RCT confirms efficacy of treatable traits approach in severe asthma


By Michael Woodhead

9 Dec 2019

An Australian clinical trial has confirmed the feasibility and efficacy of managing severe asthma  with a personalised ‘Treatable Traits’ approach.

In a study involving 140 patients with  severe asthma, clinicians at Newcastle University and John Hunter Hospital, NSW showed that a 16-week treatment program of multidimensional assessment was able to identify many treatable traits and use targeted treatments for these traits to deliver significant improvements in Health-Related Quality of Life (HRQoL), asthma control and asthma attacks.

In the assessment part of the program,  patients with severe asthma were found to have a mean of 10.44 traits per person, comprising an average of 3.01 pulmonary, 4.85 extrapulmonary and 2.58 risk-factor/behavioural traits.

A biomarker-driven inflammometry treatment-decision algorithm identified phenotypes such eosinophilic or neutrophilic inflammatory asthma, and directed treatments such as inhaled corticosteroid, prednisolone or azithromycin according to phenotype.

Patients were also given a treatment care plan based on the results of the multidimensional assessment, which  described the problems that patients and clinicians saw as a priority and detailed the individualised interventions needed to address them. Packaged interventions were monitored by a respiratory nurse case-manager who also gave add on therapies where needed.

When the program was tested in a prospective double blind fashion in 55 patients, those in the intervention group showed a significant improvement in the primary outcome of HRQoL during four months of follow up compared to those assigned to the control group of usual care for severe asthma (difference 0.86 units, p<0.001).

There were also significant and clinically important differences in secondary outcomes of asthma control (difference 0.73, p=0.01 compared to control) and GP visits for acute asthma attacks (incident rate ratio 0.14)

The study authors, led by Dr Vanessa McDonald from the Centre of Excellence in Severe Asthma, said this was the first reported randomised controlled trial of the treatable traits approach in asthma and it showed results consistent with a proof-of-concept controlled study of a similar intervention in COPD.

They said it was notable that the holistic personalised approach improved quality of life to a greater degree than that seen in recent studies of monoclonal antibodies and macrolide antibiotics, “suggesting that the multidimensional intervention which targets traits in each domain is multiplicative and treatment beyond pharmacotherapy is necessary.”

“Severe asthma has a major impact on health-status that results in long-term and devastating burdens. Therefore, improving health-status is an important goal from a patient perspective, that has not yet been achieved despite advances in pharmacotherapy,” they wrote.

Another key finding was the poor self-management traits in patients with severe asthma, they added.

“This suggests that the basic management strategies and goals are not adequately achieved as part of usual disease management. Sub-optimal self-management skills are associated with increased risk of attacks in severe asthma, and our intervention ensured the assessment of these traits and applied individualised treatments to improve them.

And the use of a case-manager was crucial to the delivery of the intervention, they said.

“This was a key difference from the usual-care severe asthma clinic, and suggests the importance of this role in the delivery of complex and multicomponent interventions.”

They acknowledged the findings from their small RCT should be replicated in larger studies. But if confirmed and implemented on a wider scale, the personalised interventions based on treatable traits could potentially reduce the iatrogenic consequences of toxic treatment and the cost of asthma attacks and  this save millions of dollars in care costs as well as improving outcomes for patients with severe asthma.

The findings are published in the European Respiratory Journal.

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