A Patients and Families Support Group

A UK website about atypical Haemolytic Uraemic Syndrome (aHUS)

Ready, get SETS, Go!

Ready, get SETS, Go!

The UK Trial of the withdrawal of eculizumab treatment for aHUS patients formally commenced on 1 September.

Known as SETS – Stopping eculizumab treatment safely the trial will be the most statistically significant exercise done so far about who can successfully withdraw from treatment and what factors may have determined that success whilst ensuring the safety of patient care.

Recruitment of the first patient to the trial will begin in the New Year and recruitment will continue for a further eighteen months in to 2019 . The results will be reported sometime in 2020.

It is expected that around 30 patients will be enrolled but these will not include anyone who has already with drawn ,for whatever reason , from treatment already . Only the trialists will benefit from the safe care pathway that will be established for stopping treatment. This pathway is being tested for future use within the aHUS specialised service.

Potential trialists will be selected using a range of criteria which identifies those at minimal risk of TMA ,thrombotic microangiopathy , recurrence. If clinician and patient are then content the site will join the trial.

Once treatment is withdrawn the monitoring begins more intensely at the start, because if the TMA is to happen it is more than likely to happen in the first six months; after which the frequency of recurrence drops off significantly if it is going to happen at all.

Between now and January  all the forms and protocols to be used by the patient, local clinician, expert centre and the trial management team have to be drafted and approved in a number of stages to be ready to begin recruitment. Answers for aHUS will be represented in that process.

Patient feedback will be an important part of the outcome of the trial and both those who chose to join the trial and those who chose not to will get the opportunity to express their feelings about withdrawing from treatment. This will be important evidence not just for NICE but to help develop patient counselling about treatment withdrawal when the time comes.

The study was called for by NICE as an important qualification of its decision to approve eculizumab for aHUS. That decision was certainly world class and the outcome of this trial will add further to the world class treatment that UK aHUS patients are given, treatment when needed for as long as is needed.

So it all systems GO  for SETS  having being READY for a while for it to happen.

 

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