[Note: the following statement was translated from the Norwegian on Mar 16 by Ellen V. Piro and Eva Stormorken, Norwegian ME Association. The translation has been approved by Professor Olav Mella, is published with his permission, and has been shared broadly via Invest in ME and Co-Cure Listserv. We know that: researchers collaborating with the Cedars-Sinai Chronic Fatigue Syndrome Research Center have planned to take part in Rituximab research, and Dr. Kogelnik’s new Open Medicine Institute is running a pilot rituximab trial via its ME/CFS physician research network.]
What is Happening with the Research into ME and Rituximab?
By Anette Gilje, Secretary General, Norwegian ME Association
The cancer doctors Oystein 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 benefited from the immune modulator rituximab, the Government allocated http://www.prohealth.com/library/showArticle.cfm?libid=16664 two million Norwegian Kroners (approx. 220,000 pounds or $351,370) to the Western Norway Regional Health Authority to help fund a larger follow-up study.
• 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.
A scientific study of this scale cannot be initiated before the whole project is fully funded.
So far Drs. Fluge and Mella are working to a draft protocol for a larger study in cooperation with the 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:
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• 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 reactions.
• Our experiences in working with cancer patients show that this is a drug that does 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 infection.
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[ing] rituximab and know what to do if allergic reactions occur, we see this as an easy treatment, Dr. Mella reassures.
• 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 adverse reactions.
• 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.