Special SeriesThe Asthma Controller Step-down Yardstick
Introduction
Guidelines for asthma recommend a series of treatment steps (Fig 1) as a framework for disease management.1, 2 The steps allow individualized adjustments in controller therapy in an upward or downward manner in response to a patient's level of asthma control over time. For patients with inadequately controlled asthma, a step-up is recommended.1, 2 Strategies for stepping up controller therapy are described in detail in the adult and pediatric Asthma Yardsticks.3, 4 For patients whose asthma has been well controlled for at least 3 months (or longer for the highest risk patients), controller treatment may be stepped down. Comprehensive reviews are available that discuss the challenges of reducing therapy and potential strategies for a step-down.5, 6, 7 However, supporting data are limited; and neither how to identify patients appropriate for step-down nor the operational aspects of stepping down therapy are clearly defined.8 This Yardstick presents recommendations for stepping down asthma controller therapy according to guideline-defined control levels (Fig 1), based on the available data and the authors' clinical experience.
Stepping down controller therapy serves to1:
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Identify the minimum effective treatment that will maintain well-controlled asthma based on both impairment and risk domains
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Minimize the risk of adverse effects from higher doses of medication(s) than may be needed to maintain control
Additionally, stepping down therapy can simplify the patient's treatment regimen and may enhance adherence, because reducing exposure to higher doses of medication(s) is generally consistent with patient values and preferences.9, 10 A step-down also has the potential to reduce treatment costs.1, 11 Tapering treatment also may be used to re-assess a current diagnosis of asthma.12, 13 Considerations for stepping down asthma therapy and reasons for not stepping down therapy are shown in Table 1.
When and how to implement a step-down in therapy is not always clear, and the timing and process may vary between patients. Factors to consider before attempting to step down controller therapy include: 1) the patient's current and previous levels of asthma control, especially the frequency and severity of previous asthma exacerbations; 2) the patient's current and previous patterns of asthma control (eg, seasonal variation); 3) the time lapsed since the patient's last asthma exacerbation; 4) factors contributing to symptom instability; and 5) potential barriers to success (Table 2).8
Asthma control is defined according to the frequency and intensity of symptoms, functional limitations, and potential negative effects of treatment (eTable 1).1, 2, 3, 4 Current guidance suggests that a reduction in controller therapy may be considered when disease control has been maintained for several months (eg, 3-6 months), depending on the patient's initial level of severity.1 For patients with more severe asthma, a longer period of symptom stability may be needed.14, 15
Any 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. 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.1, 8 Validated tools for assessing control and treatment response are available (eTable 2), and they can be used to determine when to consider a step-down in therapy and to monitor the result of treatment reduction. Monitoring is critical. Before stepping down treatment, the patient should be provided with a written asthma action plan that describes the step-down protocol, how to self-monitor asthma control, instructions for what to do if symptoms worsen, and when to call the doctor.1
Factors that could negatively impact step-down therapy (Table 2) also should be evaluated before proceeding. These can increase the risk of symptom instability, and patients may require extra care if treatment is tapered. A careful medical history is critical. The impact of poor adherence with therapy, poor device technique, lack of understanding of asthma and its treatment, perceptions of step-care, and lack of access to care is more difficult to decipher, but they are all elements that can impede a successful step-down.6 Finally, treatment reduction should not occur during times of potential symptom lability for the patient, such as during pregnancy, illness, peak virus or allergen seasons, or a period of travel or high stress (eg, related to work or family concerns).
Once a step-down is determined to be appropriate, the approach should be individualized according to the patient's current treatment, risk factors, values, and preferences. Step-down strategies by guideline level of severity are described in the following pages. The supporting evidence is limited in terms of both medication choices and the operational aspects of stepping down. Considerations for children are included in each section as appropriate. Development of this Yardstick is described in the Supplementary Materials (eMethods).
Section snippets
Stepping Down from Step 2 Therapy
Stepping down from step 2 therapy is one of the most common step-down events for asthma patients because the step-down is often initiated by the patient through lapses in adherence, intentional or non-intentional, when symptoms are perceived to be controlled. A step-down at this level also may be used as a check on the diagnosis of asthma. Asthma is a dynamic condition, and remission is possible. Overdiagnosis and misdiagnosis also have been documented, likely related to a failure to confirm
Stepping Down from Step 3 Therapy
Step 3 patients will be using 1 of 3 types of controller regimens: low-dose ICS/LABA, medium-dose ICS, or low-dose ICS + another medication (eg, LM).1, 3, 4 Patients with aspirin-exacerbated respiratory disease may be using zileuton.30 A low-dose ICS/LABA strategy is preferred for most adult and adolescent patients, because patients can be maintained at lower doses of ICS compared with the other options.1, 3, 4 For school-age children (6-11 years old), the guideline-recommended option is
Summary and Recommendations
The data are limited for how to step-down therapy for a patient whose condition is well controlled at the step 3 level. Minimizing the dose of ICS to reduce the potential for adverse effects is a priority, and the authors recommend the strategy that permits control at the lowest dose of ICS for the patient. A combination of approaches may be needed to step-down the patient to the least amount of medication that controls symptoms, maintains lung function, and minimizes risk, and the process of
Stepping Down from Step 4 Therapy
A step-down from step 4 therapy (Fig 1) may be considered for the patient who has achieved and maintained control as previously described (eTable 1) with appropriate maintenance treatment.3, 4 When considering a step-down in therapy, the patient should be assessed for the duration of asthma control, including exacerbations in the previous year and other factors that might limit success (Table 2), such as adherence to the treatment plan, adequacy of inhalation technique, and previous allergic
Stepping Down from Step 5 Therapy
Stepping down therapy for patients being treated at the step 5 level should be approached with greater caution. These patients are at the most severe level of asthma and likely have experienced poor asthma control in the past.3, 4, 77, 78, 79, 80, 81, 82 They may have failed initial treatments with ICS alone and even subsequent treatments with additional controller medications such as LABA, LAMA, and LM. Duration of control is a critical factor for these patients; many do not experience
Summary and Recommendations
Patients being treated with step 5 therapy are at the most severe level of asthma and likely have experienced poor asthma control in the past.3, 4, 77, 78, 79, 80, 81, 82 Any step-down should be approached with greater caution. Almost all of these patients use OCS, frequently to treat exacerbations and some on a chronic basis (C-OCS) as maintenance therapy.3, 4, 82, 83, 84, 85 Recent epidemiologic studies convincingly document the increase in disease burden and costs associated with C-OCS use.
A
Discussion
Stepping down asthma therapy is an important component of managing patients with asthma, from the mildest end of the severity spectrum to the most difficult-to-treat patient. However, although current guidelines recommend stepping down therapy in a patient with stable asthma, the operational focus has been on how to step up treatment when asthma is inadequately controlled.1, 2 This Yardstick provides recommendations for how to step-down therapy using guideline-based severity levels.
Several
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Disclosures: Dr. Chipps serves as a consultant and a member of speakers' bureaus for AstraZeneca, Boehringer Ingelheim, Genentech/Novartis, and Merck. Dr. Bacharier has received consulting and/or lecture fees from Aerocrine, AstraZeneca, Cephalon, GlaxoSmithKline, Genentech/Novartis, TEVA, Merck, and Boehringer Ingelheim; serves on advisory boards for Merck, Sanofi, Vectura Group and Circasia; serves on a data and safety monitoring board for DBV Technologies; and reports honoraria for CME program development from WebMD/Medscape. Dr. Murphy has received consultancy and speaker fees and has participated in advisory boards for AstraZeneca, Boehringer Ingelheim, Genentech, Greer, Merck, Mylan, Novartis, and Teva. Dr. Lang serves as a consultant for GlaxoSmithKline, AstraZeneca, and Merck; and serves as a consultant, performs research, and receives honoraria from Genentech and Novartis. Dr. Farrar has no financial interests to disclose. Dr Rank has no financial interests to disclose. Dr. Oppenheimer is a consultant or advisor to AstraZeneca, GlaxoSmithKline, Mylan, Novartis, and Teva; received royalties from UpToDate, and received research funding from AstraZeneca, MedImmune, Novartis, and Sanofi. Dr. Zeiger is a consultant for Genentech/ Novartis, TEVA, AstraZeneca, Patara, and Regeneron.
Funding Sources: The American College of Allergy, Asthma and Immunology was the sponsor for this article, which included editorial support and an honorarium for each of the authors.