Kucharczyk Aleksandra, Więsik-Szewczyk Ewa, Poznańska Anna, Jahnz-Różyk Karina
Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland.
Department of Population Health Monitoring and Analysis, National Institute of Public Health - National Institute of Hygiene, Warsaw, Poland.
J Asthma Allergy. 2020 Dec 14;13:659-668. doi: 10.2147/JAA.S282203. eCollection 2020.
Omalizumab is a high-cost therapy recommended for the treatment of severe allergic asthma.
To find clinical parameters that are related to the sustained response to omalizumab.
This retrospective, real-life, 4-year follow-up was provided in Poland between March 2013 and May 2019. The success of omalizumab was assessed based on composed subjective and objective criteria. Simple/multiple regression analyses were performed to search for predictors of the response to omalizumab.
A total of 989 severe allergic asthma patients were referred for omalizumab therapy, of whom 854 patients were considered eligible for treatment. At weeks 16 and 52, omalizumab was successful in 84% and 91% of patients, respectively. Treatment effectiveness was maintained up to the 4-year follow-up. Four predictors of the response to omalizumab were found at week 16 and two at week 52. The results at week 16 may be used as predictors of success at week 52 based on the model including baseline FEV1% and change in ACQ-7 and miniAQLQ score at week 16: the area under the ROC curve equals 0.746 [95% CI: 0.672-0.820].
Omalizumab therapy is very effective, with this efficacy sustained after 4 years of treatment. Success of the therapy can be predicted from the baseline FEV1% and clinical improvement (based on ACQ-7 and miniAQLQ scores) at week 16.
奥马珠单抗是一种推荐用于治疗重度过敏性哮喘的高成本疗法。
寻找与奥马珠单抗持续反应相关的临床参数。
本回顾性、真实生活的4年随访研究于2013年3月至2019年5月在波兰进行。基于主观和客观综合标准评估奥马珠单抗的治疗效果。进行简单/多元回归分析以寻找奥马珠单抗反应的预测因素。
共有989例重度过敏性哮喘患者被转诊接受奥马珠单抗治疗，其中854例患者被认为符合治疗条件。在第16周和第52周时，奥马珠单抗分别在84%和91%的患者中取得成功。治疗效果维持至4年随访期。在第16周发现了4个奥马珠单抗反应的预测因素，在第52周发现了2个。基于包含基线FEV1%以及第16周时ACQ - 7和miniAQLQ评分变化的模型，第16周的结果可作为第52周成功的预测因素：ROC曲线下面积等于0.746 [95% CI：0.672 - 0.820]。
奥马珠单抗治疗非常有效，治疗4年后疗效仍持续。该疗法的成功可根据第16周时的基线FEV1%和临床改善情况（基于ACQ - 7和miniAQLQ评分）进行预测。
