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18 Diseases |  |
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- || Allergen immunotherapy / Stallergenes
P4 data, Journal: Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. (Pubmed Central) - Jul 22, 2024
P2, P2/3,
The 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR)...4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported...Safety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status. NCT00674700; Retrospectively registered 06 May 2008.NCT01199133; Retrospectively registered 09 September 2010.NCT01527188; Retrospectively registered 01 February 2012.NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.
- | Allergen immunotherapy / Stallergenes
Journal, Adherence: Satisfaction, Qol and adherence of patients allergic to dust mites and/or pollens undergoing sublingual immunotherapy. (Pubmed Central) - Jun 18, 2024
Patients were highly satisfied and most of them adhered to SLIT, being forgetfulness the main non-adherence motive. SLIT is a quick effective treatment against persistent moderate-to-severe symptoms in ARC and asthma but it should been improve forgetfulness, as non-adherence reason.
- Allergen immunotherapy / Stallergenes
Effect of 300 IR house dust mite sublingual immunotherapy tablet in paediatric patients and relationship with disease activity (Palma) - May 25, 2024 - Abstract #EAACI2024EAACI_2991;
Conclusion In this post hoc analysis of a paediatric RCT, the greatest improvements were observed in the tertile in which patients showed higher disease activity during the evaluation period, hence reflecting the true effect of 300 IR HDM SLIT tablet. Such findings confirm the benefit of this treatment during the periods when the patient's symptoms are most troublesome.
- Allergen immunotherapy / Stallergenes
LILRA5 and CCL25 as candidate predictive biomarkers of AIT efficacy (Palma) - May 25, 2024 - Abstract #EAACI2024EAACI_2956;
Background Allergen immunotherapy (AIT) is recognised as a safe and efficacious treatment for type I respiratory allergies...When focusing on polysensitised patients with asthma, we observed an improvement in ROC analyses with area under curves reaching 0.84 and 0.7 for LILRA5 and CCL25, respectively. Conclusion Altogether, our findings clearly identify that the levels of LILRA5 and CCL25 in the blood before AIT serve as a reflection of the patient's inflammatory status, thus offering insights into the potential clinical responses expected during house dust mite immunotherapy.
- | Allergen immunotherapy / Stallergenes
Journal: Impact of liquid sublingual immunotherapy on asthma onset and progression in patients with allergic rhinitis: a nationwide population-based study (EfficAPSI study). (Pubmed Central) - May 6, 2024
Conclusion Altogether, our findings clearly identify that the levels of LILRA5 and CCL25 in the blood before AIT serve as a reflection of the patient's inflammatory status, thus offering insights into the potential clinical responses expected during house dust mite immunotherapy. The sensitive definition of asthma event considered the first asthma drug dispensation, hospitalisation or long-term disease (LTD) for asthma, the specific one omitted drug dispensation and the combined one considered omalizumab or three ICS
- Allergen immunotherapy / Stallergenes
Short-term benefits of sublingual immunotherapy in routine clinical practice: Patient Benefit Index by class in the observational, prospective, longitudinal study PRACTIS (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2497;
Conclusion This post hoc analysis in a large, real-world study showed the benefits of SLIT met expectations for about 90% of treated patients with AR/AA/AC regardless of their age and the causal allergen, with notably more than half of them showing a PBI score ?2.5. Treatment duration had no impact on the benefit perceived by HDM and GP allergic patients receiving SLIT.
- Allergen immunotherapy / Stallergenes
Impact of liquid sublingual immunotherapy on asthma worsening prevention: GINA treatment stepping up results from the real-world EfficAPSI study (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2496;
Expert Rev Clin Immunol. 2023; doi: 10.1080/1744666X.2023.2294040
- Allergen immunotherapy / Stallergenes
300 IR 5-grass pollen sublingual immunotherapy tablet for allergic rhinoconjunctivitis: A systematic review and meta-analysis of randomised studies (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2495;
J Clin Epidemiol. 2022; 142: 200
- Allergen immunotherapy / Stallergenes
Short-term benefits of sublingual immunotherapy in routine clinical practice: deciphering factors influencing the patient satisfaction in the observational, prospective, longitudinal study PRACTIS (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2285;
Also, for patients following the prescription correctly, the probability of PBI ?1 increased with OR = 6.97 [1.67; 29.06] compared to those who were unable to do so. Conclusion This large, real-world study showed the benefits of SLIT in patients with AR/AA/AC can be enhanced by compliance to treatment, suggesting that patient education should be pursued to achieve this goal.
- Allergen immunotherapy / Stallergenes, Staloral (allergy immunotherapy sublingual) / Stallergenes
Prospective, pilot, phase 1 study of iPUMP (Innovation Hub) - Apr 21, 2024 - Abstract #EAACI2024EAACI_1760;
It is easy to use and the functions in the connected device and app. can be consulted by patients to monitor their own compliance.
- Allergen immunotherapy / Stallergenes
Sublingual immunotherapy for house dust mite allergy induces expansions of allergen-specific memory B cells expressing CD29 and downregulating IL4R? (Palma) - Apr 5, 2024 - Abstract #EAACI2024EAACI_1107;
might render the cells less responsive to type 2 immune signals and contribute to the observed desensitization. In ongoing studies, the kinetics of immune memory changes, as well as the functional relevance of the immunophenotypical changes, are studied.
- Allergen immunotherapy / Stallergenes
Coordinated specific IgG2 and IgE responses are associated with high clinical benefit of allergen immunotherapy with 300 IR house dust mite sublingual tablets in a large European cohort (Granada) - Apr 5, 2024 - Abstract #EAACI2024EAACI_978;
Such differences between high responders and the other groups were not observed in subjects administered placebo. Conclusion This study confirmed with a more than four times larger population the previous finding that coordinated IgG2 and IgE responses are associated with a high clinical benefit of AIT with 300 IR HDM tablets.
- Allergen immunotherapy / Stallergenes
Impact of liquid sublingual immunotherapy with mixed pollen allergens on asthma prevention in polyallergic patients: results from the real-world EfficAPSI study (Cordoba) - Apr 5, 2024 - Abstract #EAACI2024EAACI_698;
Expert Rev Clin Immunol. 2023; doi: 10.1080/1744666X.2023.2294040
- Allergen immunotherapy / Stallergenes
Carry-over effect of 300 IR house dust mite sublingual immunotherapy tablet and relationship with disease activity: a post hoc analysis (Granada) - Apr 5, 2024 - Abstract #EAACI2024EAACI_604;
Conclusion In this RCT, efficacy of 300 IR HDM SLIT tablet was demonstrated during treatment and maintained over the post-treatment year, with the greatest improvements observed in the tertile wherein patients reflected a higher disease activity corresponding to most troublesome symptoms. The tertile approach provides more accurate and meaningful measurements of efficacy and benefit for patients.
- || Allergen immunotherapy / Stallergenes
Retrospective data, Review, Journal: IR (index of reactivity)-house dust mite sublingual immunotherapy liquid formulation for allergic rhinoconjunctivitis: Systematic review and meta-analysis of randomized and nonrandomized studies. (Pubmed Central) - Feb 8, 2024
Metaregression showed that symptom improvement was correlated with treatment duration with consistent results in NRS and RCT with 12-month SS data: -0.87 (interquartile range, -1.02, -0.77) and -0.75 (interquartile range, -0.93, -0.41), respectively. This meta-analysis showed comparable clinical benefit of IR-HDM SLIT liquid formulation increasing over time in both NRS and RCT, suggesting that NRS may reliably integrate RCT results and be considered for guidelines.
- | Allergen immunotherapy / Stallergenes
Reimbursement, US reimbursement, Journal: A successful linkage of a named patient products of sublingual immunotherapy-dispensing registry to French healthcare insurance database (SNDS): methodological constitution of the EfficAPSI cohort. (Pubmed Central) - Dec 19, 2023
To date, the EfficAPSI cohort has the largest number of person-years of follow-up in the field of AIT. The completeness of the data allows to evaluate SLIT liquid effectiveness with rigorous methodology, leading to important insights on personalized medicine in real-life.
- | Allergen immunotherapy / Stallergenes
Journal, Patient reported outcomes: Patient-reported outcome measures (PROMs) in birch pollen allergic patients treated with sublingual immunotherapy reflect real life. (Pubmed Central) - Apr 4, 2023
The completeness of the data allows to evaluate SLIT liquid effectiveness with rigorous methodology, leading to important insights on personalized medicine in real-life. No abstract available
- | Allergen immunotherapy / Stallergenes
Biomarker, Journal, IO biomarker: Current advances in house dust mite allergen immunotherapy (AIT): Routes of administration, biomarkers and molecular allergen profiling. (Pubmed Central) - Mar 6, 2023
We also highlight recent data in more exploratory routes (i.e., oral, intralymphatic, epicutaneous and intradermal) and discuss respective advantages of various route, as well as their foreseen modes of action. Finally, we provide an update on biomarkers as well as on the relevance of the molecular profiling of allergic individuals related to treatment efficacy or asthma prediction.
- || Allergen immunotherapy / Stallergenes
Clinical, Journal, IO biomarker: Correlation of serum vitamin D concentration with humoral specific IgG2 and IgG4 levels in high responders to immunotherapy with a 300 IR sublingual house dust mite tablet. (Pubmed Central) - Oct 7, 2022
Such correlations are not observed in low responders to SLIT. Overall, this study points to a previously evidenced specific behaviour of immune responses in high responders to SLIT.
- | Allergen immunotherapy / Stallergenes
Journal: Impact of COVID-19 in allergen immunotherapy: An Italian survey. (Pubmed Central) - Sep 18, 2022
The results show that Italian physicians (N=66) did not consider that the COVID-19 pandemic presented an added risk to patients with allergic asthma or rhinitis receiving AIT. Although most treatments continued, there were reduced rates of AIT therapy initiations and sublingual AIT was favored over subcutaneous AIT.
- | Allergen immunotherapy / Stallergenes
Journal: The MaDo real-life study of dose adjustment of allergen immunotherapy liquid formulations in an indication of respiratory allergic disease: Reasons, practices, and outcomes. (Pubmed Central) - Aug 27, 2022
In France, dose adjustment of SLIT liquid preparations as a function of the patient profile and/or treatment response is anchored in clinical practice. Precision dosing might optimize the overall benefit-risk profile of AIT for individual patients throughout their entire treatment course, enabling them to achieve both short- and long-term treatment goals, whilst maximizing the safety and tolerability.
- || Oralair (grass pollen allergen extract) / Stallergenes
Review, Journal: Update about Oralair® as a treatment for grass pollen allergic rhinitis. (Pubmed Central) - Jul 24, 2022
Effectiveness has been substantiated in subsequent observational studies with sustained efficacy following treatment cessation and a favorable level of adherence, quality of life, benefit, and satisfaction for the patients. Supportive evidence for a benefit in reducing the risk or delaying the development of allergic asthma is emerging.
- | Allergen immunotherapy / Stallergenes
Journal: Efficacy of subcutaneous house dust mite immunotherapy in patients with moderate to severe allergic rhinitis. (Pubmed Central) - Jun 9, 2022
P4
SCIT is efficacious for HDM allergy in patients with AR, generating a strong immunological response. Trial Registration Number: EUCTR2009-018155-16-ES (Cochrane Central Register of Controlled Trials).
- || Allergen immunotherapy / Stallergenes
Clinical, Journal, IO biomarker: Coordinated IgG2 and IgE responses as a marker of allergen immunotherapy efficacy. (Pubmed Central) - Apr 22, 2022
We provide evidence for coordinated serum immune responses upon AIT in HDM-allergic subjects exhibiting high clinical benefit when compared with low responders. Assessing HDM-specific IgE, IgG2 and IgG4 in serum could be used as follow-up combined markers to support decision as to AIT continuation and/or adaptation.
- | Oralair (grass pollen allergen extract) / Stallergenes
Journal: Standardisation of allergen products: 4. Validation of a Candidate European Pharmacopoeia Standard Method for Quantification of Major Grass Pollen Allergen Phl p 5. (Pubmed Central) - Apr 9, 2022
Assessing HDM-specific IgE, IgG2 and IgG4 in serum could be used as follow-up combined markers to support decision as to AIT continuation and/or adaptation. Based on the collaborative study results, the assessed Phl p 5-specific immunoassay is appropriate to be proposed as European Pharmacopoeia standard method.
- | Allergen immunotherapy / Stallergenes
Journal: Decrease in CD38 TH2A cell frequencies following immunotherapy with house-dust mite tablet correlates with humoral responses. (Pubmed Central) - Mar 1, 2022
We highlight the interest of CD38 to better identify the subset of TH2A cell downregulated by AIT. Finally, correlated cellular and humoral responses observed in immunoreactive individuals stress that coordinated pathways occur in the adaptive responses during AIT.
- || Allergen immunotherapy / Stallergenes
Clinical, Observational data, Journal: Patient needs and benefits of sublingual immunotherapy for grass pollen-induced allergic rhinitis: an observational study. (Pubmed Central) - Feb 2, 2022
All subgroups reported relevant benefits, with significantly higher scores in some subgroups. Treatment with Oralair was associated with considerable patient-relevant benefit in all age groups.
- | Allergen immunotherapy / Stallergenes
Preclinical, Journal: Bet v 1 contiguous overlapping peptides anchored to virosomes with TLR4 agonist enhance immunotherapy efficacy in mice. (Pubmed Central) - Jan 15, 2022
Whereas sublingual allergen immunotherapy (AIT) is routinely performed without any adjuvant or delivery system, there is a strong scientific rationale to better target the allergen(s) to oral dendritic cells known to support regulatory immune responses by using appropriate presentation platforms...We report herein for the first time on the capacity of a novel and safe presentation platform, i.e. virosomes with membrane-integrated TLR4 agonist, to improve dramatically sublingual AIT efficacy in a murine model due to its intrinsic dual properties of targeting and stimulating to further promote anti-allergic immune responses. As such, our study paves the ground for further clinical development of this allergen presentation platform for patients suffering from respiratory allergies.
- ||| Allergen immunotherapy / Stallergenes
Clinical, P3 data, Journal: A 300°IR sublingual tablet is an effective, safe treatment for house-dust-mite-induced allergic rhinitis: an international, double-blind, placebo-controlled, randomized Phase III clinical trial. (Pubmed Central) - Sep 24, 2021
P3
The 300°IR sublingual HDM tablet is an effective, safe treatment for HDM-induced AR. (NCT02443805, EudraCT 2014-004223-46) CLINICAL IMPLICATIONS: A 300 index of reactivity sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae extract is a safe, effective treatment for moderate-to-severe house-dust-mite-induced allergic rhinitis.
- | Allergen immunotherapy / Stallergenes
Journal: Personalized medicine and allergen immunotherapy: the beginning of a new era? (Pubmed Central) - Jul 9, 2021
AIT also broadens the field of possibilities for healthcare professionals and patients, by allowing to choose the galenic formulation according to patient preferences and on the basis of their clinical history, adapting the product composition to the patient's sensitization profiles and the underlying biological mechanisms identified at the diagnostic stage, while guaranteeing quality of the prescribed product as the production of allergens and allergoids is today more regulated than in the past years. In the management of AIT, it is also possible to involve patients in decisions throughout their care pathway thanks to multiple services, offering personalized follow-up and support, to ensure the highest treatment efficacy levels, and recalling medication intake, medical appointments and prescription renewals.
- || Allergen immunotherapy / Stallergenes
Review, Journal, IO biomarker: Personalized Medicine for allergy treatment: allergen immunotherapy still a unique and unmatched model. (Pubmed Central) - May 15, 2021
The stakes of PM in allergic patients are molecular diagnostics, to detect specific IgE to single allergen molecules and to distinguish the causative molecules from those merely cross-reactive, pursuit of patient's treatable traits addressing genetic, phenotypic and psychosocial features, and omics, such as proteomics, epi-genomics, metabolomics and breathomics, to forecast patient's responsiveness to therapies, to detect biomarker and mediators, and verify the disease control. This new approach has already improved the precision of allergy diagnosis and is likely to significantly increase, through the higher performance achieved with the personalized treatment, the effectiveness of allergen immunotherapy by enhancing its already known and unique characteristics of treatment that acts on the causes.
- Allergen immunotherapy / Stallergenes
[VIRTUAL] Medication compliance of sublingual immunotherapy in patients with house dust mite induced allergic rhinitis in Japan: a retrospective database study () - Aug 14, 2020 - Abstract #WAC2020WAC_681;
This new approach has already improved the precision of allergy diagnosis and is likely to significantly increase, through the higher performance achieved with the personalized treatment, the effectiveness of allergen immunotherapy by enhancing its already known and unique characteristics of treatment that acts on the causes. The password to see abstracts was announced to registrants by email.
- ||||| Allergen immunotherapy / Stallergenes
European regulatory: Stallergenes Greer Submits a Marketing Authorisation Application in Europe for Its Sublingual House Dust Mite Allergen Immunotherapy Tablet https://t.co/NzMoCZcQhi (Twitter) - May 4, 2020
- ||||| Allergen immunotherapy / Stallergenes
Clinical: Stallergenes Greer and Anergis Initiate New Study to Predict Efficacy of Second-Generation Allergen Immunotherapy https://t.co/aPE5aRng0E (Twitter) - Oct 17, 2019
- |||| Allergen immunotherapy / Stallergenes
Trial completion: Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma (clinicaltrials.gov) - Dec 18, 2015
P2, N=386, Completed, Sponsor: Stallergenes
The password to see abstracts was announced to registrants by email. Active, not recruiting --> Completed
- ||| Allergen immunotherapy / Stallergenes
Trial completion: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts (clinicaltrials.gov) - Jul 1, 2014
P1, N=94, Completed, Sponsor: Stallergenes
Active, not recruiting --> Completed Recruiting --> Completed
- ||| Allergen immunotherapy / Stallergenes
Trial completion, Trial primary completion date: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts (clinicaltrials.gov) - Jun 29, 2014
P1, N=96, Recruiting, Sponsor: Stallergenes
Recruiting --> Completed Trial primary completion date: Oct 2013 --> Sep 2014 | Recruiting --> Completed
- || Allergen immunotherapy / Stallergenes
Trial primary completion date: Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma (clinicaltrials.gov) - May 27, 2014
P2, N=480, Active, not recruiting, Sponsor: Stallergenes
Trial primary completion date: Oct 2013 --> Sep 2014 | Recruiting --> Completed Trial primary completion date: Mar 2015 --> Jul 2015
- || Allergen immunotherapy / Stallergenes
Trial completion date: Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma (clinicaltrials.gov) - May 27, 2014
P2, N=480, Active, not recruiting, Sponsor: Stallergenes
Trial primary completion date: Mar 2015 --> Jul 2015 Trial completion date: May 2015 --> Sep 2015
- ||| Allergen immunotherapy / Stallergenes
Enrollment closed: Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma (clinicaltrials.gov) - May 27, 2014
P2, N=480, Active, not recruiting, Sponsor: Stallergenes
Trial completion date: May 2015 --> Sep 2015 Recruiting --> Active, not recruiting
- | Allergen immunotherapy / Stallergenes
Trial completion date: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts (clinicaltrials.gov) - May 27, 2014
P1, N=96, Recruiting, Sponsor: Stallergenes
Recruiting --> Active, not recruiting Trial completion date: Dec 2013 --> Oct 2014
- | Allergen immunotherapy / Stallergenes
Trial completion: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents (clinicaltrials.gov) - Jan 2, 2014
P1, N=37, Completed, Sponsor: Stallergenes
Trial completion date: Dec 2013 --> Oct 2014 Recruiting --> Completed
- |||| Allergen immunotherapy / Stallergenes
Enrollment open: Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma (clinicaltrials.gov) - Sep 16, 2013
P2, N=480, Recruiting, Sponsor: Stallergenes
Recruiting --> Completed Active, not recruiting --> Recruiting
- ||||| Allergen immunotherapy / Stallergenes
New P2 trial: Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma (clinicaltrials.gov) - Aug 27, 2013
P2, N=480, Recruiting, Sponsor: Stallergenes
- || Allergen immunotherapy / Stallergenes
Enrollment change: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts (clinicaltrials.gov) - Aug 12, 2013
P1, N=96, Recruiting, Sponsor: Stallergenes
Active, not recruiting --> Recruiting N=64 --> 96
- | Allergen immunotherapy / Stallergenes
New P1 trial: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents (clinicaltrials.gov) - Aug 7, 2013
P1, N=37, Completed, Sponsor: Stallergenes
- ||| Allergen immunotherapy / Stallergenes
Trial completion, IO biomarker: Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1 (clinicaltrials.gov) - Jun 25, 2013
P1, N=57, Completed, Sponsor: Stallergenes
N=64 --> 96 Recruiting --> Completed
- |||||||||| Allergen immunotherapy / Stallergenes
New P3 trial, IO biomarker: Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis (clinicaltrials.gov) - Nov 19, 2012
P3, N=574, Completed, Sponsor: Stallergenes
- ||||||| Allergen immunotherapy / Stallergenes
Trial completion: Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets (clinicaltrials.gov) - Jun 3, 2012
P3, N=633, Completed, Sponsor: Stallergenes
Recruiting --> Completed Active, not recruiting --> Completed
- ||| Allergen immunotherapy / Stallergenes
New P1 trial: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts (clinicaltrials.gov) - May 29, 2012
P1, N=96, Recruiting, Sponsor: Stallergenes