Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis
© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology..
OBJECTIVE: To investigate the safety and efficacy of subcutaneous tocilizumab (SC-TCZ) treatment in a long-term extension (LTE) of clinical trials in polyarticular or systemic juvenile idiopathic arthritis (pJIA, sJIA).
METHODS: Patients with pJIA or sJIA from two open-label, 52-week phase 1 b core trials of SC-TCZ who had adequate response per investigator assessment entered the LTE and continued SC-TCZ treatment according to body weight-based dosing regimens until commercial availability or up to 5 years. Pharmacokinetics, pharmacodynamics, and efficacy were assessed for up to 3 years and safety for up to 5 years in the LTE.
RESULTS: Forty-four patients with pJIA and 38 patients with sJIA entered the LTE. Tocilizumab trough concentrations were maintained within the range expected to provide clinical benefit (mean values: pJIA, ∼10 μg/ml; sJIA, ∼75 μg/ml over 3 years). Pharmacodynamic parameters (interleukin-6, soluble interleukin-6 receptor, erythrocyte sedimentation rate, C-reactive protein) were maintained throughout the LTE at levels achieved in the core trials. Inactive disease per American College of Rheumatology provisional criteria was reported for 90% (17/19) and 53% (8/15) of patients with pJIA and 91% (10/11) and 92% (12/13) of patients with sJIA in the <30 kg and ≥30 kg body weight groups, respectively. Serious adverse events in the LTE were reported in six patients with pJIA (13.6%; five serious infections) and five patients with sJIA (13.2%; one serious infection).
CONCLUSION: Patients with pJIA or sJIA experienced long-term disease control with SC-TCZ treatment. Long-term safety was consistent with the known tocilizumab safety profile.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Rheumatology (Oxford, England) - (2024) vom: 29. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Brunner, Hermine I [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Revised 29.03.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1093/rheumatology/keae180 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370418468 |
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| 100 | 1 | |a Brunner, Hermine I |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. | ||
| 520 | |a OBJECTIVE: To investigate the safety and efficacy of subcutaneous tocilizumab (SC-TCZ) treatment in a long-term extension (LTE) of clinical trials in polyarticular or systemic juvenile idiopathic arthritis (pJIA, sJIA) | ||
| 520 | |a METHODS: Patients with pJIA or sJIA from two open-label, 52-week phase 1 b core trials of SC-TCZ who had adequate response per investigator assessment entered the LTE and continued SC-TCZ treatment according to body weight-based dosing regimens until commercial availability or up to 5 years. Pharmacokinetics, pharmacodynamics, and efficacy were assessed for up to 3 years and safety for up to 5 years in the LTE | ||
| 520 | |a RESULTS: Forty-four patients with pJIA and 38 patients with sJIA entered the LTE. Tocilizumab trough concentrations were maintained within the range expected to provide clinical benefit (mean values: pJIA, ∼10 μg/ml; sJIA, ∼75 μg/ml over 3 years). Pharmacodynamic parameters (interleukin-6, soluble interleukin-6 receptor, erythrocyte sedimentation rate, C-reactive protein) were maintained throughout the LTE at levels achieved in the core trials. Inactive disease per American College of Rheumatology provisional criteria was reported for 90% (17/19) and 53% (8/15) of patients with pJIA and 91% (10/11) and 92% (12/13) of patients with sJIA in the <30 kg and ≥30 kg body weight groups, respectively. Serious adverse events in the LTE were reported in six patients with pJIA (13.6%; five serious infections) and five patients with sJIA (13.2%; one serious infection) | ||
| 520 | |a CONCLUSION: Patients with pJIA or sJIA experienced long-term disease control with SC-TCZ treatment. Long-term safety was consistent with the known tocilizumab safety profile | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Autoinflammatory conditions | |
| 650 | 4 | |a Biologic therapies | |
| 650 | 4 | |a Juvenile idiopathic arthritis | |
| 650 | 4 | |a Paediatric/juvenile rheumatology | |
| 650 | 4 | |a Pharmacology | |
| 650 | 4 | |a clinical trial | |
| 650 | 4 | |a interleukin-6 | |
| 650 | 4 | |a long-term extension | |
| 650 | 4 | |a pharmacovigilance | |
| 650 | 4 | |a tocilizumab | |
| 700 | 1 | |a Ruperto, Nicolino |e verfasserin |4 aut | |
| 700 | 1 | |a Ramanan, Athimalaipet V |e verfasserin |4 aut | |
| 700 | 1 | |a Horneff, Gerd |e verfasserin |4 aut | |
| 700 | 1 | |a Minden, Kirsten |e verfasserin |4 aut | |
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| 700 | 1 | |a De Benedetti, Fabrizio |e verfasserin |4 aut | |
| 700 | 0 | |a PRINTO and PRCSG investigators |e verfasserin |4 aut | |
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