Sposato Bruno, Scalese Marco, Latorre Manuela, Novelli Federica, Scichilone Nicola, Milanese Manlio, Olivieri Carmela, Perrella Antonio, Paggiaro Pierluigi
Pneumologia, Ospedale Misericordia, Grosseto, Italy.
Istituto di Fisiologia Clinica, CNR, Pisa, Italy.
Pulm Pharmacol Ther. 2017 Jun;44:38-45. doi: 10.1016/j.pupt.2017.03.004. Epub 2017 Mar 14.
It is unknown whether Omalizumab effectiveness changes over the course of time. Our retrospective real-life study tried to analyze whether Omalizumab response may be influenced by treatment duration.
340 severe asthmatics treated with Omalizumab for different periods of time were recruited. They were subdivided into 4 groups according to the Omalizumab treatment length: <12, between 12 and 24, between 24 and 60 and >60 months. Omalizumab treatment results (FEV, exacerbations, ACT, SABA use, asthma control levels, medications used e and ICS doses) were compared.
ACT, exacerbations, GINA control levels, ICS doses and SABA use were similar in all groups with different Omalizumab treatment durations. Using a linear regression model, corrected for all confounding variables, a higher significant positive increase in FEV% in subjects treated for 12-24 (β = 9.49; p = 0.034) or 24-60 months (β = 8.56; p = 0.043) was found when compared with subjects treated for a shorter period. Treatment duration was positively associated with a step down of the other associated therapies (OR: 1.013; p = 0.019). This association was more relevant (OR: 4.167; p = 0.005) when we considered Omalizumab treatment duration >60 months compared to the shorter therapy. In particular, the percentage of subjects that were taking Montelukast, LABAs and oral corticosteroids was lower in the group treated with Omalizumab for a longer period of time.
In real-life, the positive Omalizumab response remained stable for over 60 months. Long term Omalizumab treatment may lead to a discontinuation of some associated medications and to a slowing down of FEV decline.
奥马珠单抗的有效性是否会随时间变化尚不清楚。我们的回顾性真实世界研究试图分析奥马珠单抗的反应是否会受到治疗持续时间的影响。
招募了340名接受不同时间段奥马珠单抗治疗的重度哮喘患者。根据奥马珠单抗治疗时长将他们分为4组:<12个月、12至24个月、24至60个月和>60个月。比较了奥马珠单抗的治疗结果(第一秒用力呼气容积、急性加重次数、哮喘控制测试评分、短效β2受体激动剂使用情况、哮喘控制水平、使用的药物及吸入性糖皮质激素剂量)。
在接受不同奥马珠单抗治疗持续时间的所有组中,哮喘控制测试评分、急性加重次数、全球哮喘防治创议控制水平、吸入性糖皮质激素剂量和短效β2受体激动剂使用情况相似。使用校正了所有混杂变量的线性回归模型,发现与治疗时间较短的受试者相比,接受12 - 24个月(β = 9.49;p = 0.034)或24 - 60个月(β = 8.56;p = 0.043)治疗的受试者第一秒用力呼气容积百分比有更高的显著正向增加。治疗持续时间与其他相关治疗的逐步减少呈正相关(比值比:1.013;p = 0.019)。与较短疗程相比,当我们考虑奥马珠单抗治疗持续时间>60个月时,这种关联更显著(比值比:4.167;p = 0.005)。特别是,在接受奥马珠单抗治疗时间较长的组中,服用孟鲁司特、长效β2受体激动剂和口服糖皮质激素的受试者百分比更低。
在现实生活中,奥马珠单抗的阳性反应在超过60个月的时间里保持稳定。长期使用奥马珠单抗治疗可能导致一些相关药物的停用,并减缓第一秒用力呼气容积的下降。