Alopecia areata, Aifa ok to reimbursement of new treatment

The Italian Medicines Agency (AIFA) has authorized reimbursement for ritlecitinib, a treatment indicated for severe alopecia areata in adults and adolescents aged 12 years and older who are candidates for systemic therapy and who have responded inadequately or are intolerant to alternative treatment options or for whom alternative treatment options are not appropriate. The reimbursement regime for ritlecitinib – reports a note from Pfizer – was established by the AIFA resolution published in the Official Journal on 17 September (GU n.218 170924). The drug, in class H, in the 50 mg hard capsule formulation for oral administration, is subject to limited medical prescription, to be renewed each time, by hospital centers or specialists – dermatologist and pediatrician.

Ritlecitinib, already authorized in Europe by the EMA on September 15, 2023 – it is written – works by reducing the activity of enzymes called JAK3 and Tec kinases involved in the inflammation of the hair follicle. This reduces inflammation, promoting hair regrowth in patients with alopecia areata. As reported by the EMA – the note reports – the approval process is based on a main study conducted on 718 adults and adolescents over the age of 12 with severe alopecia areata, 261 of whom were treated with 50 mg of ritlecitinib or placebo. All patients had hair loss of more than 50% before starting treatment.

After 24 weeks of treatment, the symptoms of the disease improved in patients treated with ritlecitinib: 13% of them were close to remission, meaning they had more than 90% coverage of the scalp, and 23% had more than 80% coverage. Such improvements were seen in 1.5% of patients treated with placebo. After 48 weeks, 31% of patients treated with the drug were close to remission. When asked whether their hair loss had improved, 49% of patients treated with ritlecitinib said that their condition was moderately or extremely improved, compared with 9% of patients who had received placebo. Alopecia areata is an autoimmune disease characterised by patchy or complete loss of hair on the scalp or hair on the face and/or other parts of the body. The disease has an immuno-inflammatory origin and develops when the immune system attacks the hair follicles, causing hair loss. It affects approximately 2% of the population, regardless of age, sex, or ethnicity, and causes significant psychosocial distress in affected individuals.