Session Title: Osteoarthritis - Clinical Aspects
Session Type: Abstract Submissions (ACR)
Background/Purpose: Continuous nonsteroidal anti-inflammatory drug (NSAID) treatment is significantly more efficacious than intermittent dosing1during 22-weeks in preventing flares in patients with osteoarthritis (OA) of the knee or hip who have successfully treated an initial flare. The objective was to characterize the effect of age on efficacy, as measured by the number of flares, of continuous daily celecoxib treatment versus intermittent celecoxib treatment.
Methods: An exploratory analysis of a multinational, randomized clinical trial1was conducted to determine if the number of OA flares during the blinded postrandomization period was different for patients aged < or ≥ 60 years. In the trial, 858 patients aged 18 to 80 years with OA of the knee or hip, meeting 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) treatment. Analyses were performed on the intention-to-treat (ITT) population (≥ 1 dose of study medication post-randomization) 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 ages were 51.3 and 67.2 years in the 2 continuous treatment groups (n = 236 and n = 195, respectively) and 51.2 and 66.7 years in the 2 intermittent treatment groups (n = 220 and n = 207, respectively). For patients aged < 60 years, 0.50 flares/month (SD 0.60) were reported in the group receiving continuous treatment, while 0.89 flares/month (SD 0.98) were observed in those receiving intermittent treatment (P < 0.0001). For patients aged ≥ 60 years, the continuous treatment group had 0.59 flares/month (SD 0.87) compared with 0.97 flares/month (SD 1.04) in the intermittent group (P < 0.0001). These results are consistent with the primary results.1
In the flare-modified ITT population, patients aged < 60 years receiving continuous treatment had 0.45 flares/month (SD 0.61) vs 0.87 flares/month (SD 1.15) for the intermittent group (P < 0.0001). The older flare-modified ITT population (≥ 60 years) had similar results: 0.55 flares/month (SD 1.02) vs 1.02 flares/month (SD 1.22) for the continuous and intermittent groups, respectively (P = 0.001). The mean number of flares was significantly lower in the continuous group than in the intermittent group irrespective of whether the patients were aged < or ≥ 60 years.
Conclusion: Daily celecoxib treatment was significantly more efficacious, as assessed by the number of flares/month, than intermittent use, irrespective of whether the patients were aged < or ≥ 60 years. These data may be useful in considering the treatment of OA patients aged ≥ 60 years.
Reference: 1. Strand V, et al. J Rheumatol. 2011;38:2625-34.
G. H. Sands,
M. Noyes Essex,
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