Long-term efficacy and safety of omalizumab in patients with allergic asthma: A real-life study

DOI Web Site 1 Citations
  • Andriana I. Papaioannou
    From the 2nd Respiratory Medicine Department, National and Kapodistrian University of Athens, 2nd Respiratory Medicine Department, “Attikon” University Hospital, Chaidari, Athens, Greece;
  • Myrto Mplizou
    From the 2nd Respiratory Medicine Department, National and Kapodistrian University of Athens, 2nd Respiratory Medicine Department, “Attikon” University Hospital, Chaidari, Athens, Greece;
  • Konstantinos Porpodis
    Prof, Respiratory Medicine Department, Aristotle University of Thessaloniki, G Papanikolaou Hospital, Thessaloniki, Greece;
  • Evangelia Fouka
    Prof, Respiratory Medicine Department, Aristotle University of Thessaloniki, G Papanikolaou Hospital, Thessaloniki, Greece;
  • Eleftherios Zervas
    7th Respiratory Medicine Department, Sotiria Hospital, Athens. Greece;
  • Konstantinos Samitas
    7th Respiratory Medicine Department, Sotiria Hospital, Athens. Greece;
  • Miltiadis Markatos
    Pulmonologist-Chania, Crete, Greece;
  • Petros Bakakos
    National and Kapodistrian University of Athens National and Kapodistrian University of Athens, 1st Respiratory Medicine Department, “Sotiria” Hospital, Athens, Greece
  • Spyridon Papiris
    From the 2nd Respiratory Medicine Department, National and Kapodistrian University of Athens, 2nd Respiratory Medicine Department, “Attikon” University Hospital, Chaidari, Athens, Greece;
  • Mina Gaga
    7th Respiratory Medicine Department, Sotiria Hospital, Athens. Greece;
  • Despoina Papakosta
    Prof, Respiratory Medicine Department, Aristotle University of Thessaloniki, G Papanikolaou Hospital, Thessaloniki, Greece;
  • Stelios Loukides
    From the 2nd Respiratory Medicine Department, National and Kapodistrian University of Athens, 2nd Respiratory Medicine Department, “Attikon” University Hospital, Chaidari, Athens, Greece;

Abstract

<jats:p><jats:bold>Background:</jats:bold>The efficacy and safety of omalizumab in patients with severe allergic asthma have been established in both randomized controlled trials and real-life studies.<jats:bold>Objective:</jats:bold>To evaluate the sustained effectiveness and safety of long-term treatment with omalizumab in a real-world setting.<jats:bold>Methods:</jats:bold>In this retrospective study, we included patients treated with omalizumab for at least 8 years in four asthma clinics in Greece. Pulmonary function, asthma control, oral corticosteroids (OCS) dose, and exacerbations were recorded before treatment, 6 months later, and annually thereafter. Adverse events were also recorded.<jats:bold>Results:</jats:bold>Forty-five patients (66.7% women), mean ± standard deviation (SD) age 55.3 ± 12.2 years, were included. The duration of treatment with omalizumab was 10.6 ± 1.2 years. The annual exacerbation rate decreased from 4.1 before omalizumab initiation to 1.1 after 1 year of treatment and remained low up to the 8th year of treatment (p < 0.001). From the 19 patients who were receiving OCS at baseline, 21.1% patients discontinued after 6 months, 47.4% were still on OCS after 4 years of therapy, and 31.6% were on OCS after 8 years. With regard to the OCS dose, 36.8% of the patients reduced the dose ≥ 50% after 6 months and 68.4% achieved 50% reduction after 2 years. The mean daily OCS dose before omalizumab initiation was 7.8 mg of prednisolone or the equivalent, reduced to 4.7 mg/day after 6 months, which reached 1.6 mg/day after 8 years (p < 0.001). Treatment with omalizumab resulted in significant improvements of asthma control and lung function. No severe adverse events were reported.<jats:bold>Conclusion:</jats:bold>In this real-life study, omalizumab resulted in significant and sustained improvements in asthma exacerbations, asthma control, and lung function, and had a steroid sparing effect and a good safety profile.</jats:p>

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