van der Heijde Désirée, Baraf Herbert S B, Ramos-Remus Cesar, Calin Andrei, Weaver Arthur L, Schiff Michael, James Margaret, Markind Jan E, Reicin Alise S, Melian Agustin, Dougados Maxime
Department of Internal Medicine, Division of Rheumatology, University Hospital, Maastricht, The Netherlands.
Arthritis Rheum. 2005 Apr;52(4):1205-15. doi: 10.1002/art.20985.
To assess the efficacy, safety, and tolerability of etoricoxib, a cyclooxygenase 2 (COX-2) selective inhibitor, administered continuously over 52 weeks for the treatment of ankylosing spondylitis (AS).
This 2-part, multicenter, double-blind, parallel-group, 52-week study evaluated 2 doses of etoricoxib (90 and 120 mg) compared with naproxen at 1,000 mg. A 6-week, active-comparator- and placebo-controlled period (part I) was followed by a 46-week active-comparator-controlled period (part II). The primary outcome measures (on 100-mm visual analog scales) were patient's assessment of spine pain, patient's global assessment of disease activity, and the Bath Ankylosing Spondylitis Functional Index.
Of the 387 patients randomized to receive treatment, 301 (77.8%) completed part I and 284 (75.9%) completed part II. Compared with placebo over 6 weeks, those receiving 90 mg etoricoxib, 120 mg etoricoxib, and naproxen demonstrated significantly (P < 0.001) greater improvement in all primary end points; treatment effects (expressed as the difference in least squares mean change versus placebo) were 21-29 mm for spine pain, 18-25 mm for disease activity, and 11-15 mm for function. Compared with patients receiving naproxen, significantly greater improvement in all primary end points was demonstrated in the combined group receiving either 90 mg etoricoxib or 120 mg etoricoxib over 6 weeks, in each individual etoricoxib treatment group over 6 weeks, and in the combined etoricoxib group over 1 year (all P < 0.05); results for secondary and exploratory end points were generally consistent with those from the primary analysis. Among all groups, there were no significant differences in the incidence of overall clinical, drug-related, or serious adverse experiences (AEs) and discontinuations due to AEs. Safety observations during part II were generally consistent with those in part I.
Etoricoxib at doses of 90 mg and 120 mg demonstrated superior efficacy compared with placebo over 6 weeks, and compared with naproxen over 1 year. These study results demonstrate that etoricoxib is generally safe, well-tolerated, and efficacious for the treatment of AS.
评估环氧化酶-2（COX-2）选择性抑制剂依托考昔连续服用52周治疗强直性脊柱炎（AS）的疗效、安全性和耐受性。
这项为期52周的两部分多中心双盲平行组研究评估了2种剂量的依托考昔（90毫克和120毫克），并与1000毫克的萘普生进行比较。在为期6周的活性对照和安慰剂对照期（第一部分）之后是为期46周的活性对照期（第二部分）。主要结局指标（采用100毫米视觉模拟量表）包括患者对脊柱疼痛的评估、患者对疾病活动的整体评估以及巴斯强直性脊柱炎功能指数。
在随机接受治疗的387例患者中，301例（77.8%）完成了第一部分，284例（75.9%）完成了第二部分。与6周内的安慰剂相比，接受90毫克依托考昔、120毫克依托考昔和萘普生的患者在所有主要终点上均表现出显著更大的改善（P<0.001）；治疗效果（表示为与安慰剂相比最小二乘均值变化的差异）在脊柱疼痛方面为21-29毫米，在疾病活动方面为18-25毫米，在功能方面为11-15毫米。与接受萘普生的患者相比，在6周内接受90毫克依托考昔或120毫克依托考昔的联合组、6周内每个依托考昔治疗组以及1年内的依托考昔联合组在所有主要终点上均表现出显著更大的改善（均P<0.05）；次要和探索性终点的结果与主要分析结果基本一致。在所有组中，总体临床、药物相关或严重不良事件（AE）的发生率以及因AE导致的停药率均无显著差异。第二部分期间的安全性观察结果与第一部分基本一致。
90毫克和120毫克剂量的依托考昔在6周内与安慰剂相比显示出更好的疗效，在1年内与萘普生相比疗效更佳。这些研究结果表明，依托考昔在治疗AS方面总体上是安全、耐受性良好且有效的。
