PURPOSE: Recombinant anti-IgE antibody is recommended by GINA 2009 in treatment of bronchial asthma (Step 5). Anecdotal reports of its use in Cystic fibrosis with ABPA showed good response. However, use of omalizumab in non Cystic fibrosis ABPA has not been studied.
METHODS: Five patients of asthma with ABPA having recurrent exacerbations on steroids prospectively received omalizumab 150 mg once a month for 6 months at Metro Centre for Respiratory Diseases, India between June 2009 and January 2010. Pre and Post-bronchodilator FEV1, FVC, VO2max, Anaerobic threshold and Six Minute Walk Distance were measured at the start and end of treatment. Number of exacerbations, total dose of oral and intravenous steroids, rescue medicine used in 6 months before, during and on follow up (3 month) with omalizumab treatment were recorded and statistically analyzed.
RESULTS: Of five patients with ABPA 3 were males (age 42±9.3). Significant improvement was observed on ACQ5 (7.80±0.83 vs. 2.6±0.54; p-value < 0.001). After 6 months treatment Pre-bronchodilator FEV1 improved from 1.212 ±0.889 to 1.744±0.996 (p-value =0.016), post-bronchodilator FEV1 from 1.47±1.04 to1.95±1.11 (p-value 0.032) and FVC from 2.51±1.12 to 2.80±1.27 (p-value 0.016). There was also significant improvement in exercise capacity as VO 2 max increased from 1214.0±521.7 to 1376.7±497.7 (p-value 0.003), anaerobic threshold from 610.5±194.9 to 935.5±355.5 (p-value 0.038). Also significant improvement in six minute walk distance was seen from 329.0±119 to 467±75.9 (p-value 0.008). Significant reductions in total oral steroid use in six months from 5214±1294.7 mg to 76.0±55.94 (p-value 0.001) were observed. Similarly use of rescue therapy with intravenous methylprednisolone decreased (2516±454 mg vs.136±39.69; p-value 0.005) and β2 agonists (94.8±11.3nebulization vs. 6.2±4.32; p-value< 0.001). Significantly decreased numbers of exacerbations were observed was treatment (1±0.70 vs.6.60±1.14; p-value < 0.001).
CONCLUSION: Use of recombinant anti-IgE antibody led to overall significant improvement and stabilization of patients with non cystic fibrosis ABPA.
CLINICAL IMPLICATIONS: omalizumab is useful in management of difficult to control patients with non Cystic fibrosis ABPA and needs evaluation in future prospective trials.
DISCLOSURE: Deepak Talwar, No Financial Disclosure Information; No Product/Research Disclosure Information