Gattorno, Marco;
Obici, Laura;
Penadés, Inmaculada Calvo;
Kallinich, Tilmann;
Benseler, Susanne;
Dekker, Elise;
Lévy, Jérémy;
... Lachmann, Helen; + view all
(2024)
Long-Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor–Associated Periodic Syndrome: Results From a Phase III Trial.
Arthritis & Rheumatology
, 76
(2)
pp. 304-312.
10.1002/art.42695.
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Abstract
OBJECTIVES: To assess efficacy, safety, and tolerability of canakinumab in patients with tumor necrosis factor receptor-associated periodic syndrome (TRAPS) during a 72-week long-term, open-label extension of the CLUSTER study. METHODS: Patients received open-label canakinumab 150 or 300 mg, either every 4 weeks (q4w) or every 8 weeks, with up-titration permitted following on-treatment flares (maximum dose: 300 mg q4w). Efficacy assessments included physician global assessment (PGA) of disease activity, number of flares, and serum C-reactive protein (CRP) and serum amyloid A protein (SAA) levels. Adverse events were also reported. Results are described for the overall population and according to the cumulative dose of canakinumab adjusted for body weight (<36 mg/kg or ≥36 mg/kg). RESULTS: Of 53 patients entering the final phase (Epoch 4) of CLUSTER, 51 completed the treatment. At the end of Epoch 4, >94% of patients achieved no or minimal disease activity. Most patients had either no (69.8%) or one flare (24.5%), whereas at baseline the median number of flares was 9.0 per year. Median CRP levels remained at <10 mg/L. Median SAA concentrations were largely unchanged with medians of 11.5 mg/L and 14.5 mg/L in the <36 mg/kg and ≥36 mg/kg groups, respectively, at the end of study. No unexpected safety findings were identified. CONCLUSION: Control of disease activity, with low flare incidence, was maintained with long-term canakinumab treatment in patients with TRAPS during the 72-week final Epoch of the CLUSTER study, with no new safety findings. This article is protected by copyright. All rights reserved.
| Type: | Article |
|---|---|
| Title: | Long-Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor–Associated Periodic Syndrome: Results From a Phase III Trial |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1002/art.42695 |
| Publisher version: | https://doi.org/10.1002/art.42695 |
| Language: | English |
| Additional information: | © 2023 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10176357 |
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