Cibinqo Abrocitinib is being developed by Pfizer for the treatment of atopic dermatitis (eczema). It is an experimental once-daily oral Janus kinase 1 (JAK1) inhibitor.

The JAK/STAT pathway is an important factor in inflammation and pruritus in atopic dermatitis. Multiple receptors and signaling cascades are involved in eczema-related inflammation and itch, one of which is the JAK/STAT pathway.

In adolescents with moderate to severe atopic eczema, abrocitinib and topical therapy led to significant improvements in disease severity.

Atopic eczema is a chronic inflammatory skin condition that is a common problem in children and teenagers. Studies suggest that the condition affects 10 to 20 percent of teens and negatively impacts quality of life. Although the pathophysiology has not been fully elucidated, the tyrosine kinase pathway, which transmits signals from cell surface receptors, has been identified as playing an important role in immune-mediated conditions such as atopic eczema.

One such group of cytoplasmic kinases is the Janus family of proteins and is critical in the normal transmission of cytokine and growth factor signals. Janus kinase pathway (JAK) inhibitors have been used to treat inflammatory diseases such as rheumatoid arthritis, but are increasingly being used to treat other immune-mediated diseases.

One such inhibitor is abrocitinib, which as monotherapy has been shown to improve disease severity in adults and adolescents with atopic eczema. However, the efficacy of abrocitinib in combination with topical therapy is less well studied.

This was the goal of the JADE TEEN trial, an international phase 3 trial conducted in several countries by a team from Rady’s Children’s Hospital, San Diego, Department of Dermatology and Pediatrics, University of California, USA.

Eligible patients were 12 to 17 years of age with moderate to severe disease as assessed by An Investigator’s Global Assessment (IGA) score > 3 and Eczema Area and Severity Index (EASI) score > 16. peak itch numeric (PP-NRS) , which measures the severity of itch on a scale of 0 to 10, where 0 = no itch and 10 = worst itch imaginable, and included patients must have a PP-NRS score > 4.

Participants were randomized 1:1:1 to oral abrocitinib 200 mg, 100 mg, or placebo plus topical therapy for 12 weeks. Permitted topical treatments include emollients, low and medium potency topical steroids, topical calcineurin inhibitors, or chrysaborol. The primary endpoint was the percentage of patients who achieved an IGA score of 0/1 (clear or almost clear) and 2 grade or more improvement in IGA score and/or EASI75 (i.e., 75% improvement in disease severity) . A secondary outcome was a 4-point improvement from baseline in PP-NRS at weeks 2, 4, and 12.

0/5 (0 Reviews)