Background Worsening of joint x-rays has been observed with nonsteroidal anti-inflammatory drug (NSAID) use.
Objectives The effect of celecoxib, a specific cyclooxygenase-2 inhibitor, on index joint (knee or hip) x-rays in patients with OA was determined during a long-term safety trial.
Methods X-rays were obtained from all patients prior to entry into a controlled clinical trial, prior to subsequent entry into the long-term safety trial, and at Month 12 or early termination visit of the long-term safety trial. Blinded x-rays were graded on a semiquantitative scale assessing multiple aspects of joint morphology.
Results Overall qualitative interpretation of the individual scores for hip and knee films indicated mild to moderate OA equivalent to an average Kellgren-Lawrence grade of between 2 and 3 at entry to the long-term safety trial. Data from 147 pairs of knee films were analysed prior to and after participation in the long-term safety trial (average duration of treatment, 1 year). Shift table analysis was not significant for any parameters of joint morphology (knee [medial and lateral] joint space narrowing, knee [medial and lateral] spurs, knee [medial and lateral] sclerosis, and knee malalignment). Small mean changes over time were noted for these parameters, but all 95% confidence intervals (CI) overlapped 0. Data from 158 pairs of hip films were analysed prior to and after participation in the long-term safety trial (average duration of treatment, 1 year). Shift table analysis was significant for worsening of hip narrowing (p = 0.029) but not other parameters of joint morphology (hip cysts, hip spurs, and hip sclerosis). Mean change analysis demonstrated a change of 0.14 units/year in hip narrowing (95% CI 0.08–0.20), equivalent to a change of approximately 3% per year. Mean change analysis demonstrated a change of 0.04 units/year in hip cysts (95% CI 0.01–0.08), equivalent to a change of approximately 0.2% per year. These changes were not dose-dependent, and similar changes were noted prior to entry into the long-term safety trial.
Conclusion Celecoxib did not affect index joint x-rays in OA. Modest changes in hip narrowing noted were consistent with the natural history of the disorder.
Sponsored by Pharmacia Corporation and Pfizer, Inc.
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