OBJECTIVE: To evaluate the efficacy and safety of celecoxib in patients with ankylosing spondylitis (AS). METHODS: This was a 12-week randomized, double-blind, placebo-controlled study with 4 treatment arms: celecoxib 200 mg qd, celecoxib 400 mg qd, naproxen 500 mg bid, and placebo. Patients (age 18-75 yrs) requiring daily treatment with nonselective nonsteroidal antiinflammatory drugs, and with a pain intensity on visual analog scale (VAS) > or = 50 mm worsening by 30% compared with a preinclusion visit (14 days prior) were studied. Primary endpoints were least-squares mean changes from baseline in pain intensity, disease activity (patient global assessment VAS), and functional impairment [Bath Ankylosing Spondylitis Functional Index (BASFI)]. Adverse events were monitored throughout the study. RESULTS: Of 611 randomized patients, 137 were allocated to celecoxib 200 mg, 161 to celecoxib 400 mg, 157 to naproxen, and 156 to placebo. Improvements in least-squares mean pain intensity, disease activity, and BASFI scores were significantly greater in the celecoxib 200 mg, celecoxib 400 mg, and naproxen groups than in the placebo group (p < or = 0.001) at Week 12 and the interim timepoints, Weeks 1, 3, and 6. Celecoxib 400 mg was as effective as naproxen; however, naproxen was more effective than celecoxib 200 mg. Celecoxib was well tolerated, with an adverse event profile similar to placebo. However, 3 naproxen-treated patients experienced serious treatment-related gastrointestinal (GI) adverse events (one severe gastric ulcer, one moderate GI hemorrhage, one severe GI hemorrhage). CONCLUSION: In this 12-week study, celecoxib 200 mg qd and 400 mg qd were efficacious and well tolerated in treating signs and symptoms of AS.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of celecoxib in patients with ankylosing spondylitis (AS). METHODS: This was a 12-week randomized, double-blind, placebo-controlled study with 4 treatment arms: celecoxib 200 mg qd, celecoxib 400 mg qd, naproxen 500 mg bid, and placebo. Patients (age 18-75 yrs) requiring daily treatment with nonselective nonsteroidal antiinflammatory drugs, and with a pain intensity on visual analog scale (VAS) > or = 50 mm worsening by 30% compared with a preinclusion visit (14 days prior) were studied. Primary endpoints were least-squares mean changes from baseline in pain intensity, disease activity (patient global assessment VAS), and functional impairment [Bath Ankylosing Spondylitis Functional Index (BASFI)]. Adverse events were monitored throughout the study. RESULTS: Of 611 randomized patients, 137 were allocated to celecoxib 200 mg, 161 to celecoxib 400 mg, 157 to naproxen, and 156 to placebo. Improvements in least-squares mean pain intensity, disease activity, and BASFI scores were significantly greater in the celecoxib 200 mg, celecoxib 400 mg, and naproxen groups than in the placebo group (p < or = 0.001) at Week 12 and the interim timepoints, Weeks 1, 3, and 6. Celecoxib 400 mg was as effective as naproxen; however, naproxen was more effective than celecoxib 200 mg. Celecoxib was well tolerated, with an adverse event profile similar to placebo. However, 3 naproxen-treated patients experienced serious treatment-related gastrointestinal (GI) adverse events (one severe gastric ulcer, one moderate GI hemorrhage, one severe GI hemorrhage). CONCLUSION: In this 12-week study, celecoxib 200 mg qd and 400 mg qd were efficacious and well tolerated in treating signs and symptoms of AS.
Authors: U Kiltz; J Sieper; H Kellner; D Krause; M Rudwaleit; J-F Chenot; A Stallmach; S Jaresch; J Braun Journal: Z Rheumatol Date: 2014-09 Impact factor: 1.372
Authors: Jeroen P Jansen; Sabine Gaugris; Ernest H Choy; Andrew Ostor; Julian T Nash; Wiro Stam Journal: Pharmacoeconomics Date: 2010 Impact factor: 4.981
Authors: U Kiltz; J Braun; A Becker; J-F Chenot; M Dreimann; L Hammel; A Heiligenhaus; K-G Hermann; R Klett; D Krause; K-F Kreitner; U Lange; A Lauterbach; W Mau; R Mössner; U Oberschelp; S Philipp; U Pleyer; M Rudwaleit; E Schneider; T L Schulte; J Sieper; A Stallmach; B Swoboda; M Winking Journal: Z Rheumatol Date: 2019-12 Impact factor: 1.372