12:00 AM
Oct 27, 2011
 |  BC Innovations  |  Targets & Mechanisms

Rituxan: re-energizing CFS

Even as xenotropic murine leukemia virus-related virus has been taken off the table as a cause of chronic fatigue syndrome, new research from a Norwegian group points to the condition as a B cell disorder and suggests the potential to repurpose Rituxan rituximab and other CD20 antibodies. Indeed, the team reported that Rituxan, an anti-CD20 antibody, improved fatigue symptoms in a Phase II/III trial.1

The origins of the trial date back to 2003, when physicians at Haukeland University Hospital diagnosed a CFS patient with Hodgkin's lymphoma. Over the next several years the patient received four different chemotherapy regimens, one of which included methotrexate, an inhibitor of folate metabolism also known to deplete B cells.2

Only the methotrexate-containing regimen improved the patient's CFS symptoms including fatigue, headaches and muscle pain.3 Because some CFS patients exhibit abnormalities in B cells and other immune cells,4 the Haukeland team hypothesized that the patient's improvement resulted from methotrexate's B cell inhibition.

To test their hypothesis, the researchers turned to Rituxan, which specifically targets CD20 on B cells. In an open-label pilot study, two of three patients showed a decrease in CFS symptoms starting six weeks after treatment. The third showed improvement at 26 weeks.

In the study, patients received two doses of Rituxan two weeks apart.

Now, the team has reported results of a Phase II/III study. The double-blind, placebo-controlled trial enrolled 30 CFS patients who received 2 infusions of rituximab or saline. The infusions were given two weeks apart, in doses comparable to the standard dosing of Rituxan to treat rheumatoid arthritis (RA).

The primary endpoint was a significant improvement in patients' self-reported fatigue scores at three months after completion of dosing. The endpoint was a composite of overall fatigue, postexertion exhaustion, the need for rest, and daily functioning.

Secondary endpoints were improvements in fatigue scores assessed at 2-month intervals during 12 months...

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