戈利木单抗，一种新型人肿瘤坏死因子α抗体，每四周皮下注射一次用于治疗银屑病关节炎：一项随机、安慰剂对照研究的24周疗效和安全性结果。

Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study.

作者信息

Kavanaugh Arthur, McInnes Iain, Mease Philip, Krueger Gerald G, Gladman Dafna, Gomez-Reino Juan, Papp Kim, Zrubek Julie, Mudivarthy Surekha, Mack Michael, Visvanathan Sudha, Beutler Anna

机构信息

University of California, San Diego, La Jolla, CA 92093-0943, USA.

出版信息

Arthritis Rheum. 2009 Apr;60(4):976-86. doi: 10.1002/art.24403.

DOI:10.1002/art.24403

PMID:19333944

Abstract

OBJECTIVE

To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA).

METHODS

Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic nail disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index).

RESULTS

At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric nail disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated.

CONCLUSION

Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and nail psoriasis through week 24.

摘要

目的

评估戈利木单抗治疗活动性银屑病关节炎（PsA）患者的疗效和安全性。

方法

患有PsA且至少有3个关节肿胀和3个关节压痛以及活动性银屑病的成年患者被随机分配，每4周皮下注射安慰剂（n = 113）、50 mg戈利木单抗（n = 146）或100 mg戈利木单抗（n = 146），共治疗20周。至24周的疗效评估包括美国风湿病学会20%改善标准（ACR20）；对于基线时至少3%体表面积受银屑病影响的患者，评估银屑病面积和严重程度指数（PASI）；36项简明健康调查（SF - 36）；健康评估问卷（HAQ）残疾指数；甲银屑病严重程度指数（NAPSI）；医生对银屑病甲病的整体评估；以及附着点炎（使用PsA改良的马斯特里赫特强直性脊柱炎附着点炎评分[MASES]指数）。

结果

在第14周时，所有接受戈利木单抗治疗的患者中有48%、接受50 mg戈利木单抗治疗的患者中有51%以及接受100 mg戈利木单抗治疗的患者中有45%达到ACR20反应（主要终点），而接受安慰剂治疗的患者中这一比例为9%（所有比较P < 0.001）。在基线时至少3%体表面积受银屑病影响的74%患者中，50 mg戈利木单抗组40%的患者以及100 mg戈利木单抗组58%的患者在第14周时PASI至少改善75%（主要次要终点），而安慰剂治疗患者中这一比例为3%（两种剂量P均 < 0.001）。与安慰剂相比，各戈利木单抗组在其他主要次要终点（HAQ和SF - 36）、NAPSI、医生对银屑病甲病的整体评估以及PsA改良的MASES指数方面均有显著改善。这种疗效维持至24周。戈利木单抗总体耐受性良好。