Ruxolitinib cream, to be sold under the name Opzelura, is the first topical Janus kinase inhibitor cream for the treatment of atopic dermatitis.
The first topical Janus kinase (JAK) inhibitor cream for the treatment of atopic dermatitis (AD) was approved this week by the FDA.
Ruxolitinib cream, to be sold under the name Opzelura, was approved for the short-term and noncontinuous chronic treatment of mild to moderate AD in nonimmunocompromised patients 12 years 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 12 years and older in the United States and is characterized by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. Patients are also more susceptible to bacterial, viral, and fungal infections.
The FDA approval was based on data from the TRuE-AD (Topical Ruxolitinib Evaluation in Atopic Dermatitis) clinical trial program, consisting of 2 randomized, double-blind, vehicle-controlled rhase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of the cream in more than 1200 adolescents and adults with mild to moderate AD.
Patients experienced significantly clearer skin and itch reduction when treated with medicated cream 1.5% twice daily (BID), compared with nonmedicated cream.
In addition, significantly more patients treated with ruxolitinib cream achieved Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS; primary end point) at week 8 (defined as an IGA score of 0 [clear] or 1 [almost clear] with at least a 2-point improvement from baseline): 53.8% in TRuE-AD1 and 51.3% in TRuE-AD2, compared with nonmedicated treatment (15.1% in TRuE-AD1, 7.6% in TRuE-AD2; P < .0001).
Significantly more patients treated with ruxolitinib cream experienced a clinically meaningful reduction in itch from baseline at week 8, as measured by at least a 4-point reduction in the itch Numerical Rating Scale (itch NRS4): 52.2% in TRuE-AD1 and 50.7% in TRuE-AD2, compared with nonmedicated cream (15.4% in TRuE-AD1, 16.3% in TRuE-AD2; P <.0001), among patients with an NRS score of at least 4 at baseline.
As with some other drugs in the class, ruxolitinib cream carries boxed warnings for serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis.
“Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease,” Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology and director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences, said in a statement.
“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” added 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.”
In clinical trials, the most common treatment-emergent adverse reactions in patients treated with ruxolitinib cream were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea.