Think of feeling itchy for more than half the day, an itch so intense and persistent that you can’t sleep at night, which leads you to scratch until your skin bleeds. Or imagine going to take a shower and starting to see your hair falling out in clumps, suddenly, for no apparent reason. These situations are just two of the examples that those suffering from atopic dermatitis and severe alopecia areata could describe: rare dermatological diseases – but not too rare – which are united by exaggerated and abnormal reactions of the immune system, with a terrible impact on physical and psychological and quality of life of patients. However, they also have something else in common: a drug, baricitinib, is changing the history of these diseases and is now finally reimbursable in band H (i.e. distributed only by hospital facilities) for adult patients.
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Atopic dermatitis is a chronic inflammatory skin disease whose main symptoms are eczema and persistent and intense itching, which in severe forms does not abandon the patient for more than 12 hours during the day and which becomes worse at night , preventing proper rest. “It’s not a simple itch – he explains Mauro Picozza, president of Andea (national atopic dermatitis association) and FederAsmallergie – there is also the pain of the lesions and the embarrassment of the aesthetic manifestations. And then there is also the fear of going to sleep and waking up with new, ugly self-inflicted injuries unknowingly in your sleep. There is social exclusion, the impossibility of moving as one would like, even limitations in the choice of clothes.” The impact of this disease, which affects approximately 8% of adults and 30% of children, is truly great, not to mention that it is often accompanied by other conditions (allergic rhinitis, asthma, food allergies attributable to the anomalous activation of same components of the immune system that cause eczema and itching) and to psychiatric disorders such as depression.
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A similar impact on people’s well-being is that caused by the onset of alopecia areata (1-4% of the population, in Italy it is estimated that almost 18 thousand people suffer from it), which presents with sudden hair loss, from patches well-defined on the scalp to total hair loss (alopecia totalis), up to loss of body hair all over the body (alopecia universalis). And it’s not just an aesthetic issue: patients are more susceptible, for example, to sunburn, eye irritation, allergies, poor thermoregulation. “What as a patient and as president of Aipaf (Italian Association of Alopecia Patients and Friends) I want to convey to those who do not know and do not live with this disease is that perhaps one does not die physically from alopecia areata, but one risks dying inside – he comments Claudia Cassia – It’s difficult to make people understand the shock you feel immediately and the discomfort of having to live with a new appearance that doesn’t match yours. Not to mention social discrimination – children above all are subject to ruthless bullying – and even the change in relationships with others.”
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From hope to reality
Both atopic dermatitis and alopecia areata are diseases that you have to live with. The manifestations can disappear even for prolonged periods, only to reappear later in life and in the most serious cases they stop responding to treatments. For a few years, however, the new drug has been available, which is capable of selectively blocking the molecules that drive inflammatory reactions and which are among the causes of atopic dermatitis and alopecia areata. Already approved for rheumatoid arthritis, baricitinib has received the green light from the European Medicines Agency (EMA) for moderate and severe forms of atopic dermatitis (2020) and alopecia areata (2022) in adult patients, and it is now reimbursed in band H also in Italy. “The reimbursement for baricitinib is a big step forward because it was the first drug ever approved for the treatment and clinical studies have widely demonstrated its safety and effectiveness – he specifies Bianca Maria Piraccini, Director of the IRCCS Dermatology Unit Policlinico di Sant’Orsola University of Bologna – Suffice it to say that within a few weeks patients see hair and hair regrow even when they have been missing for years”. Having developed a drug that acts specifically by blocking a particular inflammatory pathway has also made it possible to recognize alopecia areata as an autoimmune disease. With reimbursement in band H, then, it becomes available in a more widespread way throughout the area, making the treatment more accessible to patients, who will perhaps not be forced to make long journeys to the dermatological reference centre. “Baricitinib – he concludes Antonio Costanzo, Director of the Dermatology Operating Unit of Humanitas – is an inhibitor of two particular cytokines. Already widely used in the treatment of rheumatoid arthritis, it has a well-characterized safety profile and has few drug interactions. On a therapeutic level for atopic dermatitis, as demonstrated by clinical studies, it has the advantage of acting quickly, calming itching and also acting on skin lesions. Reimbursability is excellent news also because there are still few systemic therapies.”