Development of an allergen extract for sublingual immunotherapy – evaluation of Staloral

Frati, Franco; Scurati, Silvia; Panina-Bordignon, Paola; Justicia, José L; Adamec, Tomas; Sieber, Hans Jochen; Ras, Liesbeth; David, M.; Marcucci, Francesco; Incorvaia, Cristoforo

doi:10.1517/14712590903146869

Cited by 22 publications

(10 citation statements)

References 66 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The sublingual solution contains standardized extracts of target allergens (eg, against hose dust mites and grass or tree pollens) at various concentrations, expressed as the index of reactivity (IR), with the final composition and concentration tailored toward the sensitizing allergen. In many of the clinical studies and in routine clinical practice, a standardized 300 IR daily dose is used 13,14. This solution is administered in a pre- and coseasonal scheme in which treatment is started before the onset of the pollen season and is continued until the end of the season, corresponding to 4–6 months of use each year across 2 years 13,14…”

Section: Introductionmentioning

confidence: 99%

“…In many of the clinical studies and in routine clinical practice, a standardized 300 IR daily dose is used 13,14. This solution is administered in a pre- and coseasonal scheme in which treatment is started before the onset of the pollen season and is continued until the end of the season, corresponding to 4–6 months of use each year across 2 years 13,14…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of a sublingual immunotherapy solution in olive-induced respiratory allergy in Jordan: a retrospective observational study

Al-Asad

Al-Nazer

Al-Faqih

et al. 2017

JAA

View full text Add to dashboard Cite

BackgroundOlive pollen is an important cause of respiratory allergy in the Middle East. In this study, the clinical characteristics of adults and children with confirmed allergic rhinitis (AR; with or without asthma) in Jordan were described, and the use of sublingual immunotherapy (SLIT) in a real-life clinical setting was assessed.MethodsThis retrospective observational study evaluated the clinical features of olive-induced allergy and the use of an SLIT solution of standardized extracts toward Ole e 1 given in a pre- and coseasonal scheme with a daily dose of 300 index of reactivity for two consecutive seasons. Inclusion criteria were as follows: ≥5 years of age, AR, proven olive sensitization, and at least 2 years follow-up after SLIT initiation. The following data were recorded at SLIT initiation: clinical characteristics, rhinitis and asthma symptom scores, and concomitant symptomatic medications. During follow-up and at the end of each season, the following data were recorded: symptom progression/scores, any changes to symptomatic medications, and treatment compliance. The secondary objective was to determine any effect on quality of life, use of concomitant AR medications, and treatment compliance.ResultsEighty-six patients with seasonal AR were included in this analysis (52.3% with coexisting asthma). Between the initiation of treatment and the end of second pollen season, symptoms of AR and asthma were decreased by 79.5% and 41.7%, respectively, with an improvement in quality of life score in 71.5% of the patients (P<0.0001 for all). Physicians reported that after 2 years of SLIT, there was an improvement in the symptoms of both AR (95.2%) and asthma (93.3%), with 98.8% of the patients showing good treatment compliance. A reduction in symptomatic medications was also found. SLIT was well tolerated with no systemic reactions being reported.ConclusionIn children and adults with olive-associated respiratory allergy in Jordan, the use of a pre- and coseasonal SLIT with a 300 index of reactivity daily dose is effective in reducing the clinical burden of AR and asthma with no tolerability issues.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Evaluation of a sublingual immunotherapy solution in olive-induced respiratory allergy in Jordan: a retrospective observational study

Al-Asad

Al-Nazer

Al-Faqih

et al. 2017

JAA

View full text Add to dashboard Cite

show abstract

“…However, the use of crude extracts has several disadvantages. It could induce severe anaphylactic side reactions or lead to sensitization towards new allergens present in the mixture [13, 14]. Different strategies have been designed to try to overcome these negative effects, as the use of allergen-derived B cell peptides, allergen-derived T cell epitope containing peptides, or vaccination with allergen-encoding DNA [15].…”

Section: Introductionmentioning

confidence: 99%

In SilicoPrediction of T and B Cell Epitopes of Der f 25 inDermatophagoides farinae

Yang

Chen

et al. 2014

International Journal of Genomics

View full text Add to dashboard Cite

The house dust mites are major sources of indoor allergens for humans, which induce asthma, rhinitis, dermatitis, and other allergic diseases. Der f 25 is a triosephosphate isomerase, representing the major allergen identified in Dermatophagoides farinae. The objective of this study was to predict the B and T cell epitopes of Der f 25. In the present study, we analyzed the physiochemical properties, function motifs and domains, and structural-based detailed features of Der f 25 and predicted the B cell linear epitopes of Der f 25 by DNAStar protean system, BPAP, and BepiPred 1.0 server and the T cell epitopes by NetMHCIIpan-3.0 and NetMHCII-2.2. As a result, the sequence and structure analysis identified that Der f 25 belongs to the triosephosphate isomerase family and exhibited a triosephosphate isomerase pattern (PS001371). Eight B cell epitopes (11–18, 30–35, 71–77, 99–107, 132–138, 173–187, 193–197, and 211–224) and five T cell epitopes including 26–34, 38–54, 66–74, 142–151, and 239–247 were predicted in this study. These results can be used to benefit allergen immunotherapies and reduce the frequency of mite allergic reactions.

show abstract

“…For extracts from Stallergenes (Antony, France), the potency is measured by the index of reactivity (IR) per milliliter, with 100 IR/mL corresponding to the allergenic potency of an extract eliciting a mean wheal diameter of 7 mm by skin prick tests performed in patients allergic to the specific allergen source 17. The product Staloral300, obtained from the same source material used for BM products but titrated only in IR, was demonstrated to be efficacious by 20 double-blind, placebo-controlled trials on patients allergic to pollens and dust mites 18. The quantification of allergens is generally made by antibody-based techniques such as radioimmunoassay, ELISA, radial immunodiffusion, and rocket immunoelectrophoresis (RIE), but due to the variations of measurement depending on the technique used, the modern approach used in production to quantify the relevant allergens is also based on mass spectrometry (MS) 19.…”

Section: Production Technologymentioning

confidence: 99%

New product development with the innovative biomolecular sublingual immunotherapy formulations for the management of allergic rhinitis

Frati¹,

Cecchi²,

Scala³

et al. 2014

BTT

Self Cite

View full text Add to dashboard Cite

The molecular allergy technique, currently defined as component-resolved diagnosis, significantly improved the diagnosis of allergy, allowing for differentiation between molecules actually responsible for clinical symptoms (genuine sensitizers) and those simply cross-reacting or shared by several sources (panallergens), thus influencing the appropriate management of a patient’s allergy. This also concerns allergen immunotherapy (AIT), which may be prescribed more precisely based on the component-resolved diagnosis results. However, the advance in diagnosis needs to be mirrored in AIT. According to consensus documents and to expectations of specialists, therapy should be based on standardized extracts containing measured amounts of the clinically relevant molecules, ie, the major allergens. The new generation of extracts for sublingual immunotherapy fulfills these requirements and are thus defined as biomolecular (BM). BM refers to natural extracts with a defined content of major allergens in micrograms. All Staloral BM products are indicated for the treatment of allergic rhinitis with or without asthma. The effectiveness of AIT is related to its ability to modify the immunological response of allergic subjects. The 5-grass and house dust mite extracts were evaluated addressing the T helper 1, T helper 2, and T helper 3 cells by polymerase chain reaction array on mRNA extracted from Waldeyer’s ring tissue (adenoids). Sublingual immunotherapy with a defined content of major allergens in micrograms induced a strong downregulation of genes involved in T helper 2 and T helper 1 activation and function, allowing the definition of the immunologic effect as “bio-homeostatic”. This clinical and immunological model must be implemented with respect to other allergens, thus expanding the application of a treatment with a unique disease-modifying capacity.

show abstract

Development of an allergen extract for sublingual immunotherapy – evaluation of Staloral

Cited by 22 publications

References 66 publications

Evaluation of a sublingual immunotherapy solution in olive-induced respiratory allergy in Jordan: a retrospective observational study

Evaluation of a sublingual immunotherapy solution in olive-induced respiratory allergy in Jordan: a retrospective observational study

In SilicoPrediction of T and B Cell Epitopes of Der f 25 inDermatophagoides farinae

New product development with the innovative biomolecular sublingual immunotherapy formulations for the management of allergic rhinitis

Contact Info

Product

Resources

About