A recent ALLEGRO-LT trial reported strong results on the use of ritlecitinib for treating alopecia areata (AA), characterized by patchy or total hair loss. The study published in the Journal of the European Academy of Dermatology and Venereology focused on patients with at least 25% scalp hair loss and tracked their progress over a 24-month period.
The patients who had not received treatment in previous ALLEGRO studies, were now available and show that ritlecitinib offers sustained efficacy along with a manageable safety profile. The participants, aged 12 years and older, were initially given a 4-week 200-mg daily loading dose of ritlecitinib, followed by a daily 50-mg maintenance dose. A total of 449 patients were included in this analysis, with an average drug exposure of nearly 2 years.
By the 24-month mark, efficacy outcomes were notable: 73.5% of patients achieved a Severity of Alopecia Tool (SALT) score ≤20, which indicated they had recovered at least 80% of their scalp hair. Almost, 66.4% reached a SALT score ≤10, that reflected 90% or more hair regrowth. A strong 82.4% reported improvement in their condition based on the Patient Global Impression of Change (PGI-C), describing their symptoms as “moderately” or “greatly improved.”
Regarding facial hair restoration, 60.8% experienced a meaningful eyebrow (EBA) response, and 65.7% showed similar improvement in eyelash (ELA) regrowth. These improvements were measured by either a 2-grade or more increase from baseline or a return to a normal score. In terms of safety, 86.1% of patients reported treatment-emergent adverse events (AEs), most of which were categorized as mild to moderate in severity.
The most frequently observed AEs included, positive SARS-CoV-2 test (24.2%), headache (20.8%) and fever (13.0%). The study documented a total of 4.9% serious AEs, 6.0% severe AEs, 6.5% treatment discontinuations. Also, there were 6 cases of herpes zoster, 4 serious infections, and 3 cases each of malignancies (excluding nonmelanoma skin cancer) and major adverse cardiovascular events.
Overall, this study supports ritlecitinib as a long-term, effective treatment option for patients with moderate-to-severe alopecia areata. With nearly 3-quarters of patients experiencing significant scalp hair regrowth and high levels of patient-reported improvement, the data reinforce the potential of ritlecitinib as a breakthrough therapy.
Source:
Tziotzios, C., Sinclair, R., Lesiak, A., Mehlis, S., Kinoshita-Ise, M., Tsianakas, A., Luo, X., Law, E. H., Ishowo-Adejumo, R., Wolk, R., Sadrarhami, M., & Lejeune, A. (2025). Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the ALLEGRO-LT phase 3, open-label study. Journal of the European Academy of Dermatology and Venereology: JEADV, 39(6), 1152–1162. https://doi.org/10.1111/jdv.20526
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