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Article summary:

1. This study evaluated the effects of an anti-GM-CSF antibody (KB003) on forced expiratory volume in 1 second (FEV1), asthma control, and asthma exacerbations in adult asthmatics with inadequately controlled asthma.

2. The study found that FEV1 improved significantly in eosinophilic asthmatics and those with prebronchodilator FEV1 ≤50% predicted at baseline.

3. There were no effects on asthma control or exacerbation rates, and the most frequent adverse events were rhinosinusitis and headache.

Article analysis:

This article is a Phase 2, randomized placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. The study was conducted across 47 ambulatory asthma care centres globally, with 311 participants screened, 160 randomised and 129 completing the study. The primary outcome measure was change in FEV1 at week 24, while secondary outcome measures included asthma control, exacerbation rates and safety in all participants as well as prespecified subgroups.

The results of the study showed that FEV1 improved significantly in eosinophilic asthmatics and those with prebronchodilator FEV1 ≤50% predicted at baseline; however, there were no effects on asthma control or exacerbation rates. The most frequent adverse events reported were rhinosinusitis and headache.

The article is generally reliable; however, there are some potential biases that should be noted. Firstly, the sample size was relatively small for a Phase 2 trial – only 311 participants were screened out of which only 129 completed the study – which may have affected the accuracy of the results obtained from this trial. Secondly, GM-CSF levels were not measured in blood or sputum to clearly identify responders prospectively; this could have resulted in inaccurate results due to lack of data regarding GM-CSF levels among participants who responded positively to KB003 treatment. Finally, it should also be noted that this trial was not dose ranging; thus it is unclear whether higher doses would have yielded different results than those reported here.