Arzu Yorgancıoğlu1, Ferda Öner Erkekol2, Dilşad Mungan3, Münevver Erdinç4, Bilun Gemicioğlu5, Zeynep Ferhan Özşeker6, Papatya Bayrak Değirmenci7, Sibel Naycı8, Aykut Çilli9, Füsun Erdenen10, Cengiz Kırmaz11, Dane Ediger12, Arzu Didem Yalçın13, Suna Büyüköztürk14, Sami Öztürk15, Mustafa Güleç16, Sacide Rana Işık17, Ali Fuat Kalyoncu18, Özlem Göksel19, Ömür Aydın3, Yavuz Havlucu1, İdilhan Baloğlu Ar20, Ahmet Erdoğdu20. 1. Department of Chest Diseases, Faculty of Medicine, Celal Bayar University, Manisa, Turkey. 2. Department of Allergy and Immunology, Atatürk Chest Diseases and Thoracic Surgery Research and Training Hospital, Ankara, Turkey. 3. Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Ankara University, Ankara, Turkey. 4. Department of Chest Diseases, Faculty of Medicine, Ege University, Izmir, Turkey. 5. Department of Chest Diseases, Cerrahpaşa School of Medicine, Istanbul University, Istanbul, Turkey. 6. Division of Allergy and Immunology, Department of Chest Diseases, Cerrahpaşa School of Medicine, Istanbul University, Istanbul, Turkey. 7. Department of Allergy and Immunology, Tepecik Research and Training Hospital, Izmir, Turkey. 8. Department of Chest Diseases, Faculty of Medicine, Mersin University, Mersin, Turkey. 9. Department of Chest Diseases, Faculty of Medicine, Akdeniz University, Antalya, Turkey. 10. Department of Internal Medicine, Istanbul Research and Training Hospital, Istanbul, Turkey. 11. Division of Allergy and Immunology, Department of Internal Medicine, Faculty of Medicine, Celal Bayar University, Manisa, Turkey. 12. Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Uludağ University, Bursa, Turkey. 13. Department of Internal Medicine, Antalya Research and Training Hospital, Antalya, Turkey. 14. Division of Allergy and Immunology, Department of Internal Medicine, Faculty of Medicine, İstanbul University, Istanbul, Turkey. 15. Division of Allergy and Immunology, Department of Internal Medicine, Gulhane Military Medical Academy and Medical School (Haydarpaşa), Istanbul, Turkey. 16. Division of Allergy and Immunology, Department of Internal Medicine, Gulhane Military Medical Academy and Medical School, Ankara, Turkey. 17. Department of Allergy and Immunology, Yedikule Chest Diseases and Thoracic Surgery Research and Training Hospital, Istanbul, Turkey. 18. Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Hacettepe University, Ankara, Turkey. 19. Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Ege University, Izmir, Turkey. 20. Medical Department, Novartis Pharmaceuticals, Istanbul, Turkey.
Abstract
BACKGROUND: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. METHODS: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. RESULTS: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. CONCLUSION: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good.
BACKGROUND:Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. METHODS: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. RESULTS: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. CONCLUSION:Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good.