Research Summary

Can Ritlecitinib Offer Sustained Benefit in Patients with Alopecia Areata?

Anthony Calabro, MA

Key Highlights

  • At 2 years, 73.5% of patients achieved Severity of Alopecia Tool (SALT) score of less than or equal to 20 and 66.4% achieved SALT score of less than or equal to 10.
  • More than 80% of participants reported moderate or great improvement, according to the Patient Global Impression of Change scale.
  • Eyebrow and eyelash regrowth was found in less than 60% of patients.
  • Long-term treatment was generally well tolerated with few serious adverse events.

In the long-term phase 3 ALLEGRO-LT trial, ritlecitinib demonstrated sustained clinical benefit over 24 months in adolescents and adults with alopecia areata (AA) and at least 25% scalp hair loss. By Month 24, 73.5% of patients reached a Severity of Alopecia Tool (SALT) score of less than or equal to 20, and 66.4% achieved SALT less than or equal to 10. Additionally, 82.4% of participants reported feeling "moderately" or "greatly" improved, while more than 60% experienced clinically meaningful regrowth of eyebrows and eyelashes.

Alopecia areata is a chronic autoimmune condition often associated with psychological distress and reduced quality of life. While short-term efficacy of ritlecitinib has been shown in earlier trials, longer-term outcomes are essential to determine the durability of clinical responses and safety over extended periods. The ALLEGRO-LT trial aimed to fill this evidence gap by examining 2-year outcomes in patients who had not previously participated in earlier ritlecitinib trials.

This multicenter, open-label, phase 3 study enrolled 449 de novo patients aged 12 years or older with less than or equal to 25% scalp hair loss. All participants received a 200 mg daily loading dose of ritlecitinib for 4 weeks, followed by 50 mg daily as maintenance. The reported outcomes are based on data collected up to December 2022. Efficacy was evaluated using SALT scores, Patient Global Impression of Change (PGI-C), and assessments of eyebrow and eyelash regrowth. Safety assessments included incidence and severity of adverse events (AEs), serious AEs, infections, malignancies, and major cardiovascular events.

Mean treatment exposure was approximately 729 days. At Month 24, 73.5% of patients achieved SALT less than or equal to 20 and 66.4% reached SALT less than or equal to 10. In terms of patient-reported outcomes, 82.4% reported moderate or great improvement per PGI-C. For facial hair regrowth, 60.8% and 65.7% of patients demonstrated eyebrow and eyelash response, respectively.

Adverse events were reported by 86.1% of patients, most of which were mild or moderate. The most common AEs included positive SARS-CoV-2 test (24.2%), headache (20.8%), and pyrexia (13.0%). Serious AEs, severe AEs, and treatment discontinuation rates were low at 4.9%, 6.0%, and 6.5%, respectively. Notable but infrequent events included six cases of herpes zoster, four serious infections, and three cases each of malignancy and major cardiovascular events.

Limitations include the open-label design and lack of a control group, which may introduce bias in efficacy reporting. Additionally, the reliance on as-observed data could influence interpretation of long-term response durability.

“In patients with AA and less than or equal to 25% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long-term treatment,” Tziotzios and colleagues concluded.

 

Reference
Tziotzios C, Sinclair R, Lesiak A, et al. 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. J Eur Acad Dermatol Venereol. 2025;39(6):1152-1162. doi:10.1111/jdv.20526