Charité-University Medicine Berlin, Benjamin Franklin Campus, Medical Department I, Rheumatology, Hindenburgdamm 30, 12203 Berlin, Germany.
Arthritis Res Ther. 2010;12(2):R43. doi: 10.1186/ar2953. Epub 2010 Mar 15.
The purpose of this study was to investigate the effectiveness of adalimumab in enthesitis and peripheral arthritis in patients with ankylosing spondylitis (AS).
Adults with active AS (Bath ankylosing spondylitis disease activity index [BASDAI] > or = 4) received adalimumab 40 mg every other week with standard antirheumatic therapies in a 12-week, open-label study. Effectiveness in enthesitis was assessed using the Maastricht ankylosing spondylitis enthesitis score (MASES, 0-13) and by examining the plantar fascia in patients with enthesitis (> or = 1 inflamed enthesis) at baseline; effectiveness in peripheral arthritis was evaluated using tender and swollen joint counts (TJC, 0-46; SJC, 0-44) in patients with peripheral arthritis (> or = 1 swollen joint) at baseline. Overall effectiveness measures included Assessment of SpondyloArthritis International Society 20% response (ASAS20).
Of 1,250 patients enrolled, 686 had enthesitis and 281 had peripheral arthritis. In 667 patients with MASES > or = 1 at baseline, the median MASES was reduced from 5 at baseline to 1 at week 12. At week 12, inflammation of the plantar fascia ceased in 122 of 173 patients with inflammation at baseline. The median TJC in 281 patients with SJC > or = 1 at baseline was reduced from 5 at baseline to 1 at week 12; the median SJC improved from 2 to 0. ASAS20 responses were achieved by 70.5% of 457 patients with no enthesitis and no arthritis; 71.0% of 512 patients with only enthesitis; 68.0% of 107 patients with only arthritis; and 66.7% of 174 patients with both.
Treatment with adalimumab improved enthesitis and peripheral arthritis in patients with active AS.
ClinicalTrials.gov NCT00478660.
本研究旨在探讨阿达木单抗治疗强直性脊柱炎（AS）患者附着点炎和外周关节炎的疗效。
在这项为期 12 周的开放性研究中，接受阿达木单抗治疗的成人患者患有活动性 AS（Bath 强直性脊柱炎疾病活动指数[BASDAI]≥4），并接受标准的抗风湿治疗。附着点炎的疗效通过马斯特里赫特强直性脊柱炎附着点炎评分（MASES，0-13）和基线时存在附着点炎（≥1 个炎症附着点）患者的足底筋膜进行评估；外周关节炎的疗效通过基线时存在外周关节炎（≥1 个肿胀关节）的患者的压痛关节和肿胀关节计数（TJC，0-46；SJC，0-44）进行评估。总体疗效评估包括强直性脊柱炎国际协会 20%反应（ASAS20）。
在纳入的 1250 名患者中，686 名患者患有附着点炎，281 名患者患有外周关节炎。在基线时 MASES≥1 的 667 名患者中，中位数 MASES 从基线时的 5 降至 12 周时的 1。在基线时存在炎症的 173 名患者中，122 名患者的足底筋膜炎症在 12 周时停止。在 281 名基线时 SJC≥1 的患者中，中位数 TJC 从基线时的 5 降至 12 周时的 1；SJC 的中位数从 2 降至 0。457 名无附着点炎和无关节炎患者中有 70.5%、512 名仅有附着点炎患者中有 71.0%、107 名仅有关节炎患者中有 68.0%、174 名同时存在附着点炎和关节炎患者中有 66.7%达到 ASAS20 反应。
阿达木单抗治疗可改善活动性 AS 患者的附着点炎和外周关节炎。
ClinicalTrials.gov NCT00478660。
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