Universität zu Köln

Pardeo, Manuela, Wang, Jianmei, Ruperto, Nicolino, Alexeeva, Ekaterina, Chasnyk, Vyacheslav, Schneider, Rayfel, Horneff, Gerd, Huppertz, Hans-Iko, Minden, Kirsten, Onel, Karen, Zemel, Lawrence, Martin, Alan, Kone-Paut, Isabelle, Siamopoulou-Mavridou, Antigoni, Silva, Clovis A., Porter-Brown, Benjamin, Bharucha, Kamal N., Brunner, Hermine, I and De Benedetti, Fabrizio (2019). Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. J. Rheumatol., 46 (9). S. 1117 - 1127. TORONTO: J RHEUMATOL PUBL CO. ISSN 1499-2752

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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 6.8-165) 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pardeo, Manuela UNSPECIFIED UNSPECIFIED UNSPECIFIED Wang, Jianmei UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruperto, Nicolino UNSPECIFIED UNSPECIFIED UNSPECIFIED Alexeeva, Ekaterina UNSPECIFIED UNSPECIFIED UNSPECIFIED Chasnyk, Vyacheslav UNSPECIFIED UNSPECIFIED UNSPECIFIED Schneider, Rayfel UNSPECIFIED UNSPECIFIED UNSPECIFIED Horneff, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Huppertz, Hans-Iko UNSPECIFIED UNSPECIFIED UNSPECIFIED Minden, Kirsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Onel, Karen UNSPECIFIED UNSPECIFIED UNSPECIFIED Zemel, Lawrence UNSPECIFIED UNSPECIFIED UNSPECIFIED Martin, Alan UNSPECIFIED UNSPECIFIED UNSPECIFIED Kone-Paut, Isabelle UNSPECIFIED UNSPECIFIED UNSPECIFIED Siamopoulou-Mavridou, Antigoni UNSPECIFIED UNSPECIFIED UNSPECIFIED Silva, Clovis A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Porter-Brown, Benjamin UNSPECIFIED UNSPECIFIED UNSPECIFIED Bharucha, Kamal N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brunner, Hermine, I UNSPECIFIED UNSPECIFIED UNSPECIFIED De Benedetti, Fabrizio UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-143189
DOI:	10.3899/jrheum.180795
Journal or Publication Title:	J. Rheumatol.
Volume:	46
Number:	9
Page Range:	S. 1117 - 1127
Date:	2019
Publisher:	J RHEUMATOL PUBL CO
Place of Publication:	TORONTO
ISSN:	1499-2752
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language INTERLEUKIN-6 RECEPTOR INHIBITION; RHEUMATOID-ARTHRITIS; DOUBLE-BLIND; INADEQUATE RESPONSE; TRIAL; METHOTREXATE; CHILDREN; EFFICACY; SAFETY; MULTICENTER Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14318