Øystein Fluge, Olav Mella, Ove Bruland et al. · PLoS ONE · 2011 · DOI
In this pilot RCT, 30 ME/CFS patients received rituximab (a B-cell depleting antibody used in cancer and autoimmune disease) or placebo. Two-thirds of the rituximab group showed clinical improvement, with delayed response patterns consistent with autoimmune disease mechanisms. The placebo group had minimal response.
This was the first RCT to suggest an immune (autoimmune) mechanism in ME/CFS with a therapeutic signal. The delayed response to B-cell depletion suggested ME/CFS might involve pathological antibodies. It triggered a large Phase III trial.
The Phase III rituximab trial (Fluge et al. 2019) was negative, failing to replicate these results. This pilot study, while historically important, should be interpreted in light of the negative phase III outcome.
About the PEM badge: “PEM required” means post-exertional malaise was an explicit required diagnostic criterion for participant inclusion in this study — not that PEM was studied, observed, or discussed. Studies using criteria that do not require PEM (e.g. Fukuda, Oxford) are tagged “PEM not required”. How the atlas works →
The first block is for the primary paper and is the citation you should use in research work. The atlas-snapshot line only applies if you are specifically referring to this atlas’s reading of the paper on the date shown.
Primary citation
Øystein Fluge, Olav Mella, Ove Bruland, Kristin Risa, Sissel E. Dyrstad, Kari Alme, et al. (2011). Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. PLoS ONE. https://doi.org/10.1371/journal.pone.0026358
BibTeX
@article{mecfsatlas-fluge-mella-2011-rituximab,
author = {Øystein Fluge and Olav Mella and Ove Bruland and Kristin Risa and Sissel E. Dyrstad and Kari Alme and Ingrid Rekeland and Dipak Sapkota and Gro V. Røsland and Alexander Fosså and Irini Ktoridou-Valen and Sigrid Lunde and Hanne Sorland and Katarina Lien and Ingrid Herder and Henning Kellmann and Anette B. Mjelde and Åslaug Hauge and Vidar Rygh and Per Øyvind Erde and Einar K. Bostad},
title = {Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome},
journal = {PLoS ONE},
year = {2011},
doi = {10.1371/journal.pone.0026358},
url = {https://www.mecfsatlas.com/evidence/fluge-mella-2011-rituximab},
}Atlas snapshot reference
ME/CFS Atlas. Generator v1 / Scanner v1.4 / policy v0.1. Accessed 2026-05-27. https://www.mecfsatlas.com/evidence/fluge-mella-2011-rituximab
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