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Cancer medication proves beneficial to ME patients

As of today there is no established or recognized drug treatment of chronic fatigue syndrome (CFS or ME), and the causes of the disease remain unknown. Dr.med Øystein Fluge and Professor Olav Mella at the Cancer Department, Haukeland University Hospital, have published a study regarding the successful usage of B-cell depletion (reduction) as therapeutic intervention in ME. The results from the pilot study and the clinical study with ME patients show that treatment with Rituximab is associated with a considerable clinical response without any serious side effects in two thirds of the patients. “Based on observations and literature study our hypothesis is that ME in many patients principally is an immunologic, probably autoimmune, disease”, says Mella.
15.09.2011

Photos by Tor Erik H. Mathiesen

In 2007 a patient suffering from chronic fatigue syndrome (ME) showed considerable improvement regarding her ME whilst receiving cytotoxic drug treatment for cancer in the lymphatic system, a lymphoma. This set off a research project, the results of which now show various positive results concerning ME patients, and where there are no serious side effects.

These results were published in the prestigious journal PLOS One (Public Library of Science) www.plosone.org Fall 2011 .


What causes improvement?
“The patient was given four different combinations of the cytotoxic drug and one of these, much to her and our surprise, brought about a considerable improvement concerning her ME,“ says Dr. med. Øystein Fluge, senior consultant at the Cancer Department at Haukeland University Hospital.

Fluge’s patient went from being dependant on a wheel chair to getting up, going for walks and resuming old hobbies. After her treatment was completed she experienced a good period which lasted four months, before the ME symptoms gradually returned. Fluge and Professor Olav Mella, head of the Cancer Department, are now in charge of a research team who have carried out a pilot study of three ME patients and, furthermore, a clinical study of another thirty ME patients.

“We decided we wanted to find out what caused the first patient’s improvement,” says Mella. “Which specific drug was the patient actually responding to?”


Radical improvement
The research was based on the idea that the drugs had produced an effect on a certain part of the patient’s immune system: the so called B-lymphocytes (a type of cell belonging to the immune system). The patient, now without evidence of lymphoma, was given the immune modulating antibody Rituximab that drastically reduces the B-lymphocytes. A few months after the treatment she was responding in the same way as she had responded to the cancer treatment, and just like the last time, the improvement lasted for three or four months before the effect decreased. The pilot project’s other two participants experienced the same radical improvement.

“What’s particular is the fact that not only single symptoms were reduced, but all of those that were related to ME,” says Fluge.

The patients experienced a pronounced effect on the fatigue and exhaustion, a considerable improvement in cognitive functions such as concentration, memory and clear- mindedness and also a reduction of symptoms such as pains, diarrhoea, perspiration, sound and light sensitivity and sleeping problems.


A possible revelation of cause
According to Fluge the radical improvement found in the three pilot group patients gives a strong indication of how vital the B-lymphocytes are in the overall picture of the ME disease.

“The fact that we do observe response to this type of treatment may well tell us something about the cause of this disease, which is of vital importance to those who suffer from it”, ads Mella.

In cooperation with the Neurology Department, the Cancer Department now have carried out a study involving the use of the antibody Rituximab on 30 patients. The patients were being observed for at least one year after the intervention.

“The study has now been finally analysed. The results show significant improvement in about two thirds of the patients,” says Mella.

The effects have lasted from minimum two or three months and up to more than twelve months, and two of the patients show no signs of disease recurrence after more than two years’ observation.

“Based on observations and literature study our hypothesis is that ME in many patients principally is an immunologic, probably autoimmune, disease», he says. “Often, it is triggered off by some sort of infection».


A new study
A study on a group of 25 patients now involves expanding the concept of B-cell reduction when treating ME. Two initial Rituximab infusions two week apart are supplemented by maintenance infusions after 3, 6, 10 and 15 months.

“Our previous studies proves that the treatment works”, says Mella. “The ongoing study will show the improvement and durability of a prolonged treatment.”

Mella emphasizes that this is not yet an approved treatment for chronic fatigue syndrome. Patients or relatives interested in this must contact their family doctor (fastlege).

“The patients are receiving treatment in accordance with approved studies,” he stresses.

 

FACTS:
  • The research group at the Cancer Department, Haukeland University Hospital, have published a study regarding the successful usage of B-cell depletion (reduction) as therapeutic intervention in chronic fatigue syndrome (CFS or ME). (Fluge/Mella, 2009).
  • The pilot study, which involves repeated treatment of three patients, is the first to describe this principle of treatment of CFS/ME.
  • The radical improvement observed in the three pilot patients strongly indicates that the B-lymphocytes play a vital role in upholding the symptoms of this chronic and disabling disease. Furthermore, the study points to some likely causes regarding its catalyst.
  • In cooperation with The Neurological department, the research team has carried out a double blind, placebo controlled study of B-lymphocytes reduction by use of antibody Rituximab (Mabthera) on 30 patients who were under observation for at least one year after the intervention.
  • The results show that treatment with Rituximab is associated with a considerable clinical response without any serious side effects in two thirds of the patients.
  • At present there are two ongoing studies involving Rituximab and maintenance treatment

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