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

Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1173-1179
Number of pages7
JournalJournal of Rheumatology
Volume45
Issue number8
DOIs
Publication statusPublished - Aug 2018

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Phase III Clinical Trials
Juvenile Arthritis
Growth
Therapeutics
tocilizumab
Methotrexate
Growth Hormone
Placebos

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Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group (2018). Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial. Journal of Rheumatology, 45(8), 1173-1179. https://doi.org/10.3899/jrheum.170326

Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis : 2-year Data from a Phase III Clinical Trial. / Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group.

In: Journal of Rheumatology, Vol. 45, No. 8, 08.2018, p. 1173-1179.

Research output: Contribution to journalArticle

Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group 2018, 'Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial', Journal of Rheumatology, vol. 45, no. 8, pp. 1173-1179. https://doi.org/10.3899/jrheum.170326
Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial. Journal of Rheumatology. 2018 Aug;45(8):1173-1179. https://doi.org/10.3899/jrheum.170326
Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. / Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis : 2-year Data from a Phase III Clinical Trial. In: Journal of Rheumatology. 2018 ; Vol. 45, No. 8. pp. 1173-1179.
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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.",
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T1 - Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis

T2 - 2-year Data from a Phase III Clinical Trial

AU - Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group

AU - Bharucha, Kamal N

AU - Brunner, Hermine I

AU - Calvo Penadés, Inmaculada

AU - Nikishina, Irina

AU - Rubio-Pérez, Nadina

AU - Oliveira, Sheila

AU - Kobusinska, Katarzyna

AU - Schmeling, Heinrike

AU - Sztajnbok, Flavio

AU - Weller-Heinemann, Frank

AU - Zholobova, Elena

AU - Zulian, Francesco

AU - Allen, Roger

AU - Chaitow, Jeffrey

AU - Frane, James

AU - Wells, Chris

AU - Ruperto, Nicolino

AU - De Benedetti, Fabrizio

PY - 2018/8

Y1 - 2018/8

N2 - 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.

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.

U2 - 10.3899/jrheum.170326

DO - 10.3899/jrheum.170326

M3 - Article

C2 - 29961686

VL - 45

SP - 1173

EP - 1179

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 8

ER -