Feletar M, Brockbank J E, Schentag C T, Lapp V, Gladman D D
University of Toronto Psoriatic Arthritis Clinic, Toronto Western Hospital, Toronto, Canada.
Ann Rheum Dis. 2004 Feb;63(2):156-61. doi: 10.1136/ard.2003.006775.
To evaluate the effectiveness and toxicity of infliximab in patients with recalcitrant psoriatic arthritis (PsA).
Patients with treatment resistant PsA and at least six actively inflamed joints, who had failed to respond to at least two disease modifying agents, were included. Infliximab (5 mg/kg) was given at weeks 0, 2, 6, and every 6-8 weeks pending response. Clinical and laboratory measures included actively inflamed joint count (AJC), swollen joint count (SJC), psoriasis severity (PASI), HAQ, and SF-36. Response was defined as at least a 30% reduction in AJC and PASI. Differences from baseline were analysed using the signed rank test.
Sixteen patients (12 male, 4 female), mean age 48 and disease duration 14 years, were included. At baseline the mean AJC was 22.5 and mean PASI 4.5. Eleven patients continued receiving methotrexate. The AJC did not show a statistically significant response. SJC improved significantly at week 54 (p = 0.01). The PASI improved significantly at weeks 14 (p = 0.001) and 30 (p = 0.002) and CRP was reduced significantly at week 30 (p = 0.02). The HAQ score improved at week 30 (p = 0.02). Six patients became positive for dsDNA without clinical features of a connective tissue disease. Six patients discontinued treatment owing to lack of efficacy (1) and toxicity (5). Other serious adverse events included: urticaria (3); thrombocytopenia (1); lower gastrointestinal bleeding (2); severe diarrhoea (2); serious infections (6). Raised transaminases, at least 1.5x normal, occurred in four patients.
In refractory PsA, infliximab led to a marked improvement in psoriasis but modest response in joint disease. Toxicity and rate of treatment termination was high.
评估英夫利昔单抗治疗难治性银屑病关节炎(PsA)患者的有效性和毒性。
纳入对治疗抵抗的PsA患者,且至少有六个关节有活动性炎症,对至少两种改善病情的药物治疗无效。英夫利昔单抗(5mg/kg)在第0、2、6周给药,之后根据反应情况每6 - 8周给药一次。临床和实验室指标包括活动性炎症关节计数(AJC)、肿胀关节计数(SJC)、银屑病严重程度(PASI)、健康评估问卷(HAQ)和SF - 36。反应定义为AJC和PASI至少降低30%。使用符号秩检验分析与基线的差异。
纳入16例患者(12例男性,4例女性),平均年龄48岁,病程14年。基线时平均AJC为22.5,平均PASI为4.5。11例患者继续接受甲氨蝶呤治疗。AJC未显示出统计学上的显著反应。SJC在第54周显著改善(p = 0.01)。PASI在第14周(p = 0.001)和第30周(p = 0.002)显著改善,CRP在第30周显著降低(p = 0.02)。HAQ评分在第30周改善(p = 0.02)。6例患者双链DNA呈阳性,但无结缔组织病的临床特征。6例患者因缺乏疗效(1例)和毒性(5例)而停止治疗。其他严重不良事件包括:荨麻疹(3例);血小板减少症(1例);下消化道出血(2例);严重腹泻(2例);严重感染(6例)。4例患者转氨酶升高,至少为正常上限的1.5倍。
在难治性PsA中,英夫利昔单抗使银屑病有显著改善,但对关节疾病反应一般。毒性和治疗终止率较高。