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Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data

BACKGROUND: A significant number of systemic juvenile idiopathic arthritis (sJIA) patients discontinue biologic disease-modifying antirheumatic drugs (bDMARDs) due to lack of efficacy or safety concerns. Studies of biologic therapy switch regimens in sJIA are required. METHODS: Patients with sJIA wh...

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Autores principales: Alexeeva, Ekaterina, Krekhova, Elizaveta, Dvoryakovskaya, Tatyana, Isaeva, Ksenia, Chomakhidze, Aleksandra, Chistyakova, Evgeniya, Lomakina, Olga, Denisova, Rina, Mamutova, Anna, Fetisova, Anna, Gautier, Marina, Vankova, Dariya, Kriulin, Ivan, Saygitov, Ruslan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9992960/
https://www.ncbi.nlm.nih.gov/pubmed/36911042
http://dx.doi.org/10.3389/fped.2023.1114207
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author Alexeeva, Ekaterina
Krekhova, Elizaveta
Dvoryakovskaya, Tatyana
Isaeva, Ksenia
Chomakhidze, Aleksandra
Chistyakova, Evgeniya
Lomakina, Olga
Denisova, Rina
Mamutova, Anna
Fetisova, Anna
Gautier, Marina
Vankova, Dariya
Kriulin, Ivan
Saygitov, Ruslan
author_facet Alexeeva, Ekaterina
Krekhova, Elizaveta
Dvoryakovskaya, Tatyana
Isaeva, Ksenia
Chomakhidze, Aleksandra
Chistyakova, Evgeniya
Lomakina, Olga
Denisova, Rina
Mamutova, Anna
Fetisova, Anna
Gautier, Marina
Vankova, Dariya
Kriulin, Ivan
Saygitov, Ruslan
author_sort Alexeeva, Ekaterina
collection PubMed
description BACKGROUND: A significant number of systemic juvenile idiopathic arthritis (sJIA) patients discontinue biologic disease-modifying antirheumatic drugs (bDMARDs) due to lack of efficacy or safety concerns. Studies of biologic therapy switch regimens in sJIA are required. METHODS: Patients with sJIA who switched from tocilizumab (due to lack of efficacy or safety) to canakinumab (4 mg/kg every 4 weeks) and were hospitalized at the rheumatology department from August 2012 to July 2020 were included. Primary efficacy outcomes were 30% or greater improvement based on the paediatric criteria of the American College of Rheumatology (ACR30), achievement of inactive disease (JADAS-71 = 0) and clinical remission (ACR sJIA clinical inactive disease criteria). Follow-up from time first canakinumab dose administered was 12 months or the closest time point (not less than 6 and not more than 18 months). Data were extracted from electronic outpatient medical records. RESULTS: During the study period, 46 patients with sJIA switched from tocilizumab to canakinumab. Median age at baseline was 8.2 [interquartile range (IQR) 4.0–12.9] years, with the median sJIA duration being 1.8 (IQR 0.8–5.8) years; 37 (80%) patients received at least one conventional DMARD (cDMARD; oral corticosteroids, methotrexate and/or cyclosporine A). Study outcomes were followed up in 45 patients (one patient did not attend the follow-up for an unknown reason); median follow-up was 359 (IQR 282–404) days. During the follow-up, 1 patient discontinued canakinumab due to tuberculosis detection and the dose was reduced or the injection interval increased in 4 (9%) patients. In total, 27 (60%) patients continued to receive at least one cDMARD. Improvement according to the ACR30 criteria was achieved in 43 patients [96%; 95% confidence interval (CI) 85–99], inactive disease in 42 (93%; 95%CI 82–98), and remission in 37 (82%; 95% CI 69-91); after adjustment for actual time-at-risk, the rates were 83, 85 and 73 events per 100 person-years, respectively. During follow-up, 23 AEs (most frequently infections) were reported in 19/45 (42%) patients; 5/45 (11%) patients developed macrophage activation syndrome, with a favorable outcome in all cases. CONCLUSIONS: One-year canakinumab therapy was found to be potentially effective as second-line biologic therapy after discontinuation of tocilizumab in patients with sJIA.
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spelling pubmed-99929602023-03-09 Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data Alexeeva, Ekaterina Krekhova, Elizaveta Dvoryakovskaya, Tatyana Isaeva, Ksenia Chomakhidze, Aleksandra Chistyakova, Evgeniya Lomakina, Olga Denisova, Rina Mamutova, Anna Fetisova, Anna Gautier, Marina Vankova, Dariya Kriulin, Ivan Saygitov, Ruslan Front Pediatr Pediatrics BACKGROUND: A significant number of systemic juvenile idiopathic arthritis (sJIA) patients discontinue biologic disease-modifying antirheumatic drugs (bDMARDs) due to lack of efficacy or safety concerns. Studies of biologic therapy switch regimens in sJIA are required. METHODS: Patients with sJIA who switched from tocilizumab (due to lack of efficacy or safety) to canakinumab (4 mg/kg every 4 weeks) and were hospitalized at the rheumatology department from August 2012 to July 2020 were included. Primary efficacy outcomes were 30% or greater improvement based on the paediatric criteria of the American College of Rheumatology (ACR30), achievement of inactive disease (JADAS-71 = 0) and clinical remission (ACR sJIA clinical inactive disease criteria). Follow-up from time first canakinumab dose administered was 12 months or the closest time point (not less than 6 and not more than 18 months). Data were extracted from electronic outpatient medical records. RESULTS: During the study period, 46 patients with sJIA switched from tocilizumab to canakinumab. Median age at baseline was 8.2 [interquartile range (IQR) 4.0–12.9] years, with the median sJIA duration being 1.8 (IQR 0.8–5.8) years; 37 (80%) patients received at least one conventional DMARD (cDMARD; oral corticosteroids, methotrexate and/or cyclosporine A). Study outcomes were followed up in 45 patients (one patient did not attend the follow-up for an unknown reason); median follow-up was 359 (IQR 282–404) days. During the follow-up, 1 patient discontinued canakinumab due to tuberculosis detection and the dose was reduced or the injection interval increased in 4 (9%) patients. In total, 27 (60%) patients continued to receive at least one cDMARD. Improvement according to the ACR30 criteria was achieved in 43 patients [96%; 95% confidence interval (CI) 85–99], inactive disease in 42 (93%; 95%CI 82–98), and remission in 37 (82%; 95% CI 69-91); after adjustment for actual time-at-risk, the rates were 83, 85 and 73 events per 100 person-years, respectively. During follow-up, 23 AEs (most frequently infections) were reported in 19/45 (42%) patients; 5/45 (11%) patients developed macrophage activation syndrome, with a favorable outcome in all cases. CONCLUSIONS: One-year canakinumab therapy was found to be potentially effective as second-line biologic therapy after discontinuation of tocilizumab in patients with sJIA. Frontiers Media S.A. 2023-02-22 /pmc/articles/PMC9992960/ /pubmed/36911042 http://dx.doi.org/10.3389/fped.2023.1114207 Text en © 2023 Alexeeva, Krekhova, Dvoryakovskaya, Isaeva, Chomakhidze, Chistyakova, Lomakina, Denisova, Mamutova, Fetisova, Gautier, Vankova, Kriulin and Saygitov. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (https://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pediatrics
Alexeeva, Ekaterina
Krekhova, Elizaveta
Dvoryakovskaya, Tatyana
Isaeva, Ksenia
Chomakhidze, Aleksandra
Chistyakova, Evgeniya
Lomakina, Olga
Denisova, Rina
Mamutova, Anna
Fetisova, Anna
Gautier, Marina
Vankova, Dariya
Kriulin, Ivan
Saygitov, Ruslan
Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data
title Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data
title_full Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data
title_fullStr Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data
title_full_unstemmed Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data
title_short Efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: A single-centre cohort study using routinely collected health data
title_sort efficacy and safety of canakinumab as a second line biologic after tocilizumab treatment failure in children with systemic juvenile idiopathic arthritis: a single-centre cohort study using routinely collected health data
topic Pediatrics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9992960/
https://www.ncbi.nlm.nih.gov/pubmed/36911042
http://dx.doi.org/10.3389/fped.2023.1114207
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