Journal of IiME Volume 6 Issue 1 (June 2012) course, and the same thing happened. Major improvement after six weeks, then ten weeks with maintained improvement, and then a crash. In February 2009 he got a new infusion. “Then I had the best effect so far, and it lasted even longer. I started doing carpentry on the house, made a new roof and new walls, put down cables. I throw myself at these kinds of projects when I feel better, because I feel there is so much I have undone. As soon as my body functions again, I’m ready,” said Svein. Before treatment with Rituximab, Svein had only been able to watch pictures of his kid’s activities outside the house. “That feels terrible. When I get this treatment I manage to participate. It is like being brought back to life again,” said Svein. The two other patients in the pilot study, one of them Anne Katrine, and the other a woman in her early twenties, had similar major improvements after Rituximab treatment. Mella and Fluge were themselves surprised when they saw the astounding pilot results, where the patients at times experienced near resolution of all of their symptoms. “Then we felt that we were touching a central mechanism in the disease,” said Fluge back in 2009. They started a double blinded, placebo controlled and randomized study on Rituximab in 30 ME/CFS patients – what is called a RCT. Placebo controlled means that the patients are divided into two groups – 15 got placebo (salt water) and 15 got Rituximab. Double blinded means that neither the patients, nor the researchers, know who gets real drugs and who does not. Randomized means that it is random which group the 30 patients end up in. This is considered the gold standard in medical research on drugs. At my first meeting with the two doctors that day in 2009 none of them knew if their study would turn out positive. They did not yet know which patients got the drug and who got placebo. 2011: Praise “It’s the most encouraging drug result so far in the history of this disease. Although it’s a small trial, it’s produced dramatic results,” said Charles Shepherd, MD and medical advisor to Britain’s biggest patient association for ME/CFS, to New Scientist in October 2011. The Norwegian Rituximab study had just been published in PLoS ONE, and it generated a massive amount of media coverage. “Immune system defect may cause ME” reported BBC. “Cancer drug can help chronic fatigue” was the headline in Europe’s leading news magazine Der Spiegel. Never before had a study on a drug in ME/CFS had such promising results. The study on 30 patients showed that 10 out of 15 patients (67 %) got a significant improvement from the cancer drug Rituximab which wipes out most of the B-cells in the immune system. 9 out of the 10 responders got a “major improvement” according to the paper. In the placebo group only 2 out of 15 (13 %) got a significant improvement. The result was 10-2 between the groups. Or 9-1 if you only look at “major improvers”. It turned out that most of the responders, unlike two out of three pilot patients who were early responders, started their improvement as late as 3-7 months after the infusion with the drug. Another significant finding was that most patients relapsed when the effect of the B-cell depletion wore off, which is consistent with the effect of such treatment in some autoimmune diseases. “Thus, we believe that B-cell depletion targets a central player in the pathogenesis of the CFS disease, directly or indirectly”, the study authors wrote in their paper. The director of Haukeland University hospital, Stener Kvinnsland, who was not directly involved in the study, said to the Norwegian broadcaster TV2 that he ”had a strong feeling that this was a breakthrough”. Dr. Kvinnsland is one of Norway’s most respected cancer researchers with a solid track record, and to a Norwegian newspaper he said that the Rituximab finding was one of the Invest in ME (Charity Nr. 1114035) www.investinme.org Page 15 of 108 I followed Mella and Fluge closely the next two years. Ups and downs. Uncertainty and promise. And now we all know: new hope. Let us take a leap to October 2011.
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