SMART Therapy - Asthma

Be SMART with Asthma

Have you heard of SMART Therapy?

SMART Therapy stands for Single Maintenance and Reliever Therapy and currently recommended for patients four years of age and older with moderate to severe asthma. The treatment involves the use of one inhaler that includes an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), specifically formoterol, for both maintenance and reliever therapy.

Medications
ICS-LABA (formoterol) Combinations on the Market	Notes
Symbicort®™ (budesonide/formoterol)	Preferred for SMART Therapy; extensively studied
Dulera®™ (mometasone/formoterol)	Not currently studied

According to the Asthma Management Guidelines updated in 2020 by the National Heart, Lung, and Blood Institute (NHLBI), patients on daily ICS-LABA treatment, plus uncontrolled short-acting beta agonist (SABA), as needed, may also benefit from SMART therapy. Evidence supports switching to SMART Therapy at the same or lower maintenance ICS-LABA dose before considering a step up in maintenance treatment. If patients are well-controlled on the ICS-LABA plus SABA treatment, SMART Therapy may offer less added benefit; thus, the regimen should be maintained. Additionally, the Global Initiative for Asthma (GINA) guidelines were updated in December 2022 to include the use of SMART Therapy in moderate to severe asthma management.

Trial Data
Clinical Trial	Drugs Studied	Test Population	Results	Key Takeaways
SYGMA (Symbicort Given As Needed in Mild Asthma)	SYGMA 1 BID placebo plus prn terbutaline 0.4mg (delivered dose) OR BID placebo plus prn budesonide/formoterol 160mcg/4.5mcg (delivered dose) OR BID budesonide 200mcg plus prn terbutaline 0.4mg (delivered dose) SYGMA 2 BID placebo plus prn budesonide/formoterol 160mcg/4.5mcg (delivered dose) OR BID budesonide 200mg	Adult patients with mild asthma and patients with moderate to severe asthma	* prn budesonide/formoterol was associated with significantly lower severe exacerbation rate (26% reduction) compared to budesonide maintenance in patients previously receiving only prn SABA in both SYGMA 1 and 2 * SYGMA 1- prn budesonide/formoterol was associated with a large 66% reduction in severe exacerbation rate and an increase in time to first severe exacerbation vs prn SABA	Adults may be better protected by switching to prn ICS/formoterol vs prn SABA
Novel START (Novel Symbicort Turbuhaler Asthma Reliever Therapy)	albuterol 100mcg two puffs prn OR budesonide 200mcg BID plus prn albuterol OR budesonide/formoterol 160mg/4.5mcg one puff prn (delivered dose)	Adult patients with mild asthma	* budesonide/formoterol prn was superior to albuterol prn for prevention of asthma exacerbations with a 60% reduction in severe exacerbations	ICS/formoterol was superior to albuterol when used as needed for asthma exacerbations
MANDALA	albuterol 180mcg/budesonide 160mcg OR albuterol 180mcg/budesonide 80mcg OR albuterol 180mcg alone

Based on the current evidence and continued studies, the decrease in medication burden and reduction in medication costs for patients with asthma are clinically significant, utilizing SMART Therapy.

Important Points for All Clinicians:

Traditional asthma management uses different medications for maintenance and reliever therapy, whereas, SMART Therapy uses the same medication for BOTH!
SMART Therapy may reduce the risk of confusion on which inhaler to use for maintenance or reliever for patients, especially children.
SMART Therapy is part of the National Asthma Education and Prevention Program (NAEPP) and is detailed in the 2020 NHLBI and 2022 GINA guidelines.
SMART Therapy is not currently FDA approved for mild asthma.
In relation to the Asthma Medication Ratio (AMR) HEDIS measure, low dose ICS/LABA (formoterol) combinations are considered ‘Asthma Controller Medications’ and, when filled, lead to a higher percentage of ‘Asthma Controller Medications’ over ‘Total Asthma Medications’. This results in a higher AMR compliance rate; thus, the use of only one inhaler for those with moderate to severe asthma may enhance patient compliance while potentially decreasing exacerbations and lowering costs simultaneously.

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