Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis

Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To determine whether neutropenia is associated with increased risk for infection in patients with systemic juvenile idiopathic arthritis (sJIA) and polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ).

METHODS: Data up to Week 104 from 2 phase III trials of intravenous TCZ in sJIA (n = 112; ClinicalTrials.gov, NCT00642460) and pcJIA (n = 188; ClinicalTrials.gov, NCT00988221) were pooled. Worst common toxicity criteria grade and lowest observed absolute neutrophil count (ANC) were identified for each patient. Associations between patient characteristics and lowest observed ANC were tested using univariate regression analysis. Infection and serious infection rates per 100 patient-years (PY) in periods associated with grades 1/2 and 3/4 neutrophil counts were compared with rates associated with normal neutrophil counts.

RESULTS: ANC decreased to grade ≥ 3 in 25.0% and 5.9% of sJIA and pcJIA patients, respectively, and decreases were transient. Young age (p = 0.047) and methotrexate use (p = 0.012) were positively associated with neutropenia in patients with sJIA but not in patients with pcJIA. The rate of serious infections in patients with sJIA (10.9/100 PY; 95% CI 6.8-16.5) tended to be higher than in patients with pcJIA (5.2/100 PY; 95% CI 3-8.5). No increase in rates of serious or nonserious infections was observed during periods of neutropenia in either trial.

CONCLUSION: Patients with JIA treated with TCZ experienced transient neutropenia that was not associated with an increased number of infections.

Original languageEnglish
JournalJournal of Rheumatology
DOIs
Publication statusE-pub ahead of print - Mar 1 2019

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Juvenile Arthritis
Neutropenia
Infection
Neutrophils
Therapeutics
tocilizumab
Methotrexate
Regression Analysis

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Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG) (2019). Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. Journal of Rheumatology. https://doi.org/10.3899/jrheum.180795

Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. / Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG).

In: Journal of Rheumatology, 01.03.2019.

Research output: Contribution to journalArticle

Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG) 2019, 'Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis', Journal of Rheumatology. https://doi.org/10.3899/jrheum.180795
Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. Journal of Rheumatology. 2019 Mar 1. https://doi.org/10.3899/jrheum.180795
Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). / Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. In: Journal of Rheumatology. 2019.
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abstract = "OBJECTIVE: To determine whether neutropenia is associated with increased risk for infection in patients with systemic juvenile idiopathic arthritis (sJIA) and polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ).METHODS: Data up to Week 104 from 2 phase III trials of intravenous TCZ in sJIA (n = 112; ClinicalTrials.gov, NCT00642460) and pcJIA (n = 188; ClinicalTrials.gov, NCT00988221) were pooled. Worst common toxicity criteria grade and lowest observed absolute neutrophil count (ANC) were identified for each patient. Associations between patient characteristics and lowest observed ANC were tested using univariate regression analysis. Infection and serious infection rates per 100 patient-years (PY) in periods associated with grades 1/2 and 3/4 neutrophil counts were compared with rates associated with normal neutrophil counts.RESULTS: ANC decreased to grade ≥ 3 in 25.0{\%} and 5.9{\%} of sJIA and pcJIA patients, respectively, and decreases were transient. Young age (p = 0.047) and methotrexate use (p = 0.012) were positively associated with neutropenia in patients with sJIA but not in patients with pcJIA. The rate of serious infections in patients with sJIA (10.9/100 PY; 95{\%} CI 6.8-16.5) tended to be higher than in patients with pcJIA (5.2/100 PY; 95{\%} CI 3-8.5). No increase in rates of serious or nonserious infections was observed during periods of neutropenia in either trial.CONCLUSION: Patients with JIA treated with TCZ experienced transient neutropenia that was not associated with an increased number of infections.",
author = "{Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)} and Manuela Pardeo and Jianmei Wang and Nicolino Ruperto and Ekaterina Alexeeva and Vyacheslav Chasnyk and Rayfel Schneider and Gerd Horneff and Hans-Iko Huppertz and Kirsten Minden and Karen Onel and Lawrence Zemel and Alan Martin and Isabelle Kon{\'e}-Paut and Antigoni Siamopoulou-Mavridou and Silva, {Clovis A} and Benjamin Porter-Brown and Bharucha, {Kamal N} and Brunner, {Hermine I} and {De Benedetti}, Fabrizio",
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T1 - Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis

AU - Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

AU - Pardeo, Manuela

AU - Wang, Jianmei

AU - Ruperto, Nicolino

AU - Alexeeva, Ekaterina

AU - Chasnyk, Vyacheslav

AU - Schneider, Rayfel

AU - Horneff, Gerd

AU - Huppertz, Hans-Iko

AU - Minden, Kirsten

AU - Onel, Karen

AU - Zemel, Lawrence

AU - Martin, Alan

AU - Koné-Paut, Isabelle

AU - Siamopoulou-Mavridou, Antigoni

AU - Silva, Clovis A

AU - Porter-Brown, Benjamin

AU - Bharucha, Kamal N

AU - Brunner, Hermine I

AU - De Benedetti, Fabrizio

PY - 2019/3/1

Y1 - 2019/3/1

N2 - OBJECTIVE: To determine whether neutropenia is associated with increased risk for infection in patients with systemic juvenile idiopathic arthritis (sJIA) and polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ).METHODS: Data up to Week 104 from 2 phase III trials of intravenous TCZ in sJIA (n = 112; ClinicalTrials.gov, NCT00642460) and pcJIA (n = 188; ClinicalTrials.gov, NCT00988221) were pooled. Worst common toxicity criteria grade and lowest observed absolute neutrophil count (ANC) were identified for each patient. Associations between patient characteristics and lowest observed ANC were tested using univariate regression analysis. Infection and serious infection rates per 100 patient-years (PY) in periods associated with grades 1/2 and 3/4 neutrophil counts were compared with rates associated with normal neutrophil counts.RESULTS: ANC decreased to grade ≥ 3 in 25.0% and 5.9% of sJIA and pcJIA patients, respectively, and decreases were transient. Young age (p = 0.047) and methotrexate use (p = 0.012) were positively associated with neutropenia in patients with sJIA but not in patients with pcJIA. The rate of serious infections in patients with sJIA (10.9/100 PY; 95% CI 6.8-16.5) tended to be higher than in patients with pcJIA (5.2/100 PY; 95% CI 3-8.5). No increase in rates of serious or nonserious infections was observed during periods of neutropenia in either trial.CONCLUSION: Patients with JIA treated with TCZ experienced transient neutropenia that was not associated with an increased number of infections.

AB - OBJECTIVE: To determine whether neutropenia is associated with increased risk for infection in patients with systemic juvenile idiopathic arthritis (sJIA) and polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ).METHODS: Data up to Week 104 from 2 phase III trials of intravenous TCZ in sJIA (n = 112; ClinicalTrials.gov, NCT00642460) and pcJIA (n = 188; ClinicalTrials.gov, NCT00988221) were pooled. Worst common toxicity criteria grade and lowest observed absolute neutrophil count (ANC) were identified for each patient. Associations between patient characteristics and lowest observed ANC were tested using univariate regression analysis. Infection and serious infection rates per 100 patient-years (PY) in periods associated with grades 1/2 and 3/4 neutrophil counts were compared with rates associated with normal neutrophil counts.RESULTS: ANC decreased to grade ≥ 3 in 25.0% and 5.9% of sJIA and pcJIA patients, respectively, and decreases were transient. Young age (p = 0.047) and methotrexate use (p = 0.012) were positively associated with neutropenia in patients with sJIA but not in patients with pcJIA. The rate of serious infections in patients with sJIA (10.9/100 PY; 95% CI 6.8-16.5) tended to be higher than in patients with pcJIA (5.2/100 PY; 95% CI 3-8.5). No increase in rates of serious or nonserious infections was observed during periods of neutropenia in either trial.CONCLUSION: Patients with JIA treated with TCZ experienced transient neutropenia that was not associated with an increased number of infections.

U2 - 10.3899/jrheum.180795

DO - 10.3899/jrheum.180795

M3 - Article

C2 - 30824645

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

ER -