From the Department of Neurology (L.R., S.P., M.P., T.R., H.W.), Institute of Translational Neurology, University Hospital of Münster, Germany; Department of Neurology (J.H., C.K., R.P.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; Department of Dermatology (W.S.), University Hospital Essen, University Duisburg-Essen, Essen, Germany; and Department of Neurology (M.K., S.G.M.), University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.
Neurol Neuroimmunol Neuroinflamm. 2021 Apr 9;8(3). doi: 10.1212/NXI.0000000000000990. Print 2021 May.
To report 77 patients with multiple sclerosis (MS) who developed skin-related adverse events (AEs) following treatment with cladribine.
We evaluated our prospective bicentric cladribine cohort. Cladribine-treated patients with a skin AE were identified.
Two hundred thirty-nine cladribine-treated patients with MS were evaluated. Seventy-seven patients (32%) showed at least 1 skin AE at median 1 month after cladribine initiation (range: 1-12). Within first 3 months following last cladribine exposition, hair thinning (n = 28, 12%), skin rash (n = 20; 8%), mucositis (n = 13, 5%), and pruritus (n = 6, 3%) were observed. Furthermore, 35 patients (15%) developed herpes virus infections (time since last cladribine exposition: median 83 [range: 10-305]). In 15 patients, herpes zoster infection was severe (CTCAE grade ≥ 3) and required hospitalization. Delayed skin AEs (≥3 months after a cladribine treatment cycle) involved 1 case of leukocytoclastic vasculitis and 2 cases of alopecia areata. Finally, 2 patients presented with in total 3 isolated precancerous lesions (1 leukoplakia simplex and 2 actinic keratosis) and 1 patient developed a squamous cell carcinoma.
Skin AEs are common in patients with MS treated with cladribine. Until risk management plans have been adjusted to include these phenomena, clinicians should perform a thorough clinical follow-up and in suspicious cases seek early interdisciplinary support. In light of the observed delayed skin reactions, we further emphasize the necessity of careful clinical surveillance of cladribine-treated patients for yet undescribed secondary autoimmune events.
This study provides Class IV evidence that skin-related AEs are frequent in patients with MS following cladribine in a real-world setting.
报告 77 例多发性硬化症（MS）患者在使用克拉屈滨治疗后出现皮肤相关不良事件（AE）。
我们评估了我们前瞻性的双中心克拉屈滨队列。确定了出现皮肤 AE 的克拉屈滨治疗患者。
评估了 239 例接受克拉屈滨治疗的 MS 患者。77 例（32%）在克拉屈滨起始后 1 个月中位数（范围：1-12）时出现至少 1 种皮肤 AE。在末次克拉屈滨暴露后的前 3 个月内，观察到毛发稀疏（n=28，12%）、皮疹（n=20；8%）、黏膜炎（n=13，5%）和瘙痒（n=6，3%）。此外，35 例（15%）发生疱疹病毒感染（末次克拉屈滨暴露时间：中位数 83 [范围：10-305]）。15 例患者的带状疱疹感染严重（CTCAE 分级≥3），需要住院治疗。迟发性皮肤 AE（克拉屈滨治疗周期后≥3 个月）包括 1 例白细胞碎裂性血管炎和 2 例斑秃。最后，2 例患者总共出现 3 例孤立的癌前病变（1 例单纯性口腔白斑和 2 例光化性角化病），1 例患者发生鳞状细胞癌。
接受克拉屈滨治疗的 MS 患者常见皮肤 AE。在风险管理制度调整以纳入这些现象之前，临床医生应进行彻底的临床随访，并在可疑病例中尽早寻求多学科支持。鉴于观察到的迟发性皮肤反应，我们进一步强调有必要仔细临床监测接受克拉屈滨治疗的患者是否出现尚未描述的继发性自身免疫事件。
本研究提供了 IV 级证据，表明在真实环境中，接受克拉屈滨治疗的 MS 患者常出现皮肤相关 AE。
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