Long-term retention rate of anakinra in adult onset Still’s disease and predictive factors for treatment response

Antonio Vitale, Giulio Cavalli, Serena Colafrancesco, Roberta Priori, Guido Valesini, Lorenza Maria Argolini, Elena Baldissera, Elena Bartoloni, Daniele Cammelli, Giovanni Canestrari, Jurgen Sota, Elena Cavallaro, Maria Grazia Massaro, Piero Ruscitti, Paola Cipriani, Ginevra De Marchi, Salvatore De Vita, Giacomo Emmi, Gianfranco Ferraccioli, Micol FrassiRoberto Gerli, Elisa Gremese, Florenzo Iannone, Giovanni Lapadula, Giuseppe Lopalco, Raffaele Manna, Alessandro Mathieu, Carlomaurizio Montecucco, Marta Mosca, Ilaria Piazza, Matteo Piga, Irene Pontikaki, Micol Romano, Silvia Rossi, Maurizio Rossini, Elena Silvestri, Chiara Stagnaro, Rosaria Talarico, Angela Tincani, Ombretta Viapiana, Gianfranco Vitiello, Paola Galozzi, Paolo Sfriso, Carla Gaggiano, Donato Rigante, Lorenzo Dagna, Roberto Giacomelli, Luca Cantarini

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Anakinra (ANA) is an effective treatment choice in patients with adult onset Still’s disease (AOSD). Variables affecting treatment survival include loss of efficacy or adverse events, but also the decision to discontinue treatment after long-term clinical remission. Objectives: Aims of this study were: (i) to assess the drug retention rate (DRR) of ANA during a long-term follow-up looking for any difference related to the line of biologic treatment, the concomitant use of conventional disease modifying anti-rheumatic drugs (cDMARDs) and the different type of AOSD (systemic versus chronic articular); (ii) to identify predictive factors of lack of efficacy, loss of efficacy, and ANA withdrawal owing to long-term remission. Methods: AOSD patients classified according with Yamaguchi criteria and treated with ANA were retrospectively enrolled in 18 Italian tertiary Centers. Demographic, laboratory, clinical and therapeutic data related to the start of ANA (baseline), the 3-month assessment and the last follow-up visit while on ANA treatment were retrospectively collected and statistically analyzed. Results: One hundred and forty-one AOSD patients (48 males, 93 females) treated with ANA for a mean period of 35.96 ± 36.05 months were enrolled. The overall DRR of ANA was 44.6 and 30.5% at the 60- and 120-month assessments, respectively, with no significant differences between: (i) biologic naïve patients and those previously treated with other biologics (log-rank p = 0.97); (ii) monotherapy and concomitant use of cDMARDs (log-rank p = 0.45); (iii) systemic and chronic articular types of AOSD (log-rank p = 0.67). No variables collected at baseline could predict primary inefficacy, while the number of swollen joints at baseline was significantly associated with secondary inefficacy (p = 0.01, OR = 1.194, C.I. 1.043–1.367). The typical AOSD skin rash was negatively related with ANA withdrawal owing to long-term remission (p = 0.03, OR = 0.224, C.I. 0.058–0.863). Conclusion: Long-term DRR of ANA has been found excellent and is not affected by different lines of biologic treatment, concomitant use of cDMARDs, or type of AOSD. The risk of losing ANA efficacy increases along with the number of swollen joints at the start of therapy, while the typical skin rash is a negative predictor of ANA withdrawal related to sustained remission.

Original languageEnglish
Article number296
JournalFrontiers in Pharmacology
Volume10
Issue numberAPR
DOIs
Publication statusPublished - Jan 1 2019

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Adult-Onset Still's Disease
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutics
Joints
Exanthema
Pharmaceutical Preparations
Biological Products

Keywords

  • Autoinflammatory diseases
  • Canakinumab
  • Innovative biotechnologies
  • Interleukin-1
  • Personalized medicine
  • Systemic onset juvenile idiopathic arthritis

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Long-term retention rate of anakinra in adult onset Still’s disease and predictive factors for treatment response. / Vitale, Antonio; Cavalli, Giulio; Colafrancesco, Serena; Priori, Roberta; Valesini, Guido; Argolini, Lorenza Maria; Baldissera, Elena; Bartoloni, Elena; Cammelli, Daniele; Canestrari, Giovanni; Sota, Jurgen; Cavallaro, Elena; Massaro, Maria Grazia; Ruscitti, Piero; Cipriani, Paola; De Marchi, Ginevra; De Vita, Salvatore; Emmi, Giacomo; Ferraccioli, Gianfranco; Frassi, Micol; Gerli, Roberto; Gremese, Elisa; Iannone, Florenzo; Lapadula, Giovanni; Lopalco, Giuseppe; Manna, Raffaele; Mathieu, Alessandro; Montecucco, Carlomaurizio; Mosca, Marta; Piazza, Ilaria; Piga, Matteo; Pontikaki, Irene; Romano, Micol; Rossi, Silvia; Rossini, Maurizio; Silvestri, Elena; Stagnaro, Chiara; Talarico, Rosaria; Tincani, Angela; Viapiana, Ombretta; Vitiello, Gianfranco; Galozzi, Paola; Sfriso, Paolo; Gaggiano, Carla; Rigante, Donato; Dagna, Lorenzo; Giacomelli, Roberto; Cantarini, Luca.

In: Frontiers in Pharmacology, Vol. 10, No. APR, 296, 01.01.2019.

Research output: Contribution to journalArticle

Vitale, A, Cavalli, G, Colafrancesco, S, Priori, R, Valesini, G, Argolini, LM, Baldissera, E, Bartoloni, E, Cammelli, D, Canestrari, G, Sota, J, Cavallaro, E, Massaro, MG, Ruscitti, P, Cipriani, P, De Marchi, G, De Vita, S, Emmi, G, Ferraccioli, G, Frassi, M, Gerli, R, Gremese, E, Iannone, F, Lapadula, G, Lopalco, G, Manna, R, Mathieu, A, Montecucco, C, Mosca, M, Piazza, I, Piga, M, Pontikaki, I, Romano, M, Rossi, S, Rossini, M, Silvestri, E, Stagnaro, C, Talarico, R, Tincani, A, Viapiana, O, Vitiello, G, Galozzi, P, Sfriso, P, Gaggiano, C, Rigante, D, Dagna, L, Giacomelli, R & Cantarini, L 2019, 'Long-term retention rate of anakinra in adult onset Still’s disease and predictive factors for treatment response', Frontiers in Pharmacology, vol. 10, no. APR, 296. https://doi.org/10.3389/fphar.2019.00296
Vitale, Antonio ; Cavalli, Giulio ; Colafrancesco, Serena ; Priori, Roberta ; Valesini, Guido ; Argolini, Lorenza Maria ; Baldissera, Elena ; Bartoloni, Elena ; Cammelli, Daniele ; Canestrari, Giovanni ; Sota, Jurgen ; Cavallaro, Elena ; Massaro, Maria Grazia ; Ruscitti, Piero ; Cipriani, Paola ; De Marchi, Ginevra ; De Vita, Salvatore ; Emmi, Giacomo ; Ferraccioli, Gianfranco ; Frassi, Micol ; Gerli, Roberto ; Gremese, Elisa ; Iannone, Florenzo ; Lapadula, Giovanni ; Lopalco, Giuseppe ; Manna, Raffaele ; Mathieu, Alessandro ; Montecucco, Carlomaurizio ; Mosca, Marta ; Piazza, Ilaria ; Piga, Matteo ; Pontikaki, Irene ; Romano, Micol ; Rossi, Silvia ; Rossini, Maurizio ; Silvestri, Elena ; Stagnaro, Chiara ; Talarico, Rosaria ; Tincani, Angela ; Viapiana, Ombretta ; Vitiello, Gianfranco ; Galozzi, Paola ; Sfriso, Paolo ; Gaggiano, Carla ; Rigante, Donato ; Dagna, Lorenzo ; Giacomelli, Roberto ; Cantarini, Luca. / Long-term retention rate of anakinra in adult onset Still’s disease and predictive factors for treatment response. In: Frontiers in Pharmacology. 2019 ; Vol. 10, No. APR.
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abstract = "Background: Anakinra (ANA) is an effective treatment choice in patients with adult onset Still’s disease (AOSD). Variables affecting treatment survival include loss of efficacy or adverse events, but also the decision to discontinue treatment after long-term clinical remission. Objectives: Aims of this study were: (i) to assess the drug retention rate (DRR) of ANA during a long-term follow-up looking for any difference related to the line of biologic treatment, the concomitant use of conventional disease modifying anti-rheumatic drugs (cDMARDs) and the different type of AOSD (systemic versus chronic articular); (ii) to identify predictive factors of lack of efficacy, loss of efficacy, and ANA withdrawal owing to long-term remission. Methods: AOSD patients classified according with Yamaguchi criteria and treated with ANA were retrospectively enrolled in 18 Italian tertiary Centers. Demographic, laboratory, clinical and therapeutic data related to the start of ANA (baseline), the 3-month assessment and the last follow-up visit while on ANA treatment were retrospectively collected and statistically analyzed. Results: One hundred and forty-one AOSD patients (48 males, 93 females) treated with ANA for a mean period of 35.96 ± 36.05 months were enrolled. The overall DRR of ANA was 44.6 and 30.5{\%} at the 60- and 120-month assessments, respectively, with no significant differences between: (i) biologic na{\"i}ve patients and those previously treated with other biologics (log-rank p = 0.97); (ii) monotherapy and concomitant use of cDMARDs (log-rank p = 0.45); (iii) systemic and chronic articular types of AOSD (log-rank p = 0.67). No variables collected at baseline could predict primary inefficacy, while the number of swollen joints at baseline was significantly associated with secondary inefficacy (p = 0.01, OR = 1.194, C.I. 1.043–1.367). The typical AOSD skin rash was negatively related with ANA withdrawal owing to long-term remission (p = 0.03, OR = 0.224, C.I. 0.058–0.863). Conclusion: Long-term DRR of ANA has been found excellent and is not affected by different lines of biologic treatment, concomitant use of cDMARDs, or type of AOSD. The risk of losing ANA efficacy increases along with the number of swollen joints at the start of therapy, while the typical skin rash is a negative predictor of ANA withdrawal related to sustained remission.",
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author = "Antonio Vitale and Giulio Cavalli and Serena Colafrancesco and Roberta Priori and Guido Valesini and Argolini, {Lorenza Maria} and Elena Baldissera and Elena Bartoloni and Daniele Cammelli and Giovanni Canestrari and Jurgen Sota and Elena Cavallaro and Massaro, {Maria Grazia} and Piero Ruscitti and Paola Cipriani and {De Marchi}, Ginevra and {De Vita}, Salvatore and Giacomo Emmi and Gianfranco Ferraccioli and Micol Frassi and Roberto Gerli and Elisa Gremese and Florenzo Iannone and Giovanni Lapadula and Giuseppe Lopalco and Raffaele Manna and Alessandro Mathieu and Carlomaurizio Montecucco and Marta Mosca and Ilaria Piazza and Matteo Piga and Irene Pontikaki and Micol Romano and Silvia Rossi and Maurizio Rossini and Elena Silvestri and Chiara Stagnaro and Rosaria Talarico and Angela Tincani and Ombretta Viapiana and Gianfranco Vitiello and Paola Galozzi and Paolo Sfriso and Carla Gaggiano and Donato Rigante and Lorenzo Dagna and Roberto Giacomelli and Luca Cantarini",
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T1 - Long-term retention rate of anakinra in adult onset Still’s disease and predictive factors for treatment response

AU - Vitale, Antonio

AU - Cavalli, Giulio

AU - Colafrancesco, Serena

AU - Priori, Roberta

AU - Valesini, Guido

AU - Argolini, Lorenza Maria

AU - Baldissera, Elena

AU - Bartoloni, Elena

AU - Cammelli, Daniele

AU - Canestrari, Giovanni

AU - Sota, Jurgen

AU - Cavallaro, Elena

AU - Massaro, Maria Grazia

AU - Ruscitti, Piero

AU - Cipriani, Paola

AU - De Marchi, Ginevra

AU - De Vita, Salvatore

AU - Emmi, Giacomo

AU - Ferraccioli, Gianfranco

AU - Frassi, Micol

AU - Gerli, Roberto

AU - Gremese, Elisa

AU - Iannone, Florenzo

AU - Lapadula, Giovanni

AU - Lopalco, Giuseppe

AU - Manna, Raffaele

AU - Mathieu, Alessandro

AU - Montecucco, Carlomaurizio

AU - Mosca, Marta

AU - Piazza, Ilaria

AU - Piga, Matteo

AU - Pontikaki, Irene

AU - Romano, Micol

AU - Rossi, Silvia

AU - Rossini, Maurizio

AU - Silvestri, Elena

AU - Stagnaro, Chiara

AU - Talarico, Rosaria

AU - Tincani, Angela

AU - Viapiana, Ombretta

AU - Vitiello, Gianfranco

AU - Galozzi, Paola

AU - Sfriso, Paolo

AU - Gaggiano, Carla

AU - Rigante, Donato

AU - Dagna, Lorenzo

AU - Giacomelli, Roberto

AU - Cantarini, Luca

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Anakinra (ANA) is an effective treatment choice in patients with adult onset Still’s disease (AOSD). Variables affecting treatment survival include loss of efficacy or adverse events, but also the decision to discontinue treatment after long-term clinical remission. Objectives: Aims of this study were: (i) to assess the drug retention rate (DRR) of ANA during a long-term follow-up looking for any difference related to the line of biologic treatment, the concomitant use of conventional disease modifying anti-rheumatic drugs (cDMARDs) and the different type of AOSD (systemic versus chronic articular); (ii) to identify predictive factors of lack of efficacy, loss of efficacy, and ANA withdrawal owing to long-term remission. Methods: AOSD patients classified according with Yamaguchi criteria and treated with ANA were retrospectively enrolled in 18 Italian tertiary Centers. Demographic, laboratory, clinical and therapeutic data related to the start of ANA (baseline), the 3-month assessment and the last follow-up visit while on ANA treatment were retrospectively collected and statistically analyzed. Results: One hundred and forty-one AOSD patients (48 males, 93 females) treated with ANA for a mean period of 35.96 ± 36.05 months were enrolled. The overall DRR of ANA was 44.6 and 30.5% at the 60- and 120-month assessments, respectively, with no significant differences between: (i) biologic naïve patients and those previously treated with other biologics (log-rank p = 0.97); (ii) monotherapy and concomitant use of cDMARDs (log-rank p = 0.45); (iii) systemic and chronic articular types of AOSD (log-rank p = 0.67). No variables collected at baseline could predict primary inefficacy, while the number of swollen joints at baseline was significantly associated with secondary inefficacy (p = 0.01, OR = 1.194, C.I. 1.043–1.367). The typical AOSD skin rash was negatively related with ANA withdrawal owing to long-term remission (p = 0.03, OR = 0.224, C.I. 0.058–0.863). Conclusion: Long-term DRR of ANA has been found excellent and is not affected by different lines of biologic treatment, concomitant use of cDMARDs, or type of AOSD. The risk of losing ANA efficacy increases along with the number of swollen joints at the start of therapy, while the typical skin rash is a negative predictor of ANA withdrawal related to sustained remission.

AB - Background: Anakinra (ANA) is an effective treatment choice in patients with adult onset Still’s disease (AOSD). Variables affecting treatment survival include loss of efficacy or adverse events, but also the decision to discontinue treatment after long-term clinical remission. Objectives: Aims of this study were: (i) to assess the drug retention rate (DRR) of ANA during a long-term follow-up looking for any difference related to the line of biologic treatment, the concomitant use of conventional disease modifying anti-rheumatic drugs (cDMARDs) and the different type of AOSD (systemic versus chronic articular); (ii) to identify predictive factors of lack of efficacy, loss of efficacy, and ANA withdrawal owing to long-term remission. Methods: AOSD patients classified according with Yamaguchi criteria and treated with ANA were retrospectively enrolled in 18 Italian tertiary Centers. Demographic, laboratory, clinical and therapeutic data related to the start of ANA (baseline), the 3-month assessment and the last follow-up visit while on ANA treatment were retrospectively collected and statistically analyzed. Results: One hundred and forty-one AOSD patients (48 males, 93 females) treated with ANA for a mean period of 35.96 ± 36.05 months were enrolled. The overall DRR of ANA was 44.6 and 30.5% at the 60- and 120-month assessments, respectively, with no significant differences between: (i) biologic naïve patients and those previously treated with other biologics (log-rank p = 0.97); (ii) monotherapy and concomitant use of cDMARDs (log-rank p = 0.45); (iii) systemic and chronic articular types of AOSD (log-rank p = 0.67). No variables collected at baseline could predict primary inefficacy, while the number of swollen joints at baseline was significantly associated with secondary inefficacy (p = 0.01, OR = 1.194, C.I. 1.043–1.367). The typical AOSD skin rash was negatively related with ANA withdrawal owing to long-term remission (p = 0.03, OR = 0.224, C.I. 0.058–0.863). Conclusion: Long-term DRR of ANA has been found excellent and is not affected by different lines of biologic treatment, concomitant use of cDMARDs, or type of AOSD. The risk of losing ANA efficacy increases along with the number of swollen joints at the start of therapy, while the typical skin rash is a negative predictor of ANA withdrawal related to sustained remission.

KW - Autoinflammatory diseases

KW - Canakinumab

KW - Innovative biotechnologies

KW - Interleukin-1

KW - Personalized medicine

KW - Systemic onset juvenile idiopathic arthritis

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