杜皮卢马布每月剂量降级在CRSwNP中保持有效性:为期两年的真实世界研究
Eugenio De Corso1, Claudio Montuori2, Gabriele De Maio2
1Otorhinolaryngology Unit, A. Gemelli University Hospital Foundation IRCCS, Rome, Italy.
The Laryngoscope
|March 28, 2025
概括
将dupilumab的剂量延长到每4周一次,对于严重的带鼻息肉的慢性鼻炎 (CRSwNP) 是安全有效的. 实际数据显示,这种间隔剂量降级对治疗结果没有负面影响.
科学领域:
- 免疫学 免疫学 免疫学
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 药理学 药理学是指药理学的学科.
背景情况:
- 严重的未经控制的带鼻息肉的慢性鼻炎 (CRSwNP) 显著影响患者的生活质量.
- 杜皮卢马布已在治疗CRSwNP方面表现出有效性,但在现实环境中最佳的剂量间隔需要进一步调查.
研究的目的:
- 评估降低dupilumab剂量每4周间隔一次对CRSwNP患者治疗结果的影响.
- 在2年内实践的临床实践中,评估较少频繁的dupilumab剂量计划的安全性和有效性.
主要方法:
- 一项现实研究涉及148名患有严重不受控制的CRSwNP的患者,他们完成了2年的随访.
- 两组的比较:A组 (标准间隔) 和B组 (扩展到每月一次剂量).
- 评估的结果包括多体积,鼻腔阻塞,生活质量和嗅觉,以及安全监测.
主要成果:
- 两组在6,12和24个月 (p < 0.01) 显示出所有评估结果的显著改善.
- 将dupilumab扩展到每月剂量 (B组) 与标准剂量 (A组) 相比,治疗结果没有显著差异.
- 剂量延长的原因包括不良事件,持续的乙红蛋白,以及患者/医生对持续控制的要求.
结论:
- 降低dupilumab每4周一次的间隔是严重CRSwNP的现实实践中的一个可行的选择.
- 每月服用dupilumab可维持治疗的有效性和安全性,为患者的管理和坚持治疗提供了潜在的好处.
相关概念视频
Rational Dosage Regimen: Maintenance Dose and Loading Dose
A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady state,...
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady state,...
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel Disease...
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab (Humira),...
Bioavailability Study Design: Single Versus Multiple Dose Studies
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Drug Accumulation During Multiple Dosing: Repetitive IV Injections
Calculating drug dosage and accumulation in multiple-dose regimens is crucial for achieving therapeutic efficacy while avoiding toxicity. This involves determining the plasma drug concentrations over time to optimize dosing schedules. The principle of superposition is fundamental in this process, allowing for the prediction of drug concentration in plasma following multiple doses based on single-dose data.The principle of superposition asserts that the plasma concentration-time curves from...
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
Intermittent intravenous (IV) infusion is a method of drug administration where medications are delivered over short infusion periods followed by intervals of no drug delivery. This approach helps to prevent sustained high drug concentrations in the bloodstream, reducing the risk of adverse effects associated with prolonged exposure. Unlike continuous infusion, steady-state concentrations may not be achieved during a single dosing cycle but can be reached through repeated...

