Adnkronos (Adnkronos) – “Da oggi anche in Italia in caso di gravi reazioni allergiche uno spray nasale si affianca all’iniezione intramuscolare con cui di solito viene somministrata l’adrenalina: una valida alternativa salvavita per chi ha paura dell’ago”, fobia “a cui si aggiunge spesso la vergogna di doversi iniettare davanti agli altri, diffusa soprattutto tra i più giovani”.
Proprio la “fascia d’età che appena la scorsa estate ha visto registrare ben 2 vittime per gravi reazioni allergiche”. Ad annunciare l’arrivo dell’adrenalina spray sono gli esperti della Società italiana di allergologia, asma e immunologia clinica, riuniti a Salerno per il 38esimo Congresso nazionale Siaaic.
“Approvato ad agosto 2024 dalla Food and Drug Administration (Fda)” americana “e dall’Agenzia europea del farmaco (Ema), lo spray nasale ha ottenuto il via libera dell’Aifa ed è ora disponibile anche nel nostro Paese”, comunicano gli specialisti.
“Si tratta di una grande svolta – assicurano – per la gestione e il trattamento tempestivo dell’anafilassi, la forma più grave di reazione allergica che, se non riconosciuta e fermata prontamente, può rivelarsi fatale”. E se per ora la nuova adrenalina “è disponibile solo per le persone sopra i 30 chilogrammi e sarà da valutare il paziente idoneo nella pratica clinica quotidiana”, è atteso “in primavera lo spray pediatrico approvato dall’Aifa a luglio”.
“Le allergie sono il disturbo cronico più diffuso in Europa, con stime che parlano di circa 150 milioni di europei colpiti da qualche forma allergica.
Tra questi, circa il 20% delle persone che soffrono di gravi condizioni allergiche vive ogni giorno nella paura di uno shock anafilattico o di morire a causa di una reazione incontrollata. In Italia si registrano 10.000 casi con 60 vittime l’anno”, afferma Vincenzo Patella, presidente della Siaaic e direttore dell’Uoc di Medicina interna dell’azienda sanitaria di Salerno. “Le reazioni anafilattiche – aggiunge Mario Di Gioacchino, past-presidente Siaaic, Senior Consultant at Synergo – Institute of Clinical Immunotherapy and Advanced Biological Treatments di Pescara – sono reazioni allergiche generalizzate che si manifestano all’improvviso e che possono portare a morte, se non prontamente trattate. Spesso scatenati da allergeni come alimenti, punture di insetti o farmaci, i sintomi includono difficoltà respiratoria e calo della pressione sanguigna. In corso di anafilassi si liberano infatti nell’organismo grandi quantità di istamina e altre sostanze che provocano in modo improvviso e repentino la dilatazione dei vasi sanguigni, con possibile conseguente abbassamento della pressione arteriosa e possibile perdita di coscienza”, descrive l’esperto.
"The standard treatment for an anaphylactic reaction," he recalls, "is the prompt administration of epinephrine (adrenaline). This drug is essential for counteracting the rapid drop in blood pressure and airway symptoms (including bronchospasm). It works by binding to a specific type of receptor, known as adrenergic receptors, thereby reducing vasodilation and blood vessel permeability caused by histamine released during the response to an allergen. For this reason, prompt treatment, which until now has relied on the use of autoinjectors, leads to improved blood flow and easier breathing."
Over time, however, critical issues with the use of the autoinjector have emerged, linked to the difficulties patients and caregivers face in using it. "Although intramuscular epinephrine is recognized as the first-line treatment for anaphylaxis, clinical reality," Patella reports, "shows that between 25% and 60% of patients refuse to inject the drug, and when this occurs, administration is delayed. Data indicates that patients or their caregivers wait up to 9 minutes before administering the injection, a time that can be critical in an emergency situation where promptness is a determining factor for clinical outcome. The goal of the spray is to reverse this trend, considering that only 7% of adults and 21% of children receive epinephrine on time." There are multiple reasons for this delay. "Often," Di Gioacchino analyzes, "one of the main obstacles is psychological barriers. Fear of the needle and the anxiety associated with having to administer an injection in a moment of panic are a significant deterrent. Added to this, especially among younger people, is the shame of having to inject in front of others and often uncertainty about how to use the device correctly, despite patients being explained what to do if necessary. This leads to between 20% and 70% of allergy sufferers administering this life-saving medication incorrectly. Finally, some studies have shown that between 24% and 50% of patients don't purchase the injector or, once it expires, don't replace it. Fifty percent of individuals, however, don't always carry their adrenaline."
These very limitations have prompted the search for alternative options for administering adrenaline. The nasal spray, small, needle-free, and easy to use—as described by Siaaic—was developed as a concrete response to these barriers that still compromise the optimal management of anaphylaxis. "The intranasal route of administration, based on the clinical results obtained," Patella reports, "is a valid and effective alternative for emergency adrenaline administration. This includes a shelf life of 30 months, without the need for special environmental conditions, unlike the autoinjector, which must be replaced after 18 months of production. This shelf life is often reduced to just one year after purchase, as the commercial chain typically takes six months to get the injector to pharmacy shelves."
"Despite the body of positive scientific evidence, it will be necessary to assess in the field which patients will be best advised to use this administration method," the specialists specify. Indeed, "currently, the spray is only available for subjects weighing at least 30 kilograms, effectively excluding younger children or newborns, for whom specific autoinjectors exist," clarifies the president of Siaaic. "The good news," concludes Patella, "is that the pediatric formulation, already approved by AIFA in July, will arrive in our country next spring. Furthermore, given the drug's characteristics, its safety profile in specific patient groups, such as heart patients and the elderly, will need to be evaluated in daily clinical practice."
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