Negative trial results stall the search for an immunosignature

Last year, we reported on a newly funded study aimed at developing a biomarker to help predict patients who will respond to treatment with rituximab. Unfortunately, this study will not now be going ahead.

Rituximab is an antibody that attacks B cells and has been used to treat some cancers and autoimmune disorders. Following promising results in patients with ME/CFS, a randomised, placebo-controlled trial of rituximab was started in 2014 at five centres in Norway.

As the drug appeared to be effective in only some individuals, Prof. David Patrick at the University of British Columbia planned to use blood samples from the Norwegian patients to develop an immunosignature to help distinguish those likely to respond to the treatment.

ME Research UK awarded Prof. Patrick a grant to carry out this work, but unfortunately in November there was a major setback when one of the Norwegian investigators, Dr Olav Mella, announced preliminary negative results of the rituximab randomised trial.

Although we are still waiting for publication of the full trial results, it is likely they will not show any benefit of rituximab in ME/CFS patients. With this in mind, Prof. Patrick and ME Research UK jointly made the decision not to proceed with the immunosignature study since, in these trial patients at least, there would be nothing to show.

This is disappointing news as rituximab has been one of the greatest hopes in recent years for an effective treatment for ME/CFS. It is still to be seen whether this is the end of the road for rituximab as far as ME/CFS is concerned. There are signs that researchers are still interested in exploring its potential further, however, and it may yet prove to be beneficial for a subgroup of patients.