From the 2nd Respiratory Medicine Department, National and Kapodistrian University of Athens, 2nd Respiratory Medicine Department, "Attikon" University Hospital, Chaidari, Athens, Greece.
Prof, Respiratory Medicine Department, Aristotle University of Thessaloniki, G Papanikolaou Hospital, Thessaloniki, Greece.
Allergy Asthma Proc. 2021 May 1;42(3):235-242. doi: 10.2500/aap.2021.42.210014.
The efficacy and safety of omalizumab in patients with severe allergic asthma have been established in both randomized controlled trials and real-life studies. To evaluate the sustained effectiveness and safety of long-term treatment with omalizumab in a real-world setting. In this retrospective study, we included patients treated with omalizumab for at least 8 years in four asthma clinics in Greece. Pulmonary function, asthma control, oral corticosteroids (OCS) dose, and exacerbations were recorded before treatment, 6 months later, and annually thereafter. Adverse events were also recorded. Forty-five patients (66.7% women), mean ± standard deviation (SD) age 55.3 ± 12.2 years, were included. The duration of treatment with omalizumab was 10.6 ± 1.2 years. The annual exacerbation rate decreased from 4.1 before omalizumab initiation to 1.1 after 1 year of treatment and remained low up to the 8th year of treatment (p < 0.001). From the 19 patients who were receiving OCS at baseline, 21.1% patients discontinued after 6 months, 47.4% were still on OCS after 4 years of therapy, and 31.6% were on OCS after 8 years. With regard to the OCS dose, 36.8% of the patients reduced the dose ≥ 50% after 6 months and 68.4% achieved 50% reduction after 2 years. The mean daily OCS dose before omalizumab initiation was 7.8 mg of prednisolone or the equivalent, reduced to 4.7 mg/day after 6 months, which reached 1.6 mg/day after 8 years (p < 0.001). Treatment with omalizumab resulted in significant improvements of asthma control and lung function. No severe adverse events were reported. In this real-life study, omalizumab resulted in significant and sustained improvements in asthma exacerbations, asthma control, and lung function, and had a steroid sparing effect and a good safety profile.
奥马珠单抗在重度过敏性哮喘患者中的疗效和安全性已在随机对照试验和真实研究中得到证实。为了评估奥马珠单抗在真实环境中的长期治疗的持续有效性和安全性。在这项回顾性研究中，我们纳入了在希腊的四个哮喘诊所接受奥马珠单抗治疗至少 8 年的患者。在治疗前、6 个月后和此后每年记录肺功能、哮喘控制、口服皮质类固醇（OCS）剂量和加重情况。还记录了不良事件。纳入了 45 名（66.7%女性）患者，平均年龄为 55.3±12.2 岁。奥马珠单抗治疗的持续时间为 10.6±1.2 年。奥马珠单抗治疗后，每年加重的发生率从治疗前的 4.1 例降至第 1 年的 1.1 例，在治疗的第 8 年仍然较低（p<0.001）。在基线时正在使用 OCS 的 19 名患者中，6 个月后有 21.1%的患者停用，4 年后仍有 47.4%的患者使用 OCS，8 年后有 31.6%的患者使用 OCS。关于 OCS 剂量，有 36.8%的患者在 6 个月后减少了≥50%的剂量，68.4%的患者在 2 年后减少了 50%的剂量。奥马珠单抗治疗前，每日平均 OCS 剂量为 7.8mg 泼尼松或相当剂量，治疗 6 个月后降至 4.7mg/天，治疗 8 年后降至 1.6mg/天（p<0.001）。奥马珠单抗治疗可显著改善哮喘控制和肺功能。未报告严重不良事件。在这项真实研究中，奥马珠单抗可显著和持续地改善哮喘加重、哮喘控制和肺功能，且具有皮质类固醇节约作用和良好的安全性。
