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Guideline Outlines Step-down Therapy for Asthma

A new guideline from the American College of Allergy, Asthma, and Immunology provides evidence-based recommendations for stepping down asthma medications for patients who have achieved sustained asthma control.

Stepping down asthma controller therapy allows clinicians to identify the minimum effective treatment needed to maintain wellness while reducing the burden of treatment with respect to adverse events, costs, and adherence, Bradley E. Chipps, MD, medical director of Capital Allergy and Respiratory Disease Center, in Sacramento, California, and colleagues report in the Annals of Allergy, Asthma and Immunology.

Although current practice guidelines suggest that asthma medication should be reduced once asthma symptoms have been controlled for at least 3 months, depending on the patient’s risk profile and initial level of asthma severity, none have previously provided specific, evidence-based recommendations for when and how to do it, Chipps said in an interview with Medscape Medical News.

“Our goal through this document is to provide evidence-based guidelines on how to do it safely and properly to improve outcomes,” he said. “In reality, many asthma patients are stepping down on their own, through nonadherence. At least if we arm physicians with this information, they can advise patients from the outset.”

The Asthma Controller Step-down Yardstick “is the final installment in our yardstick trifecta,” Chipps explained, referring to two previously published guidelines for stepping up controller therapy in adults and children with asthma.

According to the step-down guideline, clinicians should consider the following factors before implementing a step-down plan:

  • The patient’s current and previous levels of asthma control, including the frequency and severity of previous asthma exacerbations

  • The patient’s current and previous patterns of asthma control, such as seasonal variation

  • Time since the patient’s last asthma exacerbation

  • Factors contributing to symptom instability

  • Potential barriers to success, such as a history of poor treatment adherence, lack of access to care, or lack of understanding

For patients deemed appropriate candidates, “[a]ny step-down of asthma treatment should be considered as a therapeutic trial, with the outcome evaluated according to symptom control, lung function, and exacerbation frequency,” the authors write. “Exacerbations are a particularly significant measure and may increase if treatment is stepped down too quickly or too far, even if symptoms appear to be reasonably controlled.”

For this reason, the authors stress that stepping down “should be considered a process and not simply a jump from guideline-recommended treatment at one severity level to that at the next lower severity level. Multiple steps may be necessary to optimally step down from one severity level to the next. A partial step-down may be appropriate.”

Although the guidance document provides specific recommendations regarding appropriate medications and dosing for patients on step 2 through step 5 asthma therapy, there is no one-size-fits-all step-down strategy, the authors write. Instead, the approach for each patient “should be individualized according to the patient’s current treatment, risk factors, values, and preferences.”

Stepping Down From Step 2 Treatment

The most common asthma step-down “event” — the move from step 2 therapy (typically, a low-dose inhaled corticosteroid [ICS]) — is often initiated by the patient through lack of treatment adherence when symptoms seem to have abated, the authors explain.

Clinicians may suggest a step down from this treatment level to confirm an asthma diagnosis, in which case the recommended approach is to gradually taper medication over a series of visits during which the patient’s symptoms should be monitored and lung function tested, the authors explain.

For patients with confirmed asthma, the authors recommend the following step-down approaches:

  • Once-daily low-dose ICS monotherapy or once-daily low-dose ICS/long-acting beta-antagonist (LABA) for patients who are likely to adhere to daily ICS treatment

  • Anti-inflammatory/reliever therapy with a combination ICS and a fast-acting short-acting beta antagonist (SABA) or the LABA formoterol for patients who prefer an alternative to daily treatment or who may not adhere to daily treatment

  • A daily leukotriene modifier plus an as-needed SABA reliever for patients who prefer an oral medication or who have difficulty using an inhaler

The use of as-needed SABA alone for patients with mild, persistent asthma is not recommended, the authors state.

Stepping Down From Step 3 Treatment

Although limited evidence is available to guide the move from step 3 to step 2 therapy in patients whose asthma is well controlled at step 3, the goal should be to identify a strategy that achieves control at the lowest ICS dose, the authors write. “For most patients at this level, stepping down to a low-dose ICS/LABA may permit lower ICS exposure while maintaining asthma control,” the authors write. “This is true even for patients previously maintained on ICS monotherapy.”

For patients using an ICS/LABA combination, the authors recommend the following options:

  • Decreasing the ICS dose by changing the number of puffs or the frequency of dosing

  • Switching to a combination product with a lower ICS dose

  • Discontinuing the LABA while maintaining (and potentially tapering over time) the ICS dose

Recommendations for step 3 patients who are using only an ICS include the following:

  • Decreasing the dose of ICS

  • Stepping down to a low-dose ICS/LABA

  • Using low-dose budesonide/formoterol (Symbicort, AstraZeneca) as maintenance and reliever medication, although this approach is not approved by the US Food and Drug Adminstration

  • Immunotherapy for patients with allergic asthma to further reduce ICS dose

Stepping Down From Step 4 Treatment

Patients whose asthma is well controlled with step 4 therapy — typically, moderate to high doses of ICS, often in combination with another medication — are often not able to move down to step 3, given their struggle with moderate to severe disease. Continuous monitoring of their asthma status during step-down trials is critical, the authors write, “as is having a clear action plan for when to step up treatment and how to do that.”

For step 4 patients, the authors recommend the following step-down strategies:

  • Consider step down only after a careful review of the patient’s history confirms a minimum of 6 months of asthma control and no exacerbations during the previous year.

  • For patients using ICS/LABA, reduce the dose of ICS while maintaining LABA (and, if necessary, switching between products to allow smaller steps in the titration process).

  • For patients using tiotropium (Spiriva, Boehringer Ingelheim) with ICS, lower the dose of ICS while maintaining and possibly eventually discontinuing tiotropium if control is maintained.

  • For patients using tiotropium plus ICS/LABA, discontinue tiotropium while maintaining the ICS/LABA; wait at least 3 months between titration steps to ensure control is established.

Stepping Down From Step 5 Treatment

Stepping down therapy for patients with the most severe level of asthma who are being treated at the step 5 level “should be approached with greater caution,” the authors write. They note that these patients have likely experienced poor asthma control previously.

“Before consideration of stepping down therapy, the patient should be assessed for adequate asthma control, adherence to appropriate step 5 treatments, adequacy of techniques with various inhaler devices, and previous allergic and seasonal trigger patterns,” they write.

Patients being treated at the step 5 level typically use high-dose ICS/LABA plus other controller medications, as well as oral corticosteroids (OCS) to treat exacerbations or as maintenance therapy. For these patients, the step-down approach, when deemed appropriate on the basis of asthma control and after consideration of risk, usually begins by tapering OCS, the authors note. They stress, however, that reducing OCS doses “should be approached with caution, both to minimize the potential risk of asthma recurrence and to limit the risk of uncovering adrenal suppression.” In addition, available guidelines do not provide a recommendation for OCS tapering, and there is no consensus on tapering algorithms.

It is recommended that the following strategies be considered when initiating a step down from step 5 treatment:

  • Objectively evaluating OCS and controller therapy use to determine adherence

  • Objectively evaluating responsiveness to a minimum 3-month trial of high-dose ICS/LABA under direct supervision

  • Initiating trial treatment with an appropriate biologic agent for a minimum of 4 to 6 months, using validated tools to assess asthma control and attempting to taper OCS over 2 to 4 months

For patients receiving biologic therapy, documented evidence of improvement should include maintenance of asthma control, exacerbation reductions, and decreased OCS dose.

Regarding the duration of biologic treatment when control has been documented, the authors note that there are not enough data to recommend a taper or discontinuation schedule.

For patients at all treatment levels, “[t]he likelihood of a successful step-down is encouraged by a longer period of stability (at least 6 months) and ensuring that the patient understands and agrees to the step-down process, along with careful monitoring and use of an action plan for the patient once step-down has been initiated,” the authors write.

Because the available data supporting specific recommendations are limited, some of the recommendations “may merit revision,” depending upon evidence from ongoing and future studies, the authors write.

One or more of the guideline authors report multiple types of financial relationships with pharmaceutical and biomedical companies. A full list of disclosures is available on the journal’s website.

Ann Allergy Asthma Immunol. Published online December 11, 2018. Abstract

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