Sustained responses as measured by the Severity of Alopecia Tool (SALT) score, as well as eyebrow and eyelash assessments, were achieved with ritlecitinib in patients with alopecia areata, according to the results of a post hoc analysis presented at the 2023 Annual Meeting of the American Academy of Dermatology (AAD), held from March 17 to 21, 2023, in New Orleans, Louisiana.
Efficacy and safety of treatment with ritlecitinib — an oral JAK3/TEC kinase family inhibitor — among patients with alopecia areata experiencing at least 50% scalp hair loss for at least 6 months to 10 years were demonstrated in the ALLEGRO phase 2b/3 trial (ClinicalTrials.gov Identifier: NCT03732807). In the current study, investigators sought to determine if patients with alopecia areata who had a clinical response to ritlecitinib at week 24 in ALLEGRO sustained scalp, eyebrow, and eyelash hair regrowth at week 48.
They conducted a post hoc analysis of the ALLEGRO phase 2b/3 study that included patients with alopecia areata at least 12 years of age with at least 50% scalp hair loss who received ritlecitinib 10 mg (n=63), 30 mg (n=132), 50 mg (n=130), 200/30 mg (n=130), 200/50 mg (n=132), or placebo (n=131) for 24 weeks (± a 4-week 200 mg-daily loading dose). In a 24-week extension, participants receiving ritlecitinib continued with assigned doses and participants in the placebo group switched to ritlecitinib 200/50 mg or 50 mg. Patients with previous use of any JAK inhibitor or with other causes of alopecia were excluded.
Patients receiving ritlecitinib tended to be women (65%- 86% per group), at least 18 years of age (mean per ritlecitinib group ranged from 32 years to 37 years), and White with mean disease duration of 7 to 10 years, mean duration of current alopecia areata episode of more than 2 years, and a mean baseline SALT score between 78 and 84.
Based on SALT score equal to or less than 20 (≤20% scalp without hair), SALT score equal to or less than 10, eyebrow response (≥2-grade improvement or a normal eyebrow score at week 24 in patients with abnormal eyebrow scores at baseline) or eyelash response (same definition using eyebrow scores), patients who responded at week 24 after receiving ritlecitinib were further evaluated for sustained response at week 48 (meeting response criteria at weeks 24 and 48 without loss of response in between).
Investigators reported that at least 85% of patients receiving ritlecitinib who achieved SALT score equal to or less than 20 at week 24 experienced a sustained response through week 48. At least 68% of patients receiving ritlecitinib who achieved SALT score equal to or less than 10 experienced a sustained response through week 48. Between 70.4% and 96.9% of patients with eyebrow response at week 24 and between 52.4% and 94.1% of patients with eyelash response at week 24 experienced a sustained response through week 48. The investigators noted ritlecitinib was well tolerated. The most common adverse events occurring in at least 5% of patients in any treatment group included urticaria, nasopharyngitis, upper respiratory tract infection, and headache.
Post hoc analysis limitations include the nature of post hoc study design. In addition, the preponderance of women participating in the study may limit generalizability of findings.
“Sustained hair regrowth response was achieved with continued ritlecitinib treatment through Week 48 in the majority of patients with [alopecia areata] who had a clinical response based on scalp, eyebrow, or eyelash regrowth at Week 24,” the investigators concluded. They further comment, “Additional trials are required to assess longer-term sustained hair regrowth in patients receiving ritlecitinib, as some patients may need >24 weeks to reach a clinical response.”
Disclosure: This research was supported by Pfizer Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Piliang M, Lynde C, King B, et al. Sustained scalp, eyebrow, and eyelash hair regrowth with ritlecitinib through week 48 in patients with alopecia areata: post hoc analysis of the ALLEGRO phase 2b/3 study. Abstract presented at: AAD 2023 Annual Meeting; March 17-21, 2023; New Orleans, LA. Poster 42005.