The anti-inflammatory biologic drug anakinra does not seem to reduce fatigue severity in women with chronic fatigue syndrome (CFS). The findings of a randomized, placebo-controlled trial are published in Annals of Internal Medicine.
CFS is characterized by severe, persistent, and disabling fatigue. While case definitions differ, the Centers for Disease Control and Prevention (CDC) criteria suggest that patients with fatigue also report at least four of eight accompanying symptoms including, impairment of short-term memory or concentration, headache, muscle pain, tender lymph nodes, or sore throat to be diagnosed with CFS. Interleukin-1 (IL-1), a pro-inflammatory cytokine, has been associated with CFS in some studies and there is extensive experience with blocking IL-1 in different diseases with the IL-1 receptor antagonist anakinra. Several studies in inflammatory and noninflammatory illnesses have assessed the effect of IL-1 inhibition on fatigue severity, and most have found positive effects.
Researchers from Radboud University Medical Centre in the Netherlands conducted a randomized, placebo-controlled trial to evaluate the effects of anakinra injections versus placebo on fatigue severity in patients with CFS. Since CFS typically affects women, the researchers included only female patients to investigate a homogeneous group. Fifty women with severe fatigue leading to functional impairment were randomly assigned to receive daily anakinra injections (100 mg) or placebo for 4 weeks followed by an additional 20 weeks of after treatment for all of the participants.
Fatigue severity, the primary outcome, was assessed via questionnaire at 4 weeks. The secondary outcomes of level of impairment, physical and social functioning, psychological distress, and pain severity were assessed at 4 and 24 weeks. The researchers found no clinically meaningful difference in fatigue severity with anakinra. They also found no statistically significant differences between groups for secondary outcomes. The researchers conclude that if IL-1 plays a role in CFS, blocking it with anakinra has no effect.
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