Allergy immunotherapy (AIT) has evolved significantly over the last decade, triggered by the need for more evidence-based medicine. ALK has worked with the allergy community to develop the field’s most robust clinical programme, enrolling over 22,000 patients, enabling prescribing decisions to move from experience-based to evidence-based. ALK is now complementing its pivotal studies with the REWEAL programme, bringing robust, real world evidence to the field of AIT. We like to think of it as – the Best In Both Worlds.

The first major study to report within the REWEAL programme is the REACT (REAl world effeCtiveness of allergy immunoTherapy) study. Following the highest scientific standards, and using real world data from clinical practice just like yours, the effectiveness of AIT was assessed in more than 92,000 patients for up to 9 years. ALK believes that bridging from randomised clinical trials (RCTs) with high internal validity, to real world studies with high external validity, can help better inform your clinical decision making.

Our aim of REACT was to provide valuable insights into some of the most important, but as yet unanswered, questions:

• Are RCT results generalisable to broader patient populations treated in everyday clinical practice?
• AIT is a causal treatment, but are the effects sustained in the long term? i.e., beyond the follow-up period for RCTs.
• Can AIT lead to long-term, improved asthma control and the prevention of asthma exacerbations?
• Is there supportive evidence for new hypotheses around the benefits of AIT for patients? e.g., A reduced risk of respiratory tract infections, or a reduced risk of hospitalisations.

….Read on to learn about the results of the REACT study.

Key result 1: Sustain to maintain

A key feature of allergy immunotherapy (AIT) is the potential to treat the underlying cause of allergy, changing the course of the disease, and providing long-term and sustained effects. Being able to experience improvements in their respiratory allergy within weeks, while taking AIT, combined with being able to achieve long-term sustained effects even after treatment completion, may be a key motivation for maintaining treatment – and a vital part of the physician/patient dialogue.

In the REACT study, the real world effectiveness of AIT was confirmed across 9 years of follow up by greater reductions in prescriptions for allergic rhinitis (AR) symptom symptom-relieving medications in patients treated with AIT, versus AR patients not treated with AIT. These included reductions in both antihistamine and intranasal corticosteroid (INCS) prescriptions, which are some of the most common AR prescription medications.

To help your patients understand the potential benefits of AIT, the REACT study provides further confidence that AIT is associated with reductions in AR as well as asthma medication for up to 9 years after treatment initiation.

“Sustain to maintain” if you want the long-term benefits of AIT.

Key result 2: Step down, take control and don’t move!

As a physician, you know that allergic rhinitis patients often have concomitant asthma associated with their respiratory allergy.

In the REACT study, subjects with AR and pre-existing asthma treated with allergy immunotherapy (AIT) reduced both controller and reliever medication, providing confirmation of real world improvements in asthma control for AIT treated patients. The greater reduction in asthma medication among AIT treated patients, were driven mainly by short-acting beta agonist (SABA) and inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) prescriptions. In addition, AIT was associated with a greater likelihood of stepping down patients’ asthma treatment regimen. This could mean that a patient, for example, was able to step down from a dual therapy with ICS and LABA to a monotherapy of ICS only. Not only were the AIT treated patients with pre-existing asthma more likely to step down in their asthma treatment, they also had a reduced likelihood of stepping up.

The addition of the REACT study to the clinical trial body of evidence points to the very real possibility of providing your AR and asthma patients with the opportunity to step down their asthma medication.

Allowing patients to step down on asthma medication, take control of their disease and don’t move back up again.

Key Result 3: Less is more… much more

You know that your patients living with allergic rhinitis (AR) and asthma not only run the very real risk of lower airway infections, such as pneumonia and related antibiotics use, but their condition also increases the likelihood of severe asthma exacerbations. Combined, these consequently can impact quality of life for both patients and their families.

The REACT study was designed to look at outcomes for both asthma exacerbations as well as pneumonia.

It showed that, over 9 years, allergy immunotherapy (AIT) was associated with a reduced likelihood of experiencing a severe asthma exacerbation, suggesting a long-term and sustained preventative effect of AIT on asthma exacerbations. Also, the number of asthma exacerbations per patient was consistently reduced over 9 years, whereas reductions for patients not receiving AIT remained at the same level over time.

Additionally, over the 9 years, patients treated with AIT were consistently less likely to be diagnosed with pneumonia. AIT was also associated with a reduced likelihood of antibiotic prescriptions related to pneumonia, suggesting a protective effect on the lower airways.

Avoiding these events can improve outcomes for your patients, meaning fewer severe exacerbation events and MORE of their own life, back to them and their families.

Key Result 4: Fewer, shorter, lower

Patients suffering from allergic rhinitis (AR) often have related comorbidities. Asthma is one of the most prevalent of these, but eczema, conjunctivitis, and even depression, are also common comorbidities.

The complex comorbidity pattern increases the risk of inpatient hospitalisation, lowering quality of life for patients and becoming a significant cost driver for the health care system.

Across 9 years of follow-up, the REACT study showed that allergy immunotherapy (AIT) is associated with a lower risk of inpatient hospitalisation for patients with pre-existing asthma, but also for all patients with AR who had been treated with AIT. Not only did AIT-treated patients require fewer inpatient stays, but when they did go into the hospital, they had shorter stays, resulting in lower costs for inpatient hospitalisation over the 9 years of follow up.

These results are important complementary evidence, showing potential additional benefits for patients and the health care system – fewer hospitalisations, shorter stays, and lower costs.

Key Result 5: Reacting to the REACT study

So, what can we conclude from REWEAL’s landmark study, REACT?

With its rigorous methodology and long follow-up period, the REACT study further complement existing evidence from randomised clinical trials (RCTs) and added new information about the effects of allergy immunotherapy (AIT) beyond the follow-up period for RCTs. The unique feature of AIT being a causal treatment, with the potential to change the underlying allergic disease, was supported and confirmed throughout the 9 years of follow-up.

The REACT study set out to show the effects of AIT in a large and broad patient population, just like the patients you meet in your everyday practice. The results from REACT showed that not only were the effects of AIT sustained for up to 9 years of follow-up, the results also consistently favoured AIT across many clinically relevant outcomes, and were robust in a broad and diverse group of patients – patients who received AIT for their respiratory allergy as part of normal clinical practice. The findings complement what has been seen in RCTs previously, confirming that AIT is an effective treatment across patients with respiratory allergies also in the real world. It’s time to REACT in AIT.

REWEAL. Real patients. Real questions. Answered.