RT Journal Article
SR Electronic
T1 Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.170326
DO 10.3899/jrheum.170326
A1 Kamal N.  Bharucha
A1 Hermine I.  Brunner
A1 Inmaculada Calvo Penadés
A1 Irina Nikishina
A1 Nadina Rubio-Pérez
A1 Sheila Oliveira
A1 Katarzyna Kobusinska
A1 Heinrike Schmeling
A1 Flavio Sztajnbok
A1 Frank Weller-Heinemann
A1 Elena Zholobova
A1 Francesco Zulian
A1 Roger Allen
A1 Jeffrey Chaitow
A1 James Frane
A1 Chris Wells
A1 Nicolino Ruperto
A1 Fabrizio De Benedetti
A1 for the Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group
YR 2018
UL http://www.jrheum.org/content/early/2018/06/21/jrheum.170326.abstract
AB Objective Evaluate growth in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ) for up to 2 years in a phase III trial. Methods Patients with pcJIA lasting at least 6 months and inadequate response to methotrexate received open-label TCZ intravenously every 4 weeks (randomly assigned to 8 or 10 mg/kg if they weighed < 30 kg; received 8 mg/kg if they weighed ≥ 30 kg) for 16 weeks. Patients with JIA American College of Rheumatology 30 response at Week 16 were randomly assigned to TCZ or placebo for 24 weeks, with an open-label extension through Week 104. Mean ± SD height velocity (cm/yr) and World Health Organization (WHO) height SD score (SDS) were measured in patients receiving ≥ 1 dose of TCZ who did not receive growth hormone and in patients whose baseline Tanner stage was ≤ 3. Results The study included 187 of 188 patients (99.5%) with mean WHO height SDS –0.5 ± 1.2, which was unrelated to age or disease duration (Spearman rank correlations r = 0.08 and r = –0.12, respectively). There were 123 patients at Tanner stage ≤ 3 at baseline, among whom 103 completed the study with 2 years of height SDS data. Mean height SDS increased from baseline to year 2 (+0.40, p < 0.0001). In 74 of 103 patients (72%), height SDS was greater than at baseline, and mean height velocity was 6.7 ± 2.0 cm/year. Conclusion Among patients with pcJIA at Tanner stage ≤ 3 at baseline, 72% (74/103) had increased height SDS at the end of the study.