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...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Union of pediatricians of Russia
2016-02-01
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| Series: | Педиатрическая фармакология |
| Subjects: | |
| Online Access: | https://www.pedpharma.ru/jour/article/view/1367 |
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| Summary: | 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. |
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| ISSN: | 1727-5776 2500-3089 |