Dataset Information

The SQ HDM SLIT-Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A "real-life" French study.

ABSTRACT:

Background

The SQ House Dust Mite (HDM) SubLingual ImmunoTherapy (SLIT)-Tablet (Acarizax) is the only allergen immunotherapy authorized by European regulatory authorities to treat HDM-induced allergic asthma (AA) that is not well-controlled by inhaled corticosteroids and associated with mild-to-severe HDM allergic rhinitis (AR). The aim of this study was to add evidence on the safety of the SQ HDM SLIT-Tablet in patients with AR, alone or with AA, under real-life conditions.

Methods

This was a French "real-life", multicenter, non-comparative, longitudinal, prospective study. It included patients initiating the SQ HDM SLIT-Tablet for either persistent moderate-to-severe HDM AR or AA not well-controlled by inhaled corticosteroids and associated with mild-to-severe HDM AR. Adverse Events (AEs) were collected at the first intake and throughout the study. Logistic regression was used to compare safety according to asthma control before treatment initiation.

Results

Between May 09, 2018 and May 29, 2019, 1526 patients were enrolled at 185 sites and 1483 were included in the safety population (SAF). Of them, 33.6% had suspected clinical manifestations of AA. Asthma was uncontrolled for 18.2% of the patients, partially controlled for 27.9% and well-controlled for 53.8%. Overall, 31.9% of the SAF patients experienced at least one AE. The percentage of patients with AEs was 29.9% among patients with AR alone and 35.9% among those with AA (p = 0.0193). No significant difference was observed in the rate of AE or SAE depending on asthma control at inclusion (2.2% of SAEs reported for patients with uncontrolled asthma, 1.4% for partly controlled and 1.1% for well-controlled).

Conclusions

The overall results indicate a good SQ HDM SLIT-Tablet safety profile consistent with that reported in previous studies, regardless of asthma control.

SUBMITTER: Demoly P

PROVIDER: S-EPMC8967264 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

The SQ HDM SLIT-Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A "real-life" French study.

Demoly Pascal P Leroyer Christophe C Serrano Elie E Le Maux Annelore A Magnier Gabrielle G Chartier Antoine A

Clinical and translational allergy 20220301 3

<h4>Background</h4>The SQ House Dust Mite (HDM) SubLingual ImmunoTherapy (SLIT)-Tablet (Acarizax) is the only allergen immunotherapy authorized by European regulatory authorities to treat HDM-induced allergic asthma (AA) that is not well-controlled by inhaled corticosteroids and associated with mild-to-severe HDM allergic rhinitis (AR). The aim of this study was to add evidence on the safety of the SQ HDM SLIT-Tablet in patients with AR, alone or with AA, under real-life conditions.<h4>Methods</ ...[more]

PMID: 35344293

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Project description:BackgroundAllergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child's quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children.MethodsPhase III, randomised, double-blind, placebo-controlled trial in younger children (5-11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22.FindingsA total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%).InterpretationThe trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5-11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children.FundingALK-Abellό, Hørsholm, Denmark.

Project description:BackgroundOne of the important pathogeneses of eustachian tube dysfunction (ETD) is nasal inflammatory disease. The prevalence of allergic rhinitis (AR) in adults ranges from 10 to 30% worldwide. However, research on the status of eustachian tubes in AR patients is still very limited.MethodsThis prospective controlled cross-sectional study recruited 59 volunteers and 59 patients with AR from Sun Yat-sen Memorial Hospital. Visual analogue scale (VAS) scores for AR symptoms and seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) scores were collected for both groups. Nasal endoscopy, tympanography and eustachian tube pressure measurement (tubomanometry, TMM) were used for objective assessment. All AR patients underwent 1 month of treatment with mometasone furoate nasal spray and oral loratadine. Then, the nasal condition and eustachian tube status were again evaluated.ResultsTMM examination revealed that 22 patients (39 ears, 33.1%) among the AR patients and 5 healthy controls (7 ears, 5.9%) had abnormal eustachian pressure. Twenty-two AR patients (37.3%) and 9 healthy controls had an ETDQ-7 score ≥ 15. With regard to nasal symptoms of AR, the VAS scores of nasal obstruction were correlated with the ETDQ-7 scores, and the correlation coefficient was r = 0.5124 (p < 0.0001). Nasal endoscopic scores were also positively correlated with ETDQ-7 scores, with a correlation coefficient of 0.7328 (p < 0.0001). After 1 month of treatment, VAS scores of nasal symptoms, endoscopic scores and ETDQ-7 scores were significantly decreased in AR patients (p < 0.0001), and TMM examination also suggested that eustachian tube function was significantly improved after treatment (p < 0.0001).ConclusionsAR patients, especially those with severe nasal obstruction, could have ETD. The local conditions of the pharyngeal orifices of the eustachian tubes are closely related to the symptoms of ETD. After treatment with nasal glucocorticoids and oral antihistamines, eustachian tube function can significantly improve as nasal symptoms subside.Trial registration Chinese Clinical Trial Registery (ChiCTR2000029071) Registered 12 January 2020-Retrospectively registered, http://www.chictr.org.cn/edit.aspx?pid=48328&htm=4.

Dataset Information

The SQ HDM SLIT-Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A "real-life" French study.

Background

Methods

Results

Conclusions

Publications

The SQ HDM SLIT-Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A "real-life" French study.

Similar Datasets

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