The Invest in ME Research Centre of Excellence for ME includes a strategy of translational biomedical research. The UK rituximab trial fits into this strategy perfectly. The fundraising target is £520,000. IiMER update – click here.

 

 

 

BACKGROUND

At the 2011 Invest in ME international conference, Norwegian cancer specialists Dr Øystein Fluge and Professor Olav Mella announced strikingly successful results in their pilot study of the immunotherapy drug Rituximab on ME/CFS patients. In that study [1] 67% of ME/CFS patients had moderate to major improvement, compared to only 13% of controls. The pattern of response indicated that ME may have an autoimmune component because rituximab works by temporarily wiping out immune-system B cells, which are implicated in autoimmune disease.

These groundbreaking results gained international attention when the study was published. Dr Fluge and Professor Mella began a confirmatory trial in January 2014, part-funded by the Norwegian government; at the IiME 2015 conference, they presented further evidence of the efficacy of rituximab in the treatment of ME patients.

 

 

PRELIMINARY B-CELL STUDY OVERVIEW

  • This research is led by Dr Jo Cambridge (Principal Investigator) at University College London.

  • The aim of the initial study at UCL was to establish baseline parameters in anticipation of monitoring the numbers, sub-types and functions of B-cells (a sub-population of white blood cells) during the clinical trial of rituximab.

  • Thanks to the support of Invest in ME, the team employed Fane Mensah as a Research Assistant at UCL.

  • The Clinical Co-ordinator for the study at UCLH was Dr Coziana Ciurtin, Consultant Rheumatologist at UCLH who also provided practical advice and obtained Ethical Approval for the study.

  • Also on the team, Dr Arti Sharma, who is also an Immunologist, volunteered her expert services in clinical trial administration to sort out the extremely complicated logistics involved in recruiting, consenting, setting up appointments and taking blood samples plus all the considerable associated paperwork.

  • The research has been up and running since summer 2014.

  • The paper on the initial study was published in 2016. For a lay summary, click here.

  • The UCL team’s experience with rituximab treatment in patients with a number of other diseases over the last 15 years allows them to have a good idea of what to look for in ME, particularly with respect to changes in certain types of B-cells which give them clues as to which ones may be involved in responding to this treatment and therefore what may underlie some of the symptoms.

 

We are also interested in certain molecules present in non-cellular fractions of the blood (i.e. serum), the levels of which change in relation to B cell activity.

As serum samples can be easily frozen we can perform these tests developed here at UCL on large batches of samples from other centers.

We are currently in the process of measuring these molecules in patients with CFS/ME and have already got some extremely exciting results which we look forward to publishing as soon as possible.

Briefly, it may help us identify why some patients may respond better than others to rituximab.

Dr Jo Cambridge (Principal Investigator) and Team, Rayne Institute, UCL, London. August, 2014.

 

 

RITUXIMAB CLINICAL TRIAL OVERVIEW

  • Invest in ME Research (IiMER) have initiated a UK rituximab trial.

  • IiMER’s advisor on the trial is Professor Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London (UCL).

    Professor Edwards was responsible for both the phase I and the proof of concept phase II (NEJM 2004) studies in rheumatoid arthritis, which formally established the validity of B cell depletion in autoimmune disorders. It all started with a paper called ‘Do self-perpetuating B lymphocytes drive human autoimmune disease?’ published in Immunology in 1999 [2].

    There is no other expert in the UK who is better placed than Professor Edwards in advising the charity in setting up a rituximab trial to benefit ME patients.

  • In order to build a trials protocol and identify likely responders a preliminary B-cell study led by Dr Jo Cambridge was set up at UCL in collaboration with clinicians with expertise in ME from around London, in particular Dr Amolak Bansal. Professor Edwards believes this is a useful study in its own right and pre-requisite to a clinical trial.

  • The rituximab clinical trial is planned to take place in Norwich. See trial update here.

 

 

COLLABORATION

The University College London and Norwich Research Park teams are also working closely with the Norwegian researchers at Haukeland, Bergen in Norway, who are performing a Phase III multi-centre clinical trial. This has been described, by several highly-regarded researchers, as the best bet for ME research currently underway.

The UCL team is taking samples from Norway, sharing data and building excellent collaboration with the Norwegian researchers. So this is a team effort between Norway and UK and IiMER have been instrumental in making this international collaboration happen – one of the objectives of the charity.

 

 

RITUXIMAB TRIAL NEWS HIGHLIGHTS

 
See the full list of trial updates on the rituximab trial site here.
 
Thank you for helping to make this happen!
 

 

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References:

1 Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study http://bit.ly/11Ht7VW
2 Edwards JC, Cambridge G, Abrahams VM. Do self-perpetuating B lymphocytes drive human autoimmune disease? Immunology. 1999;97:188–196. [PMC free article] [PubMed]

 

LAST UPDATED JANUARY 2017