Fibromyalgia is a chronic, complex pain condition characterized by widespread pain and a diverse range of symptomatic manifestations, including fatigue, sleep disturbance, dyscognition, diminished physical functioning, and mood disturbances.
To date, patient-reported outcomes remain the best method for characterizing the many facets of fibromyalgia. Patient-reported outcomes are gaining traction as a highly effective option for capturing the impact of chronic illness and gauging treatment response. In clinical trials of chronic pain, patient-reported evidence is essential for establishing both efficacy and the potential advantages of an investigational drug over existing products. Moreover, with growing cost pressure and the need for product differentiation in a highly competitive market, sponsors are increasingly relying on patient perspectives to generate value propositions that go beyond traditional safety and clinical efficacy messages.
Patient-reported outcomes are particularly important in conditions, such as fibromyalgia, where symptoms cannot be directly observed. Fibromyalgia has no cure, and no clear biomarkers are available to guide its management or measure response to therapy. Until there is a cure, treatment for fibromyalgia will be focused on managing symptoms and improving functional status, as well as quality of life. To date, the only way to know whether treatments are effective is to rely on patient self-report.
In this white paper, we will explore patient-reported outcome instruments that can be used for diagnosis, monitoring, and characterization of fibromyalgia. We will also discuss the use of patient-reported outcomes in clinical trials.
Fibromyalgia is a chronic pain condition characterized by chronic, widespread pain accompanied by fatigue, sleep disturbance, cognitive dysfunction, diminished physical functioning, mood disturbances, and the presence of other chronic overlapping pain conditions (COPCs). Individuals with fibromyalgia often report diminished quality of life,3 diminished functional status, and higher-than-expected healthcare utilization.5 Given the diverse range of symptoms in fibromyalgia, comprehensive assessment of all these components can be challenging.