Salvarani Carlo, Cantini Fabrizio, Olivieri Ignazio, Macchioni Pierluigi, Padula Angela, Niccoli Laura, Catanoso Maria Grazia, Scocco Giovanni Lo, Boiardi Luigi
Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
Arthritis Rheum. 2003 Aug 15;49(4):541-5. doi: 10.1002/art.11201.
To evaluate the efficacy and safety of the anti-tumor necrosis factor alpha monoclonal antibody infliximab in the treatment of active psoriatic arthritis (PsA) resistant to previous symptom modifying antirheumatic drugs.
Sixteen patients with peripheral active PsA with at least 6 months of methotrexate (MTX) therapy at a stable dosage were treated with infliximab administered at a dosage of 3 mg/kg at 0, 2, 6, 14, 22, and 30 weeks while continuing to receive MTX. Intake of nonsteroidal antiinflammatory drugs and corticosteroids was stable during the study period. Standard clinical assessments, erythrocyte sedimentation rate (ESR), and C reactive protein (CRP) were determined at baseline and at weeks 2, 6, 14, 22, and 30.
By week 2, significant improvements were registered in the number of swollen and tender joints, visual analog scale for pain, patient and doctor global disease assessment scores, Health Assessment Questionnaire, Dougados functional index, ESR, and CRP. At week 30, the percentages of patients satisfying American College of Rheumatology (ACR) 20%, ACR 50%, and ACR 70% response rates were 64%, 57%, and 57%, respectively. In the 3 patients with active axial disease, spinal stiffness and pain resolved almost completely at week 2 and the improvement did not diminish over time. Psoriasis Area Severity Index improvement was 37% at week 2 and 86% at week 30. No patients dropped out for treatment failure. Side effects were observed in 4 of 16 patients, 2 of whom suspended the therapy due to a severe allergic reaction.
In patients with resistant PsA, infliximab is an effective therapy without major side effects.
评估抗肿瘤坏死因子α单克隆抗体英夫利昔单抗治疗既往使用症状改善抗风湿药物无效的活动性银屑病关节炎(PsA)的疗效和安全性。
16例外周活动性PsA患者,已接受至少6个月稳定剂量甲氨蝶呤(MTX)治疗,在继续接受MTX治疗的同时,于第0、2、6、14、22和30周接受英夫利昔单抗治疗,剂量为3mg/kg。在研究期间,非甾体抗炎药和皮质类固醇的摄入量保持稳定。在基线以及第2、6、14、22和30周时进行标准临床评估、测定红细胞沉降率(ESR)和C反应蛋白(CRP)。
到第2周时,肿胀和压痛关节数量、疼痛视觉模拟量表、患者和医生整体疾病评估评分、健康评估问卷、Dougados功能指数、ESR和CRP均有显著改善。在第30周时,达到美国风湿病学会(ACR)20%、ACR 50%和ACR 70%缓解率的患者百分比分别为64%、57%和57%。在3例活动性中轴疾病患者中,脊柱僵硬和疼痛在第2周时几乎完全缓解,且改善情况未随时间减弱。银屑病面积和严重程度指数在第2周时改善了37%,在第30周时改善了86%。没有患者因治疗失败而退出。16例患者中有4例出现副作用,其中2例因严重过敏反应而中止治疗。
对于难治性PsA患者,英夫利昔单抗是一种有效的治疗方法,且无严重副作用。