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Multicenter Study
. 2018 Oct 10;20(1):227.
doi: 10.1186/s13075-018-1728-3.

Persistence and adverse events of biological treatment in adult patients with juvenile idiopathic arthritis: results from BIOBADASER

Juan José Bethencourt Baute  1 , Carlos Sanchez-Piedra  2 , Dolores Ruiz-Montesinos  3 , Marta Medrano San Ildefonso  4 , Carlos Rodriguez-Lozano  5 , Eva Perez-Pampin  6 , Ana Ortiz  7 , Sara Manrique  8 , Rosa Roselló  9 , Victoria Hernandez  10 , Cristina Campos  11 , Agustí Sellas  12 , Walter Alberto Sifuentes-Giraldo  13 , Javier García-González  14 , Fernando Sanchez-Alonso  2 , Federico Díaz-González  15 , Juan Jesús Gómez-Reino  6 , Sagrario Bustabad Reyes  16 ; BIOBADASER study group
Affiliations
Multicenter Study

Persistence and adverse events of biological treatment in adult patients with juvenile idiopathic arthritis: results from BIOBADASER

Juan José Bethencourt Baute et al. Arthritis Res Ther. .

Abstract

Background: Biologic therapy has changed the prognosis of patients with juvenile idiopathic arthritis (JIA). The aim of this study was to examine the pattern of use, drug survival, and adverse events of biologics in patients with JIA during the period from diagnosis to adulthood.

Methods: All patients included in BIOBADASER (Spanish Registry for Adverse Events of Biological Therapy in Rheumatic Diseases), a multicenter prospective registry, diagnosed with JIA between 2000 and 2015 were analyzed. Proportions, means, and SDs were used to describe the population. Incidence rates and 95% CIs were calculated to assess adverse events. Kaplan-Meier analysis was used to compare the drug survival rates.

Results: A total of 469 patients (46.1% women) were included. Their mean age at diagnosis was 9.4 ± 5.3 years. Their mean age at biologic treatment initiation was 23.9 ± 13.9 years. The pattern of use of biologics during their pediatric years showed a linear increase from 24% in 2000 to 65% in 2014. Biologic withdrawal for disease remission was higher in patients who initiated use biologics prior to 16 years of age than in those who were older (25.7% vs 7.9%, p < 0.0001). Serious adverse events had a total incidence rate of 41.4 (35.2-48.7) of 1000 patient-years. Patients younger than 16 years old showed significantly increased infections (p < 0.001).

Conclusions: Survival and suspension by remission of biologics were higher when these compounds were initiated in patients with JIA who had not yet reached 16 years of age. The incidence rate of serious adverse events in pediatric vs adult patients with JIA treated with biologics was similar; however, a significant increase of infection was observed in patients under 16 years old.

Keywords: Biologic treatment; Clinical practice; Juvenile idiopathic arthritis; Safety therapy.

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Conflict of interest statement

Ethics approval and consent to participate

The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethics approval for the study was obtained from Hospital Clinic (Barcelona, Spain). The institutional review board at each participating center approved the protocol.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Dot plot showing the variations in the percentage of patients with juvenile idiopathic arthritis included in BIOBADASER annually who received their first biologic before age 16 since years 2000 to 2015
Fig. 2
Fig. 2
Kaplan-Meier survival curves. a Drug survival estimates by age (p = 0.02). b Drug survival estimates by monotherapy or combined therapy (p = 0.52). c Drug survival estimates by non-tumor necrosis factor inhibitor (non-TNFi) or TNF-i, only considering first and second lines of treatment (p = 0.06)
See this image and copyright information in PMC

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