PT - JOURNAL ARTICLE AU - Ashok Mahashur AU - Deepak Talwar AU - Randeep Guleria AU - Mangala Kotnis TI - Outcomes with omalizumab in Indian patients with allergic (IgE-mediated) asthma: Results at 16 and 28 weeks DP - 2013 Sep 01 TA - European Respiratory Journal PG - P907 VI - 42 IP - Suppl 57 4099 - http://erj.ersjournals.com/content/42/Suppl_57/P907.short 4100 - http://erj.ersjournals.com/content/42/Suppl_57/P907.full SO - Eur Respir J2013 Sep 01; 42 AB - Omalizumab (OMA) is an add-on therapy for patients with moderate-to-severe allergic (IgE–mediated) asthma, uncontrolled despite GINA step 4 therapies. Here, we report the interim results of a 52-week observational study of OMA in India.In this open-label, non-comparative, non-interventional study, patients (age ≥12 years) with moderate-to-severe 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 and mean change in FEV1, ACQ5 score, ACT score and ICS dose versus baseline. Data were analyzed using chi-squared and paired t-tests. All parameters were compared between baseline and Weeks 16 and 28 post-OMA treatment.To date, 100 patients (mean [SD] age: 51.5 [15.2] years) have completed 28 weeks’ follow-up. The proportion of patients with ≥1 exacerbation decreased from 26% at baseline to 4% (p=0.226) and 1% (p=0.551) at Weeks 16 and 28, respectively. Versus baseline, FEV1 increased by 0.5L (p=0.000) and 1.0L (p=0.000) at Weeks 16 and 28, respectively. Mean ACQ5 score decreased significantly, by -0.9 (p=0.000) and -1.5 (p=0.000) at Weeks 16 and 28, respectively. Composite ACQ5 score also declined significantly. ACT scores increased significantly, by 5.0 (p=0.000) and 9.7 (p=0.000) at Weeks 16 and 28, respectively. Mean ICS dose declined at both time-points; the decrease was statistically significant at Week 28 (-196.8µg; p=0.002).28 weeks’ treatment with OMA was associated with reductions in asthma exacerbations, improved lung function and asthma control, and reductions in ICS dose.