Omalizumab has been shown to be an effective add-on therapy for patients with uncontrolled severe persistent allergic asthma. There has been a steady accumulation of evidence on the long-term effectiveness of omalizumab; however, data on real-life outcomes beyond one year of treatment is limited. In this study, we report on long-term outcomes of omalizumab treatment. We collected data from our severe asthma registry on hospitalisations, exacerbations, corticosteroid sparing, asthma control, lung function, biomarkers and side effects, to determine if the benefit was sustained and treatment was safe on the long term. Forty-five patients [mean age 44.9 years (range 19-69), females 37/45 (82%), mean duration of omalizumab treatment = 60.7 ± 30.9 months (range 23-121) were included in the analysis. We observed a reduction in the annual acute asthma related hospital admissions for the total population from 207 at baseline to 40 on treatment (80.7% reduction), whilst the per patient annual hospitalisations were reduced from a mean of 4.8 to 0.89 post-omalizumab treatment (p < 0.00001). There was a 76.7% reduction in daily mean maintenance OCS dose (prednisolone equivalent) from 25.8 mg (n = 43) to 6.0 mg (p < 0.0001), associated with clinically significant improvement in asthma control questionnaire (ACQ) from mean score of 4.1 (range 3.7-4.7) to 2.27 (range 0.5-4.1) p < 0.0001. The mean % predicted FEV has improved from 59.2% at baseline to 75.7% on treatment (p = 0.001). There was a statistically non-significant reduction in median peripheral blood eosinophils (PBE) from 300 cells/μl (range 40-1050) at baseline to 175 cells/μl (range 0-1500) post-treatment (p = 0.068), and statistically significant reduction of median fraction exhaled nitric oxide (FeNO) level from 37 parts per billion (range 12-178) to 24 ppb (range 7-50) (p = 0.0067). The work/school missed days were reduced in 17/19 patients who were at employment or school. The overall safety profile of the treatment seemed acceptable and was consistent with published experience. In conclusion, results from this real-life study demonstrate that improved outcomes in patients with severe allergic asthma are sustained with longer-term omalizumab therapy.

Sixty eight neonates requiring total or supplemental parenteral nutrition in the first week of life were randomly allocated either Vamin 9 glucose (n=34) or MB233G (n=34) in a double blind trial. Twenty infants were withdrawn: four because they died before 5 days of age and 16 because the amino acids were required for less than the five days of the trial. The solutions were isocaloric (1-6 MJ/Il, 380 kcal/l) and with the same nitrogen content (2-79 g/l) and were infused at rates and volumes determined by clinical staff on the basis on the infants, clinical condition and serum electrolyte biochemistry. There was an excess of deaths in the group treated with Vamin 9 glucose particularly related to babies weighing 31000 g. Infants <1000 g receiving the Vamin 9 glucose preparation required amino acids for twice as long. There was no significant difference between the weight losses or head circumference during the study period. Plasma aminograms in the group receiving Vamin 9 glucose showed concentrations of phenylalanine, tyrosine, proline, serine, and aspartic acid to be significantly higher than the reference range. Multiple regression analysis suggested that phenylalanine was the primary abnormality. The intravenous amino acid preparation MB233G maintained the plasma aminogram of newborn infants within the reference range of normal newborn infants.

FORM group and 0.756 in the combination group, with 58% and 56% of patients experiencing a clinically relevant change in overall AQLQ score, respectively. The difference between the groups in each analysis was not statistically significant. Conclusion FP/FORM has a similar effect on the quality of life of asthma patients as other combination treatments, with a similar improvement shown in each treatment group for both pools. Over 50% of patients in both treatment groups showed a clinically relevant change in AQLQ from baseline to end of study. -2013-204457.320 Rationale Given the known effectiveness of tiotropium in chronic obstructive pulmonary disease (COPD) and the significant benefit observed in COPD patients with concomitant features of asthma, it is relevant to investigate whether patients included in the recent large trials of tiotropium in asthma can be confidently considered to have asthma alone. Methods Baseline characteristics were analysed for patients enrolled in two replicate Phase III, randomised, double-blind, placebo-controlled, parallel-group studies of tiotropium in asthma patients symptomatic despite treatment with inhaled corticosteroids plus long-acting beta agonists (Kerstjens et al. NEJM 2012). The entry criteria were: age 18-75 years; asthma diagnosed before the age of 40 years; =5-year history of asthma; score of =1.5 in the Asthma Control Questionnaire (ACQ) 7; and life-long non-smokers or ex-smokers (<10 pack-years). Patients were also required to have persistent airflow limitation. Asthma diagnosis was confirmed in line with current Global Initiative for Asthma guidelines. Patients with a diagnosis of COPD or other lung disease were excluded from the studies. Results 912 patients were enrolled: 456 received add-on treatment with tiotropium and 456 received placebo. Mean age of the study population was 53.0 years; 37.6% of patients were aged =50 years. Mean age at diagnosis of asthma was 22.7 (range 0-44) years. Median duration of asthma was 28.0 (range 5-72) years, with 76.5% of patients having asthma for =20 years before enrolment. The majority of patients (75.9%) were life-long non-smokers; 24.1% were ex-smokers with a median number of pack-years of only 5.0. Mean ACQ score was 2.6 (range 1-5). Mean immunoglobulin E was 1210 mmol/L. The mean ( ± SD) bronchodilator response to salbutamol was 217 ± 217 mL. Conclusions The age of onset, duration of symptoms, lack of smoking, allergic status and bronchodilator response provide reasonable certainty that the patients enrolled in these studies had asthma and not COPD. Features compatible with COPD were thus more likely to reflect the effects of long-standing severe persistent asthma than the alternative diagnosis, and the efficacy demonstrated by tiotropium to represent improvement of asthma. Omalizumab has been shown to be an effective add-on therapy for patients with uncontrolled severe persistent allergic (IgE-mediated) asthma. There has been a steady accumulation of evidence on long-term effectiveness of omalizumab; however, data...

disease. A key problem for patients with severe asthma is impaired exercise capacity and often reported as a trigger for symptoms. In COPD it is recognised that reduced Physical Activity (PA) levels can be linked with poorer morbidity and increased exacerbations. In Severe Asthma (SA) there has to date been no formal evaluation of self reported PA levels in comparison to objective measurements and Quality of Life (QoL The 6MWT 19).Conclusion Patients appear to estimate PA levels accurately with the DASI, with higher scores of estimated METs correlating with increased 6MWT distance. QoL appears higher in those patients who achieve a greater distance in their 6MWT, especially in relation to their physical function. FEV 1 preservation also appears to correlate with improved 6MWT distances. Further investigation of PA in this popoulation is warranted.

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