Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology, University of Bari Aldo Moro, Bari, Italy.
Scientific Directorate, IRCCS Burlo Garofolo, Trieste, Italy.
Ann Allergy Asthma Immunol. 2018 Oct;121(4):474-478. doi: 10.1016/j.anai.2018.06.014. Epub 2018 Jun 24.
Omalizumab is a recombinant anti-immunoglobulin E (IgE) antibody used in the treatment of patients with chronic spontaneous urticaria (CSU).
This multicentric study assessed the safety and efficacy of omalizumab in patients (n=322) with CSU refractory to second-generation antihistamines, also investigating predictors of poor treatment outcome and time lag to response to anti-IgE therapy by serum auto-reactivity.
This retrospective observational study comprised a 4-week pretreatment period, a 24-week treatment period with omalizumab (300 mg/month), and a 16-week follow-up period. Primary efficacy endpoints were mean and median change in 7-day urticaria activity score (UAS7), weekly itch severity score (ISS), and hive score from baseline to 4-, 12-, and 24-week values. Secondary endpoints included the proportion of patients (defined "responders") with well-controlled urticaria (UAS7 ≤ 6) and complete treatment response (UAS7=0). Safety in terms of side effects was also assessed.
Omalizumab significantly and consistently reduced the mean UAS7, ISS, and hive score from baseline to weeks 4, 12, and 24, with a clear decreasing trend over time. At the end of the treatment period (week 24), 84.2% of patients had a UAS7 score of 6 or less and 66.7% had a UAS7 of 0. Higher pretreatment IgE levels were less likely to be associated with poor treatment response (ie, UAS7 > 6). Patients with a positive autologus serum skin test (ASST) were significantly more likely to be "slow responders" to omalizumab treatment (ie, response beyond 8 days since omalizumab administration) than ASST-negative patients (P < .001). No treatment-related adverse events were recorded.
Monitoring baseline characteristics of patients before introduction of omalizumab therapy may help to predict treatment outcome in CSU patients.
奥马珠单抗是一种重组抗免疫球蛋白 E（IgE）抗体，用于治疗慢性自发性荨麻疹（CSU）患者。
本多中心研究评估了奥马珠单抗治疗第二代抗组胺药难治性 CSU 患者的安全性和疗效，并通过血清自身反应性研究预测不良治疗结局和抗 IgE 治疗反应的时间滞后。
这是一项回顾性观察研究，包括 4 周的预处理期、24 周的奥马珠单抗（300mg/月）治疗期和 16 周的随访期。主要疗效终点为 7 天荨麻疹活动评分（UAS7）、每周瘙痒严重程度评分（ISS）和基线至 4、12 和 24 周的风团评分的平均和中位数变化。次要终点包括具有良好控制的荨麻疹（UAS7≤6）和完全治疗反应（UAS7=0）患者的比例（定义为“应答者”）。还评估了安全性方面的副作用。
奥马珠单抗从基线到第 4、12 和 24 周显著且一致地降低了平均 UAS7、ISS 和风团评分，且随着时间的推移呈下降趋势。在治疗期末（第 24 周），84.2%的患者 UAS7 评分≤6，66.7%的患者 UAS7 为 0。较高的预处理 IgE 水平不太可能与不良治疗反应相关（即 UAS7>6）。与 ASST 阴性患者相比，自体血清皮肤试验（ASST）阳性的患者对奥马珠单抗治疗的“慢反应者”显著更多（即自奥马珠单抗给药后 8 天以上才有反应）（P<.001）。未记录与治疗相关的不良事件。
在引入奥马珠单抗治疗之前监测患者的基线特征可能有助于预测 CSU 患者的治疗结局。
