Holm Jesper Grønlund, Agner Tove, Sand Carsten, Thomsen Simon Francis
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
Int J Dermatol. 2017 Jan;56(1):18-26. doi: 10.1111/ijd.13353. Epub 2016 Jun 23.
Omalizumab is a recombinant humanized monoclonal antibody targeting the high-affinity Fc receptor of IgE, registered for the treatment of chronic spontaneous urticaria and severe allergic asthma. We present a case series of nine patients with atopic dermatitis (AD) treated off-label with omalizumab and a systematic review of the existing literature. Patients were selected consecutively from a tertiary dermatological referral center during a 5-year period. All patients were treated with omalizumab at a starting dose of 300 mg subcutaneously every 4 weeks. Systematic literature searches were performed in PubMed, Web of Science, EMBASE, and ClinicalTrials.gov to identify any study (case reports, case series, and controlled trials) evaluating the effect of treatment with omalizumab in AD. Based on physicians' assessment, 50% of our patients had a good or excellent response to treatment with omalizumab; a further 12.5% had a moderate response, while 37.5% experienced no response or deterioration of symptoms during treatment. Treatment was generally well tolerated. Twenty-six studies with a median of four patients each (range 1-21), comprising 174 patients, were included in the systematic review. Summed over all studies, a total of 129 patients (74.1%) experienced a beneficial effect of treatment ranging from little to complete response. Omalizumab appears to be a safe and well tolerated, however expensive, treatment with some clinical benefit in patients with severe recalcitrant AD. Recommendation for use in clinical practice awaits evidence from larger randomized controlled trials.
奥马珠单抗是一种重组人源化单克隆抗体，靶向IgE的高亲和力Fc受体，已注册用于治疗慢性自发性荨麻疹和重度过敏性哮喘。我们报告了一组9例接受奥马珠单抗超说明书用药治疗的特应性皮炎（AD）患者的病例系列，并对现有文献进行了系统综述。在5年期间，从一家三级皮肤科转诊中心连续选取患者。所有患者均接受奥马珠单抗治疗，起始剂量为300mg，每4周皮下注射一次。在PubMed、科学网、EMBASE和ClinicalTrials.gov上进行了系统的文献检索，以确定任何评估奥马珠单抗治疗AD效果的研究（病例报告、病例系列和对照试验）。根据医生的评估，我们50%的患者对奥马珠单抗治疗反应良好或极佳；另有12.5%的患者反应中等，而37.5%的患者在治疗期间无反应或症状恶化。治疗一般耐受性良好。系统综述纳入了26项研究，每项研究的患者中位数为4例（范围1 - 21例），共174例患者。汇总所有研究，共有129例患者（74.1%）经历了从轻微到完全缓解的治疗有益效果。奥马珠单抗似乎是一种安全且耐受性良好的治疗方法，尽管价格昂贵，但对重度难治性AD患者有一定临床益处。在临床实践中的使用建议有待来自更大规模随机对照试验的证据。
