1. Efficacy and safety of adalimumab as the first- and second-line biologic therapy for children with juvenile idiopathic arthritis under four years of age
- Author
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Rina Denisova, T. Dvoryakovskaya, Alexandra Chomahidze, A. Fetisova, Alina Alshevskaya, A. Mamutova, Ekaterina Alexeeva, T. Sleptsova, Andrey Moskalev, and K. Isaeva
- Subjects
Prior treatment ,lcsh:Immunologic diseases. Allergy ,Pediatrics ,medicine.medical_specialty ,business.industry ,Adalimumab ,Arthritis ,Biologics ,Juvenile idiopathic arthritis ,medicine.disease ,Second line ,Prior Therapy ,Rheumatology ,Switching ,Medicine ,Juvenile ,Observational study ,Registry data ,business ,lcsh:RC581-607 ,medicine.drug - Abstract
Background New biologics developed to treat juvenile idiopathic arthritis (JIA) and the broadening range of indications for young children offer new drug switch options if the first-line treatment has proved ineffective. Nevertheless, the question regarding selection of the optimal medication depending on patients' characteristics and prior therapy still needs to be solved. Aim of the work To evaluate the efficacy and safety of adalimumab (ADA) as the first and subsequent biologic drug in children under 4 years of age. Patients and methods Analysis was performed using the Research Center for Children’s Health registry data, including the prospective observational results involving children with JIA who had started ADA treatment between 2009 and 2012. Patients were allocated into the biologic-switcher (n = 8) and biologic-naive (n = 17) groups according to prior treatment. The response to therapy was assessed using the ACR Pedi and the modified Wallace criteria. Results The percentage of patients who had achieved ACR50/70/90 after 24-month therapy was 82.4/76.5/64.7% in the biologic-naive and 62.5/50.0/37.5% in the biologic-switcher group. The percentages of patients who had achieved remission were comparable between the two groups (41.2 and 37.5%, respectively). 23 AEs occurred in 16 (64%) patients throughout the follow-up period. ADA was withdrawn from 6(24%) patients. One (5.9%) biologic-naive patient and 2(25%) biologic-switchers discontinued treatment because of lack of efficacy. Conclusions ADA is efficacious and relatively safe in children younger than 4 years. However, ADA showed better efficacy in achieving ACR70/90 and maintaining the lowest disease activity at 24 months treatment in biologic-naive patients.
- Published
- 2020