Ophthalmology and Therapy (Jan 2024)
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,
- Mohamed Tharwat Hegazy,
- Alex Fonollosa,
- Maria Pia Paroli,
- Emanuela Del Giudice,
- Maria Cristina Maggio,
- Marco Cattalini,
- Lampros Fotis,
- Giovanni Conti,
- Angela Mauro,
- Adele Civino,
- Federico Diomeda,
- Alejandra de-la-Torre,
- Carlos Cifuentes-González,
- Samar Tharwat,
- José Hernández-Rodríguez,
- Verónica Gómez-Caverzaschi,
- Laura Pelegrín,
- Kalpana Babu,
- Vishali Gupta,
- Francesca Minoia,
- Piero Ruscitti,
- Stefania Costi,
- Luciana Breda,
- Saverio La Bella,
- Alessandro Conforti,
- Maria Antonietta Mazzei,
- Ester Carreño,
- Rana Hussein Amin,
- Salvatore Grosso,
- Bruno Frediani,
- Gian Marco Tosi,
- Alberto Balistreri,
- Luca Cantarini,
- Claudia Fabiani
Affiliations
- Maria Tarsia
- Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena
- 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”
- Carla Gaggiano
- 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”
- Jurgen Sota
- 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”
- Anna Maselli
- Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena
- Chiara Bellantonio
- Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena
- Silvana Guerriero
- Department of Ophthalmology and Otolaryngology, University of Bari
- Rosanna Dammacco
- Department of Ophthalmology and Otolaryngology, University of Bari
- Francesco La Torre
- Department of Pediatrics, Giovanni XXIII Pediatric Hospital, University of Bari
- Gaafar Ragab
- Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University
- Mohamed Tharwat Hegazy
- Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University
- Alex Fonollosa
- Department of Ophthalmology, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, University of the Basque Country
- Maria Pia Paroli
- Uveitis Service, Ophthalmologic Unit, Department of Sense Organs, Sapienza University of Rome
- Emanuela Del Giudice
- Pediatric Rheumatology Unit, Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome
- Maria Cristina Maggio
- University Department PROMISE “G. D’Alessandro”, University of Palermo
- Marco Cattalini
- Pediatric Clinic, University of Brescia and Spedali Civili di Brescia
- Lampros Fotis
- Third Department of Paediatrics, National and Kapodistrian University of Athens, General University Hospital “Attikon”
- Giovanni Conti
- Pediatric Nephrology and Rheumatology Unit with Dialysis, Department of Human Pathology in Adulthood and Childhood “G. Barresi”, AOU Policlinic “G. Martino”, Messina University
- Angela Mauro
- Pediatric Rheumatology Unit, Department of Childhood and Developmental Medicine, Fatebenefratelli-Sacco Hospital
- Adele Civino
- Pediatric Rheumatology and Immunology Unit, Vito Fazzi Hospital
- Federico Diomeda
- Pediatric Rheumatology and Immunology Unit, Vito Fazzi Hospital
- Alejandra de-la-Torre
- Neuroscience Research Group (NEUROS), Neurovitae Center for Neuroscience, Institute of Translational Medicine (IMT), School of Medicine and Health Sciences, Universidad del Rosario
- Carlos Cifuentes-González
- Neuroscience Research Group (NEUROS), Neurovitae Center for Neuroscience, Institute of Translational Medicine (IMT), School of Medicine and Health Sciences, Universidad del Rosario
- Samar Tharwat
- Rheumatology and Immunology Unit, Department of Internal Medicine, Faculty of Medicine, Mansoura University
- José Hernández-Rodríguez
- Unidad 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)
- Verónica Gómez-Caverzaschi
- Unidad 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)
- Laura Pelegrín
- Unidad 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)
- Kalpana Babu
- Department of Uveitis and Ocular Inflammation, Vittala International Institute of Ophthalmology and Prabha Eye Clinic and Research Centre
- Vishali Gupta
- Advanced Eye Centre, Post-Graduate Institute of Medical Education and Research (PGIMER)
- Francesca Minoia
- Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
- Piero Ruscitti
- Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila
- Stefania Costi
- Università degli Studi di Milano
- Luciana Breda
- Department of Paediatrics, University of Chieti-Pescara
- Saverio La Bella
- Department of Paediatrics, University of Chieti-Pescara
- Alessandro Conforti
- Department of General Medicine, Ospedale San Paolo
- Maria Antonietta Mazzei
- Unit of Diagnostic Imaging, Department of Medical, Surgical and Neuro Sciences and of Radiological Sciences, University of Siena, Azienda Ospedaliero-Universitaria Senese
- Ester Carreño
- Department of Ophthalmology, Hospital Universitario Rey Juan Carlos
- Rana Hussein Amin
- Opthalmology Department, Faculty of Medicine, Cairo University
- Salvatore Grosso
- Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena
- Bruno Frediani
- 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”
- Gian Marco Tosi
- Department of Medicine, Surgery and Neurosciences, Ophthalmology Unit, ERN RITA Center, Policlinico “Le Scotte”, University of Siena
- Alberto Balistreri
- Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena
- Luca Cantarini
- 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”
- Claudia Fabiani
- Department of Medicine, Surgery and Neurosciences, Ophthalmology Unit, ERN RITA Center, Policlinico “Le Scotte”, University of Siena
- DOI
- https://doi.org/10.1007/s40123-023-00863-1
- Journal volume & issue
-
Vol. 13,
no. 3
pp. 761 – 774
Abstract
Abstract Introduction Since 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). Methods Data 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). Results Forty-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. Conclusions TNF 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 Registration ClinicalTrials.gov ID NCT05200715.
Keywords
- Adverse events
- Biosimilars
- Drug retention rate
- Pediatric uveitis
- Steroid-sparing effect
- Tumor necrosis factor (TNF)-inhibitors
