Evidence map›Paper›PMID 38206518›Full record

ArticleOphthalmology and therapy2024

Effectiveness and Safety of Biosimilars in Pediatric Non-infectious Uveitis: Real-Life Data from the International AIDA Network Uveitis Registry.

Maria Tarsia, Antonio Vitale, Carla Gaggiano, Jurgen Sota, Anna Maselli, Chiara Bellantonio, Silvana Guerriero, Rosanna Dammacco, Francesco La Torre, Gaafar Ragab and 34 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05200715 (Development of an International Multicenter Registry of Patients With Monogenic and Polygenic Autoinflammatory Diseases Aimed at Clinical and Therapeutical Data Collection and Analysis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.8field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05200715 recruitingnot on this map

Development of an International Multicenter Registry of Patients With Monogenic and Polygenic Autoinflammatory Diseases Aimed at Clinical and Therapeutical Data Collection and Analysis

Typeobservational_patient_registrySponsorUniversity of SienaRan2020 to 2030Enrolled3,500ConditionsHereditary Autoinflammatory Diseases, Schnitzler Syndrome, Behcet Syndrome, PFAPA SyndromeArmsNo intervention is foreseen by the protocol.
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Adalimumab biosimilars compared to originator: impact on uveitic macular edema.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  2. Biosimilars in Adult and Pediatric Noninfectious Uveitis.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Review
  3. Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

44 authors at 20 institutions in 6 countries.

Maria Tarsia *Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy.
Antonio Vitale *Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, ERN RITA Center, Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Policlinico "Le Scotte", Viale Bracci 1, 53100, Siena, Italy.
Carla GaggianoResearch Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, ERN RITA Center, Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Policlinico "Le Scotte", Viale Bracci 1, 53100, Siena, Italy.
Jurgen SotaResearch Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, ERN RITA Center, Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Policlinico "Le Scotte", Viale Bracci 1, 53100, Siena, Italy.
Anna MaselliClinical Paediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy.
Chiara BellantonioClinical Paediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy.
Silvana GuerrieroDepartment of Ophthalmology and Otolaryngology, University of Bari, Bari, Italy.
Rosanna DammaccoDepartment of Ophthalmology and Otolaryngology, University of Bari, Bari, Italy.
Francesco La TorreDepartment of Pediatrics, Giovanni XXIII Pediatric Hospital, University of Bari, 70126, Bari, Italy.
Gaafar RagabInternal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt.
Mohamed Tharwat HegazyInternal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt.
Alex FonollosaDepartment of Ophthalmology, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, University of the Basque Country, Barakaldo, Spain.
Maria Pia ParoliUveitis Service, Ophthalmologic Unit, Department of Sense Organs, Sapienza University of Rome, Rome, Italy.
Emanuela Del GiudicePediatric Rheumatology Unit, Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Rome, Italy.
Maria Cristina MaggioUniversity Department PROMISE "G. D'Alessandro", University of Palermo, Palermo, Italy.
Marco CattaliniPediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy.
Lampros FotisThird Department of Paediatrics, National and Kapodistrian University of Athens, General University Hospital "Attikon", Athens, Greece.
Giovanni ContiPediatric Nephrology and Rheumatology Unit with Dialysis, Department of Human Pathology in Adulthood and Childhood "G. Barresi", AOU Policlinic "G. Martino", Messina University, Messina, Italy.
Angela MauroPediatric Rheumatology Unit, Department of Childhood and Developmental Medicine, Fatebenefratelli-Sacco Hospital, Piazzale Principessa Clotilde, 20121, Milan, Italy.
Adele CivinoPediatric Rheumatology and Immunology Unit, Vito Fazzi Hospital, 73100, Lecce, Italy.
Federico DiomedaPediatric Rheumatology and Immunology Unit, Vito Fazzi Hospital, 73100, Lecce, Italy.
Alejandra de-la-TorreNeuroscience Research Group (NEUROS), Neurovitae Center for Neuroscience, Institute of Translational Medicine (IMT), School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia.
Carlos Cifuentes-GonzálezNeuroscience Research Group (NEUROS), Neurovitae Center for Neuroscience, Institute of Translational Medicine (IMT), School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia.
Samar TharwatRheumatology and Immunology Unit, Department of Internal Medicine, Faculty of Medicine, Mansoura University, El Gomhouria St, Mansoura, Dakahlia Governorate, Egypt.
José Hernández-RodríguezUnidad Clínica de Enfermedades Autoinflamatorias y Grupo de Investigación en Vasculitis, Servicio de Enfermedades Autoimmunes, Hospital Clínic de Barcelona, Universitat de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Verónica Gómez-CaverzaschiUnidad Clínica de Enfermedades Autoinflamatorias y Grupo de Investigación en Vasculitis, Servicio de Enfermedades Autoimmunes, Hospital Clínic de Barcelona, Universitat de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Laura PelegrínUnidad Clínica de Enfermedades Autoinflamatorias y Grupo de Investigación en Vasculitis, Servicio de Enfermedades Autoimmunes, Hospital Clínic de Barcelona, Universitat de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Kalpana BabuDepartment of Uveitis and Ocular Inflammation, Vittala International Institute of Ophthalmology and Prabha Eye Clinic and Research Centre, Bengaluru, Karnataka, India.
Vishali GuptaAdvanced Eye Centre, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Francesca MinoiaFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Piero RuscittiDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Delta 6 Building, PO Box 67100, L'Aquila, Italy.
Stefania CostiUniversità degli Studi di Milano, Milan, Italy.
Luciana BredaDepartment of Paediatrics, University of Chieti-Pescara, Chieti, Italy.
Saverio La BellaDepartment of Paediatrics, University of Chieti-Pescara, Chieti, Italy.
Alessandro ConfortiDepartment of General Medicine, Ospedale San Paolo, Civitavecchia, Italy.
Maria Antonietta MazzeiUnit of Diagnostic Imaging, Department of Medical, Surgical and Neuro Sciences and of Radiological Sciences, University of Siena, Azienda Ospedaliero-Universitaria Senese, 53100, Siena, Italy.
Ester CarreñoDepartment of Ophthalmology, Hospital Universitario Rey Juan Carlos, Madrid, Spain.
Rana Hussein AminOpthalmology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Salvatore GrossoClinical Paediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy.
Bruno FredianiResearch Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, ERN RITA Center, Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Policlinico "Le Scotte", Viale Bracci 1, 53100, Siena, Italy.
Gian Marco TosiDepartment of Medicine, Surgery and Neurosciences, Ophthalmology Unit, ERN RITA Center, Policlinico "Le Scotte", University of Siena, Viale Bracci 16, 53100, Siena, Italy.
Alberto BalistreriBioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
Luca CantariniResearch Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, ERN RITA Center, Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Policlinico "Le Scotte", Viale Bracci 1, 53100, Siena, Italy. cantariniluca@hotmail.com.ORCID http://orcid.org/0000-0002-7352-1275
Claudia FabianiDepartment of Medicine, Surgery and Neurosciences, Ophthalmology Unit, ERN RITA Center, Policlinico "Le Scotte", University of Siena, Viale Bracci 16, 53100, Siena, Italy. claudia.fabiani@aidanetwork.org.
University of Siena · ITCairo University · EGHospital Clínic de Barcelona · ESOspedale Vito Fazzi · ITSapienza University of Rome · ITUniversidad del Rosario · COUniversity of Bari Aldo Moro · ITUniversity of Chieti-Pescara · ITASST Fatebenefratelli Sacco · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITHospital Universitario Rey Juan Carlos · ESMansoura University · EGNational and Kapodistrian University of Athens · GROspedale Pediatrico Giovanni XXIII · ITOspedale San Paolo · ITPost Graduate Institute of Medical Education and Research · INUniversity of L'Aquila · ITUniversity of Messina · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSince many biological drug patents have expired, biosimilar agents (BIOs) have been developed; however, there are still some reservations in their use, especially in childhood. The aim of the current study is to evaluate the efficacy and safety of tumor necrosis factor (TNF) inhibitors BIOs as treatment for pediatric non-infectious uveitis (NIU).

methodsData from pediatric patients with NIU treated with TNF inhibitors BIOs were drawn from the international AutoInflammatory Disease Alliance (AIDA) registries dedicated to uveitis and Behçet's disease. The effectiveness and safety of BIOs were assessed in terms of frequency of relapses, risk for developing ocular flares, best-corrected visual acuity (BCVA), glucocorticoids (GCs)-sparing effect, drug survival, frequency of ocular complications, and adverse drug event (AE).

resultsForty-seven patients (77 affected eyes) were enrolled. The BIOs employed were adalimumab (ADA) (89.4%), etanercept (ETA) (5.3%), and infliximab (IFX) (5.3%). The number of relapses 12 months prior to BIOs and at last follow-up was 282.14 and 52.43 per 100 patients/year. The relative risk of developing ocular flares before BIOs introduction compared to the period following the start of BIOs was 4.49 (95% confidence interval [CI] 3.38-5.98, p = 0.004). The number needed to treat (NNT) for ocular flares was 3.53. Median BCVA was maintained during the whole BIOs treatment (p = 0.92). A significant GCs-sparing effect was observed throughout the treatment period (p = 0.002). The estimated drug retention rate (DRR) at 12-, 24-, and 36-month follow-up were 92.7, 83.3, and 70.8%, respectively. The risk rate for developing structural ocular complications was 89.9/100 patients/year before starting BIOs and 12.7/100 patients/year during BIOs treatment, with a risk ratio of new ocular complications without BIOs of 7.1 (CI 3.4-14.9, p = 0.0003). Three minor AEs were reported.

conclusionsTNF inhibitors BIOs are effective in reducing the number of ocular uveitis relapses, preserving visual acuity, allowing a significant GCs-sparing effect, and preventing structural ocular complications.

trial registrationClinicalTrials.gov ID NCT05200715.

Indexed as

Adverse eventsBiosimilarsDrug retention ratePediatric uveitisSteroid-sparing effectTumor necrosis factor (TNF)-inhibitors

Identifiers

PMID38206518
PMCPMC10853125
OpenAlexW4390739662

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.