Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, Munich, Germany.
Department of Dermatology, Medicine and Pathology, University of Rochester Medical Center, Rochester, NY, USA.
Br J Dermatol. 2022 Mar;186(3):453-465. doi: 10.1111/bjd.20810. Epub 2021 Nov 28.
Tralokinumab, a fully human IgG4 monoclonal antibody that specifically binds with high affinity to interleukin-13, effectively reduces moderate-to-severe atopic dermatitis (AD) when given every 2 weeks. The incidence of conjunctivitis is elevated vs. placebo, but severity and aetiology have not been examined.
To analyse conjunctivitis data recorded in five randomized, placebo-controlled trials of tralokinumab in adult patients with moderate-to-severe AD.
Overall, 2285 adults with AD were studied up to 16 weeks. Cochran-Mantel-Haenszel weights were applied to calculate the adjusted incidence of adverse events.
The incidence of conjunctivitis was higher (7·5%) with tralokinumab than with placebo (3·2%). Most events were mild or moderate in severity, and 78·6% and 73·9% of events resolved during the trial in the tralokinumab and placebo groups, respectively. Two (1·4%) events led to the permanent discontinuation of tralokinumab. An increased incidence of conjunctivitis, regardless of treatment group, was associated with more severe baseline AD, and history of allergic conjunctivitis/atopic keratoconjunctivitis, as well as the number of atopic comorbidities.
This analysis reports events up to week 16 only, with limited confirmation of conjunctivitis and its aetiology by an ophthalmologist, and insufficient reporting of ophthalmic treatments.
Treatment with tralokinumab was associated with an increased incidence of conjunctivitis vs. placebo, but these cases were mostly mild and transient.
特利鲁单抗是一种完全人源化 IgG4 单克隆抗体，能够特异性地以高亲和力结合白细胞介素-13，在每 2 周给药时可有效减轻中重度特应性皮炎（AD）。与安慰剂相比，结膜炎的发生率升高，但严重程度和病因尚未研究。
分析特利鲁单抗治疗中重度 AD 成人患者的 5 项随机、安慰剂对照临床试验中记录的结膜炎数据。
共有 2285 名 AD 成人患者接受了研究，随访时间长达 16 周。采用 Cochran-Mantel-Haenszel 权重计算不良事件的调整发生率。
特利鲁单抗组结膜炎的发生率（7.5%）高于安慰剂组（3.2%）。大多数事件为轻度或中度，特利鲁单抗组和安慰剂组分别有 78.6%和 73.9%的事件在试验期间得到缓解。有 2 例（1.4%）事件导致特利鲁单抗永久停药。不论治疗组如何，结膜炎发生率的增加与基线 AD 更严重、过敏结膜炎/特应性角结膜炎病史以及特应性合并症的数量有关。
本分析仅报告了第 16 周之前的数据，对结膜炎及其病因由眼科医生进行的确认有限，并且对眼科治疗的报告不足。
与安慰剂相比，特利鲁单抗治疗与结膜炎发生率增加相关，但这些病例大多为轻度和一过性。
