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- W4386439109 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." @default.
- W4386439109 created "2023-09-06" @default.
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- W4386439109 date "2023-09-05" @default.
- W4386439109 modified "2023-10-18" @default.
- W4386439109 title "Long‐term efficacy/safety of canakinumab in patients with tumor necrosis factor receptor‐associated periodic syndrome: results from a phase III trial" @default.
- W4386439109 doi "https://doi.org/10.1002/art.42695" @default.
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- W4386439109 hasPublicationYear "2023" @default.
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