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1. The administration of methotrexate in patients with Still’s disease, “real-life” findings from AIDA Network Still Disease Registry

Author

362., Ruscitti P, Sota, J, Vitale, A, Lopalco, G, Iannone, F, Morrone, M, Giardini, Ham, D'Agostin, Ma, Antonelli, Ipb, Almaghlouth, I, Asfina, Kn, Khalil, N, Sfikakis, Pp, Laskari, K, Tektonidou, M, Ciccia, F, Iacono, D, Riccio, F, Ragab, G, Hussein, Ma, Govoni, M, Ruffilli, F, Direskeneli, H, Alibaz-Oner, F, Giacomelli, R, Navarini, L, Bartoloni, E, Riccucci, I, Martín-Nares, E, Torres-Ruiz, J, Cipriani, P, Di Cola, I, Hernández-Rodríguez, J, Gómez-Caverzaschi, V, Dagna, L, Tomelleri, A, Makowska, J, Brzezinska, O, Iagnocco, A, Bellis, E, Caggiano, V, Gaggiano, C, Tarsia, M, Mormile, I, Emmi, G, Sfriso, P, Monti, S, Erten, Ş, Del Giudice, E, Lubrano, R, Conti, G, Olivieri, An, Lo Gullo, A, Tharwat, S, Karamanakos, A, Gidaro, A, Maggio, Mc, La Torre, F, Cardinale, F, Ogunjimi, B, Maier, A, Sebastiani, Gd, Opris-Belinski, D, Frassi, M, Viapiana, O, Bizzi, E, Carubbi, F, Fotis, L, Tufan, A, Kardas, Rc, Więsik-Szewczyk, E, Jahnz-Różyk, K, Fabiani, C, Frediani, B, Balistreri, A, Rigante, Donato, Cantarini, L, 362. Ruscitti P, Sota J, Vitale A, Lopalco G, Iannone F, Morrone M, Giardini HAM, D'Agostin MA, Antonelli IPB, Almaghlouth I, Asfina KN, Khalil N, Sfikakis PP, Laskari K, Tektonidou M, Ciccia F, Iacono D, Riccio F, Ragab G, Hussein MA, Govoni M, Ruffilli F, Direskeneli H, Alibaz-Oner F, Giacomelli R, Navarini L, Bartoloni E, Riccucci I, Martín-Nares E, Torres-Ruiz J, Cipriani P, Di Cola I, Hernández-Rodríguez J, Gómez-Caverzaschi V, Dagna L, Tomelleri A, Makowska J, Brzezinska O, Iagnocco A, Bellis E, Caggiano V, Gaggiano C, Tarsia M, Mormile I, Emmi G, Sfriso P, Monti S, Erten Ş, Del Giudice E, Lubrano R, Conti G, Olivieri AN, Lo Gullo A, Tharwat S, Karamanakos A, Gidaro A, Maggio MC, La Torre F, Cardinale F, Ogunjimi B, Maier A, Sebastiani GD, Opris-Belinski D, Frassi M, Viapiana O, Bizzi E, Carubbi F, Fotis L, Tufan A, Kardas RC, Więsik-Szewczyk E, Jahnz-Różyk K, Fabiani C, Frediani B, Balistreri A, Rigante D (ORCID:0000-0001-7032-7779), Cantarini L, 362., Ruscitti P, Sota, J, Vitale, A, Lopalco, G, Iannone, F, Morrone, M, Giardini, Ham, D'Agostin, Ma, Antonelli, Ipb, Almaghlouth, I, Asfina, Kn, Khalil, N, Sfikakis, Pp, Laskari, K, Tektonidou, M, Ciccia, F, Iacono, D, Riccio, F, Ragab, G, Hussein, Ma, Govoni, M, Ruffilli, F, Direskeneli, H, Alibaz-Oner, F, Giacomelli, R, Navarini, L, Bartoloni, E, Riccucci, I, Martín-Nares, E, Torres-Ruiz, J, Cipriani, P, Di Cola, I, Hernández-Rodríguez, J, Gómez-Caverzaschi, V, Dagna, L, Tomelleri, A, Makowska, J, Brzezinska, O, Iagnocco, A, Bellis, E, Caggiano, V, Gaggiano, C, Tarsia, M, Mormile, I, Emmi, G, Sfriso, P, Monti, S, Erten, Ş, Del Giudice, E, Lubrano, R, Conti, G, Olivieri, An, Lo Gullo, A, Tharwat, S, Karamanakos, A, Gidaro, A, Maggio, Mc, La Torre, F, Cardinale, F, Ogunjimi, B, Maier, A, Sebastiani, Gd, Opris-Belinski, D, Frassi, M, Viapiana, O, Bizzi, E, Carubbi, F, Fotis, L, Tufan, A, Kardas, Rc, Więsik-Szewczyk, E, Jahnz-Różyk, K, Fabiani, C, Frediani, B, Balistreri, A, Rigante, Donato, Cantarini, L, 362. Ruscitti P, Sota J, Vitale A, Lopalco G, Iannone F, Morrone M, Giardini HAM, D'Agostin MA, Antonelli IPB, Almaghlouth I, Asfina KN, Khalil N, Sfikakis PP, Laskari K, Tektonidou M, Ciccia F, Iacono D, Riccio F, Ragab G, Hussein MA, Govoni M, Ruffilli F, Direskeneli H, Alibaz-Oner F, Giacomelli R, Navarini L, Bartoloni E, Riccucci I, Martín-Nares E, Torres-Ruiz J, Cipriani P, Di Cola I, Hernández-Rodríguez J, Gómez-Caverzaschi V, Dagna L, Tomelleri A, Makowska J, Brzezinska O, Iagnocco A, Bellis E, Caggiano V, Gaggiano C, Tarsia M, Mormile I, Emmi G, Sfriso P, Monti S, Erten Ş, Del Giudice E, Lubrano R, Conti G, Olivieri AN, Lo Gullo A, Tharwat S, Karamanakos A, Gidaro A, Maggio MC, La Torre F, Cardinale F, Ogunjimi B, Maier A, Sebastiani GD, Opris-Belinski D, Frassi M, Viapiana O, Bizzi E, Carubbi F, Fotis L, Tufan A, Kardas RC, Więsik-Szewczyk E, Jahnz-Różyk K, Fabiani C, Frediani B, Balistreri A, Rigante D (ORCID:0000-0001-7032-7779), and Cantarini L

Abstract

Objectives: To describe clinical characteristics of patients with Still's disease treated with methotrexate (MTX) and to assess drug effectiveness evaluating change in disease activity, reduction of inflammatory markers, and glucocorticoid (GC)-sparing effect. Methods: Patients with Still's disease treated with MTX were assessed among those included in AIDA Network Still Disease Registry. Results: In this registry, 171 patients with Still's disease were treated with MTX (males 43.3%, age 37.1 ± 16.0 years). They were mainly characterised by joint features and fever without a prominent multiorgan involvement. MTX was administered with GCs in 68.4% of patients, with other conventional synthetic DMARDs in 6.4%, and with biologic DMARDs in 25.1%. A significant reduction of the modified systemic score was observed, and 38.6% patients were codified as being in clinical remission at the end of follow-up. The concomitant administration of a biologic DMARD resulted a predictor of the clinical remission. Furthermore, a reduction of inflammatory markers and ferritin levels was observed following the administration of MTX. Additionally, a marked reduction of the dosage of concomitant GCs was identified, while 36.7% discontinued such drugs. Male gender appeared as a predictor of GC discontinuation. MTX was discontinued in 12.3% of patients because of adverse effects, and in 12.3% for lack of efficacy. Conclusions: Clinical characteristics of patients with Still's disease treated with MTX were described, mainly joint features and fever without a prominent multiorgan involvement. The clinical usefulness of MTX was reported in reducing the disease activity, decreasing the inflammatory markers, and as GC-sparing agent.

Published
2023

2. The AutoInflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases

Author

Gaggiano, C, Vitale, A, Tufan, A, Ragab, G, Aragona, E, Wiesik-Szewczyk, E, Ait-Idir, D, Conti, G, Iezzi, L, Maggio, Mc, Cattalini, M, La Torre, F, Lopalco, G, Verrecchia, E, de Paulis, A, Sahin, A, Insalaco, A, Sfikakis, Pp, Marino, A, Frassi, M, Ogunjimi, B, Opris-Belinski, D, Parronchi, P, Emmi, G, Shahram, F, Ciccia, F, Piga, M, Hernández-Rodríguez, J, Pereira, Rmr, Alessio, M, Naddei, R, Olivieri, An, Giudice, Ed, Sfriso, P, Ruscitti, P, Gobbi, Fl, Kucuk, H, Sota, J, Hussein, Ma, Malizia, G, Jahnz-Różyk, K, Sari-Hamidou, R, Romeo, M, Ricci, F, Cardinale, F, Iannone, F, Casa, Fd, Natale, Mf, Laskari, K, Giani, T, Franceschini, F, Sabato, V, Yildirim, D, Caggiano, V, Hegazy, Mt, Marzo, Rd, Kucharczyk, A, Khellaf, G, Tarsia, M, Almaghlouth, Ia, Laymouna, Ah, Mastrorilli, V, Dotta, L, Benacquista, L, Grosso, S, Crisafulli, F, Parretti, V, Giordano, Hf, Mahmoud, Aaa, Nuzzolese, R, Musso, M, Chighizola, Cb, Gentileschi, S, Morrone, M, Cola, Id, Spedicato, V, Giardini, Ham, Vasi, I, Renieri, A, Fabbiani, A, Mencarelli, Ma, Frediani, B, Balistreri, A, Tosi, Gm, Fabiani, C, Lidar, M, Rigante, D, Cantarini, L, Gaggiano C, Vitale A, Tufan A, Ragab G, Aragona E, Wiesik-Szewczyk E, Ait-Idir D, Iezzi L, Maggio MC, Cattalini M, La Torre F, Lopalco G, Verrecchia E, de Paulis A, Sahin A, Insalaco A, Sfikakis PP, Marino A, Frassi M, Ogunjimi B, Opris-Belinski D, Parronchi P, Emmi G, Shahram F, Ciccia F, Piga M, Hernández-Rodríguez J, Pereira RMR, Alessio M, Naddei R, Olivieri AN, Giudice ED, Sfriso P, Ruscitti P, Gobbi FL, Kucuk H, Sota J, Hussein MA, Malizia G, Jahnz-Różyk K, Sari-Hamidou R, Romeo M, Ricci F, Cardinale F, Iannone F, Casa FD, Natale MF, Laskari K, Giani T, Franceschini F, Sabato V, Yildirim D, Caggiano V, Hegazy MT, Marzo RD, Kucharczyk A, Khellaf G, Tarsia M, Almaghlouth IA, Laymouna AH, Mastrorilli V, Dotta L, Benacquista L, Grosso S, Crisafulli F, Parretti V, Giordano HF, Mahmoud AAA, Nuzzolese R, Musso M, Chighizola CB, Gentileschi S, Morrone M, Cola ID, Spedicato V, Giardini HAM, Vasi I, Renieri A, Fabbiani A, Mencarelli MA, Frediani B, Balistreri A, Tosi GM, Fabiani C, Lidar M, Rigante D (ORCID:0000-0001-7032-7779), Cantarini L, Conti G, Gaggiano, C, Vitale, A, Tufan, A, Ragab, G, Aragona, E, Wiesik-Szewczyk, E, Ait-Idir, D, Conti, G, Iezzi, L, Maggio, Mc, Cattalini, M, La Torre, F, Lopalco, G, Verrecchia, E, de Paulis, A, Sahin, A, Insalaco, A, Sfikakis, Pp, Marino, A, Frassi, M, Ogunjimi, B, Opris-Belinski, D, Parronchi, P, Emmi, G, Shahram, F, Ciccia, F, Piga, M, Hernández-Rodríguez, J, Pereira, Rmr, Alessio, M, Naddei, R, Olivieri, An, Giudice, Ed, Sfriso, P, Ruscitti, P, Gobbi, Fl, Kucuk, H, Sota, J, Hussein, Ma, Malizia, G, Jahnz-Różyk, K, Sari-Hamidou, R, Romeo, M, Ricci, F, Cardinale, F, Iannone, F, Casa, Fd, Natale, Mf, Laskari, K, Giani, T, Franceschini, F, Sabato, V, Yildirim, D, Caggiano, V, Hegazy, Mt, Marzo, Rd, Kucharczyk, A, Khellaf, G, Tarsia, M, Almaghlouth, Ia, Laymouna, Ah, Mastrorilli, V, Dotta, L, Benacquista, L, Grosso, S, Crisafulli, F, Parretti, V, Giordano, Hf, Mahmoud, Aaa, Nuzzolese, R, Musso, M, Chighizola, Cb, Gentileschi, S, Morrone, M, Cola, Id, Spedicato, V, Giardini, Ham, Vasi, I, Renieri, A, Fabbiani, A, Mencarelli, Ma, Frediani, B, Balistreri, A, Tosi, Gm, Fabiani, C, Lidar, M, Rigante, D, Cantarini, L, Gaggiano C, Vitale A, Tufan A, Ragab G, Aragona E, Wiesik-Szewczyk E, Ait-Idir D, Iezzi L, Maggio MC, Cattalini M, La Torre F, Lopalco G, Verrecchia E, de Paulis A, Sahin A, Insalaco A, Sfikakis PP, Marino A, Frassi M, Ogunjimi B, Opris-Belinski D, Parronchi P, Emmi G, Shahram F, Ciccia F, Piga M, Hernández-Rodríguez J, Pereira RMR, Alessio M, Naddei R, Olivieri AN, Giudice ED, Sfriso P, Ruscitti P, Gobbi FL, Kucuk H, Sota J, Hussein MA, Malizia G, Jahnz-Różyk K, Sari-Hamidou R, Romeo M, Ricci F, Cardinale F, Iannone F, Casa FD, Natale MF, Laskari K, Giani T, Franceschini F, Sabato V, Yildirim D, Caggiano V, Hegazy MT, Marzo RD, Kucharczyk A, Khellaf G, Tarsia M, Almaghlouth IA, Laymouna AH, Mastrorilli V, Dotta L, Benacquista L, Grosso S, Crisafulli F, Parretti V, Giordano HF, Mahmoud AAA, Nuzzolese R, Musso M, Chighizola CB, Gentileschi S, Morrone M, Cola ID, Spedicato V, Giardini HAM, Vasi I, Renieri A, Fabbiani A, Mencarelli MA, Frediani B, Balistreri A, Tosi GM, Fabiani C, Lidar M, Rigante D (ORCID:0000-0001-7032-7779), Cantarini L, and Conti G

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. NCT 05200715 available at https://clinicaltrials.gov

Published
2022

4. Topic: AS01-Diagnosis/AS01c-Molecular aberrations (cytogenetic, genetic, gene expression): A CARTOGRAPHY OF UBA1 GENE TESTING, EPIDEMIOLOGY AND CLINICAL-GENOMIC CHARACTERISTICS: THE VEXAS/MDS ITALIAN EXPERIENCE

Author

Gurnari, C., primary, Pascale, M.R., additional, Vitale, A., additional, Diral, E., additional, Galossi, E., additional, Falconi, G., additional, Bruno, A., additional, Crisafulli, F., additional, Frassi, M., additional, Cattaneo, C., additional, Bertoli, D., additional, Bernardi, M., additional, Condorelli, A., additional, Morsia, E., additional, Crisà, E., additional, Triggianese, P., additional, Brussino, L., additional, Battipaglia, G., additional, Bindoli, S., additional, Sfriso, P., additional, Caroni, F., additional, Olivieri, A., additional, Kordasti, S., additional, Albano, F., additional, Pane, F., additional, Musto, P., additional, Bocchia, M., additional, Lugli, E., additional, Rambaldi, A., additional, Greco, R., additional, Franceschini, F., additional, Ciceri, F., additional, Cantarini, L., additional, and Voso, M.T., additional

Published
2023
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5. Axial spondyloarthritis in patients with recurrent fever attacks: data from the AIDA network registry for undifferentiated autoinflammatory diseases (USAIDs)

Author

Vitale, A, Caggiano, V, Silva, I, Oliveira, Dg, Ruscitti, P, Ciccia, F, Vasi, I, Tufan, A, Lopalco, G, Almaghlouth, Ia, Sota, J, Wiesik-Szewczyk, E, Gaggiano, C, Giardini, Ham, Spedicato, V, Ragab, G, Iannone, F, Balistreri, A, Frassi, M, Hernández-Rodríguez, J, Fabiani, C, Falsetti, P, Di Meglio, N, Frediani, B, Mazzei, Ma, Rigante, Donato, Faria, R, Cantarini, L, Rigante D (ORCID:0000-0001-7032-7779), Vitale, A, Caggiano, V, Silva, I, Oliveira, Dg, Ruscitti, P, Ciccia, F, Vasi, I, Tufan, A, Lopalco, G, Almaghlouth, Ia, Sota, J, Wiesik-Szewczyk, E, Gaggiano, C, Giardini, Ham, Spedicato, V, Ragab, G, Iannone, F, Balistreri, A, Frassi, M, Hernández-Rodríguez, J, Fabiani, C, Falsetti, P, Di Meglio, N, Frediani, B, Mazzei, Ma, Rigante, Donato, Faria, R, Cantarini, L, and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Background: Despite the recent advances in the field of autoinflammatory diseases, most patients with recurrent fever episodes do not have any defined diagnosis. The present study aims at describing a cohort of patients suffering from apparently unexplained recurrent fever, in whom non-radiographic axial spondylarthritis (SpA) represented the unique diagnosis identified after a complete clinical and radiologic assessment. Materials and methods: Patients' data were obtained from the international registry on Undifferentiated Systemic AutoInflammatory Diseases (USAIDs) developed by the AutoInflammatory Disease Alliance (AIDA) network. Results: A total of 54 patients with recurrent fever episodes were also affected by non-radiographic axial SpA according to the international classification criteria. SpA was diagnosed after the start of fever episodes in all cases; the mean age at the diagnosis of axial SpA was 39.9 ± 14.8 years with a diagnostic delay of 9.3 years. The highest body temperature reached during flares was 42°C, with a mean temperature of 38.8 ± 1.1°C. The most frequent manifestations associated to fever were: arthralgia in 33 (61.1%) cases, myalgia in 24 (44.4%) cases, arthritis in 22 (40.7%) cases, headache in 15 (27.8%) cases, diarrhea in 14 (25.9%) cases, abdominal pain in 13 (24.1%) cases, and skin rash in 12 (22.1%) cases. Twenty-four (44.4%) patients have taken daily or on-demand non-steroidal anti-inflammatory drugs (NSAIDs) and 31 (57.4%) patients have been treated with daily or on demand oral glucocorticoids. Colchicine was used in 28 (51.8%) patients, while other conventional disease modifying anti-rheumatic drugs (cDMARDs) were employed in 28 (51.8%) patients. Forty (74.1%) patients underwent anti-tumor necrosis factor (TNF) agents and 11 (20.4%) were treated with interleukin (IL)-1 inhibitors. The response to TNF inhibitors on recurrent fever episodes appeared more effective than that observed with anti-IL-1 agents; colchicine and other cDMARD

Published
2023

6. Musculoskeletal manifestations in children with Behçet's syndrome: data from the AIDA Network Behçet's Syndrome Registry

Author

Gaggiano, C, Maselli, A, Sfikakis, Pp, Laskari, K, Ragab, G, Hegazy, Mt, Laymouna, Ah, Lopalco, G, Almaghlouth, Ia, Asfina, Kn, Alahmed, O, Giardini Mayrink, Ha, Parente de Brito Antonelli, I, Cattalini, M, Piga, M, Sota, J, Gentileschi, S, Maggio, Mc, Opris-Belinski, D, Hatemi, G, Insalaco, A, Olivieri, An, Tufan, A, Karadeniz, H, Kardaş, Rc, La Torre, F, Cardinale, F, Marino, A, Guerriero, S, Ruscitti, P, Tarsia, M, Vitale, A, Caggiano, V, Telesca, S, Iannone, F, Parretti, V, Frassi, M, Aragona, E, Ciccia, F, Wiesik-Szewczyk, E, Ionescu, R, Şahin, A, Akkoç, N, Hinojosa-Azaola, A, Tharwat, S, Hernández-Rodríguez, J, Espinosa, G, Conti, G, Del Giudice, E, Govoni, M, Emmi, G, Fabiani, C, Balistreri, A, Frediani, B, Rigante, Donato, Cantarini, L, Rigante D (ORCID:0000-0001-7032-7779), Gaggiano, C, Maselli, A, Sfikakis, Pp, Laskari, K, Ragab, G, Hegazy, Mt, Laymouna, Ah, Lopalco, G, Almaghlouth, Ia, Asfina, Kn, Alahmed, O, Giardini Mayrink, Ha, Parente de Brito Antonelli, I, Cattalini, M, Piga, M, Sota, J, Gentileschi, S, Maggio, Mc, Opris-Belinski, D, Hatemi, G, Insalaco, A, Olivieri, An, Tufan, A, Karadeniz, H, Kardaş, Rc, La Torre, F, Cardinale, F, Marino, A, Guerriero, S, Ruscitti, P, Tarsia, M, Vitale, A, Caggiano, V, Telesca, S, Iannone, F, Parretti, V, Frassi, M, Aragona, E, Ciccia, F, Wiesik-Szewczyk, E, Ionescu, R, Şahin, A, Akkoç, N, Hinojosa-Azaola, A, Tharwat, S, Hernández-Rodríguez, J, Espinosa, G, Conti, G, Del Giudice, E, Govoni, M, Emmi, G, Fabiani, C, Balistreri, A, Frediani, B, Rigante, Donato, Cantarini, L, and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

This study aims to describe musculoskeletal manifestations (MSM) in children with Behçet’s syndrome (BS), their association with other disease manifestations, response to therapy, and long-term prognosis. Data were retrieved from the AIDA Network Behçet’s Syndrome Registry. Out of a total of 141 patients with juvenile BS, 37 had MSM at disease onset (26.2%). The median age at onset was 10.0 years (IQR 7.7). The median follow-up duration was 21.8 years (IQR 23.3). Recurrent oral (100%) and genital ulcers (67.6%) and pseudofolliculitis (56.8%) were the most common symptoms associated with MSM. At disease onset, 31 subjects had arthritis (83.8%), 33 arthralgia (89.2%), and 14 myalgia (37.8%). Arthritis was monoarticular in 9/31 cases (29%), oligoarticular in 10 (32.3%), polyarticular in 5 (16.1%), axial in 7 (22.6%). Over time, arthritis became chronic-recurrent in 67.7% of cases and 7/31 patients had joint erosions (22.6%). The median Behçet's Syndrome Overall Damage Index was 0 (range 0–4). Colchicine was inefcacious for MSM in 4/14 cases (28.6%), independently from the type of MSM (p=0.46) or the concomitant therapy (p=0.30 for cDMARDs, p=1.00 for glucocorticoids); cDMARDs and bDMARDs were inefcacious for MSM in 6/19 (31.4%) and 5/12 (41.7%) cases. The presence of myalgia was associated with bDMARDs inefcacy (p=0.014). To conclude, MSM in children with BS are frequently associated with recurrent ulcers and pseudofolliculitis. Arthritis is mostly mono- or oligoarticular, but sacroiliitis is not unusual. Prognosis of this subset of BS is overall favorable, though the presence of myalgia negatively afects response to biologic therapies.

Published
2023

7. P013 - Topic: AS01-Diagnosis/AS01c-Molecular aberrations (cytogenetic, genetic, gene expression): A CARTOGRAPHY OF UBA1 GENE TESTING, EPIDEMIOLOGY AND CLINICAL-GENOMIC CHARACTERISTICS: THE VEXAS/MDS ITALIAN EXPERIENCE

Author

Gurnari, C., Pascale, M.R., Vitale, A., Diral, E., Galossi, E., Falconi, G., Bruno, A., Crisafulli, F., Frassi, M., Cattaneo, C., Bertoli, D., Bernardi, M., Condorelli, A., Morsia, E., Crisà, E., Triggianese, P., Brussino, L., Battipaglia, G., Bindoli, S., Sfriso, P., Caroni, F., Olivieri, A., Kordasti, S., Albano, F., Pane, F., Musto, P., Bocchia, M., Lugli, E., Rambaldi, A., Greco, R., Franceschini, F., Ciceri, F., Cantarini, L., and Voso, M.T.

Published
2023
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8. Baseline characteristics of systemic lupus erythematosus patients included in the Lupus Italian Registry of the Italian Society for Rheumatology

Author

Sebastiani, G, Spinelli, F, Bartoloni, E, Bortoluzzi, A, Bozzolo, E, Canofari, C, Canti, V, Conigliaro, P, Ditto, M, Emmi, G, Franceschini, F, Frassi, M, Iaccarino, L, Iuliano, A, Manfredi, A, Pacucci, V, Parisi, S, Pazzola, G, Perricone, R, Prevete, I, Ramirez, G, Scarpato, S, Scirocco, C, Silvagni, E, Zen, M, Zanetti, A, Carrara, G, Scire, C, Conti, F, Doria, A, Sebastiani G. D., Spinelli F. R., Bartoloni E., Bortoluzzi A., Bozzolo E., Canofari C., Canti V., Conigliaro P., Ditto M. C., Emmi G., Franceschini F., Frassi M., Iaccarino L., Iuliano A., Manfredi A., Pacucci V., Parisi S., Pazzola G., Perricone R., Prevete I., Ramirez G. A., Scarpato S., Scirocco C., Silvagni E., Zen M., Zanetti A., Carrara G., Scire C. A., Conti F., Doria A., Sebastiani, G, Spinelli, F, Bartoloni, E, Bortoluzzi, A, Bozzolo, E, Canofari, C, Canti, V, Conigliaro, P, Ditto, M, Emmi, G, Franceschini, F, Frassi, M, Iaccarino, L, Iuliano, A, Manfredi, A, Pacucci, V, Parisi, S, Pazzola, G, Perricone, R, Prevete, I, Ramirez, G, Scarpato, S, Scirocco, C, Silvagni, E, Zen, M, Zanetti, A, Carrara, G, Scire, C, Conti, F, Doria, A, Sebastiani G. D., Spinelli F. R., Bartoloni E., Bortoluzzi A., Bozzolo E., Canofari C., Canti V., Conigliaro P., Ditto M. C., Emmi G., Franceschini F., Frassi M., Iaccarino L., Iuliano A., Manfredi A., Pacucci V., Parisi S., Pazzola G., Perricone R., Prevete I., Ramirez G. A., Scarpato S., Scirocco C., Silvagni E., Zen M., Zanetti A., Carrara G., Scire C. A., Conti F., and Doria A.

Abstract

Objective: To report baseline data of SLE patients enrolled in the Lupus Italian Registry (LIRE). Methods: Patients affected by SLE aged ≥ 16 years were consecutively recruited in a multicenter prospective study comparing two cohorts: patients starting biologic immunosuppressants (BC) and patients starting non-biologic immunosuppresants (NBC). Results: 308 patients were enrolled, 179 in NBC and 129 in BC. Mean age at disease onset and at diagnosis was significantly higher in NBC (p = 0.023, p = 0.045, respectively). Disease duration was longer in BC (p = 0.022). Patients in BC presented arthritis more frequently (p = 0.024), those in NBC nephropathy (p = 0.03). Quality of life was worse in BC (p = 0.031). Anti-dsDNA, low C3, were significantly more frequent in BC (p < 0.001, p = 0.009, respectively). Mycophenolate, methotrexate and azathioprine were the drugs more frequently prescribed in NBC, Belimumab and Rituximab in BC. Conclusion: The predominant organ involvement was different in the two cohorts: kidney involvement predominated in NBC, joint involvement in BC. Despite the younger age at disease onset, patients of the BC had a longer disease duration and more frequently had taken a cumulative prednisone dosage greater than 10 g. Even the pattern of clinical manifestations inducing to prescribe biological rather than conventional immunosuppressants was quite different. Keywords: Autoantibody(ies), autoimmune disease, belimumab, cohort studies, glucocorticoids, immunosuppressants, rituximab, systemic lupus erythematosus.

Published
2021

9. Development and implementation of the AIDA International Registry for patients with undifferentiated systemic autoinflammatory diseases

Author

Della Casa, F, Vitale, A, Lopalco, G, Ruscitti, P, Ciccia, F, Emmi, G, Cattalini, M, Wiesik-Szewczyk, E, Maggio, Mc, Ogunjimi, B, Sfikakis, Pp, Tufan, A, Al-Mayouf, Sm, Del Giudice, E, Aragona, E, La Torre, F, Sota, J, Colella, S, Di Cola, I, Iacono, D, Mattioli, I, Jahnz-Rózyk, K, Joos, R, Laskari, K, Gaggiano, C, Abbruzzese, A, Cipriani, P, Rozza, G, Alsaleem, A, Yildirim, D, Tarsia, M, Ragab, G, Ricci, F, Cardinale, F, Korzeniowska, M, Frassi, M, Caggiano, V, Saad, Ma, Pereira, Rm, Berlengiero, V, Gentileschi, S, Guerriero, S, Giani, T, Gelardi, V, Iannone, F, Giardini, Ham, Almaghlouth, Ia, Kardas, Rc, Ait-Idir, D, Frediani, B, Balistreri, A, Fabiani, C, Rigante, Donato, Cantarini, L, Rigante D (ORCID:0000-0001-7032-7779), Della Casa, F, Vitale, A, Lopalco, G, Ruscitti, P, Ciccia, F, Emmi, G, Cattalini, M, Wiesik-Szewczyk, E, Maggio, Mc, Ogunjimi, B, Sfikakis, Pp, Tufan, A, Al-Mayouf, Sm, Del Giudice, E, Aragona, E, La Torre, F, Sota, J, Colella, S, Di Cola, I, Iacono, D, Mattioli, I, Jahnz-Rózyk, K, Joos, R, Laskari, K, Gaggiano, C, Abbruzzese, A, Cipriani, P, Rozza, G, Alsaleem, A, Yildirim, D, Tarsia, M, Ragab, G, Ricci, F, Cardinale, F, Korzeniowska, M, Frassi, M, Caggiano, V, Saad, Ma, Pereira, Rm, Berlengiero, V, Gentileschi, S, Guerriero, S, Giani, T, Gelardi, V, Iannone, F, Giardini, Ham, Almaghlouth, Ia, Kardas, Rc, Ait-Idir, D, Frediani, B, Balistreri, A, Fabiani, C, Rigante, Donato, Cantarini, L, and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: This paper points out the design, development and deployment of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to pediatric and adult patients affected with Undifferentiated Systemic AutoInflammatory Diseases (USAIDs). Methods: This is a physician-driven, population- and electronic-based 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 thought to gain standardised information for real-life research and has been developed to change over time according to the scientific acquisitions and potentially communicate with other similar instruments; this platform ensures security, data quality and data governance. Results: The 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, 99 centres from 20 countries and 4 continents have joined the AIDA project. Forty-eight centres have already obtained the approval from their local Ethics Committees. Currently, the platform counts 265 users (99 Principal Investigators, 162 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry is collecting baseline and follow-up data using 3357 fields organised into 23 instruments, which include demographics, history, symptoms, trigger/risk factors, therapies, and healthcare access for USAIDs patients. Conclusions: The development of the AIDA International Registry for USAIDs patients will facilitate the on-line collection of standardised data, connecting a worldwide group of researchers: the Registry constitutes an international multicentre observational groundwork aimed at increasing the study cohort of patients with USAIDs in order to improve our knowledge of this peculiar cluster of autoinflammatory diseases.

Published
2022

10. 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, Ö, 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 &amp, Autoinflammatory Diseases Alliance (AIDA), Network, Conti G (ORCID:0000-0002-8566-9365), Rigante D (ORCID:0000-0001-7032-7779), 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, Ö, 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 &amp, Autoinflammatory Diseases Alliance (AIDA), Network, Conti G (ORCID:0000-0002-8566-9365), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: 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). Methods: The Registry is a clinical physician-driven 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. Results: Starting from January 31st to November 23rd, 2021, 99 centres from 20 countries in 4 continents have been involved. Forty-eight of these have already obtained the approval from their local Ethics Committees. Currently, the platform counts 265 users (99 Principal Investigators, 162 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry collects baseline and follow-up data using 5474 fields organised into 15 instruments, including patient’s demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access. Conclusions: 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.

Published
2022

11. Development and implementation of the AIDA International Registry for patients with VEXAS syndrome

Author

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, Giorgio, 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, Donato, Cantarini, L, Conti G (ORCID:0000-0002-8566-9365), Rigante D (ORCID:0000-0001-7032-7779), 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, Giorgio, 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, Donato, Cantarini, L, Conti G (ORCID:0000-0002-8566-9365), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: The 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. Methods: The present 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, enhancing international collaboration and data sharing for research purposes. The registry is handy enough to be easily modified to meet future needs regarding VEXAS syndrome. Results: To date (April 2022), 105 Centers from 23 Countries in 4 continents have been involved; 287 users (106 Principal Investigators, 177 Site Investigators, 2 Lead Investigators, and 2 data managers) may already enter the registry for data collection and sharing. The registry includes 4950 fields organised 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. Conclusions: This international Registry for patients with VEXAS syndrome will allow the achievement of a comprehensive knowledge about this new disease in a relatively short time with the final goal to obtain real-world evidence data for daily clinical practice. This project can be found on https://clinicaltrials.gov NCT 05200715

Published
2022

12. Development and implementation of the AIDA International Registry for patients with Schnitzler’s syndrome

Author

Sota, J, Vitale, A, Więsik-Szewczyk, E, Frassi, M, Lopalco, G, Emmi, G, Govoni, M, de Paulis, A, Marino, A, Gidaro, A, Monti, S, Opris-Belinski, D, Pereira, Rmr, Jahnz-Rózyk, K, Gaggiano, C, Crisafulli, F, Iannone, F, Mattioli, I, Ruffilli, F, Mormile, I, Rybak, K, Caggiano, V, Airò, P, Tufan, A, Gentileschi, S, Ragab, G, Almaghlouth, Ia, Aboul-Fotouh Khalil, A, Cattalini, M, La Torre, F, Tarsia, M, Giardini, Ham, Ali Saad, M, Bocchia, M, Caroni, F, Giani, T, Cinotti, E, Ruscitti, P, Rubegni, P, Dagostin, Ma, Frediani, B, Guler, Aa, Della Casa, F, Maggio, Mc, Recke, A, von Bubnoff, D, Krause, K, Balistreri, A, Fabiani, C, Rigante, Donato, Cantarini, L, Rigante D (ORCID:0000-0001-7032-7779), Sota, J, Vitale, A, Więsik-Szewczyk, E, Frassi, M, Lopalco, G, Emmi, G, Govoni, M, de Paulis, A, Marino, A, Gidaro, A, Monti, S, Opris-Belinski, D, Pereira, Rmr, Jahnz-Rózyk, K, Gaggiano, C, Crisafulli, F, Iannone, F, Mattioli, I, Ruffilli, F, Mormile, I, Rybak, K, Caggiano, V, Airò, P, Tufan, A, Gentileschi, S, Ragab, G, Almaghlouth, Ia, Aboul-Fotouh Khalil, A, Cattalini, M, La Torre, F, Tarsia, M, Giardini, Ham, Ali Saad, M, Bocchia, M, Caroni, F, Giani, T, Cinotti, E, Ruscitti, P, Rubegni, P, Dagostin, Ma, Frediani, B, Guler, Aa, Della Casa, F, Maggio, Mc, Recke, A, von Bubnoff, D, Krause, K, Balistreri, A, Fabiani, C, Rigante, Donato, Cantarini, L, and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: The present paper describes the design, development, and implementation of the AutoInflammatory Disease Alliance (AIDA) International Registry specifically dedicated to patients with Schnitzler syndrome. Methods: This is a clinical physician-driven, population- and electronic-based registry implemented for the retrospective and prospective collection of real-life data from patients with Schnitzler’s syndrome; the registry is based on the Research Electronic Data Capture (REDCap) tool, which is thought to collect standardised information for clinical research, and has been realised to change over time according to future scientific acquisitions and potentially communicate with other existing or future similar registries. Results: Since its launch, 112 centres from 23 countries in 4 continents have been involved. Fifty-four have already obtained the approval from their local Ethics Committees. The platform counts 303 users (113 Principal Investigators, 186 Site Investigators, 2 Lead Investigators, and 2 data managers) at current (April 12th 2022). The registry collects baseline and follow-up data using 3922 fields organised into 25 instruments, including patient’s demographics, history, clinical manifestations and symptoms, trigger/risk factors, laboratory, instrumental exams, therapies, socioeconomic information, and healthcare access. Conclusions: This International Registry for patients with Schnitzler syndrome facilitates standardised data collection, enabling international collaborative projects through data sharing and dissemination of knowledge; in turn, it will shed light into many blind spots characterizing this complex autoinflammatory disorder

Published
2022

13. Development and implementation of the AIDA International Registry for patients with Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis syndrome

Author

Della Casa, F, Vitale, A, Cattalini, M, La Torre, F, Capozio, G, Del Giudice, E, Maggio, Mc, Conti, Giorgio, Alessio, M, Ogunjimi, B, Ragab, G, Emmi, G, Aragona, E, Giani, T, Lopalco, G, Parronchi, P, Shahram, F, Verrecchia, Elena, Ricci, F, Cardinale, F, Di Noi, Silvia, Nuzzolese, R, Lubrano, R, Patroniti, S, Naddei, R, Sabato, V, Hussein, Ma, Dotta, L, Mastrorilli, V, Gentileschi, S, Tufan, A, Caggiano, V, Hegazy, Mt, Sota, J, Almaghlouth, Ia, Ibrahim, A, Wiȩsik-Szewczyk, E, Ozkiziltas, B, Grosso, S, Frassi, M, Tarsia, M, Pereira, Rmr, Taymour, M, Gaggiano, C, Colella, S, Fabiani, C, Morrone, M, Ruscitti, P, Frediani, B, Spedicato, V, Giardini, Ham, Balistreri, A, Rigante, Donato, Cantarini, L, Conti G (ORCID:0000-0002-8566-9365), Verrecchia E, Di Noi S, Rigante D (ORCID:0000-0001-7032-7779), Della Casa, F, Vitale, A, Cattalini, M, La Torre, F, Capozio, G, Del Giudice, E, Maggio, Mc, Conti, Giorgio, Alessio, M, Ogunjimi, B, Ragab, G, Emmi, G, Aragona, E, Giani, T, Lopalco, G, Parronchi, P, Shahram, F, Verrecchia, Elena, Ricci, F, Cardinale, F, Di Noi, Silvia, Nuzzolese, R, Lubrano, R, Patroniti, S, Naddei, R, Sabato, V, Hussein, Ma, Dotta, L, Mastrorilli, V, Gentileschi, S, Tufan, A, Caggiano, V, Hegazy, Mt, Sota, J, Almaghlouth, Ia, Ibrahim, A, Wiȩsik-Szewczyk, E, Ozkiziltas, B, Grosso, S, Frassi, M, Tarsia, M, Pereira, Rmr, Taymour, M, Gaggiano, C, Colella, S, Fabiani, C, Morrone, M, Ruscitti, P, Frediani, B, Spedicato, V, Giardini, Ham, Balistreri, A, Rigante, Donato, Cantarini, L, Conti G (ORCID:0000-0002-8566-9365), Verrecchia E, Di Noi S, and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: Aim of this paper is to illustrate the methodology, design, and development of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to patients with the Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis (PFAPA) syndrome. Methods: This is a physician-driven, population- and electronic-based registry proposed to gather real-world demographics, clinical, laboratory, instrumental and socioeconomic data from patients suffering from PFAPA syndrome. Data recruitment is realized through the on-line Research Electronic Data Capture (REDCap) tool. This registry is thought to collect standardized information for clinical research leading to solid real-life evidence. The international scope and the flexibility of the registry will facilitate the realization of cutting-edge study projects through the constant updating of variables - as required by future scientific acquisitions - and the possible merging and transfer of data between current and future registries devoted to this disease. Results: One hundred and twelve centers have already been involved from 23 countries and 4 continents starting from August 24th, 2021, to March 21st, 2022. Fifty-five out of 112 have already obtained the formal approval from their local Ethics Committees. At current, the platform counts 287 users (108 principal investigators, 179 site investigators, 2 lead investigators, and 2 data managers). The registry collects retrospective and prospective data using 3845 fields organized into 24 instruments, including PFAPA patient’s demographics, medical histories, symptoms, triggers/risk factors, therapies, and impact on the healthcare systems. Conclusions: The development of the AIDA International Registry for patients with PFAPA syndrome will enable the on-line collection of standardized data prompting real-life studies through the connection of worldwide groups of physicians and researchers. This project can be found on https://clinicaltrials.gov

Published
2022

14. Development and implementation of the AIDA International Registry for patients with Still’s disease

Author

Vitale, A, Della Casa, F, Lopalco, G, Pereira, Rm, Ruscitti, P, Giacomelli, R, Ragab, G, La Torre, F, Bartoloni, E, Del Giudice, E, Lomater, C, Emmi, G, Govoni, M, Maggio, Mc, Maier, A, Makowska, J, Ogunjimi, B, Sfikakis, Pp, Sfriso, P, Gaggiano, C, Iannone, F, Dagostin, Ma, Di Cola, I, Navarini, L, Ahmed Mahmoud, Aa, Cardinale, F, Riccucci, I, Paroli, Mp, Marucco, Em, Mattioli, I, Sota, J, Abbruzzese, A, Antonelli, Ipb, Cipriani, P, Tufan, A, Fabiani, C, Ramadan, Mm, Cattalini, M, Kardas, Rc, Sebastiani, Gd, Giardini, Ham, Hernández-Rodríguez, J, Mastrorilli, V, Więsik-Szewczyk, E, Frassi, M, Caggiano, V, Telesca, S, Giordano, Hf, Guadalupi, E, Balistreri, A, Rigante, Donato, Cantarini, L., Rigante D (ORCID:0000-0001-7032-7779), Vitale, A, Della Casa, F, Lopalco, G, Pereira, Rm, Ruscitti, P, Giacomelli, R, Ragab, G, La Torre, F, Bartoloni, E, Del Giudice, E, Lomater, C, Emmi, G, Govoni, M, Maggio, Mc, Maier, A, Makowska, J, Ogunjimi, B, Sfikakis, Pp, Sfriso, P, Gaggiano, C, Iannone, F, Dagostin, Ma, Di Cola, I, Navarini, L, Ahmed Mahmoud, Aa, Cardinale, F, Riccucci, I, Paroli, Mp, Marucco, Em, Mattioli, I, Sota, J, Abbruzzese, A, Antonelli, Ipb, Cipriani, P, Tufan, A, Fabiani, C, Ramadan, Mm, Cattalini, M, Kardas, Rc, Sebastiani, Gd, Giardini, Ham, Hernández-Rodríguez, J, Mastrorilli, V, Więsik-Szewczyk, E, Frassi, M, Caggiano, V, Telesca, S, Giordano, Hf, Guadalupi, E, Balistreri, A, Rigante, Donato, Cantarini, L., and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: Aim of this paper is to present the design, construction, and modalities of dissemination of the AutoInflammatory Disease Alliance (AIDA) International Registry for patients with systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s disease (AOSD), which are the pediatric and adult forms of the same autoinflammatory disorder. Methods: This Registry is a clinical, physician-driven, population- and electronic-based instrument implemented for the retrospective and prospective collection of real-world data. The collection of data is based on the Research Electronic Data Capture (REDCap) tool and is intended to obtain evidence drawn from routine patients’ management. The collection of standardized data is thought to bring knowledge about real-life clinical research and potentially communicate with other existing and future Registries dedicated to Still’s disease. Moreover, it has been conceived to be flexible enough to easily change according to future scientific acquisitions. Results: Starting from June 30th to February 7th, 2022, 110 Centers 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 4449 fields organized into 14 instruments, including patient’s demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access. Conclusions: This international Registry for patients with Still’s disease will allow a robust clinical research through collection of standardized data, international consultation, dissemination of knowledge, and implementation of observational studies based on wide cohorts of patients followed-up for very long periods. Solid evidence drawn from “real-life” data represents the ultimate goal of t

Published
2022

15. Development and implementation of the AIDA International Registry for patients with non-infectious uveitis

Author

Della Casa, F, Vitale, A, Guerriero, S, Sota, J, Cimaz, R, Ragab, G, Ruscitti, P, Pereira, Rmr, Minoia, F, Del Giudice, E, Emmi, G, Lomater, C, Monti, S, Canofari, C, Gaggiano, C, Alessio, G, Miserocchi, E, Conforti, A, Dagostin, Ma, Mapelli, C, Paroli, Mp, Parretti, V, Albano, V, Favale, R, Marelli, L, Hegazy, Mt, Cipriani, P, Antonelli, Ipb, Caggiano, V, Aragona, E, Laymouna, Ah, Tosi, Gm, Tarsia, M, Cattalini, M, La Torre, F, Lopalco, G, Więsik-Szewczyk, E, Frassi, M, Gentileschi, S, Giordano, Hf, Frediani, B, Shinjo, Sk, Rigante, Donato, Sfikakis, Pp, Balistreri, A, Hussein, Ma, Amin, Rh, Cantarini, L, Fabiani, C, Rigante D (ORCID:0000-0001-7032-7779), Della Casa, F, Vitale, A, Guerriero, S, Sota, J, Cimaz, R, Ragab, G, Ruscitti, P, Pereira, Rmr, Minoia, F, Del Giudice, E, Emmi, G, Lomater, C, Monti, S, Canofari, C, Gaggiano, C, Alessio, G, Miserocchi, E, Conforti, A, Dagostin, Ma, Mapelli, C, Paroli, Mp, Parretti, V, Albano, V, Favale, R, Marelli, L, Hegazy, Mt, Cipriani, P, Antonelli, Ipb, Caggiano, V, Aragona, E, Laymouna, Ah, Tosi, Gm, Tarsia, M, Cattalini, M, La Torre, F, Lopalco, G, Więsik-Szewczyk, E, Frassi, M, Gentileschi, S, Giordano, Hf, Frediani, B, Shinjo, Sk, Rigante, Donato, Sfikakis, Pp, Balistreri, A, Hussein, Ma, Amin, Rh, Cantarini, L, Fabiani, C, and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Introduction: The aim of this paper is to point out the design, development and deployment of the AutoInflammatory Disease Alliance(AIDA) International Registry for paediatric and adult patients with non-infectious uveitis(NIU). Methods: This is a physician-driven, population- and electronic-based registry implemented for both retrospective and prospective collection of real-world demographics, clinical, laboratory, instrumental and socioeconomic data of patients with uveitis and other non-infectious inflammatory ocular diseases recruited through the AIDA Network. Data recruitment, based on the Research Electronic Data Capture (REDCap) tool, is thought to collect standardised information for real-life research and has been developed to change over time according to future scientific acquisitions and potentially communicate with other similar instruments. Security, data quality and data governance are cornerstones of this platform. Results: Ninety-five centres have been involved from 19 countries and four continents from 24 March to 16 November 2021. Forty-eight out of 95 have already obtained the approval from their local ethics committees. At present, the platform counts 259 users (95 principal investigators, 160 site investigators, 2 lead investigators, and 2 data managers). The AIDA Registry collects baseline and follow-up data using 3943 fields organised into 13 instruments, including patient’s demographics, history, symptoms,trigger/risk factors, therapies and health care utilization for patients with NIU. Conclusions: The development of the AIDA Registry for patients with NIU will facilitate the collection of standardised data leading to real-world evidence and enabling international multicentre collaborative research through inclusion of patients and their families worldwide.

Published
2022

18. Development and Implementation of the AIDA International Registry for Patients With Still's Disease

Author

Vitale, A. Della Casa, F. Lopalco, G. Pereira, R.M. Ruscitti, P. Giacomelli, R. Ragab, G. La Torre, F. Bartoloni, E. Del Giudice, E. Lomater, C. Emmi, G. Govoni, M. Maggio, M.C. Maier, A. Makowska, J. Ogunjimi, B. Sfikakis, P.P. Sfriso, P. Gaggiano, C. Iannone, F. Dagostin, M.A. Di Cola, I. Navarini, L. Ahmed Mahmoud, A.A. Cardinale, F. Riccucci, I. Paroli, M.P. Marucco, E.M. Mattioli, I. Sota, J. Abbruzzese, A. Antonelli, I.P.B. Cipriani, P. Tufan, A. Fabiani, C. Ramadan, M.M. Cattalini, M. Kardas, R.C. Sebastiani, G.D. Giardini, H.A.M. Hernández-Rodríguez, J. Mastrorilli, V. Więsik-Szewczyk, E. Frassi, M. Caggiano, V. Telesca, S. Giordano, H.F. Guadalupi, E. Giani, T. Renieri, A. Colella, S. Cataldi, G. Gentile, M. Fabbiani, A. Al-Maghlouth, I.A. Frediani, B. Balistreri, A. Rigante, D. Cantarini, L. The Autoinflammatory Diseases Alliance (AIDA) Network

Abstract

Objective: Aim of this paper is to present the design, construction, and modalities of dissemination of the AutoInflammatory Disease Alliance (AIDA) International Registry for patients with systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still's disease (AOSD), which are the pediatric and adult forms of the same autoinflammatory disorder. Methods: This Registry is a clinical, physician-driven, population- and electronic-based instrument implemented for the retrospective and prospective collection of real-world data. The collection of data is based on the Research Electronic Data Capture (REDCap) tool and is intended to obtain evidence drawn from routine patients' management. The collection of standardized data is thought to bring knowledge about real-life clinical research and potentially communicate with other existing and future Registries dedicated to Still's disease. Moreover, it has been conceived to be flexible enough to easily change according to future scientific acquisitions. Results: Starting from June 30th to February 7th, 2022, 110 Centers 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 4449 fields organized into 14 instruments, including patient's demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access. Conclusions: This international Registry for patients with Still's disease will allow a robust clinical research through collection of standardized data, international consultation, dissemination of knowledge, and implementation of observational studies based on wide cohorts of patients followed-up for very long periods. Solid evidence drawn from “real-life” data represents the ultimate goal of this Registry, which has been implemented to significantly improve the overall management of patients with Still's disease. NCT 05200715 available at https://clinicaltrials.gov/. Copyright © 2022 Vitale, Della Casa, Lopalco, Pereira, Ruscitti, Giacomelli, Ragab, La Torre, Bartoloni, Del Giudice, Lomater, Emmi, Govoni, Maggio, Maier, Makowska, Ogunjimi, Sfikakis, Sfriso, Gaggiano, Iannone, Dagostin, Di Cola, Navarini, Ahmed Mahmoud, Cardinale, Riccucci, Paroli, Marucco, Mattioli, Sota, Abbruzzese, Antonelli, Cipriani, Tufan, Fabiani, Ramadan, Cattalini, Kardas, Sebastiani, Giardini, Hernández-Rodríguez, Mastrorilli, Więsik-Szewczyk, Frassi, Caggiano, Telesca, Giordano, Guadalupi, Giani, Renieri, Colella, Cataldi, Gentile, Fabbiani, Al-Maghlouth, Frediani, Balistreri, Rigante and Cantarini.

Published
2022

19. Erratum: Management of adult-onset Still's disease with interleukin-1 inhibitors: Evidence- And consensus-based statements by a panel of Italian experts (Arthritis Res Ther (2019) 21:275 DOI: 10.1186/s13075-019-2021-9)

Author

Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., Sinigaglia, L., Alivernini, S., Baldissera, E., Bartoloni, E., Berti, A., Bugatti, S., Camellino, D., Cammelli, D., Caporali, R., Caso, F., Cavallaro, E., Cavalli, G., Colaci, M., Costa, L., Di Scala, G., Emmi, G., Frassi, M., Gerli, R., Giacomelli, R., Gremese, E., Iannone, F., Lapadula, G., Leveghi, L., Lopalco, G., Manna, R., Marotto, D., Mathieu, A., Neri, R., Patisso, I., Piga, M., Punzi, L., Romano, M., Ruscitti, P., Salvarani, C., Scarpa, R., Scrivo, R., Talarico, R., Verrecchia, E., Viapiana, O., Vitale, A., AOSD Consensus Group: Alivernini S, Vitiello G., Baldissera, E, Bartoloni, E, Berti, A, Bugatti, S, Camellino, D, Cammelli, D, Caporali, R, Caso, F, Cavallaro, E, Cavalli, G, Colaci, M, Costa, L, di Scala, G, Emmi, G, and Frassi, M

Published
2020

20. Drug survival of anakinra and canakinumab in monogenic autoinflammatory diseases: observational study from the International AIDA Registry

Author

Sota, J, Rigante, D, Cimaz, R, Cattalini, M, Frassi, M, Manna, R, Sicignano, Ll, Verrecchia, E, Aragona, E, Maggio, Mc, Lopalco, G, Emmi, G, Parronchi, P, Cauli, A, Wiesik-Szewczyk, E, Hernández-Rodríguez, J, Gaggiano, C, Tarsia, M, Mourabi, M, Ragab, G, Vitale, A, Fabiani, C, Frediani, B, Lamacchia, V, Renieri, A, Cantarini, L, Rigante D (ORCID:0000-0001-7032-7779), Manna R (ORCID:0000-0003-1560-3907), Sicignano LL, Verrecchia E, Sota, J, Rigante, D, Cimaz, R, Cattalini, M, Frassi, M, Manna, R, Sicignano, Ll, Verrecchia, E, Aragona, E, Maggio, Mc, Lopalco, G, Emmi, G, Parronchi, P, Cauli, A, Wiesik-Szewczyk, E, Hernández-Rodríguez, J, Gaggiano, C, Tarsia, M, Mourabi, M, Ragab, G, Vitale, A, Fabiani, C, Frediani, B, Lamacchia, V, Renieri, A, Cantarini, L, Rigante D (ORCID:0000-0001-7032-7779), Manna R (ORCID:0000-0003-1560-3907), Sicignano LL, and Verrecchia E

Abstract

Objectives: To investigate survival of interleukin (IL)-1 inhibitors in monogenic autoinflammatory disorders (mAID) through drug retention rate (DRR) and identify potential predictive factors of drug survival from a real-life perspective. Patients and methods: Multicentre retrospective study analyzing patients affected by the most common mAID treated with anakinra or canakinumab. Survival curves were analyzed with the Kaplan-Meier method. Statistical analysis included a Cox-proportional hazard model to detect factors responsible for drug discontinuation. Results: Seventy-eight patients for a total of 102 treatment regimens were enrolled. The mean treatment duration was 29.59 months. The estimated DRR of IL-1 inhibitors at 12, 24, and 48 months of follow-up was 75.8%, 69.7% and 51.1%, respectively. Patients experiencing an adverse event had a significantly lower DRR (p = 0.019). In contrast, no significant differences were observed between biologic-naïve patients and those previously treated with biologic drugs (p = 0.985) Patients carrying high-penetrance mutations exhibited a significantly higher DRR compared with those with low-penetrance variants (p = 0.015). Adverse events were the only variable associated with a higher hazard of treatment withdrawal (HR 2.573 [CI: 1.223-5.411], p = 0.013) on regression analysis. A significant glucorticoid-sparing effect was observed (p < 0.0001). Conclusions: IL-1 inhibitors display an excellent long-term effectiveness in terms of DRR, and their survival is not influenced by the biologic line of treatment. They display a favorable safety profile, that deserves however a close monitoring given its impact on treatment continuation. Special attention should be paid to molecular diagnosis and mutation penetrance, as patients carrying low-penetrance variants are more likely to interrupt treatment.

Published
2021

21. OP0093 RETENTION RATE OF IL-1 INHIBITORS IN PATIENTS WITH SCHNITZLER’S SYNDROME

Author

Crisafulli, F., primary, Vitale, A., additional, Gaggiano, C., additional, Dagna, L., additional, Cavalli, G., additional, Cimaz, R., additional, Viapiana, O., additional, Iannone, F., additional, Lopalco, G., additional, Bortolotti, R., additional, Abdel Jaber, M., additional, Montecucco, C., additional, Monti, S., additional, Balduzzi, S., additional, Emmi, G., additional, Airò, P., additional, Franceschini, F., additional, Cantarini, L., additional, and Frassi, M., additional

Published
2021
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22. Systemic lupus erythematosus: State of the art on clinical practice guidelines

Author

Tamirou, F, Arnaud, L, Talarico, R, Scire, C, Alexander, T, Amoura, Z, Avcin, T, Bortoluzzi, A, Cervera, R, Conti, F, Cornet, A, Devilliers, H, Doria, A, Frassi, M, Fredi, M, Govoni, M, Houssiau, F, Llado, A, Macieira, C, Martin, T, Massaro, L, Moraes-Fontes, M, Pamfil, C, Paolino, S, Tani, C, Tas, S, Tektonidou, M, Tincani, A, Van Vollenhoven, R, Bombardieri, S, Burmester, G, Eurico, F, Galetti, I, Hachulla, E, Mueller-Ladner, U, Schneider, M, Smith, V, Cutolo, M, Mosca, M, Costedoat-Chalumeau, N, Tamirou F., Arnaud L., Talarico R., Scire C. A., Alexander T., Amoura Z., Avcin T., Bortoluzzi A., Cervera R., Conti F., Cornet A., Devilliers H., Doria A., Frassi M., Fredi M., Govoni M., Houssiau F., Llado A., Macieira C., Martin T., Massaro L., Moraes-Fontes M. F., Pamfil C., Paolino S., Tani C., Tas S. W., Tektonidou M., Tincani A., Van Vollenhoven R. F., Bombardieri S., Burmester G., Eurico F. J., Galetti I., Hachulla E., Mueller-Ladner U., Schneider M., Smith V., Cutolo M., Mosca M., Costedoat-Chalumeau N., Tamirou, F, Arnaud, L, Talarico, R, Scire, C, Alexander, T, Amoura, Z, Avcin, T, Bortoluzzi, A, Cervera, R, Conti, F, Cornet, A, Devilliers, H, Doria, A, Frassi, M, Fredi, M, Govoni, M, Houssiau, F, Llado, A, Macieira, C, Martin, T, Massaro, L, Moraes-Fontes, M, Pamfil, C, Paolino, S, Tani, C, Tas, S, Tektonidou, M, Tincani, A, Van Vollenhoven, R, Bombardieri, S, Burmester, G, Eurico, F, Galetti, I, Hachulla, E, Mueller-Ladner, U, Schneider, M, Smith, V, Cutolo, M, Mosca, M, Costedoat-Chalumeau, N, Tamirou F., Arnaud L., Talarico R., Scire C. A., Alexander T., Amoura Z., Avcin T., Bortoluzzi A., Cervera R., Conti F., Cornet A., Devilliers H., Doria A., Frassi M., Fredi M., Govoni M., Houssiau F., Llado A., Macieira C., Martin T., Massaro L., Moraes-Fontes M. F., Pamfil C., Paolino S., Tani C., Tas S. W., Tektonidou M., Tincani A., Van Vollenhoven R. F., Bombardieri S., Burmester G., Eurico F. J., Galetti I., Hachulla E., Mueller-Ladner U., Schneider M., Smith V., Cutolo M., Mosca M., and Costedoat-Chalumeau N.

Abstract

Systemic lupus erythematosus (SLE) is the paradigm of systemic autoimmune diseases characterised by a wide spectrum of clinical manifestations with an unpredictable relapsing-remitting course. The aim of the present work was to identify current available clinical practice guidelines (CPGs) for SLE, to provide their review and to identify physicians' and patients' unmet needs. Twenty-Three original guidelines published between 2004 and 2017 were identified. Many aspects of disease management are covered, including global disease management, lupus nephritis and neuropsychiatric involvement, management of pregnancies, vaccinations and comorbidities monitoring. Unmet needs relate with disease management of some clinical manifestations and adherence to treatment. Many patient's unmet needs have been identified starting with faster diagnosis, need for more therapeutic options, guidelines on lifestyle issues, attention to quality of life and adequate education.

Published
2018

23. Erratum. management of adult-onset still's disease with interleukin-1 inhibitors. evidence- and consensus-based statements by a panel of Italian experts

Author

Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., Sinigaglia, L., Alivernini, S., Baldissera, E., Bartoloni, E., Berti, A., Bugatti, S., Camellino, D., Cammelli, D., Caporali, R., Caso, F., Cavallaro, E., Cavalli, G., Colaci, M., Costa, L., Di Scala, G., Emmi, G., Frassi, M., Gerli, R., Giacomelli, R., Gremese, E., Iannone, F., Lapadula, G., Leveghi, L., Lopalco, G., Manna, R., Marotto, D., Mathieu, A., Neri, R., Patisso, I., Piga, M., Punzi, L., Romano, M., Ruscitti, P., Salvarani, C., Scarpa, R., Scrivo, R., Talarico, R., Verrecchia, E., Viapiana, O., Vitale, A., and Vitiello, G.

Subjects
030203 arthritis & rheumatology, 0301 basic medicine, medicine.medical_specialty, Pediatrics, Adult-onset Still's disease, lcsh:Diseases of the musculoskeletal system, business.industry, Published Erratum, MEDLINE, Interleukin, Rheumatology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Internal medicine, medicine, lcsh:RC925-935, business
Abstract

Following publication of the original article [1], it was brought to our attention that the AOSD Consensus Group was incorrectly tagged and therefore not searchable. The publishers apologize for this error.

Published
2020

24. Comparison of early vs. delayed anakinra treatment in patients with adult onset Still's disease and effect on clinical and laboratory outcomes

Author

Vitale, A, Cavalli, G, Ruscitti, P, Sota, J, Colafrancesco, S, Priori, R, Valesini, G, Argolini, Lm, Baldissera, E, Bartoloni, E, Cammelli, D, Canestrari, G, Cavallaro, E, Massaro, Mg, Cipriani, P, De Marchi, G, De Vita, S, Emmi, G, Frassi, M, Gerli, R, Gremese, Elisa, Iannone, F, Fornaro, M, Paladini, A, Lopalco, G, Manna, Raffaele, Mathieu, A, Montecucco, C, Mosca, M, Piazza, I, Piga, M, Pontikaki, I, Romano, M, Rossi, S, Rossini, M, Silvestri, E, Stagnaro, C, Talarico, R, Frediani, B, Tincani, A, Viapiana, O, Vitiello, G, Galozzi, P, Sfriso, P, Gaggiano, C, Grosso, S, Rigante, Donato, Dagna, L, Giacomelli, R, Cantarini, L., Gremese E (ORCID:0000-0002-2248-1058), Manna R (ORCID:0000-0003-1560-3907), Rigante D (ORCID:0000-0001-7032-7779), Vitale, A, Cavalli, G, Ruscitti, P, Sota, J, Colafrancesco, S, Priori, R, Valesini, G, Argolini, Lm, Baldissera, E, Bartoloni, E, Cammelli, D, Canestrari, G, Cavallaro, E, Massaro, Mg, Cipriani, P, De Marchi, G, De Vita, S, Emmi, G, Frassi, M, Gerli, R, Gremese, Elisa, Iannone, F, Fornaro, M, Paladini, A, Lopalco, G, Manna, Raffaele, Mathieu, A, Montecucco, C, Mosca, M, Piazza, I, Piga, M, Pontikaki, I, Romano, M, Rossi, S, Rossini, M, Silvestri, E, Stagnaro, C, Talarico, R, Frediani, B, Tincani, A, Viapiana, O, Vitiello, G, Galozzi, P, Sfriso, P, Gaggiano, C, Grosso, S, Rigante, Donato, Dagna, L, Giacomelli, R, Cantarini, L., Gremese E (ORCID:0000-0002-2248-1058), Manna R (ORCID:0000-0003-1560-3907), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Background: Aim of this study was to search for any difference in the outcome of patients with adult onset Still's disease (AOSD) treated with anakinra (ANK) in relation with the interval between disease onset and the start of anti-interleukin(IL)-1 treatment and according with the different lines of ANK treatment. Patients and Methods: One hundred and forty-one AOSD patients treated with ANK have been retrospectively assessed. Statistically significant differences (p < 0.05) were analyzed in the frequency of ANK effectiveness, primary or secondary inefficacy to ANK and rate of resolution of clinical and laboratory AOSD manifestations after 3, 6, and 12 months since ANK treatment according with different lines of treatment and different times between AOSD onset and start of ANK. Results: No significant differences were identified in the ANK effectiveness and frequency of primary or secondary inefficacy for patients starting ANK within 6 months (p = 0.19, p = 0.14, and p = 0.81, respectively) or 12 months (p = 0.37, p = 0.23, and p = 0.81, respectively) since AOSD onset compared with patients starting ANK thereafter; no significant differences were identified in ANK effectiveness and primary or secondary inefficacy according with different lines of ANK treatment (p = 0.06, p = 0.19, and p = 0.13, respectively). Patients starting ANK within 6 and 12 months since AOSD onset showed a significantly quicker decrease of erythrocyte sedimentation rate and C-reactive protein than observed among patients undergoing ANK treatment after 6 and 12 months. The number of swollen joints at the 3 month follow-up visit was significantly lower among patients undergoing ANK within 6 months since AOSD onset (p = 0.01), while no significance was identified at the 6 and 12 month assessments (p = 0.23 and p = 0.45, respectively). At the 3 and 6 month visits, the number of swollen joints was significantly higher among patients previously treated with conventional and biological disease mo

Published
2020

25. PBI57 Effectiveness of Biologic Treatments for Psoriatic Arthritis in Italy: Preliminary Results of the Chronos Study

Author

Colombo, D., primary, Simoni, L., additional, Ori, A., additional, Fiocchi, M., additional, Frassi, M., additional, Pagano Mariano, G., additional, Fusaro, E., additional, Lomater, C., additional, Del Medico, P., additional, Iannone, F., additional, Foti, R., additional, Limonta, M., additional, Marchesoni, A., additional, Raffeiner, B., additional, Viapiana, O., additional, Grassi, W., additional, Grembiale, R.D., additional, Guggino, G., additional, Faggioli, P., additional, Tirri, E., additional, Perricone, R., additional, Sarzi Puttini, P.C., additional, De Vita, S., additional, Conti, F., additional, and Zagni, E., additional

Published
2020
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27. Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice: a nationwide multicenter retrospective observational study

Author

Sota J, Vitale A, Insalaco A, Sfriso P, Lopalco G, Emmi G, Cattalini M, Manna R, Cimaz R, Priori R, Talarico R, de Marchi G, Frassi M, Gallizzi R, Soriano A, Alessio M, Cammelli D, Maggio MC, Gentileschi S, Marcolongo R, La Torre F, Fabiani C, Colafrancesco S, Ricci F, Galozzi P, Viapiana O, Verrecchia E, Pardeo M, Cerrito L, Cavallaro E, Olivieri AN, Paolazzi G, Vitiello G, Maier A, Silvestri E, Stagnaro C, Valesini G, Mosca M, de Vita S, Tincani A, Lapadula G, Frediani B, De Benedetti F, Iannone F, Punzi L, Salvarani C, Galeazzi M, Angotti R, Messina M, Tosi GM, Rigante, Sota, J, Vitale, A, Insalaco, A, Sfriso, P, Lopalco, G, Emmi, G, Cattalini, M, Manna, R, Cimaz, R, Priori, R, Talarico, R, de Marchi, G, Frassi, M, Gallizzi, R, Soriano, A, Alessio, M, Cammelli, D, Maggio, Mc, Gentileschi, S, Marcolongo, R, La Torre, F, Fabiani, C, Colafrancesco, S, Ricci, F, Galozzi, P, Viapiana, O, Verrecchia, E, Pardeo, M, Cerrito, L, Cavallaro, E, Olivieri, An, Paolazzi, G, Vitiello, G, Maier, A, Silvestri, E, Stagnaro, C, Valesini, G, Mosca, M, de Vita, S, Tincani, A, Lapadula, G, Frediani, B, De Benedetti, F, Iannone, F, Punzi, L, Salvarani, C, Galeazzi, M, Angotti, R, Messina, M, Tosi, Gm, and Rigante

Published
2018

28. Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real life clinical practice: a nationwide multicenter retrospective observational study

Author

Sota, J, Vitale, A, Insalaco, A, Sfriso, P, Lopalco, G, Emmi, G, Cattalini, M, Manna, R, Cimaz, R, Priori, R, Talarico, R, de Marchi, G, Frassi, M, Gallizzi, R, Soriano, A, Alessio, M, Cammelli, D, Maggio, Mc, Gentileschi, S, Marcolongo, R, La Torre, F, Fabiani, C, Colafrancesco, S, Ricci, F, Galozzi, P, Viapiana, O, Verrecchia, E, Pardeo, M, Cerrito, L, Cavallaro, E, Olivieri, An, Paolazzi, G, Vitiello, G, Maier, A, Silvestri, E, Stagnaro, C, Valesini, G, Mosca, M, de Vita, S, Tincani, A, Lapadula, G, Frediani, B, De Benedetti, F, Iannone, F, Punzi, L, Salvarani, C, Galeazzi, M, Angotti, R, Messina, M, Tosi, Gm, Rigante, D, Cantarini, L, 'Working Group' of Systemic Autoinflammatory Diseases of SIR (Italian Society of, Rheumatology)., Sota, J., Vitale, A., Insalaco, A., Sfriso, P., Lopalco, G., Emmi, G., Cattalini, M., Manna, R., Cimaz, R., Priori, R., Talarico, R., de Marchi, G., Frassi, M., Gallizzi, R., Soriano, A., Alessio, M., Cammelli, D., Maggio, M. C., Gentileschi, S., Marcolongo, R., La Torre, F., Fabiani, C., Colafrancesco, S., Ricci, F., Galozzi, P., Viapiana, O., Verrecchia, E., Pardeo, M., Cerrito, L., Cavallaro, E., Olivieri, A. N., Paolazzi, G., Vitiello, G., Maier, A., Silvestri, E., Stagnaro, C., Valesini, G., Mosca, M., de Vita, S., Tincani, A., Lapadula, G., Frediani, B., De Benedetti, F., Iannone, F., Punzi, L., Salvarani, C., Galeazzi, M., Angotti, R., Messina, M., Tosi, G. M., Rigante, D., Cantarini, L., Sota, Jurgen, Vitale, Antonio, Insalaco, Antonella, Sfriso, Paolo, Lopalco, Giuseppe, Emmi, Giacomo, Cattalini, Marco, Manna, Raffaele, Cimaz, Rolando, Priori, Roberta, Talarico, Rosaria, de Marchi, Ginevra, Frassi, Micol, Gallizzi, Romina, Soriano, Alessandra, Alessio, Maria, Cammelli, Daniele, Maggio, Maria Cristina, Gentileschi, Stefano, Marcolongo, Renzo, La Torre, Francesco, Fabiani, Claudia, Colafrancesco, Serena, Ricci, Francesca, Galozzi, Paola, Viapiana, Ombretta, Verrecchia, Elena, Pardeo, Manuela, Cerrito, Lucia, Cavallaro, Elena, Olivieri, Alma Nunzia, Paolazzi, Giuseppe, Vitiello, Gianfranco, Maier, Armin, Silvestri, Elena, Stagnaro, Chiara, Valesini, Guido, Mosca, Marta, de Vita, Salvatore, Tincani, Angela, Lapadula, Giovanni, Frediani, Bruno, De Benedetti, Fabrizio, Iannone, Florenzo, Punzi, Leonardo, Salvarani, Carlo, Galeazzi, Mauro, Angotti, Rossella, Messina, Mario, Tosi, Gian Marco, Rigante, Donato, and Cantarini, Luca

Subjects
Anakinra, Autoinflammatory disorders, Canakinumab, Interleukin-1, Safety profile, 0301 basic medicine, Male, Settore MED/16 - REUMATOLOGIA, 0302 clinical medicine, Retrospective Studie, Rheumatology, Child, Antibodies, Monoclonal, General Medicine, Middle Aged, Treatment Outcome, Autoinflammation, Female, Cohort study, medicine.drug, Human, Adult, medicine.medical_specialty, Adolescent, Logistic Model, Neutropenia, Antibodies, Monoclonal, Humanized, Autoimmune Disease, Autoimmune Diseases, 03 medical and health sciences, Young Adult, Internal medicine, Injection site reaction, medicine, Humans, Anakinra, Autoinflammatory disorders, Canakinumab, Interleukin-1, Safety profile, Adolescent, Adult, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Autoimmune Diseases, Child, Female, Humans, Interleukin 1 Receptor Antagonist Protein, Logistic Models, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Young Adult, Adverse effect, Retrospective Studies, 030203 arthritis & rheumatology, business.industry, Retrospective cohort study, medicine.disease, Interleukin 1 Receptor Antagonist Protein, Logistic Models, 030104 developmental biology, Autoinflammatory disorder, Observational study, business
Abstract

A few studies have reported the safety profile of interleukin (IL)-1 blockers from real life. The aim of this study is to describe anakinra (ANA) and canakinumab (CAN) safety profile in children and adults, based on data from a real-life setting. Demographic, clinical, and therapeutic data from patients treated with ANA and CAN were retrospectively collected and analyzed. Four hundred and seventy five patients were enrolled; ANA and CAN were prescribed in 421 and 105 treatment courses, respectively. During a mean follow-up of 24.39 ± 27.04 months, 89 adverse events (AE) were recorded; 13 (14.61%) were classified as serious AE (sAE). The overall estimated rate of AE and sAE was 8.4 per 100 patients/year. Safety concerns were more frequent among patients aged ≥ 65 years compared with patients < 16 years (p = 0.002). No differences were detected in the frequency of safety concerns between monotherapy and combination therapy with immunosuppressants (p = 0.055), but a significant difference was observed when injection site reactions were excluded from AE (p = 0.01). No differences were identified in relation to gender (p = 0.462), different lines of biologic therapy (p = 0.775), and different dosages (p = 0.70 ANA; p = 0.39 CAN). The overall drug retention rate was significantly different according to the occurrence of safety concerns (p value < 0.0001); distinguishing between ANA and CAN, significance was maintained only for ANA (p < 0.0001 ANA; p > 0.05 CAN). Treatment duration was the only variable associated with onset of AE (OR = 0.399 [C.I. 0.250–0.638], p = 0.0001). ANA and CAN have shown an excellent safety profile; the risk for AE and sAE tends to decrease over time from the start of IL-1 inhibition.

Published
2018

29. Anakinra drug retention rate and predictive factors of drug survival in systemic juvenile idiopathic arthritis and adult onset Still’s disease

Author

Sota, J, Rigante, Donato, Ruscitti, P, Insalaco, A, Sfriso, P, de Vita, S, Cimaz, R, Lopalco, G, Emmi, G, La Torre, F, Fabiani, C, Olivieri, An, Cattalini, M, Cammelli, D, Gallizzi, R, Alessio, M, Manna, Raffaele, Viapiana, O, Frassi, M, Maier, A, Salvarani, C, Talarico, R, Priori, R, Maggio, Mc, Vitale, A, Giacomelli, R, and Cantarini L for the Working Group of Systemic AutoInflammatory Diseases of, S. I. R.

Subjects
Anakinra, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Juvenile idiopathic arthritis
Published
2019

30. Long-term retention rate of anakinra in adult onset Still’s disease and predictive factors for treatment response.

Author

Vitale, A, Cavalli, G, Colafrancesco, S, Priori, R, Valesini, G, Argolini, Lm, Baldissera, E, Bartoloni, E, Cammelli, D, Canestrari, G, Sota, J, Cavallaro, E, Massaro, Maria Grazia, Ruscitti, P, Cipriani, P, De Marchi, G, De Vita, S, Emmi, G, Ferraccioli, Gianfranco, Frassi, M, Gerli, R, Gremese, Elisa, Iannone, F, Lapadula, G, Lopalco, G, Manna, Raffaele, Mathieu, A, Montecucco, C, Mosca, M, Piazza, I, Piga, M, Pontikaki, I, Romano, M, Rossi, S, Rossini, M, Silvestri, E, Stagnaro, C, Talarico, R, Tincani, A, Viapiana, O, Vitiello, G, Galozzi, P, Sfriso, P, Gaggiano, C, Rigante, Donato, Dagna, L, Giacomelli, R, Cantarini, L, Ferraccioli G (ORCID:0000-0001-6246-2428), Gremese E (ORCID:0000-0002-2248-1058), Manna R (ORCID:0000-0003-1560-3907), Rigante D (ORCID:0000-0001-7032-7779), Vitale, A, Cavalli, G, Colafrancesco, S, Priori, R, Valesini, G, Argolini, Lm, Baldissera, E, Bartoloni, E, Cammelli, D, Canestrari, G, Sota, J, Cavallaro, E, Massaro, Maria Grazia, Ruscitti, P, Cipriani, P, De Marchi, G, De Vita, S, Emmi, G, Ferraccioli, Gianfranco, Frassi, M, Gerli, R, Gremese, Elisa, Iannone, F, Lapadula, G, Lopalco, G, Manna, Raffaele, Mathieu, A, Montecucco, C, Mosca, M, Piazza, I, Piga, M, Pontikaki, I, Romano, M, Rossi, S, Rossini, M, Silvestri, E, Stagnaro, C, Talarico, R, Tincani, A, Viapiana, O, Vitiello, G, Galozzi, P, Sfriso, P, Gaggiano, C, Rigante, Donato, Dagna, L, Giacomelli, R, Cantarini, L, Ferraccioli G (ORCID:0000-0001-6246-2428), Gremese E (ORCID:0000-0002-2248-1058), Manna R (ORCID:0000-0003-1560-3907), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

We have evaluated long-term retention rate of anakinra in adult onset Still disease and predictive factors for treatment response. The risk of losing anakinra efficacy increases along with the number of swollen joints at the start of therapy, while the typical skin rash is a negative predictor of anakinra withdrawal.

Published
2019

38. A snapshot on the on-label and off-label use of the interleukin-1 inhibitors in Italy among rheumatologists and pediatric rheumatologists: a nationwide multi-center retrospective observational study

Author

Vitale, A., Insalaco, A., Sfriso, P., Lopalco, G., Emmi, G., Cattalini, M., Manna, Raffaele, Cimaz, R., Priori, R., Talarico, R., Gentileschi, Stefano, de Marchi, G., Frassi, M., Gallizzi, R., Soriano, A., Alessio, M., Cammelli, D., Maggio, M. C., Marcolongo, R., La Torre, F., Fabiani, C., Colafrancesco, S., Ricci, F., Galozzi, P., Viapiana, O., Verrecchia, E., Pardeo, M., Cerrito, Lucia, Cavallaro, E., Olivieri, A. N., Paolazzi, G., Vitiello, G., Maier, A., Silvestri, E., Stagnaro, C., Valesini, G., Mosca, M., de Vita, S., Tincani, A., Lapadula, G., Frediani, B., De Benedetti, F., Iannone, F., Punzi, L., Salvarani, C., Galeazzi, M., Rigante, Donato, Cantarini, L., Manna, Raffaele (ORCID:0000-0003-1560-3907), Gentileschi, S. (ORCID:0000-0001-9682-4706), Rigante, Donato (ORCID:0000-0001-7032-7779), Vitale, A., Insalaco, A., Sfriso, P., Lopalco, G., Emmi, G., Cattalini, M., Manna, Raffaele, Cimaz, R., Priori, R., Talarico, R., Gentileschi, Stefano, de Marchi, G., Frassi, M., Gallizzi, R., Soriano, A., Alessio, M., Cammelli, D., Maggio, M. C., Marcolongo, R., La Torre, F., Fabiani, C., Colafrancesco, S., Ricci, F., Galozzi, P., Viapiana, O., Verrecchia, E., Pardeo, M., Cerrito, Lucia, Cavallaro, E., Olivieri, A. N., Paolazzi, G., Vitiello, G., Maier, A., Silvestri, E., Stagnaro, C., Valesini, G., Mosca, M., de Vita, S., Tincani, A., Lapadula, G., Frediani, B., De Benedetti, F., Iannone, F., Punzi, L., Salvarani, C., Galeazzi, M., Rigante, Donato, Cantarini, L., Manna, Raffaele (ORCID:0000-0003-1560-3907), Gentileschi, S. (ORCID:0000-0001-9682-4706), and Rigante, Donato (ORCID:0000-0001-7032-7779)

Abstract

Background: Interleukin (IL)-1 inhibitors have been suggested as possible therapeutic options in a large number of old and new clinical entities characterized by an IL-1 driven pathogenesis. Objectives: To perform a nationwide snapshot of the on-label and off-label use of anakinra (ANA) and canakinumab (CAN) for different conditions both in children and adults. Methods: We retrospectively collected demographic, clinical, and therapeutic data from both adult and pediatric patients treated with IL-1 inhibitors from January 2008 to July 2016. Results: Five hundred and twenty-six treatment courses given to 475 patients (195 males, 280 females; 111 children and 364 adults) were evaluated. ANA was administered in 421 (80.04%) courses, CAN in 105 (19.96%). Sixty-two (32.1%) patients had been treated with both agents. IL-1 inhibitors were employed in 38 different indications (37 with ANA, 16 with CAN). Off-label use was more frequent for ANA than CAN (p < 0.0001). ANA was employed as first-line biologic approach in 323 (76.7%) cases, while CAN in 37 cases (35.2%). IL-1 inhibitors were associated with corticosteroids in 285 (54.18%) courses and disease modifying anti-rheumatic drugs (DMARDs) in 156 (29.65%). ANA dosage ranged from 30 to 200 mg/day (or 1.0-2.0 mg/kg/day) among adults and 2-4 mg/kg/day among children; regarding CAN, the most frequently used posologies were 150mg every 8 weeks, 150mg every 4 weeks and 150mg every 6 weeks. The frequency of failure was higher among patients treated with ANA at a dosage of 100 mg/day than those treated with 2 mg/kg/day (p = 0.03). Seventy-six patients (14.4%) reported an adverse event (AE) and 10 (1.9%) a severe AE. AEs occurred more frequently after the age of 65 compared to both children and patients aged between 16 and 65 (p = 0.003 and p = 0.03, respectively). Conclusions: IL-1 inhibitors are mostly used off-label, especially ANA, during adulthood. The high frequency of good clinical responses suggests that IL-1 inhibitors

Published
2016

39. The CHRONOS Real-World Evidence of Biologic Treatments in Psoriatic Arthritis in Italy: A Post Hoc Gender Analysis

Author

Delia Colombo, Micol Frassi, Giuseppa Pagano Mariano, Enrico Fusaro, Claudia Lomater, Patrizia Del Medico, Florenzo Iannone, Rosario Foti, Massimiliano Limonta, Antonio Marchesoni, Bernd Raffeiner, Ombretta Viapiana, Marco Di Carlo, Rosa Daniela Grembiale, Giuliana Guggino, Paola Faggioli, Enrico Tirri, Roberto Perricone, Pier Carlo Sarzi Puttini, Salvatore De Vita, Fabrizio Conti, Sara Rizzoli, Barbara Roncari, Martina Fiocchi, Roberto Orsenigo, Emanuela Zagni, Collaboration group, Frassi Micol, Caminiti Maurizio, Fusaro Enrico, Lomater Claudia, Del Medico Patrizia, Iannone Fiorenzo, Foti Rosario, Limonta Massimiliano, Marchesoni Antonio, Raffeiner Bernd, Viapiana Ombretta, Grassi Walter, Grembiale Rosa Daniela, Guggino Giuliana, Mazzone Antonino, Tirri Enrico, Perricone Roberto, Sarzi Puttini Pier Carlo, De Vita Salvatore, and Conti Fabrizio

Subjects
biologics, effectiveness, gender differences, psoriatic arthritis, real-world evidence, observational study, Gynecology and obstetrics, RG1-991, Public aspects of medicine, RA1-1270
Abstract

Background: Phenotypic features and outcome differences between sexes have been reported in psoriatic arthritis (PsA). However, little is known about sex differences in effectiveness of biologics in clinical practice. Methods: Post hoc gender analysis of the CHRONOS, a multicenter, noninterventional, retroprospective Italian real-world study assessing 6-month and 1-year effectiveness of biologics for PsA. Results: Eligible patients were 399, 43.1% men. Sociodemographic characteristics, type of arthritis, baseline Disease Activity Score 28 joints (DAS28), and duration of biologic treatment were rather homogeneous. More men were overweight/obese and naive to biologics. The most frequently used biologics were TNF-inhibitors and secukinumab in both sexes. DAS28 responders were 72.7% (women) and 70.5% (men) at 6 months, and 68.0% in both sexes at 1 year. American College of Rheumatology (ACR) response showed a trend for men versus women to achieve more frequently ACR50 (32.6% vs. 26.5% at 6 months; 34.9% vs. 20.0% at 1 year) and ACR70 (22.3% vs. 12.4% at 6 months and 25.0% vs. 13.0% at 1 year). Global satisfaction with treatment at enrollment and after 6 months was slightly higher among men [mean (standard deviation) Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) score: 68.6 (18.6) and 69.9 (18.2), respectively] than women [65.3 (18.2), 66.2 (18.5)]. Conclusions: Overall response to biologics for PsA was rather favorable. With similar baseline disease severity, men appear to have a somewhat earlier and better response with higher treatment satisfaction.

Published
2022
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41. Secukinumab for patients with plaque psoriasis affected by multiple sclerosis: a mini‐review with a representative case report.

Author

Venturini, M., Zanca, A., Venturuzzo, A., Filippini, M., Frassi, M., Tincani, A., and Calzavara‐Pinton, P.G.

Subjects
MULTIPLE sclerosis, PSORIASIS, OPTIC neuritis, PSORIATIC arthritis
Abstract

Secukinumab for patients with plaque psoriasis affected by multiple sclerosis: a mini-review with a representative case report Concerning MS, the disease remained stable over time; no other neurological symptoms were reported and MRI imaging did not show any sign of disease progression. 9 Assefa GT, Kaneko S, Oguro H, Morita E. Treatment of psoriasis and psoriatic arthritis with secukinumab after unsatisfactory response to Ustekinumab in multiple sclerosis patient. [Extracted from the article]

Published
2020
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