Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan

Background: Methotrexate is the first-line drug for treating patients with juvenile idiopathic arthritis (JIA). If it is ineffective or intolerable, prescription of genetically engineered biopharmaceuticals is indicated. Objective: The study was aimed at assessing effectiveness and safety of genetic...

Full description

Saved in:
Bibliographic Details
Main Authors: V. A. Maliyevskiy, O. A. Maliyevskiy, G. R. Gareyeva, L. S. Nazarova, A. A. Khasanova, A. Z. Nuriyakhmetova, D. D. Prolygina
Format: Article
Language:Russian
Published: Union of pediatricians of Russia 2016-02-01
Series:Педиатрическая фармакология
Subjects:
Online Access:https://www.pedpharma.ru/jour/article/view/1367
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849395890565939200
author V. A. Maliyevskiy
O. A. Maliyevskiy
G. R. Gareyeva
L. S. Nazarova
A. A. Khasanova
A. Z. Nuriyakhmetova
D. D. Prolygina
author_facet V. A. Maliyevskiy
O. A. Maliyevskiy
G. R. Gareyeva
L. S. Nazarova
A. A. Khasanova
A. Z. Nuriyakhmetova
D. D. Prolygina
author_sort V. A. Maliyevskiy
collection DOAJ
description Background: Methotrexate is the first-line drug for treating patients with juvenile idiopathic arthritis (JIA). If it is ineffective or intolerable, prescription of genetically engineered biopharmaceuticals is indicated. Objective: The study was aimed at assessing effectiveness and safety of genetically engineered biopharmaceutical adalimumab for treating children with JIA. Methods: A retrospective cohort study was conducted to analyze results of treating patients with JIA aged 2–17 years. Adalimumab would be prescribed biweekly in the dose of 24 mg/m2 (body surface) subcutaneously (if body weight is under 30 kg) or in the dose of 40 mg/m2 (if body weight is > 30 kg). Effectiveness and safety would be assessed after 4–12–24–48–96 weeks. Results: We analyzed treatment results of 17 patients (15 children with active joint syndrome, 2 — with active uveitis). All patients with active joint syndrome had been receiving adalimumab for 12 weeks, 12 patients — for 24 weeks, 8 — for 48 weeks, 5 — for 96 weeks. 30/50/70% improvement in terms of the ACRpedi criteria was observed in 15/11/4 children after 4 weeks, after 12 weeks — in 15/13/11 patients, after 48 weeks — in 7/6/6 patients. The status of inactive disease was established in 5 patients (33%) after 12 weeks, after 24 weeks — in 9 children (75%), after 48 weeks — in 7 children (70%), after 96 weeks — in 4 (80%) children. Active uveitis was terminated in all 5 patients with signs of eye damage in the treatment onset. 1 patient suffered from exacerbation of the disease after 48 weeks of therapy; the drug was withdrawn. Tubercular infection without local manifestations was established in 1 patient after 96 weeks (positive Mantoux test, papule — 10 mm). Adalimumab injection was terminated for the period of chemotherapy. Conclusion: Adalimumab has a sufficiently high effectiveness and safety for long-term (up to 2 years) treatment of children with JIA.
format Article
id doaj-art-5874dc5ac9c04eceb9c035b5d516ade4
institution Kabale University
issn 1727-5776
2500-3089
language Russian
publishDate 2016-02-01
publisher Union of pediatricians of Russia
record_format Article
series Педиатрическая фармакология
spelling doaj-art-5874dc5ac9c04eceb9c035b5d516ade42025-08-20T03:39:29ZrusUnion of pediatricians of RussiaПедиатрическая фармакология1727-57762500-30892016-02-0112664565010.15690/pf.v12i6.14871359Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of BashkortostanV. A. Maliyevskiy0O. A. Maliyevskiy1G. R. Gareyeva2L. S. Nazarova3A. A. Khasanova4A. Z. Nuriyakhmetova5D. D. Prolygina6Bashkir State Medical University, Ufa, Russian FederationBashkir State Medical University, Ufa, Russian FederationBashkir State Medical University, Ufa, Russian FederationBashkir State Medical University, Ufa, Russian FederationRepublican Clinical Pediatric Hospital, Ufa, Russian FederationRepublican Clinical Pediatric Hospital, Ufa, Russian FederationRepublican Clinical Pediatric Hospital, Ufa, Russian FederationBackground: Methotrexate is the first-line drug for treating patients with juvenile idiopathic arthritis (JIA). If it is ineffective or intolerable, prescription of genetically engineered biopharmaceuticals is indicated. Objective: The study was aimed at assessing effectiveness and safety of genetically engineered biopharmaceutical adalimumab for treating children with JIA. Methods: A retrospective cohort study was conducted to analyze results of treating patients with JIA aged 2–17 years. Adalimumab would be prescribed biweekly in the dose of 24 mg/m2 (body surface) subcutaneously (if body weight is under 30 kg) or in the dose of 40 mg/m2 (if body weight is > 30 kg). Effectiveness and safety would be assessed after 4–12–24–48–96 weeks. Results: We analyzed treatment results of 17 patients (15 children with active joint syndrome, 2 — with active uveitis). All patients with active joint syndrome had been receiving adalimumab for 12 weeks, 12 patients — for 24 weeks, 8 — for 48 weeks, 5 — for 96 weeks. 30/50/70% improvement in terms of the ACRpedi criteria was observed in 15/11/4 children after 4 weeks, after 12 weeks — in 15/13/11 patients, after 48 weeks — in 7/6/6 patients. The status of inactive disease was established in 5 patients (33%) after 12 weeks, after 24 weeks — in 9 children (75%), after 48 weeks — in 7 children (70%), after 96 weeks — in 4 (80%) children. Active uveitis was terminated in all 5 patients with signs of eye damage in the treatment onset. 1 patient suffered from exacerbation of the disease after 48 weeks of therapy; the drug was withdrawn. Tubercular infection without local manifestations was established in 1 patient after 96 weeks (positive Mantoux test, papule — 10 mm). Adalimumab injection was terminated for the period of chemotherapy. Conclusion: Adalimumab has a sufficiently high effectiveness and safety for long-term (up to 2 years) treatment of children with JIA.https://www.pedpharma.ru/jour/article/view/1367childrenjuvenile idiopathic arthritisgenetically engineered biopharmaceuticalsadalimumab
spellingShingle V. A. Maliyevskiy
O. A. Maliyevskiy
G. R. Gareyeva
L. S. Nazarova
A. A. Khasanova
A. Z. Nuriyakhmetova
D. D. Prolygina
Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan
Педиатрическая фармакология
children
juvenile idiopathic arthritis
genetically engineered biopharmaceuticals
adalimumab
title Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan
title_full Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan
title_fullStr Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan
title_full_unstemmed Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan
title_short Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan
title_sort retrospective cohort study of effectiveness and safety of adalimumab use in children with juvenile idiopathic arthritis in the republic of bashkortostan
topic children
juvenile idiopathic arthritis
genetically engineered biopharmaceuticals
adalimumab
url https://www.pedpharma.ru/jour/article/view/1367
work_keys_str_mv AT vamaliyevskiy retrospectivecohortstudyofeffectivenessandsafetyofadalimumabuseinchildrenwithjuvenileidiopathicarthritisintherepublicofbashkortostan
AT oamaliyevskiy retrospectivecohortstudyofeffectivenessandsafetyofadalimumabuseinchildrenwithjuvenileidiopathicarthritisintherepublicofbashkortostan
AT grgareyeva retrospectivecohortstudyofeffectivenessandsafetyofadalimumabuseinchildrenwithjuvenileidiopathicarthritisintherepublicofbashkortostan
AT lsnazarova retrospectivecohortstudyofeffectivenessandsafetyofadalimumabuseinchildrenwithjuvenileidiopathicarthritisintherepublicofbashkortostan
AT aakhasanova retrospectivecohortstudyofeffectivenessandsafetyofadalimumabuseinchildrenwithjuvenileidiopathicarthritisintherepublicofbashkortostan
AT aznuriyakhmetova retrospectivecohortstudyofeffectivenessandsafetyofadalimumabuseinchildrenwithjuvenileidiopathicarthritisintherepublicofbashkortostan
AT ddprolygina retrospectivecohortstudyofeffectivenessandsafetyofadalimumabuseinchildrenwithjuvenileidiopathicarthritisintherepublicofbashkortostan