Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial

• Published in: International Archives of Allergy and Immunology
• Main Authors: Yorgancioglu, Arzu, Erkekol, Ferda Oner, Mungan, Dilsad, Erdinc, Munevver, Gemicioglu, Bilun, Ozseker, Zeynep Ferhan, Degirmenci, Papatya Bayrak, Nayci, Sibel, Cilli, Aykut, Erdenen, Fusun, Kirmaz, Cengiz, Ediger, Dane, Yalcin, Arzu Didem, Buyukozturk, Suna, Ozturk, Sami, Gulec, Mustafa, Isik, Sacide Rana, Kalyoncu, Ali Fuat, Goksel, Ozlem, Aydin, Omur, Havlucu, Yavuz, Ar, Idilhan Baloglu, Erdogdu, Ahmet
• Other Authors: Ege Üniversitesi
• Format: Article in Journal/Newspaper
• Language: English
• Published: Karger 2018
• Subjects: Anti-IgE; Omalizumab; Effectiveness; Real-life trial; Long-term treatment; Dane; sami
• Online Access: https://hdl.handle.net/11454/31162; https://doi.org/10.1159/000488349

WOS: 000438864700007 PubMed ID: 29772578 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. (C) 2018 S. Karger AG, Basel Novartis Pharmaceuticals Ltd.; NovartisNovartis The study was sponsored by Novartis Pharmaceuticals Ltd. The sponsor was involved in the design of the study and conducted the analysis according to a detailed analysis agreed by the investigators. The interpretation of the results is that of the author of this paper. Arzu Yorgancioglu, Ferda Oner Erkekol, Dilsad Mungan, Munevver Erdinc, Bilun Gemicioglu, Zeynep Ferhan Ozseker, Papatya Bayrak, Sibel Atis Nayci, Aykut Cilli, Cengiz Kirmaz, Dane Ediger, Arzu Didem Yalcin, Suna Buyukozturk, Sami Ozturk, Rana Isik, Fuat Kalyoncu, and Yavuz Havlucu received grant/research support for consultations, speaking at conferences and for support to attend international conferences from Novartis. Fusun Erdenen, Mustafa Gulec, Ozlem Goksel, Omur Aydin do not have conflict of interest. Idilhan Baloglu Ar, Ahmet Erdogdu work for the Medical Department of Novartis Pharmaceuticals, Istanbul, Turkey.