PARIS — The EfficAPSI study showed with real-world data that sublingual immunotherapy (SLIT), or “desensitization,” reduces the risks for asthma onset and the worsening of asthma symptoms for patients with allergic rhinitis. The research was presented at the 18th French-language allergy conference in Paris.
These results confirm that allergen immunotherapy (AIT), or “desensitization,” is indeed an etiologic treatment of this allergic condition.
SLIT encompasses personalized solutions created for an individual specifically for allergies to dust mites, grass, birch, cats, and so on. These preparations are commonly used by allergy specialists when establishing an AIT treatment plan.
In 2017, the French Health Authority (HAS) published a report indicating that there was insufficient clinical proof regarding the efficacy of SLIT. It subsequently removed injectable forms of these allergen extracts from the list of drugs reimbursed by the state and reduced state reimbursement of sublingual SLIT preparations from 30% to 15%, a step it confirmed in March 2018 and that led to outrage from allergy specialists. The chair of the French allergy society at the time, Jocelyne Just, MD, PhD, argued that conducting double-blind, placebo-controlled studies for all types (grass pollen, birch pollen, dust mites, asthma, allergic rhinitis, subcutaneous injections, sublingual treatments, tablets, liquid preparations) would take decades. Furthermore, meta-analyses on the subject, despite being heterogeneous and unable to answer all questions, are indeed pointing to the effectiveness of SLIT. To supplement existing data and to answer the queries raised by the HAS, several studies have been launched, including EfficAPSI.
The pharmacoepidemiologic EfficAPSI study is the largest retrospective, real-world, longitudinal cohort study ever carried out regarding liquid SLIT using data stored in the French National Health Data System (SNDS). The primary objective of the study was to evaluate the real-world impact of liquid SLIT on the onset and worsening of asthma for patients with allergic rhinitis and to evaluate the impact of sublingual treatments on public health.
A cohort analysis of patients treated with SLIT and control patients treated for allergic rhinitis with or without treatment for asthma was carried out. The patients treated with SLIT for at least 2 consecutive years were anonymously selected from the SNDS using the Stallergenes Greer prescription database.
In all, 99,538 patients who received SLIT were compared with 333,082 control patients (those who had received treatment for allergic rhinitis without taking SLIT). Participants were stratified according to their treatment history for asthma and were paired using a propensity score to minimize comparison bias.
The main definition of the onset of asthma included the first prescription of an asthma medication, hospital admission for asthma, or a diagnosis of chronic asthma. The secondary definition omitted the prescription of any treatment, and the third (sensitive and specific) took into consideration an initial prescription of omalizumab or a prescription of three inhaled corticosteroids (ICSs) associated with or without a long-acting beta-2 agonist (LABA) for a period of 1 year, admission to the hospital, or chronic asthma.
Asthma Risk Reduced
Among patients with allergic rhinitis without preexisting asthma, liquid SLIT was associated with a significantly lower risk of asthma onset in comparison with the control group (primary hazard ratio [HR]: 0.77; secondary HR: 0.66; and tertiary HR: 0.62).
The risk reductions were significant and were consistent regardless of the allergens analyzed (tertiary HR dust mites: 0.57, grass: 0.52) for all age groups. These new results that were based on the tertiary definition corroborate the results from the primary and secondary definitions.
“Overall, these results suggest a more than 20% reduction in the risk of asthma onset observed in patients treated with liquid SLIT and symptomatic drugs, compared to patients treated with symptomatic drugs only,” said study co-author Philippe Devillier, MD, PhD, research director at the respiratory tract diseases center of Foch Hospital in Paris. “These results are consistent with previous studies in the same French healthcare database, as well as in a German database with SLIT preparations in tablet form. This not only confirms the soundness of the methodology but also the benefit of liquid SLIT as an etiological treatment of respiratory allergies.”
Risk for Worsening
Furthermore, in the same study, liquid SLIT treatment was associated with a 27% reduced risk for worsening asthma and a 36% reduced risk for severe asthma. Among patients with allergic rhinitis and preexisting asthma, liquid SLIT was associated with a significantly lower risk for worsening of asthma, compared with the control group (primary HR: 0.73; secondary HR: 0.61; and tertiary HR: 0.64). The primary definition was an initial prescription of an ICS-LABA combination in a patient treated with ICS alone, severe exacerbation of asthma symptoms, hospital admission, or a diagnosis of chronic asthma.
“The risk reductions were significant and consistent for the allergens analyzed,” said study co-author Pascal Demoly, MD, PhD, head of pulmonology at Montpellier University Hospital in France (tertiary HR, dust mites: 0.66; grass: 0.59, birch: 0.34, and cats: 0.77). “This was across all age groups,” he added.
“The results of the EfficAPSI real-world study on health data from the SNDS are consistent with outcomes from clinical trials, suggestive of a reduced risk of asthma onset in patients with allergic rhinitis receiving liquid SLIT, as well as a reduced risk of worsening of preexisting asthma,” said Devillier. “SLIT, in this case in the form of a liquid, thus appears to be an effective etiological treatment, since the use of symptomatic drugs, in particular preventer inhalers, but also reliever inhalers, is lower in patients treated with SLIT over at least two consecutive years, compared with paired control subjects. And it’s the same for the risk of treating asthma in nonasthmatic patients at the start of the study. EfficAPSI is the largest study using data from a comprehensive state drug reimbursement database allowing us to assess the impact of liquid SLIT on public health. These results, also obtained with other allergen preparations, particularly in tablet form in French and German studies using data from healthcare databases, demonstrate the consistency of the data regarding the efficacy of SLIT.”
This article was translated from the Medscape French Edition.
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