Stimulated by kind words about this blog by someone on Scotgoespop here after a long lapse is a new post. Blogging on published research:
From the labs of Øystein Fluge and Olave Mella in Bergen, Norway. It’s a good example of serendipity in research. They were treating a patient who had lymphoma and happened to also have Chronic Fatigue Syndrome (CFS) with a drug that lowers the numbers of a type of white blood cell that produces antibodies. This patient’s CFS improved markedly as a result. Intrigued they did a study in a small group of other CFS patients (without lymphoma). This paper describes the result of a phase II clinical trial. Phase I trials in humans test for toxicity and define the effective dose. Phase II test initial effectiveness.
CFS, also known as Myalgic Encephalomyolitis (ME) or more pejoratively as ‘yuppie flu’ is characterised by extreme loss of energy, vague flu like symptoms, muscle pains and a general malaise. Sufferers were often referred to psychiatrists with fitful results or derided as malingerers. My first encounter was because the woman now my wife had it in Halls at university. A neighbour of mine said she would appreciate some visits and company so I began to stop by and we became more and more friendly and 29 years later here we are. Seeing her collapse in the dinner queue and elsewhere convinced me it was more than a mirage. She had been a keen sportswoman, playing hockey and cricket. She got better, it seems pregnancy is an excellent gradual fitness program.
But back to the research. The hypothesis is that CFS/ME is as was suggested back in the ’80s a post viral syndrome, but not one caused by the virus hanging around but by rogue antibody producing cells attacking the body: an auto-immune syndrome. The treatment is with rituximab which is an antibody which removes CD20 antibody producing cells. The advantage of an antibody treatment is that it allows you to remove specific subsets of white blood cells. Removing all of them would open patients to opportunistic infections.
So, 29 patients were treated with infusions of the antibody two weeks apart then maintenance doses over 3, 6, 10 and 15 months. Patients were followed up over 36 months (3 years), no short term study this. They compared them to a saline infused control group from the phase I trial.
What did they find? 18/29 treated patients had both self reported decreases in fatigue score and showed clinically significant improvements. After the full 3 years 11 of the 18 were still in full remission. There were minor side effects but no toxicity of the treatment.
So it seems partially effective. It remains to be seen if the 7/18 who showed improvement but did not maintain it just need longer treatments or a repeat treatment cycle. Similarly with the 11/29 who showed no improvement. Or maybe their CD20 cells have a slight variant of the target protein and the antibody is thus less effective.
This is not a magic bullet, the quickest responders to treatment took 23 weeks to detect and improvement. Most took 32 weeks. This is also not a final word, more of a better proof of efficacy from their Phase I trial and working out doses. They seem to have done the best scientific job they could have within the constraints they have. And finally, it doesn’t work for everyone.
But the headline result is it a strong indication that CFS/ME is a real condition and that it is an auto-immune post viral syndrome. With any luck they will get funding for a larger Phase III trial and it will be approved for general release. People with CFS/ME are generally economically inactive and this costs society a lot, they also impact on the health service. So any treatment that gets them active again is likely to be cost effective. Especially as CFS/ME generally hits young adults. The good news is that since rituximab is already licensed for lymphoma rather than being a new compound rolling this out into clinics will be relatively quick.
As for my wife, the developing embryo and foetus, acting a bit like a parasite, dials down aspects of the mother’s immune system to avoid rejection. Important as the embryo/foetus is only half related to the mother. It thus seems likely that as well as the gradual fitness program that is pregnancy that this dialing down of the immune system cured her ME, as we knew it then.
Light at the end of the tunnel, one cheer for serendipity, one for the researchers and one for the patient guinea pigs.