OPZELURA is thought to inhibit IFN-γ mediated JAK-STAT signaling, a key driver of depigmentation in vitiligo. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is unknown.1-3
Nearly 1 in 3 patients achieved at least 75% improvement in the facial vitiligo scoring index* (F-VASI75) at 24 weeks (primary endpoint; 29.9% vs. 7.5% (P < 0.0001) and 29.9% vs. 12.9% (P < 0.01))1,4,5†
About half the patients remaining in the study who applied OPZELURA from Day 1 achieved F-VASI75 at 52 weeks: ≈51% for OPZELURA and ≈28% for vehicle-to-OPZELURA (Week 24 to week 52)5
52-week data were reported as observed. Therefore, no conclusions of safety or efficacy should be made based on these results.
A non-steroidal topical cream that can be used on sensitive skin areas such as on the eyelids, around the eyes and mouth, and on the external genitals1
- Apply as a thin layer, twice daily to affected areas up to 10% of the total body surface area. Patients should not use more than one 60 gram tube per week1
- For topical use only; not for intraocular, oral, or intravaginal use
STUDY DESIGN: OPZELURA was studied in 2 double-blind, randomized, vehicle-controlled trials of identical design that enrolled 674 adult and adolescent patients with nonsegmental vitiligo ≥12 years of age. Patients had depigmented areas affecting ≥0.5% facial body surface area (F-BSA), ≥3% nonfacial BSA, and total body vitiligo area (facial and nonfacial) of up to 10% BSA. Patients with complete leukotrichia within any facial lesion were excluded. Phototherapy was not permitted during the trials. In both trials, patients were randomized 2:1 to treatment with OPZELURA or vehicle cream twice daily (BID) for 24 weeks followed by a 28-week open-label extension, wherein patients originally assigned to vehicle could switch to OPZELURA.1,6
Limitations of an open-label extension: In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
*The facial vitiligo area scoring index (F-VASI) is a composite measurement of the overall area of facial vitiligo patches and degree of depigmentation within patches. As assessed, the face did not include surface area of the lips, scalp, or ears.7
†P-values from exact logistic regression: [response at Week 24 = treatment + stratification factors (Fitzpatrick skin type I and II vs. Fitzpatrick skin type III, IV, V, and VI, Region North America/Europe)].5