria.
⁴⁴ Rheumatology Unit, Department of Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
⁴⁵ College of Medicine Research Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
⁴⁶ Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy.
⁴⁷ Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy.
⁴⁸ Pediatric Rheumatology Unit, Azienda Socio-Sanitaria Territoriale (ASST) Gaetano Pini Centro Specialistico Ortopedico Traumatologico (CTO), Milan, Italy.
⁴⁹ Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
⁵⁰ Medical Genetics, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
⁵¹ Department of Medical Biotechnologies, Med Biotech Hub and Competence Center, University of Siena, Siena, Italy.
⁵² Genetica Medica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
⁵³ Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
⁵⁴ Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
⁵⁵ Familial Mediterranean Fever (FMF) Clinic, The Chaim Sheba Medical Center, Ramat-Gan, Israel.
⁵⁶ Rheumatology Unit, The Chaim Sheba Medical Center, Ramat-Gan, Israel.
⁵⁷ The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

PMID: 36160138
PMCID: PMC9500177
DOI: 10.3389/fmed.2022.980679

Abstract

Objective: The present manuscript aims to describe an international, electronic-based, user-friendly and interoperable patient registry for monogenic autoinflammatory diseases (mAIDs), developed in the contest of the Autoinflammatory Diseases Alliance (AIDA) Network.

Methods: This is an electronic platform, based on the Research Electronic Data Capture (REDCap) tool, used for real-world data collection of demographics, clinical, laboratory, instrumental and socioeconomic data of mAIDs patients. The instrument has flexibility, may change over time based on new scientific acquisitions, and communicate potentially with other similar registries; security, data quality and data governance are corner stones of the platform.

Results: AIDA project will share knowledge and expertise on mAIDs. Since its start, 118 centers from 24 countries and 4 continents have joined the AIDA project. Fifty-nine centers have already obtained the approval from their local Ethics Committees. Currently, the platform counts 337 users (122 Principal Investigators, 210 Site Investigators, 2 Lead Investigators, and 3 data managers). The Registry collects baseline and follow-up data using 3,748 fields organized into 21 instruments, which include demographics, patient history, symptoms, trigger/risk factors, therapies, and healthcare information for mAIDs patients.

Conclusions: The AIDA mAIDs Registry, acts both as a research tool for future collaborative real-life studies on mAIDs and as a service to connect all the figures called to participate. On this basis, the registry is expected to play a pivotal role in generating new scientific evidence on this group of rare diseases, substantially improving the management of patients, and optimizing the impact on the healthcare system. NCT05200715 available at https://clinicaltrials.gov.

Keywords: autoinflammatory diseases; international registry; personalized medicine; precision medicine; rare diseases.

Copyright © 2022 Gaggiano, Vitale, Tufan, Ragab, Aragona, Wiesik-Szewczyk, Ait-Idir, Conti, Iezzi, Maggio, Cattalini, Torre, Lopalco, Verrecchia, Paulis, Sahin, Insalaco, Sfikakis, Marino, Frassi, Ogunjimi, Opris-Belinski, Parronchi, Emmi, Shahram, Ciccia, Piga, Hernández-Rodríguez, Pereira, Alessio, Naddei, Olivieri, Giudice, Sfriso, Ruscitti, Gobbi, Kucuk, Sota, Hussein, Malizia, Jahnz-Różyk, Sari-Hamidou, Romeo, Ricci, Cardinale, Iannone, Casa, Natale, Laskari, Giani, Franceschini, Sabato, Yildirim, Caggiano, Hegazy, Marzo, Kucharczyk, Khellaf, Tarsia, Almaghlouth, Laymouna, Mastrorilli, Dotta, Benacquista, Grosso, Crisafulli, Parretti, Giordano, Mahmoud, Nuzzolese, Musso, Chighizola, Gentileschi, Morrone, Cola, Spedicato, Giardini, Vasi, Renieri, Fabbiani, Mencarelli, Frediani, Balistreri, Tosi, Fabiani, Lidar, Rigante and Cantarini.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

**Figure 1**
Current geographical coverage of the Autoinflammatory Diseases Alliance (AIDA) Registry of Monogenic Autoinflammatory Diseases. Countries highlighted in violet are those with at least one AIDA partner center (updated to June 20th, 2022).

See this image and copyright information in PMC

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The Autoinflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases

Affiliations

The Autoinflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical