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J Rheumatol. 2019 Mar 1. pii: jrheum.180795. doi: 10.3899/jrheum.180795. [Epub ahead of print]

Neutropenia During Tocilizumab Treatment Is Not Associated With Infection Risk in Systemic or Polyarticular-Course Juvenile Idiopathic Arthritis.

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IRCCS Ospedale Pediatrico Bambino Gesù, Division of Rheumatology, Rome, Italy; Roche Products Ltd., Welwyn Garden City, United Kingdom; IRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Genoa, Italy; Federal State Autonomous Institution "National Medical Research Center of Children's Health" of the Ministry of Health of the Russian Federation, Department of Rheumatology, and Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov, First Moscow State Medical University of the Ministry of Health of the Russian Federation, Department of Pediatrics and Pediatric Rheumatology, Moscow, Russian Federation; Saint-Petersburg State Pediatric Medical University, Department of Hospital Pediatrics, Saint-Petersburg, Russian Federation; Hospital for Sick Children, University of Toronto, Department of Pediatrics, Division of Rheumatology, Toronto, ON, Canada; Asklepios Klinik Sankt Augustin, Centre for General Pediatrics and Neonatology, Sankt Augustin, and University Hospital of Cologne, Cologne, Germany; Prof Hess Children's Hospital and Pediatric Intensive Care Medicine, Bremen, Germany; German Rheumatism Research Centre Berlin, and Charité University Medicine, Department of Rheumatology and Clinical Immunology, Berlin, Germany; Hospital for Special Surgery, Division of Pediatric Rheumatology, New York, New York; Connecticut Children's Medical Center, Pediatric Rheumatology, Hartford, Connecticut; Tulsa Bone & Joint Associates, Tulsa, Oklahoma; National Referral Centre of Auto- Inflammatory Diseases, CEREMAIA, CHU de Bicere, Department of Pediatric Rheumatology, APHP, University of Paris Sud, Le Kremlin Bicêtre, France; University Hospital of Ioannina, Unit of Paediatric Rheumatology, Paediatric Clinic, Ioannina, Greece; Children's Institute, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Pediatric Rheumatology Unit, Sao Paulo, Brazil; Genentech, South San Francisco, California; University of Cincinnati, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Department of Pediatrics, PRCSG Coordinating Center, Cincinnati, Ohio. The study was sponsored by F. Hoffmann La Roche Ltd. Support for third-party writing assistance was provided by Sara Duggan, PhD, of ApotheCom and was funded by F. Hoffmann La- Roche Ltd. Address correspondence to Fabrizio De Benedetti, MD, PhD, IRCCS Ospedale Pediatrico Bambino Gesù, Piazza S. Onofrio 4, 00165 Rome, Italy. E-mail:



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).


Data up to week 104 from 2 phase 3 trials of intravenous TCZ in sJIA (n = 112;, NCT00642460) and pcJIA (n = 188;, 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.


ANCs 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.


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


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