@article {Pardeojrheum.180795, author = {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 Clovis A. Silva and Benjamin Porter-Brown and Kamal N. Bharucha and Hermine I. Brunner and Fabrizio De Benedetti}, title = {Neutropenia During Tocilizumab Treatment Is Not Associated With Infection Risk in Systemic or Polyarticular-Course Juvenile Idiopathic Arthritis}, elocation-id = {jrheum.180795}, year = {2019}, doi = {10.3899/jrheum.180795}, publisher = {The Journal of Rheumatology}, 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 3 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 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. Conclusion Patients with JIA treated with TCZ experienced transient neutropenia that was not associated with an increased number of infections.}, issn = {0315-162X}, URL = {https://www.jrheum.org/content/early/2019/02/25/jrheum.180795}, eprint = {https://www.jrheum.org/content/early/2019/02/25/jrheum.180795.full.pdf}, journal = {The Journal of Rheumatology} }