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Anti-Inflammatory Drug Anakinra Does Not Seem to Improve Fatigue Severity in Women with Chronic Fatigue Syndrome (CFS)

The anti-inflammatory biologic drug anakinra (interleukin-1 receptor antagonist) does not reduce fatigue severity in women with chronic fatigue syndrome (CFS), according to findings of a randomized, placebo-controlled trial, the results of which were published online on March 7, 2017 in Annals of Internal Medicine. The article is titled “Cytokine Inhibition in Patients with Chronic Fatigue Syndrome: A Randomized Trial.” CFS is characterized by severe, persistent, and disabling fatigue. In order to fulfill the Centers for Disease Control and Prevention (CDC) criteria for CFS, patients have to report at least four of eight accompanying symptoms in addition to fatigue (headache, persistent muscle pain, increased malaise [extreme exhaustion and sickness] following physical activity or mental exertion, problems with sleep, difficulties with memory and concentration, joint pain [without redness or swelling], tender lymph nodes in the neck or armpit, sore throat). Interleukin-1 (IL-1), a pro-inflammatory cytokine, has been associated with CFS in some studies. There is extensive experience with blocking IL-1 in a variety of diseases with the IL-1 receptor antagonist anakinra. Several studies in inflammatory and non-inflammatory illnesses have assessed the effect of IL-1 inhibition on fatigue severity, and most have found positive effects of this intervention. Researchers from the 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. Because 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 follow-up after treatment. Fatigue severity, the primary outcome, was assessed via questionnaire at 4 and 24 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. They concluded that if IL-1 plays a role in CFS, blocking it with anakinra has no effect.

For more information regarding CFS, now also known as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), please visit the website for the Solve ME/CFS Initiative (

Carol Head is President of the Solve ME/CFS Initiative. An executive with more than 25 years of success in both the for-profit and non-profit sectors, she’s an experienced business owner, corporate executive, communicator, and problem solver.

Before assuming leadership of the Solve ME/CFS Initiative, Carol served as the CEO of two companies in the private sector and, prior to that, was the vice president of marketing for two internet-based companies. Carol spent eight years as an executive at the Los Angeles Times in a variety of marketing and strategy roles and served as associate vice president of the 1984 Los Angeles Olympic Organizing Committee.

Carol has been active in community affairs, serving on three national non-profit boards, including service as a board chair. She is also a founder of Project Redwood, a venture philanthropy fund that supports creative approaches to alleviating extreme global poverty. Carol earned a BA in English from Wellesley College (Phi Beta Kappa) and an MBA from Stanford University.

An ME/CFS patient herself, Carol was first affected by the disease in the 1980s.

In January 2017, Carol was recognized by O, The Oprah Magazine as a 2017 Health Hero, one of fourteen visionaries who are healing bodies, minds, and communities.

Please see additional information at the links provided below.

[Press release] [Annals of Internal Medicine abstract]

[Solve ME/CFS Initiative] [O Magazine’s 2017 Health Heroes] [Carol Head named 2017 Oprah Magazin Health Hero]
[Carol Head honored by Oprah Magazine YouTube video]