Study Suggests Ritlecitinib Effective Long-Term Among Patients with Alopecia Areata

Ritlecitinib treatment of patients with alopecia areata and ≥25% scalp hair loss may result in an acceptable safety profile and demonstrate clinical efficacy with long-term treatment, recent findings suggest.1

This study was led in part by Christos Tziotzios, PhD, from St John's Institute of Dermatology at King's College London. Tziotzios and colleagues highlighted the limited efficacy data available on new systemic therapies for patients with alopecia areata and 25% or more scalp hair loss.

“ALLEGRO-LT includes patients rolled over from previous index studies of ritlecitinib and a de novo cohort of patients aged ≥12 years with no previous ritlecitinib treatment and have ≥25% scalp hair loss, as measured by SALT, representing a broader patient population than prior [alopecia areata] phase 3 studies,” the investigators wrote. "Here we report a long-term safety and efficacy analysis of de novo patients in ALLEGRO-LT, including the effect of baseline SALT score on efficacy outcomes.”1,2

Study Design

The investigative team for ALLEGRO-LT involved a set of rollover patients who had previously been a part of a study intervention in the ALLEGRO phase 2a study or the 2b/3 study. Additionally, the team recruited de novo patients, all of whom had not been given treatment in either of these 2 analyses.

Within ALLERGRO-LT, all of the participants involved were required to have had ≥25% scalp hair loss as a result of their alopecia areata. This included those with alopecia totalis (AT) and those with alopecia universalis (AU), as determined through the use of the Severity of Alopecia Tool (SALT).

The investigators noted that these subjects could not have evidence of terminal hair regrowth within 6 months by the screening visit and at baseline visits. They required participants’ duration of their current hair loss episode to last ≤10 years. Additionally, patients in the adolescent category aged 12–17 years had to show a SALT score ≤20 at the 6-month mark to continue on in the research.

In this description of their analysis, the investigators’ de novo cohort results were reported. Those who were aged ≥12 years with alopecia and reporting ≥25% loss of scalp hair were provided a daily regimen, lasting 4-weeks, of 200-mg ritlecitinib loading dose. This would then be followed by 50-mg ritlecitinib each day.

The research team’s analyses were based on data gathered up until the cut-off point in December 2022. In their efficacy outcomes, the team included proportions of subjects achieving Patient Global Impression of Change (PGI-C) scores of ‘moderately improved’ or ‘greatly improved,’ eyebrow assessment (EBA) and eyelash assessment (ELA) responses with ≥2-grade improvement from the point of baseline or normal scores among those reporting abnormal baseline EBA/ELA), as well as SALT scores of ≤20 and ≤10.

Notable Findings

The investigators determined that among their 449 de novo study participants, the mean ritlecitinib exposure was shown to be 728.7 days. By the 24-month mark, the team observed that 73.5% and 66.4% of those assessed achieved SALT scores of ≤20 and ≤10.

They added that 82.4% had PGI-C response and 60.8% and 65.7% had EBA and ELA responses, respectively.

Additionally, the research team found that 86.1% reported treatment-emergent adverse events, most of which were shown to have a severity level that was mild or moderate. The team added that the most frequent of these events had been headache among 20.8%, a positive SARS-CoV-2 test among 24.2%, and pyrexia among 13.0%.

The investigators determined that serious events due to adverse events, severe adverse events, and treatment cessations had been 4.9%, 6.0% and 6.5%, respectively. Among 6 individuals, there were herpes zoster infection occurrences.

Among 4 individuals, there were serious infections, and 3 reports of malignancies. Lastly, they found that 3 major adverse cardiovascular events had been reported.

“In summary, long-term treatment with ritlecitinib 50 mg QD (with a 200-mg loading dose) was efficacious and well tolerated in adults and adolescents with [alopecia areata] and scalp hair loss ≥25%,” they wrote. “Efficacy was observed in all subgroups based on baseline scalp hair loss, including patients with AT and AU, with the highest treatment response observed in patients with 25% to 50% scalp hair loss.”1

References

1. Tziotzios C, Sinclair R, Lesiak A, Mehlis S, Kinoshita-Ise M, Tsianakas 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; 00: 1–11. https://doi.org/10.1111/jdv.20526.
2. King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022; 386(18): 1687–1699. https://doi.org/10.1056/NEJMoa2110343.