medwireNews: Researchers have analyzed a definition for clinical remission as a biologic treatment goal in patients with severe asthma and identified those patients most likely to achieve it.
Jane McDowell (Queen’s University, Belfast, Ireland) and colleagues comment in the European Respiratory Journal that given the success of biologics in reducing the need for oral corticosteroids (OCS) and transforming the management of severe asthma, “there is a need for a defined treatment goal that reflects disease quiescence or stability on treatment.”
They analyzed a primary definition for clinical remission, comprising the following criteria: an asthma control questionnaire (ACQ) score below 1.5 points; no use of OCS for disease control, including exacerbations in the previous 12 months or for disease control; and a forced expiratory volume in 1 second (FEV1) either above the lower limit of normal (LLN) or no more than 100 ml below the level at baseline prior to biologic therapy.
They applied this definition to a real-world sample of 830 patients from the UK Severe Asthma Registry, who were taking biologics, such as mepolizumab, omalizumab, and dupilumab, according to the UK National Institute for Health and Care Excellence (NICE) criteria. The participants were assessed before and at least once 9–24 months after starting treatment. The researchers note that before treatment these patients “were typical of a severe asthma patient population.”
One year after starting biologic therapy, there were significant improvements in exacerbations, FEV1, and symptom burden, but only a minority of patients achieved clinical remission, at 18.3%, the investigators report.
The patients who achieved clinical remission was more likely to be men than women (22.0 vs 15.7%), never smokers (74.7%), not obese (median BMI 27.9 kg/m2), and were more often in the high T2 biomarker category (blood eosinophil count ≥0.15/fractional exhaled nitric oxide ≥20) than the low T2 biomarker category (blood eosinophil count <0.15/fractional exhaled nitric oxide <20), at 74.8% versus 1.5%.
These patients also tended to be older at disease onset (median 32 vs 20 years old), had a shorter disease duration (median 20.0 vs 24.5 years), a lower ACQ score (median 2.0 vs 3.2 points), and fewer exacerbations (median 4 vs 5) when they initiated treatment than patients not achieving remission.
After adjusting for potential confounders, including hospital and time to first annual review, the chances of achieving clinical remission decreased by 14% with every increasing 10 years duration of asthma symptoms. Indeed, individuals who had asthma for at least 30 years were 48% less likely to achieve remission than their peers with a symptom duration of less than 10 years, McDowell and team report. The odds of clinical remission were also decreased by 39% among women, 51% among those with obesity, and 81% among individuals with an ACQ score of 1.5 points or above versus below.
By contrast, being older at the time of starting biologic treatment increased the chances of clinical remission by 31% with every increasing 10 years, as did being in the high versus the low T2 biomarker category, by 7.44-fold.
Together the findings suggest that “introduction of biologics earlier in the disease course, before comorbid disease associated with OCS exposure accumulates, may make asthma remission a more realistic target for future generations of severe asthma patients,” say McDowell and colleagues.
Receiver operating characteristic curve analysis including all these factors showed good predictability for clinical remission, with 81% accuracy.
“Recognition of these clinical and demographic characteristics at baseline will help clinicians identify patients who are more likely to achieve clinical remission, and importantly to inform patient discussion about what can realistically be achieved with biologic treatment,” the investigators comment.
They conclude that longitudinal data and further study are needed to “assess if clinical remission is maintained over time in severe asthma patients on biologics, and whether this improves clinical outcomes.”
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