Alshathri Almaha H, Abdellatif Rim Adel, Alshathri Aljohara H, Alharbi Lamees Fahad, Allehyani Roaa Abdulrahman, Alawaji Mayadah Assaf, Alajaji Abdullah
College of Medicine, King Saud University, Riyadh, Saudi Arabia.
Sulaiman Al Rajhi Colleges, College of Medicine and Surgery, Al-Bukayriyah, Saudi Arabia.
Ann Med Surg (Lond). 2025 Mar 3;87(5):2880-2888. doi: 10.1097/MS9.0000000000003047. eCollection 2025 May.
Establishing effective treatment for cutaneous lupus erythematosus (CLE) is of major importance given lack of approved medications for this autoimmune condition. Topical calcineurin inhibitors have been used to treat all types of CLE, yet there is currently no robust study that evaluated the efficacy of calcineurin inhibitors in this patient population. Our aim is to study the efficacy of topical calcineurin inhibitors for treating patients with CLE and assess the side effects associated with the use of this class of medications.
A systematic review was conducted following the AMSTAR guidelines. A systematic search for articles published between 2003 and 2024 in PubMed, MEDLINE, the Cochrane library (Cochrane Databases of Systematic Reviews), and the Cochrane Register of Controlled Trials for relevant studies that assessed the efficacy of calcineurin inhibitors in patients with CLE.
Twenty-five studies met the criteria, and we reviewed and collectively included. Based on the Quality assessment, some concerns are raised in the quality assessment of RCTs studies. However, Observational studies have high methodological quality.
In conclusion, our systematic review analyzed 25 studies to evaluate the efficacy and safety of topical calcineurin inhibitors in treating CLE. Our systematic review findings support the effectiveness of these inhibitors, namely pimecrolimus cream and tacrolimus ointment in improving clinical manifestations and disease activity in various forms of CLE, such as discoid lupus and subacute CLE. However, the result from RCTs metanalysis showed no significant difference between calcineurin inhibitors and other treatments. While calcineurin inhibitors are generally safe, the most common side effect was skin burning sensation at application site in the first few days of treatment. Further research is needed to prove the effectiveness of these drugs, explore the comparative effectiveness between different calcineurin inhibitors and comparing their types and their concentration.
鉴于皮肤红斑狼疮（CLE）缺乏获批药物，建立有效的治疗方法至关重要。局部用钙调神经磷酸酶抑制剂已用于治疗所有类型的CLE，但目前尚无强有力的研究评估钙调神经磷酸酶抑制剂在该患者群体中的疗效。我们的目的是研究局部用钙调神经磷酸酶抑制剂治疗CLE患者的疗效，并评估使用这类药物相关的副作用。
按照AMSTAR指南进行系统评价。在PubMed、MEDLINE、Cochrane图书馆（Cochrane系统评价数据库）和Cochrane对照试验注册库中系统检索2003年至2024年发表的评估钙调神经磷酸酶抑制剂对CLE患者疗效的相关研究。
25项研究符合标准，我们对其进行了综述并纳入。基于质量评估，随机对照试验研究的质量评估中存在一些问题。然而，观察性研究具有较高的方法学质量。
总之，我们的系统评价分析了25项研究，以评估局部用钙调神经磷酸酶抑制剂治疗CLE的疗效和安全性。我们的系统评价结果支持这些抑制剂，即吡美莫司乳膏和他克莫司软膏在改善各种形式的CLE（如盘状狼疮和亚急性CLE）的临床表现和疾病活动方面的有效性。然而，随机对照试验的荟萃分析结果显示钙调神经磷酸酶抑制剂与其他治疗方法之间无显著差异。虽然钙调神经磷酸酶抑制剂总体安全，但最常见的副作用是治疗开始几天应用部位的皮肤烧灼感。需要进一步研究以证明这些药物的有效性，探索不同钙调神经磷酸酶抑制剂之间的比较有效性，并比较它们的类型和浓度。
