Awasthi Sankalp, Nijhawan Manisha, Mishra Akash, Gupta Anviti
Department of Dermatology, Venereology and Leprology, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India.
Centre of Biostatistics, (Department of Community Medicine), Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Arch Dermatol Res. 2024 Dec 14;317(1):129. doi: 10.1007/s00403-024-03642-5.
Alopecia areata (AA) is a chronic, immune-mediated inflammatory disorder characterized by nonscarring hair loss. The management of AA poses challenges due to its unpredictable course and variable response to treatment. In this comparative study, we evaluated the efficacy and safety of oral apremilast, intralesional corticosteroids (ILC) and a combination of both in patients with patchy AA.
Sixty patients with patchy AA were randomly assigned to three treatment groups: oral apremilast (Group A), ILC (Group B), and a combination of both (Group C). The Severity of Alopecia Tool (SALT) score was used to assess the extent of hair loss before treatment, after 3 months, and at 6 months of follow-up. Adverse events and complications were also monitored. The changes in SALT score from baseline between the three groups were assessed by using non-parametric statistical tests. The statistical significance was judged at 5% level of significance.
Findings demonstrated significant higher reduction in median SALT scores after treatment i.e., 2.47 (1.76, 5.07), p < 0.001 as well as after six months follow up 5.08 (3.80, 7.53), p < 0.001 in patients treated with ILC compared to other two groups. Neither apremilast monotherapy nor its combination with ILC demonstrated statistically significant improvement, although individual responses were observed. Complications were minimal, with transient pain and burning sensation reported during ILC injections and a few cases of gastritis and relapse in the oral apremilast group.
These findings suggest that ILC remains an effective treatment option for patchy AA. This study did not demonstrate statistically significant efficacy of oral apremilast, either as monotherapy or in combination with ILC, though larger studies may be needed to evaluate potential benefits in specific patient subgroups. Further research with larger sample sizes and longer-term follow-up is needed to validate these findings and optimize treatment approaches for AA.
斑秃（AA）是一种慢性、免疫介导的炎症性疾病，其特征为非瘢痕性脱发。由于其病程不可预测且对治疗的反应各异，AA的治疗颇具挑战。在这项对比研究中，我们评估了口服阿普米拉斯、病灶内注射皮质类固醇（ILC）以及两者联合使用对斑秃患者的疗效和安全性。
60例斑秃患者被随机分为三个治疗组：口服阿普米拉斯组（A组）、ILC组（B组）和两者联合组（C组）。使用脱发严重程度工具（SALT）评分在治疗前、治疗3个月后及随访6个月时评估脱发程度。同时监测不良事件和并发症。采用非参数统计检验评估三组SALT评分相对于基线的变化。统计学显著性以5%的显著性水平判定。
结果显示，与其他两组相比，接受ILC治疗的患者在治疗后即中位数SALT评分显著降低，为2.47（1.76，5.07），p < 0.001，在随访6个月后为5.08（3.80，7.53），p < 0.001。尽管观察到个体反应，但阿普米拉斯单药治疗及其与ILC联合治疗均未显示出统计学上的显著改善。并发症极少，ILC注射期间报告有短暂疼痛和烧灼感，口服阿普米拉斯组有几例胃炎和复发病例。
这些发现表明，ILC仍然是斑秃的一种有效治疗选择。本研究未证明口服阿普米拉斯单药治疗或与ILC联合使用具有统计学上的显著疗效，不过可能需要更大规模的研究来评估特定患者亚组中的潜在益处。需要进一步开展更大样本量和更长随访期的研究来验证这些发现并优化斑秃的治疗方法。
