The Food and Drug Administration has approved Opzelura (ruxolitinib) cream for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
The approval was based on data from the TRuE-AD clinical trial program, which included the randomized, double-blind, vehicle-controlled phase 3 TRuE-AD1 (ClinicalTrials.gov Identifier: NCT03745638) and TRuE-AD2 (ClinicalTrials.gov Identifier: NCT03745651) studies. Both studies evaluated the efficacy and safety of Opzelura, a Janus kinase (JAK) inhibitor, in more than 1200 patients aged 12 years and older with atopic dermatitis. Patients were randomized 2:2:1 to receive Opzelura cream (0.75% or 1.5%) twice daily or vehicle cream (non-medicated) for 8 weeks.
The primary endpoint for both trials was the proportion of patients achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as a score of 0 (clear) or 1 (almost clear). A key secondary endpoint was the proportion of patients with at least a 4-point improvement in Itch Numerical Rating Scale (itch NRS) score at week 8.
Findings from TRuE-AD1 showed that 53.8% of patients treated with Opzelura cream 1.5% achieved IGA-TS compared with 15.1% of those treated with vehicle (P <.0001). Additionally, 52.2% of patients treated with Opzelura cream 1.5% achieved a clinically meaningful reduction in itch NRS score at week 8 vs 15.4% with vehicle (P <.0001).
In TRuE-AD2, the primary end point was achieved by 51.3% of patients treated with Opzelura cream 1.5% and 7.6% of those treated with vehicle (P <.0001). Moreover, 50.7% of patients treated with Opzelura cream 1.5% achieved a clinically meaningful reduction in itch NRS score at week 8 vs 16.3% with vehicle (P <.0001).
As for safety, Opzelura carries a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis associated with the use of JAK inhibitors for inflammatory conditions. The most common adverse reactions (incidence 1% and greater) for Opzelura are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea.
Opzelura is supplied in 60g tubes containing 1.5% ruxolitinib and is expected to be available by early October 2021.
Ruxolitinib is currently available in an oral tablet formulation for the treatment of myelofibrosis (MF), polycythemia vera, and steroid-refractory graft-versus-host disease.
- Incyte announces US FDA approval of Opzelura™ (ruxolitinib) cream, a topical JAK Inhibitor, for the treatment of atopic dermatitis (AD). News release. Incyte. Accessed September 22, 2021. https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura-ruxolitinib-Cream-a-Topical-JAK-Inhibitor-for-the-Treatment-of-Atopic-Dermatitis-AD/default.aspx.
- Opzelura. Package insert. Incyte; 2021. Accessed September 22, 2021. https://www.incyte.com/Portals/0/Assets/What%20We%20Do/Therapies/OPZELURA%20Full%20Prescribing%20Info%20and%20MG%20Unformatted%209_21_2021.pdf?ver=2021-09-22-000517-990.