Ritlecitinib efficacy sustained up to 3 years in ALLEGRO trials

Ritlecitinib 50 mg demonstrates clinically meaningful efficacy up to 36 months in individuals with alopecia areata (AA) in the phase IIb/III ALLEGRO and ongoing phase III ALLEGRO-LT trials.

“In AA clinical trials, the achievement of Severity of Alopecia Tool (SALT) scores ≤20 and ≤10 (≤20 and ≤10 percent scalp hair loss, respectively) are commonly reported, but we are less accustomed to hearing an achievement of SALT score 0 (complete scalp hair regrowth), perhaps the deepest and most stringent endpoints,” noted Dr Brett King from the Dermatology Physicians of Connecticut, Fairfield, Connecticut, US, at EADV 2025.

“We report efficacy results through 3 years, including the achievement of SALT score 0, in AA patients receiving the oral selective JAK3/TEC family kinase inhibitor ritlecitinib,” he continued.

The dataset included 191 participants (median age 31 years, 56 percent women) from ALLEGRO groups C (n=130) and G (n=61) who rolled over to the 60-month ALLEGRO-LT trial to continue ritlecitinib 50 mg. Group C patients are those who have been on ritlecitinib 50 mg throughout the loading and extension phases. Those in group G were on placebo during the loading and maintenance phases, then transitioned to ritlecitinib 50 mg during the extension phase.

The mean SALT score was 90.8. The data were presented as observed and imputed or last observation carried forward (LOCF). [EADV 2025, abstract LBA 335]

At 36 months, 65.1 percent (observed) and 47.1 percent (LOCF) of patients had SALT score ≤20. The corresponding SALT score ≤10 response rates were 52.3 percent and 36.7 percent, respectively.

Of note, over 80 percent of participants who achieved SALT scores ≤20 (88.3 percent [observed] and 89.6 percent [LOCF]) and ≤10 (82.6 percent and 84.8 percent, respectively) at 1 year maintained their responses at 3 years.

Some achieved complete hair regrowth

SALT score 0 response rates were 31.2 percent (observed) and 22.5 percent (LOCF). This means that approximately one-third of participants had complete scalp hair regrowth by year 3.

Of note, nearly 30 percent of participants had a SALT score 0 during at least one visit through month 36. “[About] 62 percent of these patients did not have an increase in SALT score at later visits. A third did have an increase in SALT score at a subsequent visit, but this remained at ≤20,” King noted. Only three patients in this subgroup had a SALT score >20 at a later visit, which may indicate loss of response.

Eyebrow, eyelash assessments

Among participants who had abnormal eyebrow assessment (EBA) or eyelash assessment (ELA) at baseline, EBA and ELA (observed) responses at 3 years were 63.2 percent and 60.4 percent, respectively. The corresponding rates for LOCF were 48.7 percent and 49.6 percent.

Approximately 80 percent of participants had normal EBA/ELA in at least one visit when a SALT score of 0 was achieved.

Impairs quality of life

Hair loss due to AA can be patchy or extensive, or involve complete loss of hair on the scalp, which could extend to the face and body. [Autoimmun Rev 2015;14:81-89] These manifestations may negatively impact the psychological well-being and quality of life of AA patients. [Dermatol Res Pract 2020;2020:8879343; J Am Acad Dermatol 2018;79:556-558.e1]

The initial ALLEGRO findings have paved the way for the approval of ritlecitinib as treatment for adolescent and adult patients with severe AA in several countries. [Lancet 2023;401:1518-1529; https://web.archive.org/web/20240405073315/https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-litfulo; https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721405092068; https://www.ema.europa.eu/en/medicines/human/EPAR/litfulo, accessed October 3, 2025]

“The 3-year data are all relatively new to us. The first-ever medicines that have been approved for the treatment of severe AA are brand new in the last 3 years, so this is the first time that we are seeing long-term data,” King said. “[Taken together, these results] support the long-term use of ritlecitinib in AA patients aged ≥12 years.”