Background Continuous nonsteroidal anti-inflammatory drug (NSAID) treatment is significantly more efficacious than intermittent dosing1 in preventing flares 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 on efficacy, as measured by the number of flares, of continuous daily celecoxib treatment compared to intermittent celecoxib treatment.
Methods An exploratory analysis of a multinational, randomized clinical trial1 was conducted to determine if the number of OA flares during the blinded postrandomization period was different, for patients with a body mass index (BMI) ≥30 kg/m2 or <30 kg/m2. 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 <30 kg/m2 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/m2 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 with a BMI <30 kg/m2, 0.55 flares/month (standard deviation 0.78) were observed in patients receiving continuous treatment, while 0.88 flares/month (0.86) were observed in patients receiving intermittent treatment (P <0.0001). For the patients with a BMI ≥30 kg/m2, the continuous treatment group had 0.54 flares/month (0.69) compared with 0.97 flares/month (1.13) in the intermittent group (P <0.0001). The results are consistent with the published findings.1 There were more flares in patients with a BMI ≥30 kg/m2 than in patients with a BMI <30 kg/m2 in the intermittent treatment group, while the number of flares were similar in patients with a BMI <30 kg/m2 and ≥30 kg/m2 in the continuous treatment group.
Conclusions Daily celecoxib treatment was significantly more efficacious, as assessed by the number of flares/month, than intermittent use and more so in those patients with a BMI <30 kg/m2 compared with obese patients (BMI ≥30 kg/m2). These data suggest weight loss will help reduce the burden of illness experienced by obese arthritis patients.
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