Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial
Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial
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DOI：
10.1016/s0140-6736(00)04954-0
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发表时间：
2001-06-09
期刊：
影响因子：
168.9
通讯作者：
Gottlieb, AB
中科院分区：
文献类型：
--
作者：
Chaudhari, U;Romano, P;Gottlieb, AB
背景目前可用于治疗中、重度银屑病的治疗方法要么对某些患者不完全有效，要么与毒性反应相关。由于肿瘤坏死因子α被认为在银屑病的发病机制中起作用，我们进行了一项双盲随机试验，以评估抗肿瘤坏死因子α的单抗英夫利昔单抗的临床疗效和安全性。方法33例中重度斑块型银屑病患者被随机分配到静脉注射安慰剂(n=11)、英夫利昔单抗5 mg/kg(n=11)或英夫利昔单抗10 mg/kg(n=11)，分别在0、2和6周进行评估。分析的依据是意向治疗。在33名入选的患者中，有3人退出。英夫利昔单抗5 mg/kg组11名患者中有9名(82%)有反应(PGA评分为良、良或清晰)，而安慰剂组11名患者中有2名(18%)(差异%[95%可信区间20-]，p=0.0089)，英夫利昔单抗10 mg/kg组11名患者中有10名(91%)有反应(与安慰剂组73%[30-94]，p=0.0019)。英夫利昔单抗组和英夫利昔单抗组患者的中位有效时间为4周。在这项对照试验中，接受抗肿瘤坏死因子-α制剂英夫利昔单抗作为单一疗法的患者与接受安慰剂的患者相比，在治疗中到重度斑块型银屑病方面有很高的临床益处和快速的起效时间。这些发现表明，肿瘤坏死因子-α在银屑病的发病机制中起着关键作用。
Background Currently available treatments for moderate to severe psoriasis are either incompletely effective in some patients, or are associated with toxic effects. Since tumour necrosis factor alpha (TNF-alpha) is thought to have a role in the pathogenesis of psoriasis, we did a double-blind, randomised trial to assess the clinical benefit and safety of infliximab-a monoclonal antibody against TNF-alpha.Methods 33 patients with moderate to severe plaque psoriasis were randomly assigned intravenous placebo (n=11), infliximab 5 mg/kg (n=11), or infliximab 10 mg/kg (n=11) at weeks 0, 2, and 6. Patients were assessed at week 10 for the primary endpoint (score on the physician's global assessment [PGA]). Analysis was by intention to treat.Findings Of the 33 patients enrolled, three dropped out. Nine of 11 (82%) patients in the Infliximab 5 mg/kg group were responders (good, excellent, or clear rating on PGA), compared with two of 11 (18%) In the placebo group (difference 64% [95% CI 20-89], p=0.0089), and ten of 11 (91%) patients in the infliximab 10 mg/kg group were responders (difference from placebo 73% [30-94], p=0.0019). The median time to response was 4 weeks for patients in both infliximab groups. There were no serious adverse events, and infliximab was well tolerated.Interpretation In this controlled trial, patients receiving the anti-TNF-alpha agent infliximab as monotherapy experienced a high degree of clinical benefit and rapid time to response In the treatment of moderate to severe plaque psoriasis compared with patients who received placebo. These findings suggest that TNF-alpha has a pivotal role in the pathogenesis of psoriasis.