What is the recommended step therapy approach for managing asthma?

From the Guidelines

The recommended step therapy approach for asthma management involves progressively adjusting medication based on symptom control, starting with as-needed short-acting beta-agonists (SABAs) like albuterol for mild, intermittent symptoms, and stepping up to low-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs) as needed, with the goal of achieving well-controlled asthma while minimizing medication exposure and preventing exacerbations. This approach is supported by the most recent and highest quality study, which emphasizes the importance of personalized treatment and regular assessment of asthma control 1.

Key Components of Step Therapy

• Treatment typically begins with as-needed SABAs like albuterol for mild, intermittent symptoms
• If symptoms persist, low-dose ICS such as fluticasone or budesonide are added as daily controller therapy
• For patients with moderate persistent asthma, the next step combines low-dose ICS with a LABA like salmeterol or formoterol
• If control remains inadequate, the ICS dose is increased to medium or high, still combined with a LABA
• For severe asthma, additional options include tiotropium, leukotriene modifiers like montelukast, or biologics such as omalizumab for allergic asthma or mepolizumab for eosinophilic asthma

Importance of Regular Assessment and Patient Education

• Regular assessment of asthma control is crucial to determine the effectiveness of treatment and make adjustments as needed 1
• Patient education on proper inhaler technique and the importance of adherence to treatment is essential for achieving well-controlled asthma 1
• Patients should maintain rescue inhalers for breakthrough symptoms and have an asthma action plan in place to guide treatment decisions

Considerations for Stepping Up or Down

• Before stepping up therapy, review adherence to medication, inhaler technique, environmental control, and comorbid conditions 1
• Consider alternative treatment options if an alternative was used in a previous step
• Step down therapy if symptoms are well-controlled for at least three months, to minimize medication exposure while maintaining optimal lung function and preventing exacerbations 1

From the FDA Drug Label

These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack. Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Wixela Inhub® Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with Wixela Inhub®

The recommended step therapy approach for managing asthma is to start with a low dose and gradually increase as needed, while monitoring the patient's condition.

• Initial Treatment: Start with a low dose of Wixela Inhub, such as 100/50, and adjust as needed based on the patient's response.
• Dose Titration: Gradually increase the dose by 2.5 mg of prednisone on a weekly basis, while monitoring the patient's lung function, beta-agonist use, and asthma symptoms.
• Monitoring: Carefully monitor patients for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea, and vomiting, and hypotension during withdrawal from oral corticosteroids.
• Caution: Use with caution in patients with cardiovascular or central nervous system disorders because of beta-adrenergic stimulation 2.

From the Research

Step Therapy Approach for Asthma

The recommended step therapy approach for managing asthma involves a stepwise approach for controlling symptoms and preventing exacerbations.

• The initial step for patients with intermittent asthma is the use of as-needed short-acting β2-agonists (SABAs) for rescue therapy 3.
• For patients with mild persistent asthma, either daily low-dose inhaled corticosteroids (ICS) plus as-needed SABA therapy or as-needed concomitant ICS and SABA therapy are recommended 3.
• In patients with moderate persistent asthma, formoterol in combination with an ICS in a single inhaler (single maintenance and reliever therapy) is recommended as the preferred therapy 3.
• For patients whose asthma is not controlled by ICS-formoterol therapy, add-on long-acting muscarinic antagonists are recommended 3.

Combination Therapy

Combination therapy with inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA) is a recognized treatment for adults with moderate to severe asthma 4, 5.

• The introduction of inhalers containing both an ICS and a LABA simplifies treatment and improves asthma control 4.
• Studies have shown that the combination of ICS and LABA provides greater improvements in pulmonary function and overall control of asthma compared to ICS plus leukotriene receptor antagonists (LTRAs) 5.
• Specific combinations, such as salmeterol/fluticasone propionate and budesonide/formoterol, have been shown to be effective and well-tolerated in asthma treatment 4, 5, 6.

Real-World Evidence

Real-world studies have demonstrated the effectiveness of combination therapies in improving asthma control and reducing exacerbations.

• A retrospective matched cohort study found that treatment with fluticasone furoate/vilanterol (FF/VI) resulted in lower use of short-acting β2-agonist (SABA) canisters and fewer asthma-related exacerbations compared to budesonide/formoterol (B/F) 7.
• The study also found that FF/VI use resulted in a significantly lower risk of overall and severe asthma exacerbations compared to B/F use 7.