Long-term efficacy/safety of canakinumab in patients with tumor necrosis factor receptor-associated periodic syndrome: results from a phase III trial.

Autores de IIS La Fe

• 

  Inmaculada Calvo Penadés

  Autor

Participantes ajenos a IIS La Fe

• Gattorno, Marco
• Obici, Laura
• Kallinich, Tilmann
• Benseler, Susanne
• Dekker, Elise
• Levy, Jeremy
• De Benedetti, Fabrizio
• Lachmann, Helen

Grupos

• Reumatología Pediátrica

  

  Investigador Principal

  Inmaculada Calvo Penadés

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 4weeks (q4w) or every 8weeks, 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 =36mg/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 <10mg/L. Median SAA concentrations were largely unchanged with medians of 11.5mg/L and 14.5 mg/L in the <36mg/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.

This article is protected by copyright. All rights reserved.

Keywords

• RECURRENT; TRAPS