Efficacy and safety of ritlecitinib in adolescents with alopecia areata: Results from the ALLEGRO phase 2b/3 randomized, double-blind, placebo-controlled trial.

Abstract

BACKGROUND/OBJECTIVES:

This subgroup analysis of the ALLEGRO phase 2b/3 trial (NCT03732807) evaluated the efficacy and safety of ritlecitinib, an oral, selective dual JAK3/TEC family kinase inhibitor, for the treatment of alopecia areata (AA) in patients aged 12-17 years.

METHODS:

In ALLEGRO-2b/3, patients aged ≥12 years with AA and ≥50% scalp hair loss received once-daily ritlecitinib 50 or 30 mg (±4-week 200-mg loading dose) or 10 mg or placebo for 24 weeks. In a subsequent 24-week extension period, ritlecitinib groups continued their doses, and patients initially assigned to placebo switched to 200/50 or 50 mg daily. Clinician- and patient-reported hair regrowth outcomes and safety were assessed.

RESULTS:

In total, 105 adolescents were randomized. At Week 24, 17%-28% of adolescents achieved a Severity of Alopecia Tool (SALT) score ≤20 (≤20% scalp without hair) in the ritlecitinib 30 mg and higher treatment groups versus 0% for placebo. At Week 48, 25%-50% of patients had a SALT score ≤20 across ritlecitinib treatment groups (30 mg and higher). Adolescents reporting that their AA "moderately" or "greatly" improved were 45%-61% in the ritlecitinib groups (30 mg and higher) (vs. 10%-22% for placebo) at Week 24 and 44%-80% at Week 48. The most common adverse events in adolescents were headache, acne, and nasopharyngitis. No deaths, major adverse cardiovascular events, malignancies, pulmonary embolisms, opportunistic infections, or herpes zoster infections were reported.

CONCLUSION:

Ritlecitinib treatment demonstrated clinician-reported efficacy, patient-reported improvement, and an acceptable safety profile through Week 48 in adolescents with AA with ≥50% scalp hair loss.

• Authors: Maria Hordinsky, Adelaide A Hebert, Melinda Gooderham, Ohsang Kwon, Nikolay Murashkin, Hong Fang, Kazutoshi Harada, Ernest Law, Dalia Wajsbrot, Liza Takiya, Samuel H Zwillich, Robert Wolk, Helen Tran
• Journal: Pediatric dermatology (Pediatr Dermatol) 2023 Nov-Dec Vol. 40 Issue 6 Pg. 1003-1009 ISSN: 1525-1470 [Electronic] United States
• PMID: 37455588 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2023 Pfizer Inc. Pediatric Dermatology published by Wiley Periodicals LLC.

Chemical References

• Carbazoles
• frovatriptan
• Protein Kinase Inhibitors

Topics

• Adolescent
• Humans
• Alopecia Areata (drug therapy)
• Carbazoles (therapeutic use)
• Double-Blind Method
• Protein Kinase Inhibitors (therapeutic use)
• Severity of Illness Index