Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, and Harvard Medical School, Cambridge, Mass.
Genentech, South San Francisco, Calif.
J Allergy Clin Immunol. 2014 Sep;134(3):560-567.e4. doi: 10.1016/j.jaci.2014.02.007. Epub 2014 Mar 27.
The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) assessed the long-term safety of omalizumab in a clinical practice setting as part of a phase IV US Food and Drug Administration postmarketing commitment.
We sought to evaluate long-term safety in omalizumab-treated and nonomalizumab-treated patients. Primary outcome measures focused on assessment of malignancies.
EXCELS was a prospective observational cohort study in patients (≥12 years of age) with moderate-to-severe allergic asthma. There were 2 cohorts: omalizumab (taking omalizumab at baseline) and nonomalizumab (no history of omalizumab treatment). Primary outcomes included all confirmed, incident, study-emergent primary malignancies (malignancies), including and excluding nonmelanoma skin cancer (NMSC); all malignancies were externally adjudicated.
The omalizumab cohort had a higher proportion of patients with severe asthma compared with the nonomalizumab cohort (50.0% vs 23.0%). Median follow-up was approximately 5 years for both cohorts. Crude malignancy rates were similar in the omalizumab and nonomalizumab cohorts, with a rate ratio of 0.84 (95% CI, 0.62-1.13) for all malignancies and 0.98 (95% CI, 0.71-1.36) for all malignancies excluding NMSC. Kaplan-Meier plots of time to first confirmed study-emergent primary malignancy were similar for the 2 treatment cohorts. Cox proportional hazards modeling, adjusting for confounders and risk factors, resulted in a hazard ratio (omalizumab vs nonomalizumab) of 1.09 (95% CI, 0.87-1.38) for all malignancies and 1.15 (95% CI, 0.83-1.59) for all malignancies excluding NMSC.
Results from EXCELS suggest that omalizumab therapy is not associated with an increased risk of malignancy.
Xolair（奥马珠单抗）的流行病学研究：评估中重度哮喘患者的临床疗效和长期安全性（EXCELS）评估了奥马珠单抗在作为美国食品和药物管理局（FDA）上市后承诺的第四阶段临床实践环境中的长期安全性。
我们旨在评估奥马珠单抗治疗和非奥马珠单抗治疗患者的长期安全性。主要结局指标集中在恶性肿瘤评估上。
EXCELS 是一项针对中重度过敏性哮喘患者（≥12 岁）的前瞻性观察队列研究。有 2 个队列：奥马珠单抗（基线时接受奥马珠单抗治疗）和非奥马珠单抗（无奥马珠单抗治疗史）。主要结局包括所有确诊的、新发的、研究出现的原发性恶性肿瘤（恶性肿瘤），包括和不包括非黑色素瘤皮肤癌（NMSC）；所有恶性肿瘤均经外部裁决。
奥马珠单抗队列的严重哮喘患者比例高于非奥马珠单抗队列（50.0% vs 23.0%）。两组的中位随访时间约为 5 年。奥马珠单抗和非奥马珠单抗队列的恶性肿瘤粗发生率相似，所有恶性肿瘤的比率比为 0.84（95%CI，0.62-1.13），所有恶性肿瘤排除 NMSC 的比率比为 0.98（95%CI，0.71-1.36）。两个治疗队列的首次确诊的研究出现的原发性恶性肿瘤时间的 Kaplan-Meier 图相似。调整混杂因素和危险因素的 Cox 比例风险模型得出，奥马珠单抗与非奥马珠单抗的所有恶性肿瘤的风险比（HR）为 1.09（95%CI，0.87-1.38），所有恶性肿瘤排除 NMSC 的 HR 为 1.15（95%CI，0.83-1.59）。
EXCELS 的结果表明，奥马珠单抗治疗与恶性肿瘤风险增加无关。
