Anakinra drug retention rate and predictive factors of long-term response in systemic juvenile idiopathic arthritis and adult onset still disease

Maria Cristina Maggio, Maria Alessio, Rosaria Talarico, Romina Gallizzi, Giacomo Emmi, Francesco La Torre, Alma Nunzia Olivieri, Serena Colafrancesco, Piero Ruscitti, Antonio Vitale, Giuseppe Lopalco, Carla Gaggiano, Donato Rigante, Jurgen Sota, Armin Maier, Manuela Pardeo, Ombretta Viapiana, Antonella Insalaco, Micol Frassi, Daniele CammelliMarco Cattalini, Paolo Sfriso, Claudia Fabiani, Roberta Priori, Raffaele Manna, Rolando Cimaz, Fabrizio De Benedetti, Roberto Giacomelli, Salvatore Grosso, Marta Mosca, Salvatore De Vita, Carlo Salvarani, Luca Cantarini

Risultato della ricerca: Article

1 Citazione (Scopus)

Abstract

Background and Objective: Only a few studies have reported long-term efficacy of interleukin (IL)-1 inhibition in systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still disease (AOSD). Herein we report on the effectiveness of anakinra (ANA), expressed in terms of drug retention rate (DRR), and evaluate the predictive factors of drug survival in a cohort of patients with sJIA and AOSD.Patients and Methods: This is a multicenter study reviewing retrospectively the medical records from 61 patients with sJIA and 76 with AOSD, all treated with ANA in 25 Italian tertiary referral centers.Results: The cumulative retention rate of ANA at 12-, 24-, 48-, and 60-month of follow-up was 74.3%, 62.9%, 49.4%, and 49.4%, respectively, without any significant differences between sJIA and AOSD patients (p = 0.164), and between patients treated in monotherapy compared with the subgroup coadministered with conventional diseasemodifying antirheumatic drugs (cDMARDs) (p = 0.473). On the other hand, a significant difference in DRR was found between biologic-naïve patients and those previously treated with biotechnologic drugs (p = 0.009), which persisted even after adjustment for pathology (p = 0.013). In the regression analysis, patients experiencing adverse events (AEs) {hazards ratio (HR) = 3.029 [confidence interval (CI) 1.750–5.242], p < 0.0001} and those previously treated with other biologic agents [HR = 1.818 (CI 1.007–3.282), p = 0.047] were associated with a higher HR of ANA discontinuation. The median treatment delay was significantly higher among patients discontinuing ANA (p < 0.0001). Significant corticosteroid-sparing (p = 0.033) and cDMARD-sparing effects (p < 0.0001) were also recorded. Less than one-third of our cohort developed AEs, and 85% were deemed mild in nature, with 70% of them involving the skin.Conclusions: Our findings display an overall excellent DRR of ANA on the long run for both sJIA and AOSD, that may be further optimized by closely monitoring patient’s safety issues and employing this IL-1 inhibitor as a first-line biologic as early as possible. Moreover, ANA allowed a significant drug-sparing effect and showed an overall good safety profile.
Lingua originaleEnglish
Numero di pagine8
RivistaFrontiers in Pharmacology
Volume10
Stato di pubblicazionePublished - 2019

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Adult-Onset Still's Disease
Interleukin 1 Receptor Antagonist Protein
Juvenile Arthritis
Pharmaceutical Preparations
Antirheumatic Agents
Interleukin-1
Confidence Intervals
Biological Factors
Patient Safety
Biological Products
Tertiary Care Centers
Multicenter Studies
Medical Records
Adrenal Cortex Hormones
Regression Analysis
Pathology
Safety
Skin

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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Anakinra drug retention rate and predictive factors of long-term response in systemic juvenile idiopathic arthritis and adult onset still disease. / Maggio, Maria Cristina; Alessio, Maria; Talarico, Rosaria; Gallizzi, Romina; Emmi, Giacomo; Torre, Francesco La; Olivieri, Alma Nunzia; Colafrancesco, Serena; Ruscitti, Piero; Vitale, Antonio; Lopalco, Giuseppe; Gaggiano, Carla; Rigante, Donato; Sota, Jurgen; Maier, Armin; Pardeo, Manuela; Viapiana, Ombretta; Insalaco, Antonella; Frassi, Micol; Cammelli, Daniele; Cattalini, Marco; Sfriso, Paolo; Fabiani, Claudia; Priori, Roberta; Manna, Raffaele; Cimaz, Rolando; De Benedetti, Fabrizio; Giacomelli, Roberto; Grosso, Salvatore; Mosca, Marta; De Vita, Salvatore; Salvarani, Carlo; Cantarini, Luca.

In: Frontiers in Pharmacology, Vol. 10, 2019.

Risultato della ricerca: Article

Maggio, MC, Alessio, M, Talarico, R, Gallizzi, R, Emmi, G, Torre, FL, Olivieri, AN, Colafrancesco, S, Ruscitti, P, Vitale, A, Lopalco, G, Gaggiano, C, Rigante, D, Sota, J, Maier, A, Pardeo, M, Viapiana, O, Insalaco, A, Frassi, M, Cammelli, D, Cattalini, M, Sfriso, P, Fabiani, C, Priori, R, Manna, R, Cimaz, R, De Benedetti, F, Giacomelli, R, Grosso, S, Mosca, M, De Vita, S, Salvarani, C & Cantarini, L 2019, 'Anakinra drug retention rate and predictive factors of long-term response in systemic juvenile idiopathic arthritis and adult onset still disease', Frontiers in Pharmacology, vol. 10.
Maggio, Maria Cristina ; Alessio, Maria ; Talarico, Rosaria ; Gallizzi, Romina ; Emmi, Giacomo ; Torre, Francesco La ; Olivieri, Alma Nunzia ; Colafrancesco, Serena ; Ruscitti, Piero ; Vitale, Antonio ; Lopalco, Giuseppe ; Gaggiano, Carla ; Rigante, Donato ; Sota, Jurgen ; Maier, Armin ; Pardeo, Manuela ; Viapiana, Ombretta ; Insalaco, Antonella ; Frassi, Micol ; Cammelli, Daniele ; Cattalini, Marco ; Sfriso, Paolo ; Fabiani, Claudia ; Priori, Roberta ; Manna, Raffaele ; Cimaz, Rolando ; De Benedetti, Fabrizio ; Giacomelli, Roberto ; Grosso, Salvatore ; Mosca, Marta ; De Vita, Salvatore ; Salvarani, Carlo ; Cantarini, Luca. / Anakinra drug retention rate and predictive factors of long-term response in systemic juvenile idiopathic arthritis and adult onset still disease. In: Frontiers in Pharmacology. 2019 ; Vol. 10.
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title = "Anakinra drug retention rate and predictive factors of long-term response in systemic juvenile idiopathic arthritis and adult onset still disease",
abstract = "Background and Objective: Only a few studies have reported long-term efficacy of interleukin (IL)-1 inhibition in systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still disease (AOSD). Herein we report on the effectiveness of anakinra (ANA), expressed in terms of drug retention rate (DRR), and evaluate the predictive factors of drug survival in a cohort of patients with sJIA and AOSD.Patients and Methods: This is a multicenter study reviewing retrospectively the medical records from 61 patients with sJIA and 76 with AOSD, all treated with ANA in 25 Italian tertiary referral centers.Results: The cumulative retention rate of ANA at 12-, 24-, 48-, and 60-month of follow-up was 74.3{\%}, 62.9{\%}, 49.4{\%}, and 49.4{\%}, respectively, without any significant differences between sJIA and AOSD patients (p = 0.164), and between patients treated in monotherapy compared with the subgroup coadministered with conventional diseasemodifying antirheumatic drugs (cDMARDs) (p = 0.473). On the other hand, a significant difference in DRR was found between biologic-na{\"i}ve patients and those previously treated with biotechnologic drugs (p = 0.009), which persisted even after adjustment for pathology (p = 0.013). In the regression analysis, patients experiencing adverse events (AEs) {hazards ratio (HR) = 3.029 [confidence interval (CI) 1.750–5.242], p < 0.0001} and those previously treated with other biologic agents [HR = 1.818 (CI 1.007–3.282), p = 0.047] were associated with a higher HR of ANA discontinuation. The median treatment delay was significantly higher among patients discontinuing ANA (p < 0.0001). Significant corticosteroid-sparing (p = 0.033) and cDMARD-sparing effects (p < 0.0001) were also recorded. Less than one-third of our cohort developed AEs, and 85{\%} were deemed mild in nature, with 70{\%} of them involving the skin.Conclusions: Our findings display an overall excellent DRR of ANA on the long run for both sJIA and AOSD, that may be further optimized by closely monitoring patient’s safety issues and employing this IL-1 inhibitor as a first-line biologic as early as possible. Moreover, ANA allowed a significant drug-sparing effect and showed an overall good safety profile.",
author = "Maggio, {Maria Cristina} and Maria Alessio and Rosaria Talarico and Romina Gallizzi and Giacomo Emmi and Torre, {Francesco La} and Olivieri, {Alma Nunzia} and Serena Colafrancesco and Piero Ruscitti and Antonio Vitale and Giuseppe Lopalco and Carla Gaggiano and Donato Rigante and Jurgen Sota and Armin Maier and Manuela Pardeo and Ombretta Viapiana and Antonella Insalaco and Micol Frassi and Daniele Cammelli and Marco Cattalini and Paolo Sfriso and Claudia Fabiani and Roberta Priori and Raffaele Manna and Rolando Cimaz and {De Benedetti}, Fabrizio and Roberto Giacomelli and Salvatore Grosso and Marta Mosca and {De Vita}, Salvatore and Carlo Salvarani and Luca Cantarini",
year = "2019",
language = "English",
volume = "10",
journal = "Frontiers in Pharmacology",
issn = "1663-9812",
publisher = "Frontiers Media S. A.",

}

TY - JOUR

T1 - Anakinra drug retention rate and predictive factors of long-term response in systemic juvenile idiopathic arthritis and adult onset still disease

AU - Maggio, Maria Cristina

AU - Alessio, Maria

AU - Talarico, Rosaria

AU - Gallizzi, Romina

AU - Emmi, Giacomo

AU - Torre, Francesco La

AU - Olivieri, Alma Nunzia

AU - Colafrancesco, Serena

AU - Ruscitti, Piero

AU - Vitale, Antonio

AU - Lopalco, Giuseppe

AU - Gaggiano, Carla

AU - Rigante, Donato

AU - Sota, Jurgen

AU - Maier, Armin

AU - Pardeo, Manuela

AU - Viapiana, Ombretta

AU - Insalaco, Antonella

AU - Frassi, Micol

AU - Cammelli, Daniele

AU - Cattalini, Marco

AU - Sfriso, Paolo

AU - Fabiani, Claudia

AU - Priori, Roberta

AU - Manna, Raffaele

AU - Cimaz, Rolando

AU - De Benedetti, Fabrizio

AU - Giacomelli, Roberto

AU - Grosso, Salvatore

AU - Mosca, Marta

AU - De Vita, Salvatore

AU - Salvarani, Carlo

AU - Cantarini, Luca

PY - 2019

Y1 - 2019

N2 - Background and Objective: Only a few studies have reported long-term efficacy of interleukin (IL)-1 inhibition in systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still disease (AOSD). Herein we report on the effectiveness of anakinra (ANA), expressed in terms of drug retention rate (DRR), and evaluate the predictive factors of drug survival in a cohort of patients with sJIA and AOSD.Patients and Methods: This is a multicenter study reviewing retrospectively the medical records from 61 patients with sJIA and 76 with AOSD, all treated with ANA in 25 Italian tertiary referral centers.Results: The cumulative retention rate of ANA at 12-, 24-, 48-, and 60-month of follow-up was 74.3%, 62.9%, 49.4%, and 49.4%, respectively, without any significant differences between sJIA and AOSD patients (p = 0.164), and between patients treated in monotherapy compared with the subgroup coadministered with conventional diseasemodifying antirheumatic drugs (cDMARDs) (p = 0.473). On the other hand, a significant difference in DRR was found between biologic-naïve patients and those previously treated with biotechnologic drugs (p = 0.009), which persisted even after adjustment for pathology (p = 0.013). In the regression analysis, patients experiencing adverse events (AEs) {hazards ratio (HR) = 3.029 [confidence interval (CI) 1.750–5.242], p < 0.0001} and those previously treated with other biologic agents [HR = 1.818 (CI 1.007–3.282), p = 0.047] were associated with a higher HR of ANA discontinuation. The median treatment delay was significantly higher among patients discontinuing ANA (p < 0.0001). Significant corticosteroid-sparing (p = 0.033) and cDMARD-sparing effects (p < 0.0001) were also recorded. Less than one-third of our cohort developed AEs, and 85% were deemed mild in nature, with 70% of them involving the skin.Conclusions: Our findings display an overall excellent DRR of ANA on the long run for both sJIA and AOSD, that may be further optimized by closely monitoring patient’s safety issues and employing this IL-1 inhibitor as a first-line biologic as early as possible. Moreover, ANA allowed a significant drug-sparing effect and showed an overall good safety profile.

AB - Background and Objective: Only a few studies have reported long-term efficacy of interleukin (IL)-1 inhibition in systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still disease (AOSD). Herein we report on the effectiveness of anakinra (ANA), expressed in terms of drug retention rate (DRR), and evaluate the predictive factors of drug survival in a cohort of patients with sJIA and AOSD.Patients and Methods: This is a multicenter study reviewing retrospectively the medical records from 61 patients with sJIA and 76 with AOSD, all treated with ANA in 25 Italian tertiary referral centers.Results: The cumulative retention rate of ANA at 12-, 24-, 48-, and 60-month of follow-up was 74.3%, 62.9%, 49.4%, and 49.4%, respectively, without any significant differences between sJIA and AOSD patients (p = 0.164), and between patients treated in monotherapy compared with the subgroup coadministered with conventional diseasemodifying antirheumatic drugs (cDMARDs) (p = 0.473). On the other hand, a significant difference in DRR was found between biologic-naïve patients and those previously treated with biotechnologic drugs (p = 0.009), which persisted even after adjustment for pathology (p = 0.013). In the regression analysis, patients experiencing adverse events (AEs) {hazards ratio (HR) = 3.029 [confidence interval (CI) 1.750–5.242], p < 0.0001} and those previously treated with other biologic agents [HR = 1.818 (CI 1.007–3.282), p = 0.047] were associated with a higher HR of ANA discontinuation. The median treatment delay was significantly higher among patients discontinuing ANA (p < 0.0001). Significant corticosteroid-sparing (p = 0.033) and cDMARD-sparing effects (p < 0.0001) were also recorded. Less than one-third of our cohort developed AEs, and 85% were deemed mild in nature, with 70% of them involving the skin.Conclusions: Our findings display an overall excellent DRR of ANA on the long run for both sJIA and AOSD, that may be further optimized by closely monitoring patient’s safety issues and employing this IL-1 inhibitor as a first-line biologic as early as possible. Moreover, ANA allowed a significant drug-sparing effect and showed an overall good safety profile.

UR - http://hdl.handle.net/10447/368852

M3 - Article

VL - 10

JO - Frontiers in Pharmacology

JF - Frontiers in Pharmacology

SN - 1663-9812

ER -