A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results.

Abstract

BACKGROUND:

Alopecia areata (AA) is an autoimmune form of hair loss with limited treatments.

OBJECTIVE:

To evaluate the efficacy and safety of the Janus kinase inhibitors ritlecitinib and brepocitinib in patients who have AA with ≥ 50% scalp hair loss.

METHODS:

Patients were randomized to once-daily ritlecitinib, brepocitinib, or placebo. The primary efficacy endpoint was a 24-week change from baseline in the Severity of Alopecia Tool (SALT) score. The key secondary efficacy endpoint was the proportion of patients achieving 30% improvement in SALT score (SALT30).

RESULTS:

The ritlecitinib, brepocitinib, and placebo groups included 48, 47, and 47 patients, respectively. At week 24, least-squares mean difference from placebo in SALT score change from baseline was 31.1 (95% confidence interval [CI], 18.8-43.5) for ritlecitinib and 49.2 (95% CI, 36.6-61.7) for brepocitinib (P < .0001 for both comparisons with placebo). SALT30 was achieved by 50% (90% CI, 38%-62%) of patients receiving ritlecitinib, 64% (90% CI, 51%-75%) receiving brepocitinib, and 2% (90% CI, 0%-9%) receiving placebo. Two patients experienced a serious adverse event (rhabdomyolysis) in the brepocitinib group only.

LIMITATIONS:

Only a single-dosage regimen of each study drug was included.

CONCLUSION:

Treatment with ritlecitinib or brepocitinib for 24 weeks was efficacious and generally well tolerated.

• Authors: Brett King, Emma Guttman-Yassky, Elena Peeva, Anindita Banerjee, Rodney Sinclair, Ana B Pavel, Linda Zhu, Lori Ann Cox, Brittany Craiglow, Linda Chen, Christopher Banfield, Karen Page, Weidong Zhang, Michael S Vincent
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 85 Issue 2 Pg. 379-387 (08 2021) ISSN: 1097-6787 [Electronic] United States
• PMID: 33757798 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Janus Kinase Inhibitors
• PF-06651600
• Protein Kinase Inhibitors
• Pyrazoles
• Pyrimidines
• Pyrroles
• PF-06700841

Topics

• Adult
• Alopecia Areata (drug therapy)
• Double-Blind Method
• Female
• Humans
• Janus Kinase Inhibitors (therapeutic use)
• Male
• Middle Aged
• Protein Kinase Inhibitors (therapeutic use)
• Pyrazoles (therapeutic use)
• Pyrimidines (therapeutic use)
• Pyrroles (therapeutic use)
• Time Factors
• Treatment Outcome
• Young Adult