ALLEGRO 3-Year Data Demonstrate Effectiveness in Alopecia Areata for Adults, Adolescents

An analysis of 3-year data from patients with alopecia areata in the ritlecitinib (Litfulo) clinical trial program at the European Academy of Dermatology and Venereology (EADV) 2025 Congress demonstrates the long-term of the JAK inhibitor in both adults and pediatric populations.

Results of the analysis indicate nearly 90% of those achieving Severity of Alopecia Tool (SALT) scores of 20 or less maintained the benefit out to 36-38 months, with almost 30% achieving complete scalp hair regrowth.

“A SALT score less than or equal to 10, a SALT score less than or equal to 5, a SALT score of 0 hair loss, right? These are the ultimate goals of treatment,” explained study presented Brett King, MD, PhD, of Yale University School of Medicine, in an interview with HCPLive.

Few, if any, disease states in dermatology can lay claim to same rapid revolution in pharmacotherapy witnessed with the JAK inhibitor class in alopecia areata. A disease with 0 FDA-approved therapies until 2022, dermatology has now witnessed approvals for baricitinib (Olumiant), ritlecitinib, and deuruxolitinib (Leqselvi) in June 2022, June 2023, and July 2024, respectively.2,3,4

As King explained in an interview with HCPLive, the focus has shifted from achieving SALT score of 20, which is historically the primary endpoint of phase 3 alopecia areata trials, and the field is now focused on achieving even greater outcomes for patients.1

Investigators designed the ALLEGRO analysis for EADV Congress 2025 to explore the durability of benefit and long-term safety profile of ritlecitinib in patients from the ALLEGRO-2b/3 trial who were enrolled into ALLEGRO-LT. Of note, data from patients who received placebo and switched to ritlecitinib were rebaselined to align time points across groups for analysis. Additionally, investigators leveraged both the observed and last observation carried forward (LOCF) data for this analysis.1

Endpoints of interest for the analysis included:

• Proportion of patients with SALT score ≤20, SALT score ≤10, and SALT score 0 at month 36-38
• maintenance of SALT score ≤20 response in patients who had a SALT score ≤20 at months 12 and 36-38 regardless of SALT score between timepoints,
• SALT score of 0 at ≥1 time point through month 36-38,
• Eyebrow and eyelash assessment (EBA/ELA) response at month 36-38.

Results of the study suggested 65.1% (observed) and 47.1% (90/191 LOCF) of patients had SALT score ≤20 at 36-38 months. Among those who achieved SALT score ≤20 at month 12, 88.3% (observed) and 89.6% (LOCF) of patients maintained this response at months 36-38.1

By months 36-38, complete scalp hair regrowth was achieved in 29.8% of patients, with investigators pointing out 61.4% of this group did not have a subsequent increase in SALT score at later visits. Among those who achieved a SALT score of 0 at 1 or more visits, 84.2% remained at a SALT score of ≤5.1

When assessing EBA/ELA response, investigators found 63.2% (36/57 observed) and 48.7% (75/154 LOCF) had an EBA response at month 36-38 and 60.4% (32/53 observed) and 49.6% (69/139 LOCF) had an ELA response.1

No new safety signals emerged during the study and the overall safety profile of ritlecitinib was consistent with the established profile from previous trials.1

“We see retention of clinical benefit achieved at month 12 maintained at month 36 in approximately 90% of patients, but, again, we see achievement of SALT score zero, so 0% terminal scalp hair loss in about 30% of patients out at month 36,” King added. “So really, really important data and tells us a lot about what we can do or what we can expect with treatment with ritlecitinib, of our patients with severe alopecia areata.”

References:

1. King B. Long-term efficacy and complete scalp hair regrowth in patients with alopecia areata receiving ritlecitinib 50 mg QD up to 3 years in the ALLEGRO clinical trial program. Presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

2. Pfizer Inc. FDA Approves Pfizer’s LITFULOTM (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata | Pfizer. www.pfizer.com. Published June 23, 2023. Accessed September 19, 2025. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-litfulotm-ritlecitinib-adults-and

3. Eli Lilly and Company. FDA Approves Lilly and Incyte’s OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata | Eli Lilly and Company. Eli Lilly and Company. Published June 13, 2022. Accessed September 19, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lilly-and-incytes-olumiantr-baricitinib-first-and

4. National Alopecia Areata Foundation. FDA Approves LEQSELVITM for Adults with Severe Alopecia Areata - National Alopecia Areata Foundation | NAAF. National Alopecia Areata Foundation | NAAF. Published July 26, 2024. Accessed September 19, 2025. https://www.naaf.org/news/fda-approves-leqselvi-deuruxolitinib-for-adults-with-severe-alopecia-areata/