The Clinical Efficacy of a Sublingual Monomeric Allergoid at Different Maintenance Doses: A Randomized Controlled Trial

Marogna, Maurizio; Colombo, Fausto; Cerra, Carla E.; Bruno, M.; Massolo, Alessandro; Canonica, Giorgio Walter; Falagiani, P.; Passalacqua, Giovanni

doi:10.1177/039463201002300330

Cited by 12 publications

(7 citation statements)

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“…The favourable safety profile in this study corresponds to that observed in other studies and has been confirmed in a meta‐analysis . SLIT studies using native allergens are often confounded by the high rate of local side‐effects in the actively treated groups that may unblind patient and investigator.…”

Section: Discussionsupporting

confidence: 89%

A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients

Hüser

Dieterich

Singh

et al. 2016

Allergy

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BackgroundIn sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose.MethodsIn this double‐blind, placebo‐controlled dose‐finding study, 131 patients with house dust mite‐induced allergic rhinoconjunctivitis were randomized to 12‐week treatments with 300 UA/day, 1000 UA/day, 2000 UA/day, 3000 UA/day or placebo. Conjunctival provocation tests (CPT) were performed before, during and after treatment. The change in mean allergic severity (primary endpoint), calculated from the severity of the CPT reaction, and the proportion of patients with an improved CPT threshold (secondary endpoint) determined the treatment effect.ResultsThe mean allergic severity decreased in all groups, including the placebo group. It was lower in all active treatment groups (300 UA/day: 0.14, 1000 UA/day: 0.15, 2000 UA/day: 0.10, 3000 UA/day: 0.15) than in the placebo group (0.30). However, this difference was not statistically significant (P < 0.1). The percentage of patients with an improved CPT threshold was higher in the active treatment groups (300 UA/day: 73.9%; 1000 UA/day: 76.0%; 2000 UA/day: 88.5%; 3000 UA/day: 76.0%) than in the placebo group (64.3%). The difference between placebo and 2000 UA/day was statistically significant (P = 0.04). In 13 (10%) exposed patients, a total of 20 treatment‐related adverse events of mild severity were observed.ConclusionsThe 12‐week daily treatment using 2000 UA/day monomeric allergoid sublingual tablets is well tolerated and reduces the CPT reaction in house dust mite‐allergic patients.

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Section: Discussionsupporting

confidence: 89%

A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients

Hüser

Dieterich

Singh

et al. 2016

Allergy

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“…Several double-blind randomized placebo-controlled clinical trials demonstrated the efficacy of Lais ® (Lofarma), a carbamylated allergoid, in patients with HDM-induced allergic rhinitis with or without allergic asthma, proving a reduction in the total and individual symptoms and the drug consumption [ 10 ] (Table 1 ). Another clinical trial showed a reduction in bronchial hyperactivity, nasal inflammation assessed by nasal eosinophil count and asthma and rhinitis symptoms score in patients treated with three different doses of this carbamylated allergoid vs. placebo [ 11 ]. Only one clinical trial evaluated Lais administration to 28 children (mean age 13.3 ± 2.1 year) with HDM, Parietaria and Timothy grass-induced allergic rhinitis and/or asthma to verify the occurrence of immediate adverse reactions after an ultra-rush regimen exposure [ 12 ].…”

Section: The Previous View: the Efficacy Of Ait As Product Classmentioning

confidence: 99%

A critical appraisal on AIT in childhood asthma

et al. 2018

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Allergen immunotherapy (AIT) is the only disease-modifying treatment approved for allergic rhinitis and allergic asthma and represents a suitable therapeutic option, especially in childhood, to modify the progression of respiratory allergic diseases. Starting from the previous “generic class effect” evaluation, as testified by the numerous meta analyses, AIT is now considered a product-specific pathogenic-oriented treatment.BackgroundAIT was empirically proposed more than one century ago in the subcutaneous form (SCIT), but the IgE-mediated mechanism of allergy was elucidated only after 50 years of clinical use of the treatment. The sublingual administration (SLIT) was developed during the 1980 ties, to achieve an improvement in safety and convenience. While SCIT is approved in the United States for the treatment of asthmatic patients with more than 12 years, so far few trials evaluated the clinical efficacy and safety of SLIT in children with allergic asthma, although the indications and some aspects remain unclear. Certainly, due to compliance problems, the age below 3 years may be reasonably considered a practical contraindication.ConclusionsGiven that some specific AIT products are effective and approved as drugs (AIFA, EMA, FDA), the use in children is still debated. Some aspects still need robust confirm: (a) the safety of AIT in asthma; (b) the optimal regimen of administration; (c) the role of AIT as preventative treatment for asthma development.

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“…The absence of significant side effects, even at high doses, was probably due to the low level of allergenicity. 163 For immunotherapy of atopic dermatitis, SCIT is not indicated for use because of the likelihood that it could induce exacerbations of manifest atopic dermatitis or relapses of latent atopic dermatitis. In children treated either with SLIT or placebo, Pajno et al reported a benefit from SLIT exclusively in children with atopic dermatitis sensitized against HDMs and in those with mildto-moderate variants of atopic dermatitis, adjudged by the SCORAD index (SCORing Atopic Dermatitis).…”

Section: Oralmentioning

confidence: 99%

Strategies of mucosal immunotherapy for allergic diseases

Chuang

Chiang

2011

Cell Mol Immunol

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Incidences of allergic disease have recently increased worldwide. Allergen-specific immunotherapy (SIT) has long been a controversial treatment for allergic diseases. Although beneficial effects on clinically relevant outcomes have been demonstrated in clinical trials by subcutaneous immunotherapy (SCIT), there remains a risk of severe and sometimes fatal anaphylaxis. Mucosal immunotherapy is one advantageous choice because of its non-injection routes of administration and lower side-effect profile. This study reviews recent progress in mucosal immunotherapy for allergic diseases. Administration routes, antigen quality and quantity, and adjuvants used are major considerations in this field. Also, direct uses of unique probiotics, or specific cytokines, have been discussed. Furthermore, some researchers have reported new therapeutic ideas that combine two or more strategies. The most important strategy for development of mucosal therapies for allergic diseases is the improvement of antigen formulation, which includes continuous searching for efficient adjuvants, collecting more information about dominant T-cell epitopes of allergens, and having the proper combination of each. In clinics, when compared to other mucosal routes, sublingual immunotherapy (SLIT) is a preferred choice for therapeutic administration, although local and systemic side effects have been reported. Additionally, not every allergen has the same beneficial effect. Further studies are needed to determine the benefits of mucosal immunotherapy for different allergic diseases after comparison of the different administration routes in children and adults. Data collected from large, well-designed, double-blind, placebo-controlled, and randomized trials, with post-treatment follow-up, can provide robust substantiation of current evidence.

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The Clinical Efficacy of a Sublingual Monomeric Allergoid at Different Maintenance Doses: A Randomized Controlled Trial

Cited by 12 publications

References 23 publications

A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients

A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients

A critical appraisal on AIT in childhood asthma

Strategies of mucosal immunotherapy for allergic diseases

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