1. In a randomized, placebo-controlled trial of 50 women aged 18 to 59 years with chronic fatigue syndrome (CFS), the anti-inflammatory drug anakinra was not shown to have a clinically significant reduction in fatigue severity.
2. No differences of clinical importance or statistical significance were found in impairment level, pain severity, psychological distress, or physical and social functioning between the anakinra and placebo groups.
Evidence Rating Level: 2 (Good)
Study Rundown: Patients with chronic fatigue syndrome suffer from fatigue that is severe and disabling. Some evidence suggests that interleukin-1 (IL-1), a proinflammatory cytokine, may be involved in the pathogenesis of CFS. Anakinra is an IL-1 receptor antagonist capable of blocking both IL-1α and IL-1β. In a randomized, placebo-controlled trial of 50 women aged 18 to 59 years with CFS, participants were randomly assigned to placebo or daily subcutaneous anakinra (100 mg/d) for 4 weeks, followed by 20 additional weeks of tracking. Fatigue severity was the main outcome analyzed. Secondary outcomes included impairment level, pain severity, psychological distress, and physical and social functioning at 4 and 24 weeks. No differences of clinical importance or statistical significance were found for any measured outcomes. The authors propose that the findings could be the result of anakinra not reaching the brain in adequate concentrations when administered peripherally. The lack of effect could also be due to IL-1 having a limited role in CFS. The authors suggest that future studies regarding the possible role of IL-1 focus on intracerebral processes.
Strengths of the study include randomization of the patients to the placebo or anakinra group as well as blinding of providers, patients, and researchers regarding which treatment was assigned. Limitations of the study include a small sample size and heterogeneity in symptom duration.
Relevant Reading: Interleukin-1 as a mediator of fatigue in disease: a narrative review
In-Depth [randomized controlled trial]: At the Department of Internal Medicine and the Expert Centre for Chronic Fatigue of Radboud University Medical Centre in the Netherlands, researchers randomly assigned 50 women aged 18 to 59 years with CFS to placebo (n = 25) or 100mg per day of subcutaneous anakinra (n = 25) for 4 weeks, with an additional 20 weeks of tracking for both groups. They study took place from July 2014 to May 2016. Providers, patients, and researchers were blinded to which treatment was assigned. Patients were taught how to perform the subcutaneous injection and were observed giving the first self-injection. All remaining doses were also self-administered. The Checklist Individual Strength subscale (CIS-fatigue) was used to measure fatigue severity at 4 weeks. The mean difference of 1.5 points (95%CI -4.1 to 7.2 points) between the two groups for fatigue severity and the measurements of secondary outcomes including impairment level, pain severity, psychological distress, and physical and social functioning at 4 and 24 weeks were not clinically or statistically significant. There were more injection site reactions in the anakinra group (68%) than the placebo group (4%).
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