Drug retention rate and predictive factors of drug survival for interleukin-1 inhibitors in systemic juvenile idiopathic arthritis

Jurgen Sota, Antonella Insalaco, Rolando Cimaz, Maria Alessio, Marco Cattalini, Romina Gallizzi, Maria Cristina Maggio, Giuseppe Lopalco, Francesco La Torre, Claudia Fabiani, Manuela Pardeo, Alma Nunzia Olivieri, Paolo Sfriso, Carlo Salvarani, Carla Gaggiano, Salvatore Grosso, Claudia Bracaglia, Fabrizio De Benedetti, Donato Rigante, Luca Cantarini

Research output: Contribution to journalArticle

Abstract

Background and Objectives: Few studies have reported the drug retention rate (DRR) of biologic drugs in juvenile idiopathic arthritis (JIA), and none of them has specifically investigated the DRR of interleukin (IL)-1 inhibitors on systemic JIA (sJIA). This study aims to describe IL-1 inhibitors DRR and evaluate predictive factors of drug survival based on data from a real-world setting concerning sJIA. Methods: Medical records from sJIA patients treated with anakinra (ANA) and canakinumab (CAN) were retrospectively analyzed from 15 Italian tertiary referral centers. Results: Seventy seven patients were enrolled for a total of 86 treatment courses. The cumulative retention rate of the IL-1 inhibitors at 12-, 24-, 48-, and 60-months of follow-up was 79.9, 59.5, 53.5, and 53.5%, respectively, without any statistically significant differences between ANA and CAN (p = 0.056), and between patients treated in monotherapy compared to the subgroup co-administered with conventional immunosuppressors (p = 0.058). On the contrary, significant differences were found between biologic-naive patients and those previously treated with biologic drugs (p = 0.038) and when distinguishing according to adverse events (AEs) occurrence (p = 0.04). In regression analysis, patients pre-treated with other biologics (HR = 3.357 [CI: 1.341–8.406], p = 0.01) and those experiencing AEs (HR = 2.970 [CI: 1.186–7.435], p = 0.020) were associated with a higher hazard ratio of IL-1 inhibitors withdrawal. The mean treatment delay was significantly higher among patients discontinuing IL-1 inhibitors (p = 0.0002). Conclusions: Our findings suggest an excellent overall DRR for both ANA and CAN that might be further augmented by paying attention to AEs and employing these agents as first-line biologics in an early disease phase.

Original languageEnglish
Article number1526
JournalFrontiers in Pharmacology
Volume9
Issue numberJAN
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

Juvenile Arthritis
Interleukin-1
Survival
Interleukin 1 Receptor Antagonist Protein
Pharmaceutical Preparations
Biological Products
Tertiary Care Centers
Medical Records
Regression Analysis
Therapeutics
canakinumab

Keywords

  • Anakinra
  • Canakinumab
  • Drug retention rate
  • Interleukin 1-beta
  • Systemic juvenile idiopathic arthritis
  • Therapy

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Drug retention rate and predictive factors of drug survival for interleukin-1 inhibitors in systemic juvenile idiopathic arthritis. / Sota, Jurgen; Insalaco, Antonella; Cimaz, Rolando; Alessio, Maria; Cattalini, Marco; Gallizzi, Romina; Maggio, Maria Cristina; Lopalco, Giuseppe; Torre, Francesco La; Fabiani, Claudia; Pardeo, Manuela; Olivieri, Alma Nunzia; Sfriso, Paolo; Salvarani, Carlo; Gaggiano, Carla; Grosso, Salvatore; Bracaglia, Claudia; De Benedetti, Fabrizio; Rigante, Donato; Cantarini, Luca.

In: Frontiers in Pharmacology, Vol. 9, No. JAN, 1526, 01.01.2019.

Research output: Contribution to journalArticle

Sota, Jurgen ; Insalaco, Antonella ; Cimaz, Rolando ; Alessio, Maria ; Cattalini, Marco ; Gallizzi, Romina ; Maggio, Maria Cristina ; Lopalco, Giuseppe ; Torre, Francesco La ; Fabiani, Claudia ; Pardeo, Manuela ; Olivieri, Alma Nunzia ; Sfriso, Paolo ; Salvarani, Carlo ; Gaggiano, Carla ; Grosso, Salvatore ; Bracaglia, Claudia ; De Benedetti, Fabrizio ; Rigante, Donato ; Cantarini, Luca. / Drug retention rate and predictive factors of drug survival for interleukin-1 inhibitors in systemic juvenile idiopathic arthritis. In: Frontiers in Pharmacology. 2019 ; Vol. 9, No. JAN.
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T1 - Drug retention rate and predictive factors of drug survival for interleukin-1 inhibitors in systemic juvenile idiopathic arthritis

AU - Sota, Jurgen

AU - Insalaco, Antonella

AU - Cimaz, Rolando

AU - Alessio, Maria

AU - Cattalini, Marco

AU - Gallizzi, Romina

AU - Maggio, Maria Cristina

AU - Lopalco, Giuseppe

AU - Torre, Francesco La

AU - Fabiani, Claudia

AU - Pardeo, Manuela

AU - Olivieri, Alma Nunzia

AU - Sfriso, Paolo

AU - Salvarani, Carlo

AU - Gaggiano, Carla

AU - Grosso, Salvatore

AU - Bracaglia, Claudia

AU - De Benedetti, Fabrizio

AU - Rigante, Donato

AU - Cantarini, Luca

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background and Objectives: Few studies have reported the drug retention rate (DRR) of biologic drugs in juvenile idiopathic arthritis (JIA), and none of them has specifically investigated the DRR of interleukin (IL)-1 inhibitors on systemic JIA (sJIA). This study aims to describe IL-1 inhibitors DRR and evaluate predictive factors of drug survival based on data from a real-world setting concerning sJIA. Methods: Medical records from sJIA patients treated with anakinra (ANA) and canakinumab (CAN) were retrospectively analyzed from 15 Italian tertiary referral centers. Results: Seventy seven patients were enrolled for a total of 86 treatment courses. The cumulative retention rate of the IL-1 inhibitors at 12-, 24-, 48-, and 60-months of follow-up was 79.9, 59.5, 53.5, and 53.5%, respectively, without any statistically significant differences between ANA and CAN (p = 0.056), and between patients treated in monotherapy compared to the subgroup co-administered with conventional immunosuppressors (p = 0.058). On the contrary, significant differences were found between biologic-naive patients and those previously treated with biologic drugs (p = 0.038) and when distinguishing according to adverse events (AEs) occurrence (p = 0.04). In regression analysis, patients pre-treated with other biologics (HR = 3.357 [CI: 1.341–8.406], p = 0.01) and those experiencing AEs (HR = 2.970 [CI: 1.186–7.435], p = 0.020) were associated with a higher hazard ratio of IL-1 inhibitors withdrawal. The mean treatment delay was significantly higher among patients discontinuing IL-1 inhibitors (p = 0.0002). Conclusions: Our findings suggest an excellent overall DRR for both ANA and CAN that might be further augmented by paying attention to AEs and employing these agents as first-line biologics in an early disease phase.

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