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Celebrex is indicated for the relief of signs and symptoms of Ankylosing Spondylitis (AS), an inflammatory disease that most often affects the lower back. Recommended dosage For the management of the signs and symptoms of AS, the recommended dose of Celebrex is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options. Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient. Clinical studies Celebrex was evaluated in AS patients in two placebo- and active-controlled clinical trials of 6 and 12 weeks duration. Celebrex at doses of 100 mg twice daily, 200 mg once daily and 400 mg once daily was shown to be statistically superior to placebo in these studies for all three co-primary efficacy measures assessing global pain intensity (Visual Analogue Scale), global disease activity (Visual Analogue Scale) and functional impairment (Bath Ankylosing Spondylitis Functional Index). In the 12-week study, there was no difference in the extent of improvement between the 200 mg and 400 mg Celebrex doses in a comparison of mean change from baseline, but there was a greater percentage of patients who responded to Celebrex 400 mg, 53%, than to Celebrex 200 mg, 44%, using the Assessment in Ankylosing Spondylitis response criteria (ASAS 20). The ASAS 20 defines a responder as improvement from baseline of at least 20% and an absolute improvement of at least 10 mm, on a 0 to 100 mm scale, in at least three of the four following domains: patient global pain, Bath Ankylosing Spondylitis Functional Index, and inflammation. The responder analysis also demonstrated no change in the responder rates beyond 6 weeks. |
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