Researchers in Japan Propose Criteria for Discontinuing Biologics in Patients with Severe Asthma

Researchers in Japan recently published a proposed algorithm for the discontinuation of biologics in the treatment of severe asthma that has become controlled.

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“Evidence from studies of the discontinuation of biologics suggests that discontinuation of biologics is a feasible option in a subset of patients with severe asthma who attained a well-controlled condition such as super-responders,” wrote authors in the Journal of Asthma and Allergy. “We hope that our proposed criteria support physicians’ decisions about their patients stopping or continuing biologics in cases of severe asthma. Our proposed discontinuation criteria require validation and refining through further studies.”

The proposed criteria for discontinuing biologics in patients with severe asthma consisted of the following:

• No asthma symptoms (asthma control questionnaire [ACQ] score <1.5 or asthma control test [ACT] score >19),
• No asthma exacerbations,
• No use of oral corticosteroids,
• Normalized spirometry (forced exhaled volume in 1 second [FEV1] ≥80%),
• Suppressed type 2 (T2) inflammation (blood eosinophil counts <300 μL and fractional exhaled nitric oxide [FeNO] <50 ppb), and
• Controlled asthma comorbidities.

To develop the proposed algorithm, researchers from Yamaguchi University reviewed 6 studies on the discontinuation of biologics in severe asthma that have been published to date. Of these, 2 studies were related to the anti-IgE biologic omalizumab, 3 to the anti-interleukin 5 biologic mepolizumab, and 1 study that assessed multiple biologics (omalizumab, mepolizumab, benralizumab, reslizumab, and dupilumab).

Findings from these studies verified that discontinuing biologics was feasible in suitable patients, and that successful discontinuation of biologics was associated with fewer asthma symptoms, the suppression of T2 inflammation (lower blood eosinophil count and/or FeNO level), and control of asthma comorbidities, according to the study.

In addition, the authors examined the effects of discontinuing benralizumab on 2 patients at their own hospital who had severe eosinophilic asthma that was well-controlled, noting that the presence of comorbidities appeared to make discontinuation unfeasible for 1 of the patients.

Researchers also incorporated findings from real-world observational studies of “super-responders,” whom they characterized as “patients who show a great response to biologics or complete asthma control.”

“If super-responders meet all of the criteria, they are allowed to discontinue biological therapies,” concluded researchers.

In determining their algorithm, the researchers followed a 2-step process. First, they considered a disease-activity measurement comprising various facets such as symptoms, number of exacerbations, lung function, and airway inflammation. Second, they considered optimal cut-off points for the discontinuation of biologics using disease activity and other robust tools of assessment.

“It is important to cautiously determine an optimal cut-off point for the discontinuation of biologics using comprehensive assessment tools of disease activity,” stated investigators. “If the criteria are loose, the discontinuation of biologics may worsen asthma control in patients with insufficient asthma control and residual airway inflammation.”