deleder2k
Senior Member
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Some may have seen this before. But I think a quick summary is beneficial for new readers.
Rituximab history
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.
2012:
Study on severely sick patients:
The study has ended and will not be published.
My understanding is that Rituximab doesn't produce the same effect for those who suffer from severe ME.
Source: The Biggest Chronic Fatigue Syndrome Treatment Trial ...
2015:
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 is similar to the previous study published in 2011. 2/3 responded favorably to the drug. Many more in remission 1-2 years after final infusions compared to the last study in 2011 (61% versus 20%). Probably due to prolonged B-cell depletion (6 infusions versus 2).
Study: B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment
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 July 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 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.
These are the ones to thank:
dr. Olav Mella, study coordinator Kari Sørland, and dr. Øystein Fluge (Photo by the Kavli foundation)
Rituximab history
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.
2012:
Study on severely sick patients:
We are also conducting an open-label phase II study (KTS-3-2010) aiming to include only patients with either very severe or severe ME/CFS, using the same treatment regimen with rituximab induction and maintenance as described in the study presented here (KTS-2-2010). Patients with very severe ME/CFS have special needs, and both transporting and accommodating them in a busy oncology ward have proved very difficult. Eight patients have been included, and only four with very severe ME/CFS have been given rituximab maintenance treatment in KTS-3-2010. Although the treatment had a slight beneficial effect on two out of four patients with very severe ME/CFS, none of the four will be characterized as responders.
The study has ended and will not be published.
My understanding is that Rituximab doesn't produce the same effect for those who suffer from severe ME.
Source: The Biggest Chronic Fatigue Syndrome Treatment Trial ...
2015:
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 is similar to the previous study published in 2011. 2/3 responded favorably to the drug. Many more in remission 1-2 years after final infusions compared to the last study in 2011 (61% versus 20%). Probably due to prolonged B-cell depletion (6 infusions versus 2).
Study: B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment
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."
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 July 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 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.
These are the ones to thank:
dr. Olav Mella, study coordinator Kari Sørland, and dr. Øystein Fluge (Photo by the Kavli foundation)
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