依那西普治疗中国活动性强直性脊柱炎患者的短期疗效优于白种人

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Mod Rheumatol. 2010 Dec;20(6):580-7. Epub 2010 Aug 4. Better short-term clinical response to etanercept in Chinese than Caucasian patients with active ankylosing spondylitis. Chou CT, Tsai CY, Liang TH, Chang TM, Lai CH, Wei CC, Chen KH, Lin SC, Yu CL, Liou LB, Luo SF, Lee CS, Hsue YT, Huang CM, Chen JH, Lai NS, Cheng HH, Cheng TT, Lai HM, Tsai WC, Yen JH, Lu LY, Chang CP. Division of Allergy-Immunology-Rheumatology, Veterans General Hospital, No. 201, Sec. 2, Shih-Pai Road, Shih-Pai, Taipei, 11217, Taiwan. ctchou@vghtpe.gov.tw Abstract Tumor necrosis factor-alpha (TNF-α) inhibitors including etanercept have been demonstrated to be very effective in severe ankylosing spondylitis (AS) in Caucasian patients. However, clinical efficacy of etanercept to treat active AS in Chinese patients has not been reported. In this study, a prospective, open-label trial of etanercept (25 mg BIW), involving 46 AS patients from 16 medical centers of Taiwan, was conducted. Questionnaire was utilized to record demographic data and clinical parameters, including Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Bath AS Global Index (BASGI), Assessment in Ankylosing Spondylitis (ASAS) 20, 50, and 70, and others, before and at different time intervals after etanercept treatment. Laboratory tests including blood chemistry, hematology, urine analysis, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were done at baseline and at weeks 4, 8, and 12. In this 12-week study, etanercept demonstrated rapid and significant improvement in the ASAS20 response criteria (91.3%), at as early as 2 weeks of therapy (71.3%). Partial remission of AS was achieved in 49.3% of patients after 12 weeks of treatment. Disease activity (BASDAI) and function (BASFI) were also significantly improved after 12 weeks etanercept treatment (p < 0.0001 and p < 0.0001, respectively). In addition, significant increase of chest expansion (2.77 ± 1.69 cm versus 3.56 ± 1.82 cm, p = 0.0004) and lumbar flexion (2.11 ± 2.76 cm versus 2.58 ± 3.42 cm, p = 0.0075) and significant reduction of occiput-to-wall distance (6.59 ± 7.14 cm versus 5.32 ± 6.65 cm, p = 0.0006) were also demonstrated. Both ESR and CRP declined significantly after patients were treated with etanercept. There were no severe adverse effects during the treatment period. Etanercept is generally safe, well tolerated, and effective in Chinese patients with severe AS. Clinical efficacy, including partial remission and BASDAI, is even better in Chinese than in Caucasian patients. Further study is required to assess long-term efficacy and safety in Chinese patients with AS.

依那西普治疗中国活动性强直性脊柱炎患者的短期疗效优于白种人 Chou CT, Tsai CY, et al,Mod Rheumatol. 2010 Dec;20(6):580-7. Epub 2010 Aug 4. 已经证明包括依那西普在内的肿瘤坏死因子-α（TNF-α)抑制剂治疗白种人群严重强制性脊柱炎(AS)患者非常有效。然而, 依那西普治疗中国活动性AS患者的临床疗效尚未见报道。本研究是依那西普(25mg BIW)的一项前瞻、开放性临床试验，涉及台湾16个医学中心的46例AS患者。问卷用于记录人口学数据和临床参数,包括治疗前和不同治疗观察期的Bath AS疾病活动指数(BASDAI)、Bath AS功能指数(BASFI),Bath AS总体评估(BASGI),强直性脊柱炎评价(ASAS)20、50和70等。实验室检查包括基线和治疗第4、8、12周时的血生化、血和尿常规、红细胞沉降率(ESR)、C反应蛋白(CRP)。12周的研究中,依那西普被证明能快速并显著改善ASAS20反应 (91.3%),最快2周起效(71.3%)。12周后AS部分缓解率为49.3%，疾病活动(BASDAI)和功能(BASFI)也得到明显改善 (p < 0.0001和p < 0.0001)。此外,胸廓活动度 (2.77±1.69 cm vs. 356±1.82 cm,p = 0.0004) 和腰椎屈伸度(2.11±2.76 cm vs.2.58±3.42 cm,p = 0.0075)明显增加,枕墙距（6.59±7.14cm vs. 5.32±6.65cm,p = 0.0006)明显减少。ESR和CRP在治疗前后也明显下降。整个治疗期间未发生严重不良反应。用依那西普总体上是安全的,耐受性良好,并且对中国严重的AS患者有效。甚至，中国患者的临床疗效包括部分缓解率和BASDAI要优于白种人群。中国AS患者的长期疗效和安全性仍需进一步的研究评价。