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Abstract Number: 121

Comparative Burden Of Chronic Widespread Pain and Fibromyalgia In The US Population

Caroline Schaefer1, Rachael Mann2, Elizabeth T. Masters3, Joseph C. Cappelleri4, Shoshana Daniel5, Gergana Zlateva3, Heather McElroy6, Arthi B. Chandran3, Edgar H. Adams1, Annlouise R. Assaf4, Michael McNett7, Philip Mease8, Stuart L. Silverman9 and Roland Staud10, 1Covance Market Access Services Inc., Gaithersburg, MD, 2Covance Market Access Services Inc., San Diego, CA, 3Pfizer Inc., New York, NY, 4Pfizer Inc., Groton, CT, 5Covance Market Access Services Inc., Conshohocken, PA, 6Covance Market Access Services, Sydney, Australia, 7Aurora Pain Program, Milwaukee, WI, 8Director, Rheumatology Research, Swedish Medical Center, Seattle, WA, 9Cedars-Sinai Medical Center, UCLA Center of Excellence, Los Angeles, CA, 10Dept Med/Rheum/Clin Immun Div, University of Florida, Gainesville, FL

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: fibromyalgia, health status, patient-reported outcome measures and quality of life

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Session Information

Session Title: Fibromyalgia, Soft Tissue Disorders and Pain: Treatment and Outcome Assessment

Session Type: Abstract Submissions (ACR)

Background/Purpose: Few data exist on the comparative burden of chronic widespread pain (CWP) and fibromyalgia (FM) in the general population.

Methods: 8,382 nationally representative participants (≥18 years old) completed an online screener including sociodemographic questions and the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ). Subjects who screened positive (bilateral pain, above/below waist, lasting ≥1 week in the past 3 months; CWP+), and a control group without CWP (CWP‑) were invited for a site visit for physician evaluation of FM including a tender point exam. Of 1,331 CWP+ and 502 CWP- subjects who consented to be scheduled for a visit, mutually exclusive groups of CWP- (n=125), CWP+ (n=176) and confirmed FM subjects based on physician evaluation (n=171) completed a visit and an online questionnaire to assess clinical characteristics and patient-reported outcomes (including Brief Pain Inventory-short form [BPI-SF], Medical Outcomes Study Sleep Scale [MOS-SS], 12-Item Short Form Health Survey v2 [SF-12], EQ-5D-3L). Statistical significance was tested at the 0.05 level across the 3 groups using ANOVA for continuous variables and chi-square or Fisher’s exact test for categorical variables.

Results: Age and race were similar among the 3 groups, but mean body mass index (kg/m2) increased from CWP- (28.8) to CWP+ (30.7) to FM (32.1) (P=.0044). Among those reporting comorbidities, the mean (SD) number increased from 2.4 (1.6) to 3.2 (2.0) and 4.9 (3.0) for CWP-, CWP+, and FM, respectively (P<.0001), with a corresponding greater prevalence of specific physical conditions (e.g. arthritis, headache/migraine, irritable bowel syndrome; all P<.003) and affective disorders (anxiety, depression; both P<.0001). Pain severity and interference with function progressively increased from CWP- to CWP+ to FM (P<.0001) (Table), including all BPI-SF interference subscales. Sleep quantity and quality significantly differed across the groups as indicated by the MOS-SS total score (Table) and subscales. The EQ-5D-3L and SF-12 showed progressive reduction in health status, and physical and mental health, respectively (Table); all SF-12 domains scores were lowest with FM followed by CWP+ and CWP- (P<.0001). Relative to CWP-, higher proportions of CWP+ and FM groups were taking pain-related prescription medications, 32.8%, 52.8% and 62.6%, respectively (P<.0001); opioids were the single most frequently reported pain medication class.

Conclusion: In a nationally representative sample, CWP+ and FM were characterized by a high disease burden relative to CWP- including more comorbidities and pain-related medications, poorer sleep, and reduced function and health status; the burden was highest with FM. Health status observed in FM was lower than has been reported for chronic conditions, such as cancer and diabetes (Luo et al. Health Outcomes Res Med.2011;e203-14).

 

Table. Comparative Burden in Subjects by Chronic Widespread Pain (CWP) and Fibromyalgia (FM) Status

Measure

Mean (standard deviation)

P-value

 

CWP-

(n=125)

CWP+

(n=176)

FM

(n=171)

 

BPI-SFa

 

 

 

 

  Pain Severity Index

3.0 (2.1)

4.4 (2.1)

5.5 (2.0)

<.0001

  Pain Interference Index

2.5 (2.5)

4.3 (2.6)

5.8 (2.4)

<.0001

MOS-SS total scorea

32.8 (18.7)

48.2 (18.5)

59.6 (17.5)

<.0001

SF-12b

 

 

 

 

  Physical Component Summary score

48.1 (10.8)

38.9 (11.0)

33.7 (10.5)

<.0001

  Mental Component Summary score

49.1 (10.4)

44.9 (10.8)

40.4 (10.8)

<.0001

EQ-5D-3Lb

 

 

 

 

  Health state valuation

0.85 (0.13)

0.73 (0.18)

0.61 (0.21)

<.0001

  Overall health status rating

79.8 (16.0)

68.7 (18.8)

58.7 (20.0)

<.0001

aHigher score=worse outcomes; blower score=worse outcomes


Disclosure:

C. Schaefer,

Covance Market Access Services,

3;

R. Mann,

Covance Market Access Services,

3;

E. T. Masters,

Pfizer Inc.,

3,

Pfizer Inc.,

1;

J. C. Cappelleri,

Pfizer Inc.,

1,

Pfizer Inc.,

3;

S. Daniel,

Covance Market Access Services,

3;

G. Zlateva,

Pfizer Inc.,

1,

Pfizer Inc.,

3;

H. McElroy,

Covance Market Access Services,

3;

A. B. Chandran,

Pfizer Inc.,

1,

Pfizer Inc.,

3;

E. H. Adams,

Covance Market Access Services,

3;

A. R. Assaf,

Pfizer Inc.,

1,

Pfizer Inc.,

3;

M. McNett,

Pfizer Inc.,

5,

Lilly,

8,

Pfizer Inc.,

8;

P. Mease,

Forest Laboratories,

2,

Lilly,

2,

Pfizer Inc,

2,

Forest Laboratories,

5,

Lilly,

5,

Pfizer Inc.,

5;

S. L. Silverman,

Amgen, Lilly, Medtronics and Pfizer/Wyeth ,

2,

Amgen, Lilly, Pfizer/Wyeth,

8,

Amgen, Genetech, Lilly, Novartis, Pfizer/Wyeth ,

5,

Cedars-Sinai Medical Center ,

3;

R. Staud,

Pfizer Inc.,

2,

Forest Laboratories,

2.

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