-----------------------------------------------------------
Fulltext available at-
http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0026358
Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody
Rituximab in Chronic Fatigue Syndrome. A Double-Blind and
Placebo-Controlled Study
=D8ystein Fluge1*, Ove Bruland1,2, Kristin Risa1, Anette Storstein3,
Einar K. Kristoffersen4, Dipak Sapkota1, Halvor N=E6ss3, Olav Dahl1,5,
Harald Nyland3, Olav Mella1,5
1 Department of Oncology and Medical Physics, Haukeland University
Hospital, Bergen, Norway, 2 Department of Medical Genetics and
Molecular Medicine, Haukeland University Hospital, Bergen, Norway, 3
Department of Neurology, Haukeland University Hospital, Bergen,
Norway, 4 Department of Immunology and Transfusion Medicine, Haukeland
University Hospital, and The Gade Institute, University of Bergen,
Bergen, Norway, 5 Institute of Internal Medicine, Section of Oncology,
University of Bergen, Bergen, Norway
Abstract
Background
Chronic fatigue syndrome (CFS) is a disease of unknown aetiology.
Major CFS symptom relief during cancer chemotherapy in a patient with
synchronous CFS and lymphoma spurred a pilot study of B-lymphocyte
depletion using the anti-CD20 antibody Rituximab, which demonstrated
significant clinical response in three CFS patients.
Methods and Findings
In this double-blind, placebo-controlled phase II study (NCT00848692),
30 CFS patients were randomised to either Rituximab 500 mg/m2 or
saline, given twice two weeks apart, with follow-up for 12 months.
Xenotropic murine leukemia virus-related virus (XMRV) was not detected
in any of the patients.
The responses generally affected all CFS symptoms. Major or moderate
overall response, defined as lasting improvements in self-reported
Fatigue score during follow-up, was seen in 10 out of 15 patients
(67%) in the Rituximab group and in two out of 15 patients (13%) in
the Placebo group (p =3D 0.003). Mean response duration within the
follow-up period for the 10 responders to Rituximab was 25 weeks
(range 8=9644). Four Rituximab patients had clinical response durations
past the study period. General linear models for repeated measures of
Fatigue scores during follow-up showed a significant interaction
between time and intervention group (p =3D 0.018 for self-reported, and
p =3D 0.024 for physician-assessed), with differences between the
Rituximab and Placebo groups between 6=9610 months after intervention.
The primary end-point, defined as effect on self-reported Fatigue
score 3 months after intervention, was negative. There were no serious
adverse events. Two patients in the Rituximab group with pre-existing
psoriasis experienced moderate psoriasis worsening.
Conclusion
The delayed responses starting from 2=967 months after Rituximab
treatment, in spite of rapid B-cell depletion, suggests that CFS is an
autoimmune disease and may be consistent with the gradual elimination
of autoantibodies preceding clinical responses. The present findings
will impact future research efforts in CFS.
Trial registration
ClinicalTrials.gov NCT00848692
---------------------------------------------
Send posts to CO-CURE@listserv.nodak.edu
Unsubscribe at http://www.co-cure.org/unsub.htm
Select list topic options at http://www.co-cure.org/topics.htm
---------------------------------------------
Co-Cure's purpose is to provide information from across the spectrum of
opinion concerning medical, research and political aspects of ME/CFS and/or
FMS. We take no position on the validity of any specific scientific or
political opinion expressed in Co-Cure posts, and we urge readers to
research the various opinions available before assuming any one
interpretation is definitive. The Co-Cure website <www.co-cure.org> has a
link to our complete archive of posts as well as articles of central
importance to the issues of our community.
---------------------------------------------
