Canakinumab in systemic juvenile idiopathic arthritis: clinical inactive disease rate and safety in italian patients

Risultato della ricerca: Poster

Abstract

Introduction: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The pathophysiology is still unclear, it is now well known that innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increasedknowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targetedtreatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1β 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 ItalianPaediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed theeffect of canakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) andphysician’s global assessment of disease activity score. Clinical and laboratory data were obtained using a standard data collection form.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 previouslytreated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacyin 15/27 (55.5%).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. Thirty nine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2%) achieved CID at 6months and 5/27 (18.5%) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24achieved 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 activationsyndrome 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%) (1). No serious adverse events were recorded in our population.
Lingua originaleEnglish
Numero di pagine1
Stato di pubblicazionePublished - 2019

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Juvenile Arthritis
Safety
Glucocorticoids
canakinumab
Cytokines
Interleukin 1 Receptor Antagonist Protein
Blood Sedimentation
Biological Factors
Rheumatology
Exanthema
Interleukin-1
Respiratory Tract Infections
C-Reactive Protein
Fever
Joints
Macrophages
Monoclonal Antibodies
Clinical Trials

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@conference{41eedd4b6851470db54eea4853e61487,
title = "Canakinumab in systemic juvenile idiopathic arthritis: clinical inactive disease rate and safety in italian patients",
abstract = "Introduction: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The pathophysiology is still unclear, it is now well known that innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increasedknowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targetedtreatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1β 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 ItalianPaediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed theeffect of canakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) andphysician’s global assessment of disease activity score. Clinical and laboratory data were obtained using a standard data collection form.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 previouslytreated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacyin 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. Thirty nine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2{\%}) achieved CID at 6months and 5/27 (18.5{\%}) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24achieved 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 activationsyndrome 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{\%}) (1). No serious adverse events were recorded in our population.",
author = "Maggio, {Maria Cristina}",
year = "2019",
language = "English",

}

TY - CONF

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 - Introduction: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The pathophysiology is still unclear, it is now well known that innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increasedknowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targetedtreatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1β 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 ItalianPaediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed theeffect of canakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) andphysician’s global assessment of disease activity score. Clinical and laboratory data were obtained using a standard data collection form.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 previouslytreated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacyin 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. Thirty nine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2%) achieved CID at 6months and 5/27 (18.5%) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24achieved 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 activationsyndrome 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%) (1). No serious adverse events were recorded in our population.

AB - Introduction: Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The pathophysiology is still unclear, it is now well known that innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increasedknowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targetedtreatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1β 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 ItalianPaediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed theeffect of canakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) andphysician’s global assessment of disease activity score. Clinical and laboratory data were obtained using a standard data collection form.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 previouslytreated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacyin 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. Thirty nine out of 47 patients had > 6 months of follow-up. Among these 39 patients, 27 (69.2%) achieved CID at 6months and 5/27 (18.5%) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24achieved 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 activationsyndrome 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%) (1). No serious adverse events were recorded in our population.

UR - http://hdl.handle.net/10447/369581

M3 - Poster

ER -