Long-term results from the ALLEGRO clinical trial program of Pfizer’s JAK inhibitor ritlecitinib for severe alopecia areata showed that complete scalp regrowth occurred in a good proportion of patients.
Nearly one third (31.2%) of patients taking ritlecitinib over 3 years had complete scalp hair regrowth at least once, Brett King, MD, PhD, a dermatologist based in Fairfield, Connecticut, reported during a late-breaking news session at the European Academy of Dermatology and Venereology (EADV) 2025 Congress.
“In clinical trials in alopecia areata, we are accustomed to reporting, or hearing, the data for achievement of SALT [Severity of Alopecia Tool] score less than or equal to 20 [or] SALT score less than or equal to 10; these are the same as 20% or less scalp hair loss or 10% or less scalp hair loss at the end of the trial,” King explained.
“But we're less accustomed to hearing the results of perhaps the deepest, most stringent endpoint, achievement of SALT score 0 or 0% scalp hair loss,” King said. He noted that participants who did not achieve this endpoint still cleared the high bar of a SALT score of 5 or less.
“This is all relatively new to us,” King observed. “The medicines that have been approved — the first-ever medicines approved for the treatment of severe alopecia areata — are brand new in the last 3 years. So, this is really the first time that we're seeing this very long-term data.”
The ALLEGRO Analysis
King reported efficacy results obtained at months 36 to 38 from the ALLEGRO phase 2b/3 trials and the ongoing phase 3, open-label ALLEGRO-LT studies. The main outcomes were the proportions of patients who had been treated with ritlecitinib at a dose of 50 mg once daily who had a response through 3 years (ie, SALT score of 20 or less, SALT score of 10 or less, and SALT score of 0). Results were also presented on the proportion of patients with eyebrow and eyelash regrowth. Data were given as observed and imputed (ie, the last observation carried forward [LOCF]).
The median age of participants was 31 years, 56% were women, and 64.4% were White. The median duration of alopecia areata since diagnosis was 6.9 years, and the duration of the current alopecia areata episode was 2.2 years.
At 36 months, King reported that a SALT score of 20 or less was achieved by 65.1% (observed) and 47.1% (LOCF) of patients, and that 52.3% (observed) and 36.7% (LOCF) had achieved a SALT score of 10 or less.
Of patients with a SALT score ≤ 20 at 1 year of treatment, 88.3% (observed) and 89.6% (LOCF) had maintained this response at 3 years. For those achieving a SALT score of ≤ 10 at 1 year, 82.6% (observed) and 84.8% (LOCF) maintained the response at 3 years.
Eyebrow Assessment and Eyelash Assessment responses were 63.2% (observed) and 48.7% (LOCF) and 60.4% (observed) and 49.6% (LOCF), respectively.
The LOCF value for people achieving a SALT score of 0 at least once was 22.5%.
King also reported that “almost one quarter of patients achieved complete scalp hair regrowth and normal eyebrows and normal eyelashes at more than one time point.”
Stratification and Access
“We have new drugs and new ideas on how to treat the disorders. We see that some patients benefit and others do not. What we don't know is how to stratify those patients for the therapies,” Cristina Has, MD, who co-chaired the late-breaking news session, told Medscape Medical News.
Has, a senior dermatologist and professor of experimental dermatology at the University of Freiburg in Germany, was not involved in the study. She added that access to new treatments such as ritlecitinib could vary.
“We have access to most [new] drugs, except those for hair disorders, because in Germany, hair loss is considered kind of a cosmetic thing, and those drugs are not paid for by insurance. But otherwise, we are lucky to have access.”
Although response predictors of achieving a SALT score of 0 may not have been analyzed yet, predictors of SALT scores of ≤ 20 and ≤ 10 have, King noted.
“We know that the baseline characteristics that predict [response] include short duration of current episode — the shorter the better,” he said. Also, “having hair at baseline” was important, so “treating patients before they reach the SALT score of 95 to 100 also predicts those low SALT score achievers.”
The study was funded by Pfizer. King has acted as an advisor or consultant, clinical trial investigator, or data monitoring committee member for multiple pharmaceutical companies, including Pfizer. Several co-authors of the analysis were employees of Pfizer. Has had no relevant financial relationships.
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