The Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream, a topical Janus kinase inhibitor, for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Opzelura Clinical Trial
The approval was based on data from the phase 3 TRuE-V1 (ClinicalTrials.gov Identifier: NCT04052425) and TRuE-V2 (ClinicalTrials.gov Identifier: NCT04057573) studies, which evaluated the efficacy and safety of Opzelura cream in a total of 674 patients 12 years of age and older who had been diagnosed with nonsegmental vitiligo and had depigmented areas. Patients were randomly assigned 2:1 to receive either Opzelura or vehicle cream twice daily for 24 weeks followed by an additional 28 weeks of treatment with Opzelura twice daily for all patients.
The primary endpoint was the proportion of patients achieving F-VASI75, defined as at least a 75% improvement from baseline in the Face Vitiligo Area Scoring Index (F-VASI) score at week 24. A key secondary endpoint was the proportion of patients achieving F-VASI90.
In TRuE-V1 and TRuE-V2, results showed that 29.9% and 29.9% of patients treated with Opzelura achieved F-VASI75, respectively, at week 24 compared with 7.5% and 12.9% of patients who received vehicle. Moreover, 15.5% and 15.4% of patients treated with Opzelura in TRuE-V1 and TRuE-V2, respectively, achieved F-VASI90 at week 24 compared with 2.2% and 1.9% of patients who received vehicle. At week 52, approximately 50% of patients treated with Opzelura achieved F-VASI75 and approximately 30% achieved F-VASI90.
The most common adverse reactions reported with Opzelura were application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.
Opzelura is supplied in 60g tubes containing 1.5% ruxolitinib. For patients with nonsegmental vitiligo, satisfactory response may require treatment for more than 24 weeks. Reevaluation should be considered if the patient does not find the repigmentation meaningful by 24 weeks.
Opzelura is also indicated 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.
- Incyte announces US FDA approval of Opzelura™ (ruxolitinib) cream for the treatment of vitiligo. News release. Incyte. Accessed July 19, 2022. https://www.businesswire.com/news/home/20220718005819/en/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura%E2%84%A2-ruxolitinib-Cream-for-the-Treatment-of-Vitiligo
- Opzelura. Package insert. Incyte; 2022. Accessed July 19, 2022. https://www.opzelura.com/prescribing-information.pdf