Omalizumab (OMA) is a humanised anti-immunoglobulin E (IgE) monoclonal antibody, indicated as add-on therapy for moderate-to-severe persistent allergic (IgE–mediated) asthma. Here, we report the interim results of a 52-week observational study of OMA in patients in India, stratified by baseline severity of asthma.
In this open-label, non-comparative, non-interventional study, patients (age =12 years) with moderate-to-severe persistent allergic asthma, inadequately controlled despite ICS + LABA (GINA step 4) treatment, were recruited. All patients were receiving OMA at baseline. Outcomes were assessed every 4 weeks, and included exacerbations, days missed at college or work, hospitalizations, and mean change (D) in FEV1, ACQ5 score, ACT score and oral corticosteroid (OCS) dose versus baseline. Adverse events were also recorded. Asthma severity was assessed at baseline, in accordance with GINA guidelines, and classified as either moderate (group 1) or severe (group 2). Data were analysed using chi-squared and paired t-tests. All parameters were compared between baseline and Week 28 post-OMA treatment.
To date, 100 patients have completed 28 weeks of follow-up (36 patients in group 1 and 64 in group 2). Results are presented in the Table. The proportion of patients with =1 exacerbation, missing any day at work/college and requiring hospitalisation decreased appreciably in both groups. There was also significant improvement in lung function and asthma control, and a reduction in OCS need. Overall, 5 patients (5%) reported adverse events (AEs), of whom 2 (2%) reported serious AEs (SAEs). The most frequent non-serious AEs were gastrointestinal (GI) and nervous system disorders and were suspected to be related to omalizumab. GI, respiratory, thoracic and mediastinal SAEs were reported, but were not suspected to be related to omalizumab. All reported AEs and SAEs resolved with treatment. 28 weeks’ treatment with omalizumab was associated with reductions in asthma exacerbations and OCS requirements, and improvements in lung function and asthma control, that were comparable between patients with moderate or severe asthma at baseline
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