A major step forward for sublingual immunotherapy: the quality of 5-grass pollen tablet is recognized also in Italy
Bibliographic record
Abstract
After a century of allergen immunotherapy (AIT), for the first time, the Italian Agency for Drugs (AIFA [Agenzia italiana per il farmaco]) has just approved the full reimbursement (A class) for an AIT product, such as the 5-grass pollen tablet with the indication for treating allergic rhinitis (AR).On the other hand, AR represents a relevant health issue as the worldwide prevalence is approximately 20%. 1 AR is sustained by an IgE-mediated inflammatory reaction that in turn induces typical symptom occurrence.Allergic inflammation is promoted by an allergen-specific defect of T-regulatory cells and a Th2 polarization.2 This impaired immune response characterizes the two main peculiarities of allergic reaction: systemic IgE production and nasal eosinophil infiltrate.3 AR has also a significant social burden both in terms of high costs and individual complaints, mainly negatively affecting quality of life.AR treatment is traditionally based on drug prescription, such as antihistamines and topical corticosteroids.However, the main limit of drug therapy is that it is essentially symptomatic and its efficacy quickly stops after suspension.On the contrary, AIT is the unique causal therapy of AR as it is able of inducing a long-lasting immunological and clinical tolerance toward the causal allergen.4 The mechanism of action of AIT is based on restored T-regulatory function and re-direction of immune response to a physiological Th1-oriented pathway.5 AIT consists of administering increasing doses of the causal allergen extract able to reduce allergic symptoms.6 There is strengthened evidence that AIT is effective and safe as recognized by the meta-analysis approach.7 At present, sublingual immunotherapy is commonly prescribed for AR patients as effective and well tolerated.The 5-grass pollen tablet according to a pre-co-seasonal course, has the indication for AR and/or conjunctivitis treatment in adult or pediatric (over 5 years) patients with severe symptoms as documented by two regulatory studies.8,9 AIFA's decision of full-reimbursement for the 5-grass pollen tablet has been based on the qualified requirements of this product: allergen panel composition, effectiveness, safety, standardization, adequate dosage, and pharmaco-economic impact.First, sublingual tablets are composed of 5-grass pollens, belonging to Pooideae family (Dactylis glomerata, Anthoxanthum odoratum, Lolium perenne, Poa pratensis, and Phleum pratense).This 5-grass mixture is appropriate according to the production of pollen by the grasses as evidenced by phenological studies.10 In fact, the approach by phenology demonstrated that the different grasses yield their pollen in dissimilar times of the season in Journal of Asthma and Allergy downloaded from https://www.dovepress.com
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.012 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.003 | 0.004 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.007 | 0.014 |
| Insufficient payload (model declined to judge) | 0.009 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".