Fibromyalgia Outcomes Over Time: Results from a Prospective Observational Study in the United States

Caroline P. Schaefer1, Edgar H. Adams1, Margarita Udall2, Elizabeth T. Masters2, Rachael M. Mann3, Shoshana R. Daniel4, Heather J. McElroy5, Joseph C. Cappelleri6, Andrew G. Clair2, Markay Hopps2, *, Roland Staud7, Philip Mease8, Stuart L. Silverman9
1 Covance Market Access Services Inc., Gaithersburg, MD, USA
2 Pfizer Inc., New York, NY, USA
3 Covance Market Access Services Inc., San Diego, CA, USA
4 Covance Market Access Services Inc., Conshohocken, PA, USA
5 Covance (Asia) Pte Ltd., Singapore
6 Pfizer Inc., Groton, CT, USA
7 University of Florida, Gainesville, FL, USA
8 Swedish Medical Center and University of Washington, Seattle, WA, USA
9 Cedars-Sinai Medical Center, Los Angeles, CA, USA

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Creative Commons License
© Schaefer et al.; Licensee Bentham Open

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) (, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA; Tel: 212-733-0717; E-mail:



Longitudinal research on outcomes of patients with fibromyalgia is limited.


To assess clinician and patient-reported outcomes over time among fibromyalgia patients.


At enrollment (Baseline) and follow-up (approximately 2 years later), consented patients were screened for chronic widespread pain (CWP), attended a physician site visit to determine fibromyalgia status, and completed an online questionnaire assessing pain, sleep, function, health status, productivity, medications, and healthcare resource use.


Seventy-six fibromyalgia patients participated at both time points (at Baseline: 86.8% white, 89.5% female, mean age 50.9 years, and mean duration of fibromyalgia 4.1 years). Mean number of tender points at each physician visit was 14.1 and 13.5, respectively; 11 patients no longer screened positive for CWP at follow-up. A majority reported medication use for pain (59.2% at Baseline, 62.0% at Follow-up). The most common medication classes were opioids (32.4%), SSRIs (16.9%), and tramadol (14.1%) at Follow-up. Significant mean changes over time were observed for fibromyalgia symptoms (modified American College of Rheumatology 2010 criteria: 18.4 to 16.9; P=0.004), pain interference with function (Brief Pain Inventory-Short Form: 5.9 to 5.3; P=0.013), and sleep (Medical Outcomes Study-Sleep Scale: 58.3 to 52.7; P=0.004). Patients achieving ≥2 point improvement in pain (14.5%) experienced greater changes in pain interference with function (6.8 to 3.4; P=0.001) and sleep (62.4 to 51.0; P=0.061).


Fibromyalgia patients reported high levels of burden at both time points, with few significant changes observed over time. Outcomes were variable among patients over time and were better among those with greater pain improvement.

Keywords: Burden of illness, Chronic widespread pain, Clinician-reported outcomes, Fibromyalgia, Health resource use, Outcome assessment, Patient-reported outcomes, Quality of life, Treatment patterns.