Autoinflammatory & rare systemic diseases

Long‐Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor–Associated Periodic Syndrome: Results From a Phase III Trial

Arthritis RheumatolPublished Open-label extension of the CLUSTER phase III trial

Authors' 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.

Study context

Population
Patients with tumor necrosis factor receptor-associated periodic syndrome (TRAPS) in the final phase (epoch 4) of CLUSTER51 completed
Participants
53 patients
Comparison
Canakinumab 150 or 300 mg q4w or every 8 weeks; results by cumulative weight-adjusted dose <36 vs ≥36 mg/kg
Outcome
No or minimal disease activity (physician global assessment)
Follow-up
End of epoch 4 (72 weeks)
Methodological detailslong-term extension, 72-week
  • Long-term extension
  • 72-week

Main finding

As reported in the abstract

Patients achieving no or minimal disease activity

>94%

Further findings

Serum amyloid A, median (largely unchanged) · End of study

Safety

No unexpected safety findings were identified

Original publication

Long‐Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor–Associated Periodic Syndrome: Results From a Phase III Trial. Arthritis Rheumatol. Published 8 December 2023. doi:10.1002/art.42695

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