Queen Elizabeth II Health Sciences Centre, Division of Dermatology, Department of Medicine, Dalhousie University, Halifax, Canada.
J Eur Acad Dermatol Venereol. 2012 Mar;26 Suppl 2:21-9. doi: 10.1111/j.1468-3083.2011.04412.x.
The introduction of the biologic agents, adalimumab, etanercept, infliximab and ustekinumab, has provided more options for the short- and long-term treatment of patients with psoriasis. Physicians are now able to achieve and maintain effective disease control in more patients using biologic therapies. Newly published clinical data support the introduction of novel optimization strategies to further improve outcomes in patients with psoriasis. Recent randomized controlled clinical trials have provided data on the efficacy of conventional therapies, including systemic agents, and biologics at specific time points. Switching from methotrexate to a tumour necrosis factor (TNF)-α antagonist after 16 weeks can improve response rates, as demonstrated in a study of patients with moderate-to-severe psoriasis, while the benefit of long-term methotrexate use remains unclear. In a separate study, psoriasis area and severity index (PASI) ≥ 75 response rates were maintained over time (>3 years for adalimumab), suggesting that long-term biologic therapy is an effective and sustainable treatment option for psoriasis. For each individual patient, the benefit of a particular treatment needs to be balanced with the risks. The lack of head-to-head trials of antipsoriatic therapies, particularly biologic therapies, does not help with making individualized treatment decisions. However, a benefit-risk assessment of TNF-α antagonists calculated from an integrated analysis of published literature in moderate-to-severe psoriasis can be used to aid clinical practice. The number needed to treat, number needed to harm and number of patient years of observation to detect an adverse event have been determined for adalimumab, etanercept and infliximab. The benefit-risk profiles generated demonstrated that, during the initial year of treatment, likelihood of success with TNF-α antagonists was several orders of magnitude greater than the likelihood of serious toxicity.
生物制剂阿达木单抗、依那西普、英夫利昔单抗和乌司奴单抗的引入为银屑病患者的短期和长期治疗提供了更多选择。医生现在能够使用生物疗法在更多患者中实现并维持有效的疾病控制。新发表的临床数据支持引入新的优化策略，以进一步改善银屑病患者的结局。最近的随机对照临床试验提供了关于常规疗法（包括系统药物和生物制剂）在特定时间点疗效的数据。在一项中度至重度银屑病患者的研究中，16 周后从甲氨蝶呤转换为肿瘤坏死因子（TNF）-α拮抗剂可以提高应答率，而长期使用甲氨蝶呤的益处尚不清楚。在另一项研究中，银屑病面积和严重程度指数（PASI）≥75 的应答率随着时间的推移（阿达木单抗超过 3 年）得以维持，这表明长期使用生物疗法是治疗银屑病的一种有效且可持续的治疗选择。对于每个个体患者，特定治疗的益处需要与风险相平衡。缺乏抗银屑病疗法（特别是生物制剂）的头对头试验，不利于个体化治疗决策。然而，可以使用从中度至重度银屑病发表文献的综合分析计算 TNF-α拮抗剂的获益-风险评估来辅助临床实践。已经确定了阿达木单抗、依那西普和英夫利昔单抗的治疗需要数、损害需要数和观察到不良事件的患者年数。生成的获益-风险概况表明，在治疗的初始一年中，TNF-α拮抗剂成功的可能性比严重毒性的可能性大几个数量级。
