Clinical Determinants of Successful Omalizumab Therapy in Severe Allergic Asthma Patients: 4-Year-Long, Real-Life Observation
Aleksandra Kucharczyk,1 Ewa WiÄ™sik-Szewczyk,1 Anna PoznaÅ"ska,2 Karina Jahnz-Różyk1 1Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland; 2Department of Population Health Monitoring and Analysis, National Institute of Public Health – National Institute of Hygiene, Warsaw, PolandCorrespondence: Ewa WiÄ™sik-SzewczykDepartment of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Szaserów 128, Warsaw 01-141, PolandTel/ Fax +48 261 816 581Email ewa.w.szewczyk@gmail.comIntroduction: Omalizumab is a high-cost therapy recommended for the treatment of severe allergic asthma.Objective: To find clinical parameters that are related to the sustained response to omalizumab.Patients and Methods: 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.Results: 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].Conclusion: 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.Keywords: allergic asthma, anti-IgE, biologics, personalized therapy