CANAKINUMAB IN SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS: CLINICAL INACTIVE DISEASE RATE AND SAFETY IN ITALIAN PATIENTS

Risultato della ricerca: Meeting Abstract

Abstract

Background: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increased knowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targeted treatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1b monoclonal antibody, in two clinical trials but little information are available in real life.Objectives: To evaluate clinical inactive disease rate and safety of canakinumab in Italian patients with sJIA.Methods: We have collected retrospectively clinical and laboratory data of patients with sJIA treated with canakinumab in 9 Italian Pediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed the effect ofcanakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and physician’s globalassessment of disease activity score.Results: Forty seven patients (26 F) were included in the analyses. The median age (range) at the diagnosis and at the beginning of treatment with canakinumab was 7.6 (1-14.7) and 10.2 (1.7-22.2) years, respectively. Twenty seven patients (57.4%) had been previously treated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacy in 15/27 (55.5%). Thirty patients (63.8%) were receiving concomitant treatment with glucocorticoids at the median dose (range) of 0.69 (0.02-2.75) mg/kg/die. Thirtynine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2%) achieved CID at 6 months and 5/27 (18.5%) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24 achieved 6 months of follow-up and 12 (50%) of these were able to withdraw glucocorticoids. Minor adverse events were reported in 5/30 (16.6%) patients: upper respiratory tract infections in 4 and transient injection site reaction in 1. No cases of macrophage activation syndrome was reported.Conclusion: Our results provide initial real world evidence of the efficacy of treatment with canakinumab in patients with sJIA. In our study the percentage of patients who reached CID at 6 months is slightly higher (69.2%) than reported at the end (from 3 months to one year) of the 2 published randomized trials (60%). No serious adverse events were recorded in our population.
Lingua originaleEnglish
pagine (da-a)1345-1345
Numero di pagine1
RivistaAnnals of the Rheumatic Diseases
Volume78
Stato di pubblicazionePublished - 2019

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Juvenile Arthritis
Safety
Glucocorticoids
Cytokines
Interleukin 1 Receptor Antagonist Protein
Pediatrics
Macrophages
Interleukins
Biological Factors
Macrophage Activation Syndrome
canakinumab
Sedimentation
C-Reactive Protein
Chemical activation
Monoclonal Antibodies
Blood Sedimentation
Rheumatology
Exanthema
Respiratory Tract Infections
Fever

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@article{08a23fe1b48e4f88a713bfc76dd747ae,
title = "CANAKINUMAB IN SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS: CLINICAL INACTIVE DISEASE RATE AND SAFETY IN ITALIAN PATIENTS",
abstract = "Background: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increased knowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targeted treatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1b monoclonal antibody, in two clinical trials but little information are available in real life.Objectives: To evaluate clinical inactive disease rate and safety of canakinumab in Italian patients with sJIA.Methods: We have collected retrospectively clinical and laboratory data of patients with sJIA treated with canakinumab in 9 Italian Pediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed the effect ofcanakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and physician’s globalassessment of disease activity score.Results: Forty seven patients (26 F) were included in the analyses. The median age (range) at the diagnosis and at the beginning of treatment with canakinumab was 7.6 (1-14.7) and 10.2 (1.7-22.2) years, respectively. Twenty seven patients (57.4{\%}) had been previously treated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacy in 15/27 (55.5{\%}). Thirty patients (63.8{\%}) were receiving concomitant treatment with glucocorticoids at the median dose (range) of 0.69 (0.02-2.75) mg/kg/die. Thirtynine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2{\%}) achieved CID at 6 months and 5/27 (18.5{\%}) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24 achieved 6 months of follow-up and 12 (50{\%}) of these were able to withdraw glucocorticoids. Minor adverse events were reported in 5/30 (16.6{\%}) patients: upper respiratory tract infections in 4 and transient injection site reaction in 1. No cases of macrophage activation syndrome was reported.Conclusion: Our results provide initial real world evidence of the efficacy of treatment with canakinumab in patients with sJIA. In our study the percentage of patients who reached CID at 6 months is slightly higher (69.2{\%}) than reported at the end (from 3 months to one year) of the 2 published randomized trials (60{\%}). No serious adverse events were recorded in our population.",
author = "Maggio, {Maria Cristina}",
year = "2019",
language = "English",
volume = "78",
pages = "1345--1345",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",

}

TY - JOUR

T1 - CANAKINUMAB IN SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS: CLINICAL INACTIVE DISEASE RATE AND SAFETY IN ITALIAN PATIENTS

AU - Maggio, Maria Cristina

PY - 2019

Y1 - 2019

N2 - Background: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increased knowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targeted treatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1b monoclonal antibody, in two clinical trials but little information are available in real life.Objectives: To evaluate clinical inactive disease rate and safety of canakinumab in Italian patients with sJIA.Methods: We have collected retrospectively clinical and laboratory data of patients with sJIA treated with canakinumab in 9 Italian Pediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed the effect ofcanakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and physician’s globalassessment of disease activity score.Results: Forty seven patients (26 F) were included in the analyses. The median age (range) at the diagnosis and at the beginning of treatment with canakinumab was 7.6 (1-14.7) and 10.2 (1.7-22.2) years, respectively. Twenty seven patients (57.4%) had been previously treated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacy in 15/27 (55.5%). Thirty patients (63.8%) were receiving concomitant treatment with glucocorticoids at the median dose (range) of 0.69 (0.02-2.75) mg/kg/die. Thirtynine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2%) achieved CID at 6 months and 5/27 (18.5%) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24 achieved 6 months of follow-up and 12 (50%) of these were able to withdraw glucocorticoids. Minor adverse events were reported in 5/30 (16.6%) patients: upper respiratory tract infections in 4 and transient injection site reaction in 1. No cases of macrophage activation syndrome was reported.Conclusion: Our results provide initial real world evidence of the efficacy of treatment with canakinumab in patients with sJIA. In our study the percentage of patients who reached CID at 6 months is slightly higher (69.2%) than reported at the end (from 3 months to one year) of the 2 published randomized trials (60%). No serious adverse events were recorded in our population.

AB - Background: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increased knowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targeted treatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1b monoclonal antibody, in two clinical trials but little information are available in real life.Objectives: To evaluate clinical inactive disease rate and safety of canakinumab in Italian patients with sJIA.Methods: We have collected retrospectively clinical and laboratory data of patients with sJIA treated with canakinumab in 9 Italian Pediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed the effect ofcanakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and physician’s globalassessment of disease activity score.Results: Forty seven patients (26 F) were included in the analyses. The median age (range) at the diagnosis and at the beginning of treatment with canakinumab was 7.6 (1-14.7) and 10.2 (1.7-22.2) years, respectively. Twenty seven patients (57.4%) had been previously treated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacy in 15/27 (55.5%). Thirty patients (63.8%) were receiving concomitant treatment with glucocorticoids at the median dose (range) of 0.69 (0.02-2.75) mg/kg/die. Thirtynine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2%) achieved CID at 6 months and 5/27 (18.5%) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24 achieved 6 months of follow-up and 12 (50%) of these were able to withdraw glucocorticoids. Minor adverse events were reported in 5/30 (16.6%) patients: upper respiratory tract infections in 4 and transient injection site reaction in 1. No cases of macrophage activation syndrome was reported.Conclusion: Our results provide initial real world evidence of the efficacy of treatment with canakinumab in patients with sJIA. In our study the percentage of patients who reached CID at 6 months is slightly higher (69.2%) than reported at the end (from 3 months to one year) of the 2 published randomized trials (60%). No serious adverse events were recorded in our population.

UR - http://hdl.handle.net/10447/368087

M3 - Meeting Abstract

VL - 78

SP - 1345

EP - 1345

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

ER -