What is Happening with the Research
into ME and Rituximab?
By Anette Gilje
Secretary General, Norwegian ME Association
The cancer doctors ōystein Fluge and Olav Mella, Haukeland
University Hospital, published their study on ME and rituximab
last autumn. Following their sensational and promising findings
that some people with ME had benefitted from the immune
modulator rituximab, the Government allocated two million
Norwegian Kroners (approx. 220 000 £) to the Western Norway
Regional Health Authority to help funding a larger follow-up
This is far from enough to fund a larger, double-blinded
multi-center study which is necessary to determine the
scientific research question: Does rituximab have an effect on
this patient group, or not, says Professor Mella.
– We do
believe it has, but this has to be confirmed in a larger study
to gain scientific credibility internationally. To be reasonably
certain to answer the question, the study probably has to
include between 120 and 140 carefully selected patients that
meet the Canadian Consensus criteria. The patient-sample will be
divided into two groups, one of which will receive active
treatment with rituximab, the other placebo (i.e. inactive
substance). Both groups will be closely observed for potential
effects and adverse reactions.
Providing the study can confirm a significant effect in the
group that was given rituximab and the adverse reactions are
acceptable, the placebo group will be offered treatment with
rituximab at a later point of time.
scientific study of this scale cannot be initiated before the
whole project is fully funded. So far Drs Fluge and Mella are
working on a draft protocol for a larger study in corporation
with the ME/CFS-Centre, Oslo University Hospital (Aker). When
the preliminary protocol is completed, it is time to establish
collaborations with other research communities that want to take
part in the study. After that the research protocol will be
submitted to the Committee for Medical and Health Research
Ethics and the Norwegian Medicines Agency.
Professor Mella says it is extremely important that the research
centers included in the study are dedicated to the task. They
need people who are very good at diagnostics and that can
administer the rituximab treatment in a safe manner for the
patients. - If you can’t accommodate this, it’s probably better
for the study to be carried out in fewer institutions.
Rituximab is known to have some serious, but very rare adverse
– Our experiences in working with cancer patients
show that this is a drug that do not trigger a lot of adverse
reactions, Mella says.
– What you do, is to deplete the B-cell
lymphocytes which are normally responsible for production of
antibodies. Because this is done only for a limited period of
time, many of the mature B-cells are still circulating in the
blood stream. The increase in infections in most patients
receiving this treatment is small. There is, however, a
theoretical risk for serious infections. That is why it is
necessary to be alert when looking for emerging signs of
Dr Mella explains that rituximab is a protein substance that is
partly produced from human material and partly from mouse
material. The tendency for allergic reactions is increased
compared with some other drugs. That is why it is important that
the patients receive the drug under observation, preferably at a
rheumatological-, neurological- or a cancer ward.
– If you are
used to administer rituximab and know what to do if allergic
reactions occur, we see this as an easy treatment, Dr Mella
– The patients must be under observation for some
hours when they receive the treatment in the ward, and they are
admitted for 24 hours to make it possible to deal with potential
–It is important to stress that we do not
know if ME patients may have more or other side effects compared
to patients with cancer or rheumatological diseases.
Drs Fluge and Mella have worked for almost three years in their
search for biomarkers for ME, thanks to the funding from Western
Norway Regional Health Authority. In their search, biological
samples from the study participants are investigated in the
laboratory. The patients’ clinical picture is the researchers’
starting point in their search for biomarkers. From there they
can reflect where the problem might be located and search for
abnormalities. Dr Mella admits that there is always a need for
money for research, more can be done and things can move forward
a little quicker.
Ellen V. Piro and Eva Stormorken
Norwegian ME Association
16th March 2012
The translation has been approved by Professor Olav Mella and is
published with his permission.