2009
First Rituximab study published:
Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series
2011:
Phase 2 with double-blinded placebo-controlled study published with 30 patients:
Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study
2 infusions of Rituximab two weeks apart.
Significant effect from 67% in the Rituximab group and 13% in the placebo-group.
2015:
A new phase 2 study will be published in a few weeks or months. 28 patients received Rituximab. No placebo-group. 6 infusions on day 0, day 14, after 3 months, 6 months, 9 months and 15 months. Data from a grant application shows a response rate that looks similar to the previous study published in 2011. Many more in remission 1-2 years after final infusions compared to the last study in 2011. Probably due to prolonged B-cell depletion (6 infusions versus 2).
Late 2017/early 2018:
A blinded, placebo-controlled multi-center study with 152 patients. First patients received infusions on the 27th of October 2014. Last patient is yet to receive first infusion. Looks like the study is over in May 2017. Will probably have to wait until late 2017 or early 2018 for publishing.
Source and more information:
B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study. (RituxME)
They have also carried out an open Rituximab pilot study on patients with severe ME. It is unpublished as of 2015, and will probably not be published. My understanding is that the experience is that Rituximab doesn't produce the same effect for those who suffer from severe ME. Some had an effect, while others were classified as non-responders.
They are also carrying out a study on cyclophosphamide after a small pilot study showed a major effect in 2/3 subjects. The study has just begun and it will probably be finished before the phase 3 Rituximab study due to the early reponse rate compared to B-cell depletion.
