Department of Dermatology, Massachusetts General Hospital, Harvard Combined Dermatology Residency Program, Boston, MA, USA.
Clinical Laboratory for Epidemiology and Applied Research in Skin (CLEARS), Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Expert Opin Drug Saf. 2021 Oct;20(10):1147-1161. doi: 10.1080/14740338.2021.1924147. Epub 2021 May 12.
Hidradenitis suppurativa (HS) is a chronic, debilitating inflammatory skin disorder characterized by nodules, abscesses, fistulae, and significant scarring in intertriginous areas rich in apocrine glands. Immunomodulator drugs, including biologics, are a mainstay of treatment for this disease.
This review details the safety profiles of various biologic therapies currently available commercially that have been tried for HS as assessed in clinical trials and observational studies. As the only Food and Drug Administration (FDA)-approved medication for the treatment of moderate-to-severe HS, adalimumab is discussed in the most detail. Additional biologic medications, including tumor necrosis factor α (TNFα) inhibitors, interleukin 1 (IL-1) inhibitors, IL-12 and IL-23 inhibitors, IL-17 inhibitors, and IL-23 inhibitors, are discussed as well. Safety concerns in special populations, including pregnant women and children, are outlined.
Existing data support excellent short-term and long-term safety profiles for adalimumab, although caution must be taken with use in high-risk patient populations, including those with chronic infections or increased risk of malignancy. Based on their safety data for other indications, additional biologic agents appear safe in HS as well. However, further research is needed to fully understand the safety profiles of these medications in the HS population.
化脓性汗腺炎（HS）是一种慢性、使人虚弱的炎症性皮肤疾病，其特征为结节、脓肿、瘘管以及富含大汗腺的皱褶部位出现严重的瘢痕。免疫调节剂药物，包括生物制剂，是治疗这种疾病的主要方法。
本综述详细介绍了目前在临床试验和观察性研究中尝试用于 HS 的各种商业上可获得的生物疗法的安全性概况。作为唯一经美国食品和药物管理局（FDA）批准用于治疗中重度 HS 的药物，阿达木单抗的讨论最为详细。此外，还讨论了其他生物药物，包括肿瘤坏死因子 α（TNFα）抑制剂、白细胞介素 1（IL-1）抑制剂、IL-12 和 IL-23 抑制剂、IL-17 抑制剂和 IL-23 抑制剂。还概述了特殊人群（包括孕妇和儿童）的安全问题。
现有的数据支持阿达木单抗具有出色的短期和长期安全性概况，尽管在高风险患者人群（包括患有慢性感染或恶性肿瘤风险增加的患者）中使用时必须谨慎。基于它们在其他适应症中的安全性数据，其他生物制剂在 HS 中似乎也是安全的。然而，需要进一步的研究来充分了解这些药物在 HS 人群中的安全性概况。
