Professor Jo Edwards
My interest in
ME/CFS was sparked when I was invited, unexpectedly, by IiME to the IiMEC8
Conference in May.
The meeting was
impressive: not just professional science, but at a high level. I was
particularly impressed that negative findings were given adequate weight.
became clear to me that there was a community committed to identifying and
encouraging the very best research in a difficult and neglected field.
I was aware of
the study by Fluge and Mella, using rituximab. I had not been surprised to see
some patients respond, but the type of response, which was similar to what we
had found in rheumatoid arthritis fifteen years ago, caught my attention. In
fact, the situation seemed very reminiscent of the time when we first started to
get results with targeted therapy in rheumatoid arthritis. We had the benefit of
more immunological clues then, but on the other hand, the experience we have
gained over the last decade now makes things easier in other ways.
understanding of ME/CFS is that, like arthritis, it is probably several diseases
with similar symptoms. Most colleagues who specialise in ME/CFS seem to agree.
What the Fluge/Mella study suggests is that perhaps half of those suffering from
these symptoms may have a B cell-dependent autoimmune disease.
A recent study
by Dr Amolak Bansal and colleagues also suggests that B cells may be functioning
abnormally in a significant proportion of people with ME/CFS.
To me, a key
feature of this approach, unlike chasing one particular virus or gene, is that,
if confirmed, it will provide a broad base for understanding disease mechanisms.
rituximab is a cumbersome treatment in the short term its use may not only help
a good proportion of patients directly but also begin to show us how to divide
ME/CFS into different groups. So it may be useful even for those whose disease
does not respond because once separated out from B cell-dependent disease the
role of other factors such as NK cell function or cerebral blood flow may become
Looking at the
research directions currently being pursued in ME/CFS, I am in no doubt that the
usage of rituximab is one of the most promising. There is clearly enthusiasm for
further trials. However, rituximab is not an easy drug to use and many doctors
do not feel confident with using it. This may explain why studies have been slow
to gain momentum outside Norway.
effective usage requires understanding of B cell life history and function. Each
condition has to be considered differently, especially in terms of when
treatment is repeated. But with experience its use is very effective and
probably as safe as most drugs.
After the IiME
Conference I began thinking about my personal experience of patients and friends
with ME/CFS. I was sent a copy of 'Lost Voices' by IiME, which made me think
more. It struck me that, whether or not results are positive, further trials of
rituximab for ME/CFS should be encouraged not only because impact on life for
those affected can be so severe but also because further trials could give clues
to disease mechanism. I am retired and would not be personally involved but have
suggested to IiME that I would be happy to advise and to encourage others to set
up a trial.
My feeling is
that a trial should be carried out somewhere with detailed experience in use of
rituximab in autoimmune conditions.
The UCL service
set up when we started treating rheumatoid arthritis, lupus and a range of other
conditions has the most extensive experience.
laboratory expertise in B cell immunology under Dr Jo Cambridge.
UCL also has a
new Clinical Trials Research Facility with staff appointed to manage trials of
there is enthusiasm amongst local teams for a rituximab ME/CFS trial.
suggested to IiME that this would be the ideal centre for such a trial, to be
set up in collaboration with clinicians with expertise in ME/CFS from around
London, and in particular Dr Bansal.
accepted this and this is the planned and preferred research base for this
are costly. The trial planned in Norway to confirm the results from Fluge and
Mella's initial trial will cost something like £1-2M pounds. I think it would be
most sensible to set up a smaller scale trial initially in the UK with a focus
on trying to identify which patients are most likely to benefit. A trial
treating about 30 patients, giving useful scientific information should
hopefully be feasible for around £3-400,000. Trial design will require careful
thought and some further preliminary laboratory work is likely to be needed
before it is clear what design would be optimal.
Nevertheless, I am optimistic
that a trial could be set up without major delay if funds can be raised. If the
role of B cells in at least some ME/CFS, suggested by Fluge and Mella's study,
can be confirmed I think there is a genuine chance of getting to grips with the
mechanism of the disease.
From there on things can only get easier.
Invest in ME:
above from Professor Edwards is an astonishing opportunity for those patients
with ME and their families.
somebody of Professor Edwards' standing produce such a statement, after agreeing
to advise the charity following the IIMEC8 conference, justifies completely the
conference theme of Mainstreaming ME Research.
This is a
potential breakthrough for state-of-the-art biomedical research into ME.
We believe this
study would add great value to other similar research being performed elsewhere.
It would also put the UK into the forefront of ME research.
There is no
greater expert able to advise on a trial of rituximab than Professor Edwards who
formally established the validity of B cell depletion in autoimmune disorders
via his groundbreaking rituximab trials.
the Biomedical Research into ME Colloquium (BRMEC3)
organised by Invest in ME and the Alison Hunter Memorial Foundation
Dr Jo Cambridge
from UCL was invited by the charity to attend and present to the 40 researchers
from nine countries gathered in London for the meeting. We felt it important to
get the best advice possible to help with this area of ME research. Dr Cambridge
added an enormous amount to the meeting – followed by a sincere and positive
approach to progressing research.
Professor Edwards has explained, has first-class facilities and we believe this
opportunity is unique in the UK.
If the UK
patient community wish to have a rituximab study then this is as good as it
clinical team and Dr Cambridge at UCL performing this work, and with Professor
Edwards as advisor, we are sure that a huge leap in understanding ME will be
managed to work with the experts to set up this possibility. As Professor
Edwards states “a trial could be set up without major delay if funds can be
campaign now must begin in earnest.
everyone to get behind this UK rituximab study and support us.
contributions from other organisations and companies and individuals. The
quality of the researchers and the facilities is beyond doubt.
contact other organisations to invite them to donate to this cause. One
organisation has already indicated it will support a rituximab trial. We have
other pledges already.
We now have the researchers willing to perform this trial in the UK.
The quality of the researchers and the facilities at their disposal place the capability of the UCL team to perform this trial beyond doubt.
There is enthusiasm for setting up a study at UCL.
UCL can take this forward in collaboration with Dr Bansal and with close
liaison, including visits, with Bergen. This has been agreed.
A meeting has
been arranged for Professor Edwards to visit Bergen to discuss with Dr Fluge.
by the UCL team would be a possibility and will be arranged by the charity.
We welcome this
as this will undoubtedly help both the Norwegian and the UK studies.
We need to
raise funding for this study so we urge all our supporters, and others who wish to
have a UK rituximab trial or wish to advance biomedical research into ME, to
raise awareness and interest from as many sources as possible and support us in
rituximab study has been initiated by IiME and the UCL staff who were at our
conference and BRMEC research meeting.
research team possible to undertake this trial is able to perform this.
We need now
simply to fund this.
us in this venture.