New research shows that the Janus kinase (JAK) inhibitor abrocitinib, approved in Canada for the treatment of moderate-to-severe atopic dermatitis, significantly improves the symptoms of patients with severe itching diseases that currently have no targeted therapies.
These findings were published in JAMA Dermatology.
Study results also show that there were minimal side effects from abrocitinib during the small 12-week, open-label study led by University of Maryland School of Medicine (UMSOM) researchers. It was beneficial for those with an itching disease called prurigo nodularis and those with chronic pruritus of unknown origin, a condition that causes chronic unexplainable itching symptoms.
“Very few treatments exist for prurigo nodularis and chronic pruritus of unknown origin; patients often suffer for years in horrible discomfort, which can lead to anxiety and depression, severely impacting their quality of life,” said study lead author Shawn Kwatra, MD, in a press release. “The rationale for this study came from my laboratory’s study findings of altered inflammatory mediators in these conditions that all function through JAK1. Through this trial, we hope to continue to move the needle toward personalized therapies that can provide sustainable relief for coping with these debilitating conditions.”
Dr. Kwatra is the Joseph W. Burnett Endowed Professor and Chair of Dermatology at the University of Maryland School of Medicine (UMSOM) and Chief of Service Dermatology at the University of Maryland Medical Center (UMMC).
According to the release, Dr. Kwatra’s previous research indicates that prurigo nodularis occurs more than three times as frequently in Black patients than in White patients, tends to be more common in women, and is associated with depression, diabetes, chronic kidney disease, and HIV. Chronic pruritus of unknown origin is most prevalent among older adults and causes severe itching lasting longer than six weeks. Current therapies to help manage symptoms include over-the-counter and prescription itch relief ointments and anti-inflammatory drugs such as antihistamines and corticosteroids. None of these medications, however, provide sustained relief.
The study involved 20 patients, half with prurigo nodularis and half with chronic pruritus of unknown origin. They were all treated with 200 mg of abrocitinib once a day for 12 weeks.
Abrocitinib reduced itching and pain symptoms by 78% in the prurigo nodularis patients. Patients with chronic pruritus of unknown origin experienced a 54% reduction in itching and pain symptoms. Patients in both groups also reported an improvement in their quality of life and their sleep habits.
None of the patients experienced serious adverse events. The most common side effect, seen in 10% of patients, was acneiform eruption.
“This is not only an encouraging study but also sets the stage for a Phase 3 clinical trial,” said Mark T. Gladwin, MD, who is the John Z. and Akiko K. Bowers Distinguished Professor and Dean of UMSOM and Vice President for Medical Affairs at University of Maryland, Baltimore. “It holds promise for introducing a novel treatment to patients in underserved communities disproportionately affected by prurigo nodularis, a condition historically overlooked by dermatology.”
Pfizer, Inc., manufacturer of abrocitinib, provided funding and supplied the medication for the study.