Ivarmacitinib Provides Relief in Atopic Dermatitis Study

TOPLINE:

Ivarmacitinib, a selective oral Janus kinase 1 inhibitor, significantly improved signs and symptoms in patients with moderate to severe atopic dermatitis (AD) and showed a favorable safety profile in a phase 3 trial.

METHODOLOGY:

• Researchers conducted a multicenter, double-blind, placebo-controlled phase 3 randomized trial of 336 patients aged 12-75 years (mean age, 31.1 years; 85.1%, Asian; 63.4% men) with moderate to severe AD at 53 sites in Canada and China between April 2021 and April 2022.
• Participants were randomly assigned 1:1:1 to receive once-daily oral ivarmacitinib 4 mg, ivarmacitinib 8 mg, or placebo for 16 weeks.
• Primary endpoints included the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with ≥ 2-grade improvement from baseline and Eczema Area and Severity Index score improvement of 75% (EASI-75) at week 16.

TAKEAWAY:

• At week 16, 36.3% of patients in the 4 mg ivarmacitinib group and 42.0% in the 8 mg ivarmacitinib group achieved an IGA score of 0 or 1 compared with 9.0% of patients in the placebo group (P < .001 for both).
• EASI-75 responses were significantly higher in the 4-mg (54.0%) and 8-mg (66.1%) dose groups than in the placebo group (21.6%; P < .001 for both).
• During the 16-week period, a higher proportion of patients in the 4 mg ivarmacitinib (37.2%) and 8 mg ivarmacitinib (40.2%) groups achieved at least a 4-point improvement in worst itch ratings than placebo (12.6%). Improvements were seen as early as day 3 and day 8 with the 4-mg and 8-mg doses, respectively.
• Treatment-emergent adverse events (TEAEs) occurred at similar rates across groups (4 mg ivarmacitinib, 69.0%; 8 mg ivarmacitinib, 66.1%; placebo, 64.9%), with serious TEAEs remaining low (4 mg ivarmacitinib, 2.7%; 8 mg ivarmacitinib, 1.8%; placebo, 2.7%). There were no reports of thrombosis, malignant neoplasms, or major adverse cardiac events.

IN PRACTICE:

“This phase 3 randomized clinical trial found that once-daily oral ivarmacitinib (4 or 8 mg) significantly improved the signs and symptoms of moderate to severe AD in adolescent and adult patients compared to placebo, demonstrating a favorable benefit-risk profile,” authors of the study wrote. “Ivarmacitinib represents a promising new treatment option for patients whose AD is not adequately controlled by topical therapies,” they added.

SOURCE:

The study was led by Yan Zhao, PhD, Department of Dermatology, Peking University People’s Hospital in Beijing, China, and was published online on April 30 in JAMA Dermatology.

LIMITATIONS:

The study had short-term follow-up. Additionally, the predominance of Asian patients could limit the generalizability of findings to other populations.

DISCLOSURES:

This study was funded by Jiangsu Hengrui Pharmaceuticals. Three study authors reported receiving speaking, advisory, and research fees from multiple pharmaceutical companies including AbbVie, Amgen, Incyte, Apogee, Dermira, Eli Lilly and Company, Galderma, Pfizer, Aslan, Union, Arcutis Biotherapeutics, Dermavant, Nektar, Regeneron, and Sanofi, and serving for various dermatology associations.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.