Omalizumab, a protein that resembles one type of human antibody, an injectable drug that has been approved for use by the FDA for the treatment of asthma. A recent study revealed that Omalizumab may improve symptoms in patients with severe allergic asthma that is not resolved with a combination of corticosteroids and beta-agonists. The study involved 850 adolescents and adult patients with severe asthma that is resistant to a combination of inhaled corticosteroid therapy (inhaled corticosteroid, ICS) and long working beta-agonists (long acting beta-agonist, INCOME). These patients often experience an asthma attack and requires medication "rescue" several times per week.
Patients in the treatment group were given doses of Omalizumab with 0.008 mg / kg body weight per 1 IU / mL IgE every two weeks, or double the dose every four weeks, via subcutaneous injection. During the 48-week study, dose modification Omalizumab, ICS, and PROFIT is not allowed. A total of 673 patients completed the study, with similar proportions between the two groups (Omalizumab and placebo). Incidence of asthma exacerbations requiring steroid treatment reported fewer Omalizumab group than the placebo group (0.66 vs. 0.88 per patient, p = 0.006) and time to first documented occurrence of exacerbation was longer in patients receiving Omalizumab.
Participants in the treatment group also showed improved quality of life better, referring to the Asthma Quality of Life Questionnaire, than participants in the placebo group (67.8% vs 61%, p = 0.42). The average score of asthma symptoms and the need for albuterol inhalation per day is also counted better on Omalizumab group, but not to exceed a minimum level of difference clinically significant. Incidence of side effects is approximately the same in both groups (80.4% vs. 79.5% placebo Omalizumab), as well as the frequency of serious side effects (9.3% vs. 10.5% placebo Omalizumab).
Meskipun omalizumab telah disetujui FDA untuk indikasi asma alergik berat, Dr. Hanania dan kolega, selaku peneliti, tetap memberi catatan bahwa standar terapi asma yang berlaku saat ini ialah kombinasi ICS dan LABA. Tanpa mengesampingkan fakta ini, berdasarkan temuan studi ini, para peneliti menyimpulkan bahwa kombinasi efek omalizumab dan beta-agonis kerja singkat terhadap perbaikan eksaserbasi asma, kualitas hidup, dan gejala-gejala asma akan memberi keuntungan klinis bagi pasien-pasien pengidap asma berat.
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