哮喘联盟

   摘要
   背景：奥马珠单抗的流行病学研究：评估中－重度哮喘（EXCELS）患者的临床疗效和长期安全性，评估奥马珠单抗在临床实际中的长期安全性，作为美国食品和药物管理局批准上市后承诺的Ⅳ期临床研究的一部分。
   目的：我们旨在评估奥马珠单抗治疗与非治疗的长期安全性。主要结果强调恶性肿瘤的评估。
   方法：EXCELS是一个前瞻性、观察性、队列研究，纳入患者为≥１２岁的中－重度过敏性哮喘患者。该研究分为两组：奥马珠单抗组（基线时采用奥马珠单抗治疗）和非奥马珠单抗组（无奥马珠单抗治疗史）。主要结果包括所有确诊的，发生的，研究突发的原发性恶性肿瘤（恶性肿瘤），包括和不包括非黑色素皮肤癌（NMSC）；所有恶性肿瘤均获得外部诊断。
   结果：奥马珠单抗组重度哮喘的比率比非奥马珠单抗组高（50.0% vs 23.0%）。两组平均随访时间约５年。恶性肿瘤粗发率在奥马珠单抗组和非奥马珠单抗组中相似，率比为０.８４（95% CI， 0.62-1.13）。排除ＮＭＳＣ，所有恶性肿瘤率比为０.９８（９５％ＣＩ，０．７１－１．３６）。Kaplan-Meier法首次证实的主要急性恶性肿瘤的时间在两组间相似。Cox比例风险模型，调整混杂因素和风险因素，所有恶性肿瘤的风险比（奥马珠单抗ｖｓ非奥马珠单抗）结果为１.０９（95% CI，0.87-1.38），排除ＮＭＳＣ，所有恶性肿瘤的风险比结果为１.１５（95% CI，0.83-1.59）。
   结论：ＥＸＣＥＬS研究的结果提示，奥马珠单抗治疗与恶性肿瘤风险增加无关。
 

（林江涛 审校）
JAllergyClinImmunol.2014Mar26.pii:S0091-6749(14)00204-8.doi:10.1016/j.jaci.2014.02.007. [Epub ahead of print]

 

Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab☆
 

Long A1, Rahmaoui A2, Rothman KJ3, Guinan E4, Eisner M2, Bradley MS2, Iribarren C5, Chen H2, Carrigan G2, Rosén K2, Szefler S6.

ABSTRACT
BACKGROUND: 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.
OBJECTIVE: We sought to evaluate long-term safety in omalizumab-treated and nonomalizumab-treated patients. Primary outcome measures focused on assessment of malignancies.
METHODS: 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.
RESULTS: 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 (omalizumabvsnonomalizumab) 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.
CONCLUSION: Results from EXCELS suggest that omalizumab therapy is not associated with an increased risk of malignancy.
 

JAllergyClinImmunol.2014Mar26.pii:S0091-6749(14)00204-8.doi:10.1016/j.jaci.2014.02.007. [Epub ahead of print]