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Lebrikizumab does not improve any patient-oriented outcomes in asthma

Clinical Question:
Is lebrikizumab a safe and effective treatment for adults with poorly controlled asthma?

Bottom Line:
The monoclonal antibody lebrikizumab does not improve patient-oriented outcomes for adults with poorly controlled asthma. (LOE = 1b)

Reference:
Corren J, Lemanske RF, Hanania NA, et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011;365(12):1088-1098.  [PMID:21812663]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Industry

Allocation:
Concealed

Setting:
Outpatient (specialty)

Synopsis:
This study is a classic Dangerous DOE (disease-oriented evidence that is too preliminary to warrant a change in practice because it is focused on intermediate outcomes). The study prominently published in a big time medical journal, with a positively spun conclusion in the abstract, but the drug did not improve any patient-oriented outcomes. Lebrikizumab is a monoclonal antibody that binds and inhibits interleukin-13, which in turn reduces secretion of periostin, which is thought to contribute to airway remodeling. Adults (N = 219) with asthma not well controlled by a glucocorticoid were included in the study. Alll patients had a score of at least 1.5 points on an Asthma Control Questionnaire that ranged from 0 to 6 points. The patients were randomized to receive lebrikizumab 250 mg subcutaneously once per month or matching placebo for 6 months. Groups were balanced at the start of the study, and analysis was by intention to treat. Their average age was 44 years, two thirds were women, and 85% were white. Most patients were using a long-acting beta-agonist (81%) and approximately 25% used a leukotriene modifier. Although there were improvements in FEV1 for patients with high levels of periostin, there was no difference in the likelihood of asthma exacerbation, severe exacerbation, use of rescue medications, or symptoms scores. In other words, there was no improvement in any of the things that really matter. Adverse events were similar between groups. Cost was not addressed, although monocolonal antibodies are generally very expensive.

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