OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
View photos below
After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1
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.
T-VASI, total body vitiligo area scoring index.
During the double-blind period (up to Week 24), analyses were conducted on the intention-to-treat population and multiple imputation was applied to account for missing values.2
During the open-label extension (after Week 24), responses were reported as observed.2
The line graph above shows the pooled T-VASI75 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. At Week 52, ≈21% of patients for OPZELURA and ≈9% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved T-VASI75.1,3
20.6% and 26.1% of patients using OPZELURA achieved the secondary endpoint of T-VASI50 at 24 weeks (vs. 4.9% and 11.3% with vehicle; P < 0.01)4
After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1
T-VASI, total body vitiligo area scoring index.
During the double-blind period (up to Week 24), analyses were conducted on the intention-to-treat population and multiple imputation was applied to account for missing values.2
During the open-label extension (after Week 24), responses were reported as observed.2
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 line graph above shows the pooled T-VASI50 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. At Week 52, ≈51% of patients for OPZELURA and ≈27% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved T-VASI50.3
Selected images of nonfacial lesions included in the T-VASI for a trial participant meeting the secondary endpoint of T-VASI50. Photos do not represent all lesions.3
Results not typical. Actual patient treated with OPZELURA in a clinical trial. Individual results may vary.
Lesions in areas with fewer hair follicles (such as acral areas) often repigment slowly5,6
Selected images of nonfacial lesions included in the T-VASI for a second trial participant meeting the secondary endpoint of T-VASI50. Photos do not represent all lesions.3
Results not typical. Actual patient treated with OPZELURA in a clinical trial. Individual results may vary.
Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.
No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.
Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.
In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.
Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.
Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.
In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.
Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.
Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).
There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.
Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).
OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
REFERENCES: 1. OPZELURA [Prescribing information]. Wilmington, DE: Incyte Corporation; 2022. 2. Rosmarin D, Passeron T, Pandya AG, et al. Efficacy and safety of ruxolitinib cream monotherapy for the treatment of vitiligo: results from two 52 week phase 3 studies. Presented at the American Academy of Dermatology Annual Meeting; March 25–29, 2022; Boston, MA. 3. Data on File. Incyte Corporation. 2022. 4. Rosmarin D, Pandya AG, Grimes P, et al. Efficacy and safety of ruxolitinib cream for the treatment of vitiligo: 24-week results from 2 randomized, double-blind phase 3 studies. Presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress; September 29−October 2, 2021; Virtual. 5. Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020;396(suppl):110-120. doi:10.1016/S0140-6736(20)30609-7 6. Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015
