Anonymous
Not logged in
Talk
Contributions
Create account
Log in
Search
Editing
Rituximab
(section)
From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history
Namespaces
Page
Discussion
More
More
Page actions
Read
Edit
Edit source
History
Warning:
You are not logged in. Your IP address will be publicly visible if you make any edits. If you
log in
or
create an account
, your edits will be attributed to your username, along with other benefits.
Anti-spam check. Do
not
fill this in!
==Effectiveness in ME/CFS== Two Norwegian oncologists, Øystein Fluge & Olav Mella have investigated the use of Rituximab in patients with CFS extensively. In 2004 they became intrigued by a ME/CFS patient who developed Hodgkin's disease and improved significantly after chemotherapy with methotrexate. This was the first significant improvement in her ten years of being ill with ME/CFS and her ME/CFS symptoms reappeared after chemotherapy was stopped. Fluge & Mella suspected the involvement of B-cells and tried to replicate the effect of methotrexate, with rituximab. After a delay of 6 weeks – the time required to clear preexisting autoantibody-mediated inflammation<ref name="Rowe2019">{{Cite journal | last = Rowe | first = Peter C. | date = 2019-04-02 | title = Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Trial Fails to Confirm Earlier Observations of Rituximab's Effectiveness|url=https://annals.org/aim/article-abstract/2729816/myalgic-encephalomyelitis-chronic-fatigue-syndrome-trial-fails-confirm-earlier-observations|journal=Annals of Internal Medicine|language=en|doi=10.7326/M19-0643|issn=0003-4819}}</ref> – the patient’s symptoms improved markedly. In 2009 Fluge & Mella published a case series of 3 ME/CFS patients whose ME/CFS symptoms improved each time they received a rituximab infusion.<ref>{{Cite journal | last = Fluge | first = Øystein | last2 = Mella | first2 = Olav| date = 2009-07-01 | title = Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series|url=https://www.ncbi.nlm.nih.gov/pubmed/19566965|journal=BMC neurology|volume=9|pages=28|doi=10.1186/1471-2377-9-28|issn=1471-2377|pmc=2711959|pmid=19566965}}</ref> This was followed by a small double-blind randomized, placebo-controlled trial in 2011. Although the trials primary end-point – self-reported fatigue scores 3 months after intervention – was negative, 10 out of 15 patients in the rituximab arm showed a clinically significant improvement later on in the trial, compared to only 2 in the Placebo-group.<ref name="Fluge2011" /> A subsequent Open-Label Phase II study on the correct dose and maintenance of rituximab in ME/CFS confirmed that approximately two-thirds of patients showed a clinically significant response.<ref name="Fluge2015">{{Cite journal | last = Fluge | first = Øystein | last2 = Risa | first2 = Kristin | last3 = Lunde | first3 = Sigrid | last4 = Alme | first4 = Kine| last5 = Rekeland | first5 = Ingrid Gurvin | last6 = Sapkota | first6 = Dipak | last7 = Kristoffersen | first7 = Einar Kleboe | last8 = Sørland | first8 = Kari | last9 = Bruland | first9 = Ove | date = 2015 | title=B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment|url=https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0129898|journal=PloS One|volume=10|issue=7| pages = e0129898|doi=10.1371/journal.pone.0129898|issn=1932-6203|pmc=4488509|pmid=26132314}}</ref> The results created a lot of media attention<ref>https://www.youtube.com/watch?v=jfpW4zKMaAs</ref><ref>https://www.youtube.com/watch?v=zcIPY4yCdKQ&t=72s</ref> and excitement in the ME/CFS patient community.<ref name=":3">{{Cite web|url=http://simmaronresearch.com/2017/11/norwegian-rituximab-chronic-fatigue-syndrome-mecfs-trial-fails/ | title = Norwegian Rituximab Chronic Fatigue Syndrome (ME/CFS) Trial Fails| date = 2017-11-26 | website = Simmaron Research|language=en-US|access-date=2019-04-28 | last = | first = | authorlink = |archive-url=https://web.archive.org/web/20190424141731/https://www.simmaronresearch.com/2017/11/norwegian-rituximab-chronic-fatigue-syndrome-mecfs-trial-fails/|archive-date=2019-04-24|url-status=dead}}</ref> The fact that in some patients all ME/CFS symptoms improved suggested that rituximab might target a fundamental aspect of the illness pathology.<ref name="Rowe2019" /> A larger, phase 3 study called RituxME was started with funding from the Norwegian ME Association, the Norwegian Research Council and other sources. 152 ME/CFS patients, selected using the Canadian diagnostic criteria, were randomized to receive either rituximab or a placebo. In 2017 Mella and Fluga announced the negative results of the RituxME early so that patients would not continue to try out the drug on their own.<ref name=":3" /> The results were finally published in the Annals of Internal Medicine in April 2019. Rituximab was not associated with clinical improvement in patients with ME/CFS.<ref name="phase3-2019" />
Summary:
Please make sure your edits are consistent with
MEpedia's guidelines
.
By saving changes, you agree to the
Terms of use
, and you irrevocably agree to release your contribution under the
CC BY-SA 3.0 License
and the
GFDL
. You agree that a hyperlink or URL is sufficient attribution under the Creative Commons license.
Cancel
Editing help
(opens in new window)
Navigation
Navigation
Skip to content
Main page
Browse
Become an editor
Random page
Popular pages
Abbreviations
Glossary
About MEpedia
Links for editors
Contents
Guidelines
Recent changes
Pages in need
Search
Help
Wiki tools
Wiki tools
Special pages
Page tools
Page tools
User page tools
More
What links here
Related changes
Page information
Page logs