in ME Statement
A UK Rituximab Trial for ME
In June/July Invest in ME announced that we were in
discussions to set up a UK trial of rituximab for ME
has progressed since and now we can announce more
details of this plan.
Professor Jonathan Edwards, Emeritus Professor of
Connective Tissue Medicine at University College London
(UCL) , is advising the charity on this project and
excellent progress has been made.
are now in a position to initiate a rituximab study in
the UK using the best facilities and expertise
we need to do now is raise the requisite funding.
Invest in ME is therefore asking ME support groups and
patients to rally behind our fundraising efforts to
achieve this funding target.
the statements below show this trial would be performed
by experts in this area with a team of experienced and
world-class researchers and first-class facilities.
There is no other such trial planned in the UK that we
know of and the charity is working with other
international researchers and organisations to achieve
welcome your support to make this trial a reality and to
make rapid progress in state-of-the-art biomedical
research into ME.
Professor Jonathan Edwards and Invest in ME - July
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.It became clear to me that there was a community
committed to identifying and encouraging the very best
research in a difficult and neglected field.
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.
limited 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
if 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 clear.
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.
and 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.
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.
feeling is that a trial should be carried out somewhere
with detailed experience in use of rituximab in
UCL service set up when we started treating rheumatoid
arthritis, lupus and a range of other conditions has the
most extensive experience.
There is 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 this sort.
Importantly, there is enthusiasm amongst local teams for
a rituximab ME/CFS trial.
have 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.
have accepted this and this is the planned and preferred
research base for this trial.
Clinical trials 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
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.
Statement from Invest in ME:
statement above from Professor Edwards is an astonishing
opportunity for those patients with ME and their
have 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.
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. At the Biomedical
Research into ME Collaborative meeting (BRMEC)
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.
Cambridge added an enormous amount to the meeting -
followed by a sincere and positive approach to
progressing research. UCL, as Professor Edwards has
explained, has first-class facilities and we believe
this opportunity is unique in the UK.
the UK patient community wish to have a rituximab study
then this is as good as it gets.
With the 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 possible.
IiME have 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
fundraising campaign now must begin in earnest. We
invite everyone to get behind this UK rituximab study
and support us.We welcome contributions from other
organisations and companies and individuals.
quality of the researchers and the facilities is beyond
doubt.IiME will 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.
now have the researchers willing to perform this trial
in the UK.
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.
can take this forward in collaboration with Dr Bansal
and with close liaison, including visits, with Bergen.
This has been agreed.
meeting has been arranged for Professor Edwards to visit
Bergen to discuss with Dr Fluge.
Further trips 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
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 Invest in ME in this venture.
This UK rituximab study has been initiated by IiME and
the UCL staff who were at our conference and BRMEC
best research team possible to undertake this trial is
able to perform this.
need now simply to fund this.
Please support us in this venture.
Donate to the UK rituximab Trial - click
page for the UK rituximab trial is here -
The Way Forward for ME - A Case for Clinical Trials
Invest in ME
Registered UK Charity Nr. 1114035