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Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Bharucha, KN
  • Brunner, HI
  • Nikishina, I
  • Rubio-Perez, N
  • Oliveira, S
  • Kobusinska, K
  • Schmeling, H
  • Sztajnbok, F
  • Weller-Heinemann, F
  • Zholobova, E
  • Zulian, F
  • Allen, R
  • Chaitow, J
  • Frane, J
  • Wells, C
  • Ruperto, N
  • De Benedetti, F
  • Paediat Rheumatol Int Trials Org
  • Pediat Rheumatology Collaborative

Grupos

Abstract

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.

Datos de la publicación

ISSN/ISSNe:
0315-162X, 1499-2752

JOURNAL OF RHEUMATOLOGY  J RHEUMATOL PUBL CO

Tipo:
Article
Páginas:
1173-1179
PubMed:
29961686
Factor de Impacto:
1,838 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 15

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Keywords

  • INTERLEUKINS; BIOLOGICAL THERAPY; GROWTH; JUVENILE IDIOPATHIC ARTHRITIS

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