Thursday, July 2, 2015

Rituximab maintenance infusions leads to prolonged disease remission in ME/CFS

@ Plosone:


  Background Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS) is a disease of unknown etiology. We previously reported a pilot case series followed by a small, randomized, placebo-controlled phase II study, suggesting that B-cell depletion using the monoclonal anti-CD20 antibody rituximab can yield clinical benefit in ME/CFS.

  Methods In this single-center, open-label, one-armed phase II study (NCT01156909), 29 patients were included for treatment with rituximab (500 mg/m2) two infusions two weeks apart, followed by maintenance rituximab infusions after 3, 6, 10 and 15 months, and with follow-up for 36 months.

  Findings Major or moderate responses, predefined as lasting improvements in self-reported Fatigue score, were detected in 18 out of 29 patients (intention to treat). Clinically significant responses were seen in 18 out of 28 patients (64%) receiving rituximab maintenance treatment. For these 18 patients, the mean response durations within the 156 weeks study period were 105 weeks in 14 major responders, and 69 weeks in four moderate responders. At end of follow-up (36 months), 11 out of 18 responding patients were still in ongoing clinical remission. For major responders, the mean lag time from first rituximab infusion until start of clinical response was 23 weeks (range 8–66). Among the nine patients from the placebo group in the previous randomized study with no significant improvement during 12 months follow-up after saline infusions, six achieved a clinical response before 12 months after rituximab maintenance infusions in the present study. Two patients had an allergic reaction to rituximab and two had an episode of uncomplicated late-onset neutropenia. Eight patients experienced one or more transient symptom flares after rituximab infusions. There was no unexpected toxicity.

  Conclusion In a subgroup of ME/CFS patients, prolonged B-cell depletion with rituximab maintenance infusions was associated with sustained clinical responses. The observed patterns of delayed responses and relapse after B-cell depletion and regeneration, a three times higher disease prevalence in women than in men, and a previously demonstrated increase in B-cell lymphoma risk for elderly ME/CFS patients, suggest that ME/CFS may be a variant of an autoimmune disease.

  Trial registration NCT01156909

  Citation: Fluge Ø, Risa K, Lunde S, Alme K, Rekeland IG, Sapkota D, et al. (2015) B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment. PLoS ONE 10(7): e0129898. doi:10.1371/journal.pone.0129898

  Academic Editor: Christina van der Feltz-Cornelis, Tilburg University, NETHERLANDS

  Received: February 13, 2015; Accepted:May 14, 2015; Published: July 1, 2015



Hope said...

Here's the link to the full, free article:
How curious that none of the ME/CFS "authorities" who commented on this for the print media did not mention this crucial point.
The authors write: All the patients had "myalgic encephalopathy/chronic fatigue syndrome, ME/CFS" using the Fukuda 1994 definition of CFS. Only about half the patients had the acute, infectious onset characteristic of ME, and their results were not separated from the slow onsets.
This is ghastly. Not only is this irrelevant for those millions of us around the world who are sick with Myalgic Encephalitis, but also is it a waste of the resources that could be spent on valid scientific studies on ME, which we need to help us. The Fukuda CFS excludes Myalgic Encephalitis, as Fukuda himself asserted.
Thank you for posting this, Dr Speedy.

Hope said...

Characteristically, my severe ME brain did not pick up the error in my comment on your blog. The double negative was NOT intentional. So the second line should read: How curious that none of the ME/CFS 'authorities' who commented on this for the print media mentioned this crucial point.
It would be a splendid step forward if none of them did not mention it.
Hope this leaves you smiling!


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