Medical Matters > Treatment: Rituximab

ME Essential Spring 2019

Question

Like everyone else, I was very disappointed to learn that the big clinical trial that had been carried out in Norway had failed to show any evidence of benefit for rituximab in ME/CFS. However, the doctors involved do not appear to have published a paper outlining what happened and explaining whether this is now the ‘end of the road’ for what appeared to be a very promising treatment that was actually aimed at the underlying disease process. Surely it would be a helpful to know why the trial failed and what lessons might be learnt.

Answer

I was quite surprised by the positive results obtained during the early stages of assessing this drug in ME/CFS, and equally disappointed when the news came through that the final clinical trial had reported negative results . However, this is what can happen when what appears to be a very promising treatment is then assessed in a phase 3 clinical trial – a Gold Standard assessment involving large numbers of patients and carried out in several different centres – as happened with Rituximab. The scientific team – Dr Øystein Fluge and Dr Olav Mella – did things properly and should be commended for all the work they have done with ME/CFS. I’m afraid there isn’t anything useful to add to the statement that was made at the time and to the final clinical trial publication or media articles that eventually appeared in April 2019 (below).

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Medical Matters is for information purposes only. The answers provided by Dr Shepherd and the ME Association’s other expert advisers should not be construed as medical advice. We recommend that any information you deem relevant is discussed with your GP as soon as possible. It is important to obtain advice from a GP who is in charge of your clinical care, who knows you well, and who can consider other likely causes for symptoms. Seek personalised medical advice whenever a new symptom arises, or an existing symptom worsens. Don't assume that new or worsened symptoms are a result of having ME/CFS.

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