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JAK inhibitor Ruxolitinib: The first drug therapy for vitiligo!
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JAK inhibitor Ruxolitinib: The first drug therapy for vitiligo! The first drug therapy for vitiligo!
The successful phase 3 project of JAK inhibitor Ruxolitinib cream: Significantly improve the rejuvenation of facial and body skin lesions!
Incyte recently announced the positive top-line results of a key Phase 3 TRuE-V clinical trial project evaluating Ruxolitinib cream for the treatment of vitiligo in adolescent and adult patients (age ≥12 years old).
Ruxolitinib cream is a non-steroidal, anti-inflammatory, JAK inhibitor topical therapy.
The results of the TRuE-V project show that the two phase 3 clinical studies have reached the primary and key secondary endpoints: compared with the excipient cream, Ruxolitinib cream has significant efficacy in the treatment of vitiligo, and has good safety.
Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which is a skin disease caused by the loss of pigment-producing cells, melanocytes, which often affects beauty.
Vitiligo affects about 0.5%-2.0% of the world’s population.
There is currently no drug therapy approved by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) for the treatment of vitiligo.
The disease can occur at any age, although many people with vitiligo will experience initial symptoms before the age of 20.
According to the TRuE-V project data, Incyte plans to submit a marketing application for Ruxolitinib cream for vitiligo in the United States and the European Union in the second half of 2021. If approved, Ruxolitinib cream will be the first and only drug used to treat vitiligo for repigmentation.
Ruxolitinib cream is Incyte’s patented formulation of selective Janus kinase 1 and Janus kinase 2 (JAK1/JAK2) inhibitor Ruxolitinib, designed for topical application. Incyte has the global rights to develop and commercialize Ruxolitinib cream.
Currently, Ruxolitinib cream is in phase 3 clinical development:
(1) for the treatment of mild to moderate atopic dermatitis (TRuE-AD project);
(2) for the treatment of adolescent and adult vitiligo (TRuE-V project) .
For the treatment of atopic dermatitis, the TRuE-AD project has been successfully completed in the first half of 2020. Currently, the US FDA is reviewing a New Drug Application (NDA) for Ruxolitinib cream for the treatment of atopic dermatitis in adolescents and adults (≥12 years of age).
Regarding the treatment of vitiligo, the previously published Phase 2 clinical study data showed that compared with the vehicle control (drug-free cream) group, the patients in the Ruxolitinib cream treatment group had significantly improved facial vitiligo severity index scores and systemic vitiligo skin lesions. There is a significant improvement in repigmentation.
The TRuE-V project includes two phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), which were carried out in adolescents and adults (≥12 years old) with vitiligo.
Each study enrolled approximately 300 cases of non-diagnosed cases. For patients with non-segmental vitiligo (NSV) and depigmented areas, the purpose is to evaluate the efficacy and safety of Ruxolitinib cream as a monotherapy.
In the study, patients were randomly divided into 2 groups and received 1.5% Ruxolitinib cream twice a day (BID) or vehicle control cream BID for 24 weeks of double-blind treatment.
Patients who successfully completed the baseline examination and the 24th week assessment, including those who received the vehicle control cream in the double-blind period, entered the expansion phase and were treated with 1.5% Ruxolitinib cream BID for 28 weeks.
The results announced this time showed that both TRuE-V1 and TRuE-V2 reached the primary endpoint (p<0.0001 in both studies): The data showed that at the 24th week of treatment, compared with the vehicle control cream BID treatment group A significantly higher proportion of patients in the 1.5% Ruxolitinib cream BID treatment group achieved a facial vitiligo area score index (F-VASI) improvement of ≥75% from baseline (F-VASI75).
In addition, these two studies also reached key secondary endpoints, including: the percentage improvement of F-VASI from baseline at week 24, F-VASI50 (improvement ≥50% from baseline), F-VASI90 (compared to baseline) at week 24 The proportion of patients with an improvement of ≥90%) and a systemic vitiligo regional score index (T-VASI) of ≥50% from baseline (T-VASI50) reached a Vitiligo Significance Scale (VNS) score of 4 (not so Proportion of patients with an eye-catching) or 5 points (no longer eye-catching), and patients report the results. The overall efficacy and safety of Ruxolitinib cream are consistent with the previously reported Phase 2 study data, and no new safety signals have been observed.
The long-term efficacy and safety of the two studies will continue as planned. The detailed data of these two studies will be announced at a scientific conference to be held in the second half of 2021.
Jim Lee, MD, Vice President of Incyte’s Inflammation and Autoimmune Group, said: “This is the first phase 3 data showing significant improvement in repigmentation of the facial and body skin lesions in patients with vitiligo.
These positive results confirm the use of Ruxolitinib cream for patients with vitiligo. The potential for a meaningful treatment option.
We look forward to working with regulatory agencies to bring this much-needed treatment option to patients.
If approved, Ruxolitinib cream will be the first and only one used to treat vitiligo for skin lesions Recoloring drugs.”
Dr. David Rosmarin, Department of Dermatology, Tufts Medical Center, said: “Vitiligo is a chronic immune-mediated skin disease that can significantly affect the patient’s quality of life.
As a clinician, I’ve reviewed the preliminary results of the TRuE-V project and Ruxolitinib.
The potential of creams as a topical treatment option for patients with vitiligo in the future is very encouraged, because there are currently very few treatments that can effectively and safely resolve skin lesions.
Ruxolitinib is the active pharmaceutical ingredient of Incyte’s oral drug Jakafi. The drug has been approved for 3 indications in the United States:
(1) Treatment of adult patients with polycythemia (PV) who have an insufficient or intolerant response to sulfhydryluria;
(2) Treatment of middle and high-risk adult patients with myelofibrosis (MF), including primary MF, post-PV MF, post-essential thrombocytosis MF;
(3) treatment of steroid-refractory acute graft-versus-host disease (GVHD) patients.
Among them, the third indication was approved by the FDA in May 2019, and it was the first drug approved for the treatment of this indication. Jakafi is sold by Incyte in the United States, and Novartis is sold under the Jakavi brand name in markets outside the United States.
At present, Concert is also developing a Ruxolitinib molecule modified with deuterium chemical technology-CTP-543. In a phase II clinical study, it has shown strong efficacy in the treatment of alopecia areata.
Alopecia areata is an autoimmune disease that causes partial or complete hair loss. The deuterium chemical modification of Ruxolitinib can change its human pharmacokinetics, thereby enhancing its use as a treatment for alopecia areata. In the United States, the FDA has granted CTP-543 fast track status for the treatment of alopecia areata.
JAK inhibitor Ruxolitinib: The first drug therapy for vitiligo!
(source:internet, reference only)