The US Food and Drug Administration has granted a first-ever approval of a topical Janus kinase (JAK) inhibitor for atopic dermatitis.
Ruxolitinib (Opzelura) cream, manufactured by Incyte, received approval for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
AD is a chronic skin disease affecting more than 21 million people in the US and is characterised by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections
“Many patients do not respond well to existing treatments and have uncontrolled disease,” said Dr Jonathan Silverberg of George Washington University School of Medicine and Health Sciences in Washington, in a statement from Incyte. “As a clinician, I am excited to have a nonsteroidal topical cream like Opzelura.”
Support for the approval came from the randomised, vehicle-controlled, phase III TRuE-AD1 and TRuE-AD2 clinical trials, which involved a combined total of more than 1,200 adults and adolescents with moderate-to-severe AD. Patients in both trials were randomised to twice-daily topical ruxolitinib or a non-medicated cream. The primary endpoint was Investigator's Global Assessment (IGA) of Treatment Success at week 8.
More than half of the patients randomised to ruxolitinib cream met the primary endpoint compared with 15.1% and 7.6% of patients in the control groups Additionally, more than half of the patients in the ruxolitinib groups had clinically meaningful reductions in itch versus 15-16% of patients randomised to vehicle.
In clinical trials, the most common treatment-emergent adverse reactions in patients treated with Opzelura were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis and rhinorrhea.
“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” said Julie Block, president and CEO of the National Eczema Association. “The chronic itch is difficult to cope with and related sleep issues can be exhausting. Many patients and their dermatologists are looking for additional options to meet current unmet needs in the management of AD. The approval of Opzelura is exciting news, and we welcome a new treatment option for our community.”
For more results of the TRuE-AD studies:
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