原文

译文

Seminars in Arthritis and Rheumatism
Volume 40, Issue 5 , Pages 398-406, April 2011

Sustained Clinical Response in Psoriatic Arthritis Patients Treated with Anti-TNF Agents: A 5-year Open-Label Observational Cohort Study

• Ioanna Saougou, MD

Objective

To investigate the efficacy, toxicity, and drug discontinuation in patients with psoriatic arthritis treated with anti-tumor necrosis factor agents.

Methods

Sixty-five patients with active disease were included in this open-label study. They had tender or swollen joint count ≥5, Psoriatic Arthritis Severity Index (PASI) score ≥10, and erythrocyte sedimentation rate ≥28 mm Hg/1st hour and/or C-reactive protein ≥10 mg/L. All were refractory to at least 2 disease-modifying antirheumatic drugs. Thirty were treated with infliximab, 25 with etanercept, and 10 with adalimumab. Infliximab (5 mg/kg body weight) was given intravenously at weeks 0, 2, 6, and every 8 weeks thereafter; etanercept was given subcutaneously (25 mg twice a week), while adalimumab was given subcutaneously (40 mg every other week) for a period of 5 years. Data concerning anti-tumor necrosis factor efficacy tolerability, adverse events, and drug discontinuation were recorded. The percentage of patients who achieved the Psoriatic Arthritis Response Criteria (PSARC), the improvement of PASI, the improvement according to the American College of Rheumatology (ACR) criteria, and the disease activity for 28 joint indices score (DAS-28) were recorded.

Results

After 5 years, PSARC was 60%, PASI 70 was 66.7%, PASI 90 was 63.3%, while ACR 50 was 56.7% for the patients treated with infliximab. Moreover, PsARC was 64%, PASI 70 and PASI 90 were 68%, while ACR 50 was 56% for those treated with etanercept. Furthermore, in the adalimumab group PsARC was 56%, PASI 70 and PASI 90 were 58% and 50%, respectively, while ACR 50 was 50%. Additionally, DAS-28 scores were significantly improved. Thirteen patients treated with infliximab, 6 with etanercept, and 5 patients with adalimumab were withdrawn. At the end of treatment, the survival of infliximab was 56.7%, for etanercept 76%, and for adalimumab 50%.

Conclusion

All drugs were effective, safe, and well-tolerated. The clinical improvement was maintained through the 5 years with satisfying infliximab and adalimumab survival and high etanercept survival.

5年随访显示TNF拮抗剂治疗银屑病关节疗效持久

Saougou I. Semin Arthritis Rheum. 2011;40(5):398-406.

目的: 研究TNF拮抗剂治疗银屑病关节炎(PsA)的疗效、副作用和患者停药。

方法: 该开放性研究纳入65例疾病活动性患者，他们的触痛或肿胀关节数≥5，银屑病面积与严重性指数(PASI)≥10，ESR≥28mm/小时和/或CRP≥10mg/L。所有病人均已经过至少2种DMARDs治疗但疗效欠佳。接受TNF拮抗剂治疗的病例数：依那西普25例，英夫利昔单抗30例，阿达木单抗10例。依那西普给药方法是每周2次25mg、皮下注射，英夫利昔单抗​​（5 mg/kg）在第0、2、6周及之后每8周一次静脉给药，阿达木单抗是每周40mg、皮下注射。总疗程为5年。记录有关TNF拮抗剂的疗效、耐受性、不良事件和停药。计算达到银屑病关节炎反应标准(PsARC)的病人比例、PASI改善比例、获得ACR反应和DAS28反应标准的病人比例。

结果: 治疗5年后, 依那西普治疗患者的PsARC达标率为64％，PASI 70和90达标率均为68％，而ACR 50达标率为56％。接受英夫利昔单抗治疗的PsARC达标率为60％, PASI 70和90达标率分别为66.7％和63.3％的PASI 90, ACR 50达标率为56.7%。在阿达木单抗组, PsARC达标率为56％，PASI 70和90达标率分别为58％和50％，ACR50达标率为50％。此外，DAS28评分显着改善。停药的病人数：英夫利昔单抗13例，依那西普6例，阿达木单抗5例。在随访结束时，依那西普持续用药率为76%，英夫利昔单抗和阿达木单抗分别为56.7％和50％。

结论: 所有TNF拮抗剂治疗PsA均有效，病人耐受性均良好。病情改善在5年期间得到很好维持。依那西普持续用药率最高。