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).

More information

• ME Association Statement: Negative phase III clinical trial result from Norway for Rituximab in ME/CFS | 27 November 2017
• ME Association Summary: The story of Rituximab including research publications and news-media articles | April 2019