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Anakinra does not lessen fatigue severity in women with chronic fatigue syndrome

Interleukin-1 inhibition with the receptor antagonist anakinra did not significantly improve symptom severity in women with chronic fatigue syndrome and severe fatigue after 4 weeks, according to recent study findings.

“The immune system has been a focus in the search for the pathogenesis of [chronic fatigue syndrome] because of the resemblance between [chronic fatigue syndrome] symptoms and ‘sickness behavior,’ in which proinflammatory cytokines, such as interleukin-1α (IL-1α), interleukin-1β (IL-1β) and tumor necrosis factor, play a role,” Megan E. Roerink, MD, from Radboud University Medical Center in Nijmegen, the Netherlands, and colleagues wrote.

To evaluate the effect of anakinra on fatigue severity in women with chronic fatigue syndrome, Roerink and colleagues conducted a randomized, placebo-controlled trial. Fifty women aged 18 to 59 years with severe fatigue leading to functional impairment were randomly assigned either daily anakinra injections (100 mg) or placebo for 4 weeks, followed for an additional 20 weeks of after treatment. Fatigue severity, measured by the Checklist Individual Strength subscale (CIS-fatigue), was assessed at 4 weeks. Level of impairment, physical and social functioning, physiological distress and pain severity were also measured at 4 and 24 weeks.

The results showed two of the 25 patients (8%) who received anakinra and five of 25 patients (20%) who received placebo reached a fatigue level within the range reported by healthy persons at 4 weeks. Investigators found no clinically or statistically significant differences when they compared the groups’ CIS-fatigue scores at 4 weeks (mean difference, 1.5 points [95% CI, –4.1 to 7.2]) or at the end of follow-up. They did not observe any statistically significant between-group differences in level of impairment, physical and social functioning, physiological distress and pain severity at 4 weeks or the end of follow-up. Patients in the anakinra group experienced more injection site reactions (68% [17 of 25]) compared with the placebo group (4% [1 of 25]).

“We believe that if IL-1 plays a role in [chronic fatigue syndrome], blockade of IL-1 in the peripheral tissues, such as the neuromuscular compartment, has no effect,” Roerink and colleagues wrote. “Future studies should focus on the intracerebral processes in patients with [chronic fatigue syndrome] and on reducing inflammation with agents that reduce IL-1 activity in the brain.” – by Savannah Demko

Disclosure: Roerink reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.