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A European-based real-world study has found that allergen immunotherapy for allergic rhinitis not only has longer-term effectiveness than clinical trials have demonstrated but also may enable people with asthma to use fewer asthma medications and overall reduce their chances of developing pneumonia for up to 9 years on treatment.

Reporting online in The Lancet Regional Health – Europe, the study authors claim it is the largest and most comprehensive real-world effectiveness study of allergen immunotherapy for allergic rhinitis (AR) and asthma, and that it adds new information on how allergen immunotherapy works long term.

“This confirms what allergists already know,” said Jonathan A. Bernstein, MD, an allergist at the University of Cincinnati. “Real-world evidence is very important to validate studies that confirm pivotal trials.”

REACT — Real-world Effectiveness in Allergy Immunotherapy — is a retrospective cohort study of 92, asacol side effects neck pain 048 patients with AR with and without asthma split between two groups: those treated with allergen immunotherapy; and an untreated control group. The average patient age was 29.5 years. A preexisting asthma cohort included 29,228 patients; a no-asthma cohort included 54,274 patients. Patient data were extracted from a German health insurance fund database of 5.9 million claims and covered a 10-year period ending in 2017.

Lead author Benedikt Fritzsching, MD, a pediatric pulmonologist at Children’s Doctor Service and the University of Heidelberg in Germany, said the rationale for the study was to obtain long-term, real-world data of allergen immunotherapy, which had been lacking.

“Allergen immunotherapy is considered the only causal treatment for allergy, and on a mechanistic immunological basis, peripheral immune-tolerance is thought to be the major mechanism of allergen immunotherapy,” Fritzsching said. “However, data demonstrating long-term effectiveness, which you should expect from a causative treatment with the potential to cure allergy, was missing, especially form the real-world setting.”

The study findings don’t only complement the evidence from randomized control trials, he said, but they further support clinical decision-making on how to use allergen immunotherapy for the treatment and sustained control of both allergic rhinitis and asthma.

Overall, study patients were taking fewer anti-allergy prescriptions during the study period than before, but the patients on allergen immunotherapy had steeper reductions in years 2 through 9. By year 9, patients on allergen immunotherapy had a 62% reduction of total AR prescriptions vs 58% for controls.

Treated patients in the preexisting asthma cohort had similar reductions in asthma prescriptions, ranging from a 7% reduction in prescriptions for inhaled corticosteroids and long-acting beta-2 agonists at year 2 to a 19% reduction in year 7, while controls had a reduction ranging from 3% to 2% for the same time points. By year 9, the asthma patients on allergen immunotherapy still had a 9% reduction in asthma medications; controls had a 19% increase.

“Allergen immunotherapy was associated with reductions in both control and relieved asthma medication, suggesting improved asthma control,” Fritzsching said. “This has not been seen to this extent before.”

In the no-asthma cohort, the number of asthma prescriptions was low through the study period — but they tended to increase in patients not taking allergen immunotherapy while they remained stable for those who did, Fritzsching said.

“This is one example of how important these real-world data are,” he said. “As physicians, we would like to have similar data from a very large data set; this was almost 6 million patients in the database. And we would like to have longer duration; and this is 9 years. For many diseases we don’t have this kind of real-world evidence.”

Bernstein noted, “The advantages of this study are the large number of patients enrolled and the control cohort.”

ALK A/S funded the study. Fritzsching disclosed receiving fees from ALK during the study, along with relationships with Novartis and Merck Sharp & Dohme. Bernstein is a consultant, speaker and investigator for ALK and a consultant for Allergy Therapeutics.

Lancet Reg Health Eur. 2021; doi.org/10.1016/j.lanepe.2021.100275

Richard Mark Kirkner is a medical journalist in the Philadelphia area.

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