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.


OMERACT Responder Analysis of Patients Treated with Duloxetine for Chronic Low Back Pain.

Skljarevski1,  Vladimir, Bair2,  Matthew J., Ossanna1,  Melissa J., Frakes1,  Eli, Zhang1,  Shuyu, Alaka1,  Karla

Eli Lilly and Company
Roudebush VA Medical Center

Background:

There are no standardized outcome measures to assess treatment effect in chronic low back pain (CLBP) clinical trials. The OMERACT (Outcome Measures in Rheumatology) group proposed a preliminary approach to assessing treatment responders in CLBP trials (Simon et al, 2007). This current analysis utilizes the OMERACT approach to measure response in trials of duloxetine for the treatment of CLBP.

Methods:

We analyzed three randomized, double-blind, placebo-controlled clinical trials of duloxetine in the treatment of adult patients with CLBP. Duloxetine treatment dose was 60 mg daily, 120 mg daily or flexible doses of 60–120 mg daily over 12 or 13 weeks. OMERACT treatment response was a composite outcome defined as a >=30% reduction in Brief Pain Inventory average pain, a Patient Global Impression score PGI-I <=2 ("much improved") at endpoint and Roland Morris Disability Questionnaire (RMDQ) total score reduction from baseline >=2.

Results:

In Study 1, 35.4% of patients taking duloxetine 60–120 mg (N=99) met the defined response criteria versus 18.1% of patients assigned to placebo (N=105; p=0.007). In Study 2, response criteria was met by 36.1% of patients taking 60 mg duloxetine (N=83) and 34.1% of patients taking 120 mg duloxetine (N=82), versus 27.2% of patients taking placebo (N=92; p=0.254 and p=0.328, respectively). In Study 3, 37.9% of patients taking duloxetine 60 mg (N=177) responded versus 26.8% of those taking placebo (N=179; p=0.031).

Conclusions:

Our analysis demonstrates that duloxetine was more efficacious than placebo in 2 out of 3 separate trials of patients with chronic low back pain, as assessed by the OMERACT composite outcome, including pain severity, patient perception of improvement and functional limitations. These findings suggest that duloxetine may be helpful in the clinical armamentarium for the treatment of chronic low back pain.

Reference:

1.Simon, LS, Evans, C, Katz, N, Bombardier, C, West, C, Robbins, J, Copley-Merriman, C, Markman, J & Coombs, JH. Preliminary Development of a Responder Index for Chronic Low Back Pain. J Rheumatol. 2007;34:1386–91

To cite this abstract, please use the following information:
Skljarevski, Vladimir, Bair, Matthew J., Ossanna, Melissa J., Frakes, Eli, Zhang, Shuyu, Alaka, Karla; OMERACT Responder Analysis of Patients Treated with Duloxetine for Chronic Low Back Pain. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :175
DOI: 10.1002/art.27944

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