AB0968 The efficacy of continuous vs intermittent celecoxib treatment in osteoarthritis (OA) patients with body mass index ≥30 and < 30 kg/m2

Background Continuous nonsteroidal anti-inflammatory drug (NSAID) treatment is significantly more efficacious than intermittent dosing 1 in preventing flares and for less worsening or increases in WOMAC Total scores in patients with OA of the knee or hip who have successfully treated their flare, over a 22-week period. Objectives To characterize the effect of body mass index (BMI) on the efficacy of continuous daily treatment compared with intermittent celecoxib treatment, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Total scale. Methods A prespecified exploratory analysis of a multinational, randomized clinical trial 1 was conducted to determine WOMAC Total scores (including pain, stiffness, and physical function), during the blinded postrandomization period, in patients grouped according to BMI (≥30 kg/m 2 and 2 ). 858 patients aged 18-80 years with knee or hip OA, determined by American College of Rheumatology criteria, were randomized to receive celecoxib 200 mg qd either as “continuous” (daily) or “intermittent” (celecoxib 200 mg qd when needed to treat OA flare meeting predefined criteria). Analyses were performed on the intent-to-treat (ITT population (≥1 dose of study medication postrandomization) and flare-modified ITT population (all patients meeting criteria for ITT population plus having flare durations ≤14 + 2 days), using a 2-sided type I error rate of 0.05. Results Mean age was 58.5 years in the continuous treatment group and 58.7 years in the intermittent treatment group; duration of OA was 6.3 years and 6.8 years, respectively. At baseline BMI was 2 in 48.5% (209/431) of patients in the continuous treatment group and 48.0% (205/427) of patients in the intermittent group. BMI was ≥30 kg/m 2 in 51.5% (222/431) of patients in the continuous treatment group and 52.0% (222/427) of patients in the intermittent group. In patients receiving continuous treatment, the total WOMAC least squares mean (standard error) change, over the 22 weeks of blinded therapy, was 1.33 (1.03) in those with a BMI 2 and 1.84 (0.98) in those with a BMI ≥30. For those patients receiving intermittent treatment the total WOMAC least squares mean change was 4.85 (1.03) in those with a BMI 2 and 5.12 (0.99) in those with a BMI ≥30. Consistent with the main study findings, lower WOMAC least squares mean change scores were observed in the continuous treatment group than in the intermittent group for both BMI groups (patients with BMI 2 [ P =0.016] and ≥30 kg/m 2 [ P =0.019]). There was greater worsening in the patients with BMI ≥30 kg/m 2 for both the continuous and intermittent treatment groups than in those with a BMI 2 . Conclusions Daily celecoxib treatment was significantly more efficacious than intermittent use and more so in those patients with a BMI 2 compared with obese patients (BMI ≥30 kg/m 2 ) as assessed by WOMAC Total scores. These data support the importance of including weight loss as part of the treatment regimen for obese arthritis patients. References Strand V, et al. J Rheumatol 2011;38:2625-2634. Disclosure of Interest G. Sands Employee of: Pfizer Inc, P. Bhadra Employee of: Pfizer Inc, M. Noyes Essex Employee of: Pfizer Inc