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Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial.
Yorgancioglu, Arzu; Öner Erkekol, Ferda; Mungan, Dilsad; Erdinç, Münevver; Gemicioglu, Bilun; Özseker, Zeynep Ferhan; Bayrak Degirmenci, Papatya; Nayci, Sibel; Çilli, Aykut; Erdenen, Füsun; Kirmaz, Cengiz; Ediger, Dane; Yalçin, Arzu Didem; Büyüköztürk, Suna; Öztürk, Sami; Güleç, Mustafa; Isik, Sacide Rana; Kalyoncu, Ali Fuat; Göksel, Özlem; Aydin, Ömür; Havlucu, Yavuz; Baloglu Ar, Idilhan; Erdogdu, Ahmet.
Afiliación
  • Yorgancioglu A; Department of Chest Diseases, Faculty of Medicine, Celal Bayar University, Manisa, Turkey.
  • Öner Erkekol F; Department of Allergy and Immunology, Atatürk Chest Diseases and Thoracic Surgery Research and Training Hospital, Ankara, Turkey.
  • Mungan D; Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Ankara University, Ankara, Turkey.
  • Erdinç M; Department of Chest Diseases, Faculty of Medicine, Ege University, Izmir, Turkey.
  • Gemicioglu B; Department of Chest Diseases, Cerrahpasa School of Medicine, Istanbul University, Istanbul, Turkey.
  • Özseker ZF; Division of Allergy and Immunology, Department of Chest Diseases, Cerrahpasa School of Medicine, Istanbul University, Istanbul, Turkey.
  • Bayrak Degirmenci P; Department of Allergy and Immunology, Tepecik Research and Training Hospital, Izmir, Turkey.
  • Nayci S; Department of Chest Diseases, Faculty of Medicine, Mersin University, Mersin, Turkey.
  • Çilli A; Department of Chest Diseases, Faculty of Medicine, Akdeniz University, Antalya, Turkey.
  • Erdenen F; Department of Internal Medicine, Istanbul Research and Training Hospital, Istanbul, Turkey.
  • Kirmaz C; Division of Allergy and Immunology, Department of Internal Medicine, Faculty of Medicine, Celal Bayar University, Manisa, Turkey.
  • Ediger D; Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Uludag University, Bursa, Turkey.
  • Yalçin AD; Department of Internal Medicine, Antalya Research and Training Hospital, Antalya, Turkey.
  • Büyüköztürk S; Division of Allergy and Immunology, Department of Internal Medicine, Faculty of Medicine, Istanbul University, Istanbul, Turkey.
  • Öztürk S; Division of Allergy and Immunology, Department of Internal Medicine, Gulhane Military Medical Academy and Medical School (Haydarpasa), Istanbul, Turkey.
  • Güleç M; Division of Allergy and Immunology, Department of Internal Medicine, Gulhane Military Medical Academy and Medical School, Ankara, Turkey.
  • Isik SR; Department of Allergy and Immunology, Yedikule Chest Diseases and Thoracic Surgery Research and Training Hospital, Istanbul, Turkey.
  • Kalyoncu AF; Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Hacettepe University, Ankara, Turkey.
  • Göksel Ö; Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Ege University, Izmir, Turkey.
  • Aydin Ö; Division of Allergy and Immunology, Department of Chest Diseases, Faculty of Medicine, Ankara University, Ankara, Turkey.
  • Havlucu Y; Department of Chest Diseases, Faculty of Medicine, Celal Bayar University, Manisa, Turkey.
  • Baloglu Ar I; Medical Department, Novartis Pharmaceuticals, Istanbul, Turkey.
  • Erdogdu A; Medical Department, Novartis Pharmaceuticals, Istanbul, Turkey.
Int Arch Allergy Immunol ; 176(3-4): 225-233, 2018.
Article en En | MEDLINE | ID: mdl-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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Asma / Antiasmáticos / Omalizumab Tipo de estudio: Observational_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int Arch Allergy Immunol Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Turquía Pais de publicación: Suiza
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Asma / Antiasmáticos / Omalizumab Tipo de estudio: Observational_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int Arch Allergy Immunol Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Turquía Pais de publicación: Suiza