Fluge, Øystein, Rekeland, Ingrid Gurvin, Sørland, Kari et al. · Frontiers in medicine · 2025 · DOI
Researchers tested a drug called daratumumab that targets specific immune cells (plasma cells) in 10 ME/CFS patients to see if removing these cells could improve symptoms. Six patients experienced significant improvement in fatigue, physical function, and daily activity levels after treatment, while four showed no major changes. The drug was well-tolerated with no serious side effects, and improvements were sustained over 8-24 months of follow-up.
This study provides preliminary evidence for a specific disease mechanism in a subset of ME/CFS patients—aberrant plasma cell and autoantibody production—and demonstrates that targeted immune depletion may offer clinical benefit. The sustained improvements in functional capacity and daily activity levels suggest a potentially disease-modifying approach rather than symptomatic treatment, which could transform management for patients with autoimmune-driven ME/CFS.
This small pilot study does not establish daratumumab as an effective or safe ME/CFS treatment; without randomization and blinding, placebo effect cannot be excluded. The findings do not prove that autoantibodies cause ME/CFS in all patients, only that they may play a role in a subgroup. The lack of biomarker stratification at baseline means we cannot yet reliably predict who will benefit from this approach.
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
Fluge, Øystein, Rekeland, Ingrid Gurvin, Sørland, Kari, Alme, Kine, Risa, Kristin, Bruland, Ove, et al. (2025). Plasma cell targeting with the anti-CD38 antibody daratumumab in myalgic encephalomyelitis/chronic fatigue syndrome-a clinical pilot study.. Frontiers in medicine. https://doi.org/10.3389/fmed.2025.1607353
BibTeX
@article{mecfsatlas-fluge-2025-plasma-cell,
author = {Fluge, Øystein and Rekeland, Ingrid Gurvin and Sørland, Kari and Alme, Kine and Risa, Kristin and Bruland, Ove and Tronstad, Karl Johan and Mella, Olav},
title = {Plasma cell targeting with the anti-CD38 antibody daratumumab in myalgic encephalomyelitis/chronic fatigue syndrome-a clinical pilot study.},
journal = {Frontiers in medicine},
year = {2025},
doi = {10.3389/fmed.2025.1607353},
note = {PubMed: 40703261},
url = {https://www.mecfsatlas.com/evidence/fluge-2025-plasma-cell},
}Atlas snapshot reference
ME/CFS Atlas. Generator v1 / Scanner v1.4 / policy v0.1. Accessed 2026-05-27. https://www.mecfsatlas.com/evidence/fluge-2025-plasma-cell
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