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Paediatric Rheumatology

 

Drug survival of the infliximab biosimilar (CT-P13) in paediatric patients with non-infectious uveitis


1, 2, 3, 4, 5

 

  1. Department of Paediatric Rheumatology, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
  2. Department of Paediatric Ophthalmology, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
  3. Department of Paediatric Infectious Diseases, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
  4. Department of Paediatric Infectious Diseases, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
  5. Department of Paediatric Rheumatology, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.

CER13904
Paediatric Rheumatology

purchase article

PMID: 33635217 [PubMed]

Received: 07/08/2020
Accepted : 11/12/2020
In Press: 09/02/2021

Abstract

OBJECTIVES:
Paediatric non-infectious uveitis (NIU) is an important cause of significant long-term complications and blindness in children. Infliximab (IFX) is a chimeric human/murine monoclonal antibody against TNF-α that is effective in NIU resistant to conventional therapies. In this study, we aimed to determine the efficacy and safety of an IFX biosimilar (CT-P13) in paediatric patients with NIU.
METHODS:
This was a non-interventional and retrospective study that included paediatric patients with NIU who received IFX biosimilar CT-P13 treatment between January 2016 and January 2020. Demographic data pertaining to patients and their disease were collected. The efficacy and safety of the IFX biosimilar were evaluated.
RESULTS:
Twenty-six patients (44 eyes) were enrolled in this study. The median age (interquartile range) at the diagnosis of uveitis was 9.41 (5–12.3) years. The most common site of involvement was anterior uveitis, and bilateral involvement was more commonly seen in the older age group (p=0.32). The primary diagnosis of 16 patients was juvenile idiopathic arthritis, three had Behçet’s disease, six had idiopathic disease and one had sarcoidosis. All patients were treated with CT-P13 (22 patients were biologic-naïve, and four switched from adalimumab). The median follow-up time on IFX was 14 months (range 4–48). Complete recovery was achieved in 95.4% of eyes with active uveitis, while inactive disease was not achieved in two of them. We observed a reduction in the number of flares in all patients during the follow-up period (4.5±2.2 vs. 0.89±1, p=0.01). Treatment-emergent adverse events occurred in 26.9% of patients.
CONCLUSIONS:
To our knowledge, this is the first study to assess the impact of CT-P13 treatment adherence on disease activity in children with NIU. The IFX biosimilar CT-P13 is remarkably safe and effective for the long-term treatment of paediatric NIU.

Rheumatology Article