Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Treatment with FDA Approved Therapies in Patients with Fibromyalgia.
Walitt3, Brian T., Katz2, Robert S., Wolfe1, Frederick
Usual treatment for fibromyalgia (FM) is generally considered to be unsatisfactory. Recently, the US Food and Drug Administration approved several drugs specifically for treatment of FM based on controlled clinical trials that showed modest improvement compared to placebo. These treatments include pregabalin, duloxitine, and milnacipram. The treatments are now widely advertised and available in the US. However, whether such treatments are superior to prior conventional FM therapy, as used in the community, is not known. In this study we compare the new therapies to usual therapy to determine the degree to which they improve patients with FM.
We compared clinical status in patients who received at least one of the 3 therapies when they were receiving the treatments compared with when they were not receiving any of the treatments. Patients were assessed longitudinally at 6 month intervals. We assessed 611 patients during 4,415 observations, 1,895 of which (42.9%) were on treatment and 2,520 (57.1%) were not. To assess treatment effect we used generalized estimating equations (GEE), controlling for age, sex and baseline fibromyalgia severity. The study outcome variables included visual analog scales for pain, fatigue and global, HAQ, SF-36 PCS, MCS and mood, and fibromyalgia severityusing a severity measure from the American College of Rheumatology 2010 fibromyalgia criteria.
The mean age (SD) of treated patients was 56.5 (10.7), and 97% were women. Table 1 shows the adjusted means by treatment category.
|Variable||Treatment||Mean (95% CI)||P-value|
|FM severity||Off Rx||19.9 (19.5, 20.2)||< 0.001|
|On Rx||19.2 (18.9, 19.6)|
|Pain||Off Rx||6.4 (6.2, 6.5)||0.002|
|On Rx||6.2 (6.0, 6.3)|
|Fatigue||Off Rx||6.8 (6.7, 7.0)||0.203|
|On Rx||6.7 (6.6, 6.9)|
|Global||Off Rx||5.4 (5.2, 5.6)||0.403|
|On Rx||5.5 (5.3, 5.6)|
|Mood||Off Rx||3.9 (3.7, 4.0)||0.152|
|On Rx||3.9 (3.8, 4.1)|
|HAQ||Off Rx||1.3 (1.2, 1.3)||0.146|
|On Rx||1.3 (1.2, 1.3)|
|MCS||Off Rx||30.7 (30.1, 31.3)||0.216|
|On Rx||31.0 (30.4, 31.6)|
|PCS||Off Rx||40.8 (40.0, 41.7)||0.441|
|On Rx||40.6 (39.7, 41.5)|
As shown in the table, most variables were not significantly different by treatment class. The 010 pain scale was minimally improved by 0.22 units and the 031 fibromyalgia severity scale by 0.63 units. We also analyzed the effect of each drug separately. In none of the separate analyses was a significant treatment effect detected.
Each of the treatments studied has been shown to be superior to placebo in randomized controlled trials. While our data cannot address treatment effect versus placebo, because there is no true placebo in clinic care, the data does not suggest that treatment is superior to conventional treatments used by fibromyalgia patients. The new treatments are expensive and heavily promoted. But patients in this study did not appear to have additional benefits benefit from the therapies.
To cite this abstract, please use the following information:
Walitt, Brian T., Katz, Robert S., Wolfe, Frederick; Treatment with FDA Approved Therapies in Patients with Fibromyalgia. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :117