The following article is a part of conference coverage from the 2022 American Academy of Dermatology Annual Meeting , held live from March 25 through March 29 in Boston, Massachusetts. The team at Dermatology Advisor will be reporting on the latest news and research conducted by leading experts in dermatology. Check back for more from the 2022 AAD Annual Meeting .
Daily ritlecitinib was found to have sustained efficacy through 48 weeks for the treatment of alopecia areata (AA), according to results of a study presented at the 2022 Annual Meeting of the American Academy of Dermatology (AAD), held from March 25 to 29, 2022 in Boston, Massachusetts.
The ALLEGRO study was an international, randomized, double-blind, placebo-controlled, combined dose-ranging phase 2b/3 clinical trial. Patients aged 12 years and older with AA and 50% or greater scalp hair loss were randomly assigned to receive regimens comprising 4 weeks of loading dose, 20 weeks of maintenance therapy, and 24 weeks of extension with dosing: 200/50/50 mg ritlecitinib (n=132), 200/30/30 mg ritlecitinib (n=130), 50/50/50 mg ritlecitinib (n=130), 30/30/30 mg ritlecitinib (n=132), 10/10/10 mg ritlecitinib (n=63), placebo/placebo/50 mg ritlecitinib with a 4-week 200 mg load dose (n=65), or placebo/placebo/50 mg ritlecitinib (n=66). The study endpoints were Severity of Alopecia Tool (SALT) and Patient’s Global Impression of Change (PCI-C) scores.
Among all study arms, patients were aged mean 32.4-34.5 years, 54.6%-68.3% were girls or women, and baseline SALT scores were 88.3-93.0 points.
At week 24, significantly more ritlecitinib recipients, except for the 10 mg treatment arm, achieved a SALT score of 20 or higher and 10 or higher compared with placebo (all P <.003). Treatment response (SALT score £20) was observed as early as week eight among 200/50/50 mg (P =.008), week 12 among 200/30/30 mg (P =.010), and week 18 among 50/50/50 mg (P <.001) and 30/30/30 mg (P =.008) dose recipients.
Patients in the 200/50/50, 200/30/30, 50/50/50, and 30/30/30 mg cohorts reported PGI-C responses at week 24, which remained stable through week 48.
At week 24, eyebrow or eyelash assessments improved and remained stable through week 48 among the ritlecitinib recipients, except for the 10 mg dose, compared with placebo (all P £.05).
Among the patients who switched from placebo to ritlecitinib, SALT and PGI-C scores and eyebrow and eyelash assessments improved from week 24 to 48.
Up to week 24, 69% to 75% of the cohort patients reported adverse events, including headaches, nasopharyngitis, and upper respiratory infections. Serious adverse events were observed in 0.8% to 3.2% of the patients. The safety profile up to week 48 was similar to the placebo-controlled portion of the study.
The study authors concluded that after a 200 mg loading dose, 50 mg or 30 mg ritlecitinib was effective by weeks 8 to 12 for the treatment of AA. Both clinicians and patients continued to observe improvements through week 48. Overall, ritlecitinib was well tolerated, it was noted.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Mesinkovska N, Shapiro J, King B, et al. Efficacy of the oral JAK3/TEC inhibitor ritlecitinib (PF-06651600) in patients with alopecia areata over 48 weeks: results from the ALLEGRP Phase 2b/3 randomized, double-blind, placebo-controlled trial. Presented at: the 2022 Annual Meeting; March 25-29, 2022. Abstract/Poster 33183.