This patient is NEDA-2 (no relapses or MRI activity), but is getting worse on DMF (Tecfidera). She has smouldering MS. Do I label her as having SPMS and switch her to siponimod (Mayzent), or not?
Dear professor, can her disease activity be proved via lumbar puncture and then she can continue to be treated as a case of active MS and therefore qualify to receive Siponimod or any other DMT that might be appropriate for her?
Yes, in our centre we could offer her a lumbar puncture and CSF analysis to see if her spinal fluid neurofilament light chain levels are raised. This is a biomarker of activity. However, in the NHS this is not accepted as evidence of activity and is therefore not used in clinical practice nor accepted as part of the NHS England DMT algorithm. This is why we only offer these patients off-label generics, for example, subcutaneous cladribine.
Yes, I had a few patients in the EXPAND study who completed the study with improved EDSS scores. My anecdotal experience is these patients tended to be DMT naive and therefore likely had ongoing inflammation that was suppressed by siponimod that allowed recovery to occur.
Under NHS England's DMT algorithm she is not eligible for these DMTs. In fact, as she has inactive SPMS she is not eligible for any DMT. According to the the algorithm we should stop her DMT.
This is tragic- the options are taken away from the patient and physician.
As you point out she may be in the process of progressing towards SPMS but maybe she is just failing Tecfedera..
I am 18 years into diagnosis and still fighting for strong treatment, currently in Cladribine year 1. I am only hopeful about my MS future knowing I have access to strong therapies in the future.
The concept of Hope hit home for me when I JCV Ab’d out of Tysabri and nothing stronger was available- this was Feb 2014- then I found Alemtuzumab and developed a profound understanding of the power of Hope in my MS struggle.
Being in the SPMS cul de sac and limited to but one DMT in my future would be devastating x2.
Dear professor, can her disease activity be proved via lumbar puncture and then she can continue to be treated as a case of active MS and therefore qualify to receive Siponimod or any other DMT that might be appropriate for her?
Yes, in our centre we could offer her a lumbar puncture and CSF analysis to see if her spinal fluid neurofilament light chain levels are raised. This is a biomarker of activity. However, in the NHS this is not accepted as evidence of activity and is therefore not used in clinical practice nor accepted as part of the NHS England DMT algorithm. This is why we only offer these patients off-label generics, for example, subcutaneous cladribine.
Prof. Gavin
Is there any data ( or from your experience) for patients who use the Siponimod showing improvement on EDSS.
Yes, I had a few patients in the EXPAND study who completed the study with improved EDSS scores. My anecdotal experience is these patients tended to be DMT naive and therefore likely had ongoing inflammation that was suppressed by siponimod that allowed recovery to occur.
Why not keeping this patient classified as RRMSer and offer her Lemtrada or Cladribine the switch to Siponomod in a few years?
Under NHS England's DMT algorithm she is not eligible for these DMTs. In fact, as she has inactive SPMS she is not eligible for any DMT. According to the the algorithm we should stop her DMT.
This is tragic- the options are taken away from the patient and physician.
As you point out she may be in the process of progressing towards SPMS but maybe she is just failing Tecfedera..
I am 18 years into diagnosis and still fighting for strong treatment, currently in Cladribine year 1. I am only hopeful about my MS future knowing I have access to strong therapies in the future.
The concept of Hope hit home for me when I JCV Ab’d out of Tysabri and nothing stronger was available- this was Feb 2014- then I found Alemtuzumab and developed a profound understanding of the power of Hope in my MS struggle.
Being in the SPMS cul de sac and limited to but one DMT in my future would be devastating x2.