Abe Masatoshi, Igarashi Atsuyuki, Kitajima Hiroyuki, Toyama Hiroyuki, Kabashima Kenji, Saeki Hidehisa
Kojinkai Sapporo Skin Clinic, Sapporo, Japan.
Igarashi Dermatology Higashigotanda, Tokyo, Japan.
J Dermatol. 2025 Aug 27. doi: 10.1111/1346-8138.17915.
Atopic dermatitis (AD) is a chronic inflammatory disease characterized by recurrent remissions and relapses. Topical anti-inflammatory steroids are commonly used for treatment, but their long-term use poses concerns because of potential side effects. Delgocitinib ointment, a Janus kinase inhibitor, has demonstrated efficacy in several clinical studies and is expected to be a viable alternative to topical corticosteroids (TCS). To evaluate the real-world safety and efficacy of delgocitinib in Japanese patients, we assessed the benefits of switching from TCS to delgocitinib ointment in AD patients with rashes on the trunk and extremities. Overall, data from 93 patients (mean age: 35 years) were analyzed. Patients switched from TCS to delgocitinib ointment and were followed for up to 12 weeks. Treatment outcomes were assessed using the treatment Satisfaction questionnaire for medication-9 (TSQM-9), Eczema Area and Severity Index (EASI), modified EASI (mEASI), Numerical Rating Scale (NRS) for itching, Atopic Dermatitis Control Tool (ADCT), and Patient Preference Questionnaire (PPQ). During the observation period, TSQM-9 scores were significantly improved (effectiveness 68.3 to 72.9, p < 0.05; global satisfaction 61.7 to 67.9, p < 0.01). Additionally, mEASI (8.82 to 6.92, p < 0.05), EASI (9.60 to 7.43, p < 0.001), NRS (5.6 to 4.5, p < 0.001), and ADCT (8.8 to 5.5, p < 0.001) scores were decreased during treatment. Moreover, local side effects were improved, with a > 20% reduction in the severity of skin atrophy and telangiectasia. Approximately 72% of patients reported that "the study drug is more effective" using the PPQ. Taken together, our study demonstrates that delgocitinib ointment is an effective treatment option for AD patients with rashes of the trunk and extremities, as well as for those concerned about the potential side effects of TCS. Trial Registration: The study was registered at the Japan Registry of Clinical Trials (jRCTs031230102).
特应性皮炎(AD)是一种慢性炎症性疾病,其特征为反复缓解和复发。外用抗炎类固醇常用于治疗,但由于潜在的副作用,长期使用令人担忧。JAK激酶抑制剂地尔戈替布软膏在多项临床研究中已显示出疗效,有望成为外用糖皮质激素(TCS)的可行替代药物。为了评估地尔戈替布在日本患者中的真实安全性和疗效,我们评估了躯干和四肢有皮疹的AD患者从TCS转换为地尔戈替布软膏的益处。总体而言,分析了93例患者(平均年龄:35岁)的数据。患者从TCS转换为地尔戈替布软膏,并随访长达12周。使用药物治疗满意度问卷-9(TSQM-9)、湿疹面积和严重程度指数(EASI)、改良EASI(mEASI)、瘙痒数字评定量表(NRS)、特应性皮炎控制工具(ADCT)和患者偏好问卷(PPQ)评估治疗结果。在观察期内,TSQM-9评分显著改善(有效性从68.3提高到72.9,p<0.05;总体满意度从61.7提高到67.9,p<0.01)。此外,治疗期间mEASI(从8.82降至6.92,p<0.05)、EASI(从9.60降至7.43,p<0.001)、NRS(从5.6降至4.5,p<0.001)和ADCT(从8.8降至5.5,p<0.001)评分均降低。此外,局部副作用有所改善,皮肤萎缩和毛细血管扩张的严重程度降低了20%以上。约72%的患者使用PPQ表示“研究药物更有效”。综上所述,我们的研究表明,地尔戈替布软膏对于躯干和四肢有皮疹的AD患者以及担心TCS潜在副作用的患者是一种有效的治疗选择。试验注册:该研究已在日本临床试验注册中心(jRCTs031230102)注册。