Division of Rheumatology, Allergy, Immunology, University of California, , San Diego, La Jolla, California, USA.
Ann Rheum Dis. 2013 Nov;72(11):1777-85. doi: 10.1136/annrheumdis-2012-202035. Epub 2012 Nov 17.
To assess long-term golimumab efficacy/safety in patients with active psoriatic arthritis (PsA).
Adult PsA patients (≥3 swollen, ≥3 tender joints, active psoriasis) were randomly assigned to subcutaneous injections of placebo, golimumab 50 mg or 100 mg every 4 weeks (q4wks) through week 20. All patients received golimumab 50 or 100 mg beginning week 24. Findings through 2 years are reported. Efficacy evaluations included ≥20% improvement in American College of Rheumatology (ACR20) response, good/moderate response in Disease Activity Scores incorporating 28 joints and C-reactive protein (DAS28-CRP), ≥75% improvement in Psoriasis Area and Severity Index (PASI75) and changes in PsA-modified Sharp/van der Heijde scores (SHS).
Golimumab treatment through 2 years was effective in maintaining clinical response (response rates: ACR20 63%-70%, DAS28-CRP 77%-86%, PASI75 56%-72%) and inhibiting radiographic progression (mean change in PsA-modified SHS in golimumab-treated patients: -0.36), with no clear difference between doses. No new safety signals were identified through 2 years. With the study's tuberculosis screening and prophylactic measures, no patient developed active tuberculosis through 2 years.
Golimumab 50 and 100 mg for up to 2 years yielded sustained clinical and radiographic efficacy when administered to patients with active PsA. Increasing the golimumab dose from 50 to 100 mg q4wks added limited benefit. Golimumab safety through up to 2 years was consistent with other antitumour necrosis factor α agents used to treat PsA. Treatment of patients with latent tuberculosis identified at baseline appeared to be effective in inhibiting the development of active tuberculosis.
评估戈利木单抗治疗活动性银屑病关节炎（PsA）患者的长期疗效/安全性。
成年活动性 PsA 患者（≥3 个肿胀关节、≥3 个压痛关节、活动性银屑病）按 1:1:1 随机分配至安慰剂、戈利木单抗 50mg 或 100mg 组，每 4 周（q4wks）皮下注射 1 次，治疗 20 周。所有患者自第 24 周开始均接受戈利木单抗 50mg 或 100mg 治疗。报告至 2 年的研究结果。疗效评估包括美国风湿病学会（ACR）20%应答率（ACR20）、28 个关节和 C 反应蛋白（DAS28-CRP）疾病活动度评分（DAS28-CRP）的良好/中度应答率、银屑病面积和严重程度指数（PASI75）的≥75%改善率及 PsA 改良 Sharp/van der Heijde 评分（SHS）的变化。
戈利木单抗治疗 2 年可有效维持临床应答（应答率：ACR20 63%-70%、DAS28-CRP 77%-86%、PASI75 56%-72%）和抑制影像学进展（戈利木单抗治疗患者 PsA 改良 SHS 的平均变化值为-0.36），不同剂量间无明显差异。2 年内未发现新的安全性信号。通过结核筛查和预防措施，2 年内无患者发生活动性结核病。
戈利木单抗 50mg 和 100mg 治疗长达 2 年，可使活动性 PsA 患者获得持续的临床和影像学疗效。戈利木单抗剂量由 50mg 增至 100mg/q4wks 可带来有限的额外获益。戈利木单抗治疗 2 年的安全性与其他用于治疗 PsA 的抗肿瘤坏死因子α药物一致。治疗基线时发现的潜伏性结核患者似乎可有效抑制活动性结核病的发生。
