Department of Contact Eczema and Immunoallergic Diseases, Dermatology Department, Hospital Universitario San Cecilio, Granada, Spain.
Instituto de Investigación Biosanitaria de Granada, Granada, Spain.
Australas J Dermatol. 2024 May;65(3):260-265. doi: 10.1111/ajd.14264. Epub 2024 Apr 8.
BACKGROUND/OBJECTIVES: The evaluation of the efficacy and safety of new molecules for atopic dermatitis (AD) in real clinical practice is very important to obtain information that clinical trials (EECC) lack. The pattern of AD in the head and neck (H&N) continues to be a challenge in treatment today, despite the new molecules, and real-life data on the use of tralokinumab is still missing. This is the first daily practice study of tralokinumab treatment in patients with H&N AD pattern. The objective is to evaluate the efficacy and safety of tralokinumab in the short term (16 weeks) in patients with AD with H&N pattern, for the first time.
A multicentre prospective observational study was conducted, including patients with moderate-severe AD and H&N pattern who started tralokinumab treatment in four hospitals in Andalusia. Values of severity and quality of life scales, as well as patient-reported outcomes (PROs), were collected at baseline and at Weeks 4 and 16. Safety events were also recorded.
Twelve patients were included. An improvement was observed in all efficacy and quality of life parameters evaluated at 16 weeks with respect to the baseline. No serious adverse events were recorded.
In real clinical practice, tralokinumab is demonstrated to be an effective and safe treatment for patients with AD and H&N pattern at short term.
背景/目的：评估新型特应性皮炎（AD）药物在真实临床实践中的疗效和安全性非常重要，因为这可以获取临床试验（EECC）中所缺乏的信息。尽管有了新的药物，但头颈部（H&N）AD 的治疗模式仍然是一个挑战，目前仍然缺乏关于特利鲁单抗实际应用的数据。这是第一项关于特利鲁单抗治疗 H&N AD 模式患者的日常实践研究。本研究的目的是首次评估特利鲁单抗在 H&N AD 模式的中重度 AD 患者中的短期（16 周）疗效和安全性。
进行了一项多中心前瞻性观察性研究，纳入了在安达卢西亚的四家医院开始特利鲁单抗治疗的中重度 AD 且具有 H&N 模式的患者。在基线时以及第 4 周和第 16 周时收集了严重程度和生活质量量表以及患者报告的结局（PRO）的值。还记录了安全性事件。
纳入了 12 例患者。与基线相比，在第 16 周时所有评估的疗效和生活质量参数均有所改善。未记录到严重不良事件。
在真实临床实践中，特利鲁单抗在短期治疗 H&N AD 模式的 AD 患者中显示出有效性和安全性。
