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Long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency: Results from the randomised Phase 3 CLUSTER trial

Rheumatology Sep 27, 2021

Jeyaratnam J, Simon A, Calvo I, et al. - During the 72-week research period, canakinumab was found to be beneficial in controlling disease activity and preventing flares in patients with mevalonate kinase deficiency (MKD). There were no new safety concerns noted.

  • Patients received open-label canakinumab 150 or 300 mg, every 4 or 8 weeks during a 72-week period.

  • Sixty-six of the 74 patients who began the CLUSTER study progressed to Epoch 4 and 65 finished it.

  • During the 72-week period, 42 (64%) of patients had no flares, whereas 13 (20%) had one flare, compared with a baseline median of 12 flares each year.

  • At the end of the trial, all groups had low physician global assessment scores, with > 90% reporting minimal disease activity or none at all.

  • Median C reactive protein concentrations were continuously equal to or less than 10 mg/l, whereas median serum amyloid A values were only marginally higher than the usual range of 10 mg/l.

  • There were no new or unexpected adverse events identified in the trial.

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