Kirchberger Michael Constantin, Gfesser Michael, Erdmann Michael, Schliep Stefan, Berking Carola, Heppt Markus Vincent
Hautarztzentrum Ingolstadt, Schlüterstr. 3a, 85057 Ingolstadt, Germany.
Department of Dermatology, Uniklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054 Erlangen, Germany.
J Clin Med. 2023 Jul 22;12(14):4837. doi: 10.3390/jcm12144837.
Actinic keratosis (AK) is a cutaneous lesion resulting from the proliferation of atypical epidermal keratinocytes caused by long-term exposure to ultraviolet radiation. AK may progress to cutaneous squamous cell carcinoma (cSCC) and therefore is often treated with topical agents such as 5-fluorouracil, diclofenac, imiquimod, and photodynamic therapy. Tirbanibulin has been approved based on two phase III trials in the USA. However, real-world evidence for tirbanibulin is absent.
This was a single-centre study of adult patients with clinically typical, visible AK on the face or scalp treated with tirbanibulin 1% ointment. Treatment was administered as per label once daily for 5 consecutive days on the same lesions or field. Treatment outcomes were assessed 4 weeks after treatment, with additional optional assessments conducted at later time points. Efficacy was measured using the actinic keratosis area and severity index (AKASI) and digital dermoscopy.
A total of 33 patients were treated of whom 30 were analysed. The median AKASI score was 5.6 (1.4-11) pre-treatment and 1.2 (0-7.4) post-treatment ( < 0.0001). Complete clearance as defined by AKASI scores less than 1 was achieved in 47% ( = 14) and 57% ( = 13) at the first and second follow-up, respectively. All local reactions resolved spontaneously and without sequelae. The most common local reactions were erythema (80%, = 26) and flaking or scaling (43%, = 13).
Tirbanibulin 1% ointment significantly and rapidly reduced the AKASI score in a real-world setting. The complete clearance rates were in line with those observed in the two pivotal trials.
光化性角化病（AK）是一种皮肤病变，由长期暴露于紫外线辐射导致非典型表皮角质形成细胞增殖引起。AK可能进展为皮肤鳞状细胞癌（cSCC），因此常采用5-氟尿嘧啶、双氯芬酸、咪喹莫特等局部用药及光动力疗法进行治疗。在美国，替巴替尼已基于两项III期试验获得批准。然而，替巴替尼的真实世界证据尚不存在。
这是一项针对面部或头皮患有临床典型、可见AK的成年患者的单中心研究，患者接受1%替巴替尼软膏治疗。按照标签说明，在相同皮损或区域连续5天每天给药一次。治疗4周后评估治疗结果，并在后续时间点进行额外的可选评估。使用光化性角化病面积和严重程度指数（AKASI）及数字皮肤镜检查来衡量疗效。
共治疗33例患者，其中30例进行分析。治疗前AKASI评分中位数为5.6（1.4 - 11），治疗后为1.2（0 - 7.4）（<0.0001）。在首次和第二次随访时，AKASI评分小于1所定义的完全清除率分别为47%（n = 14）和57%（n = 13）。所有局部反应均自发消退且无后遗症。最常见的局部反应为红斑（80%，n = 26）和脱屑或鳞屑（43%，n = 13）。
在真实世界环境中，1%替巴替尼软膏能显著且迅速降低AKASI评分。完全清除率与两项关键试验中观察到的结果一致。
