vitiligo

FDA approves Opzelura cream for vitiligo

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The FDA has approved the topical Janus kinase inhibitor Opzelura for the treatment of nonsegmental vitiligo in adolescents and adults, Incyte announced in a press release.

Opzelura (ruxolitinib) cream 1.5% is the first FDA-approved treatment for repigmentation in patients with vitiligo.

Vitiligo Woman
The FDA has approved the topical Janus kinase inhibitor Opzelura for the repigmentation of nonsegmental vitiligo.

“This is the start of offering some hope and options to patients who want to be repigmented and hopefully give them the chance to do that,” David Rosmarin, MD, dermatologist and vice chair of research and education for the department of dermatology at Tufts Medical Center and a lead investigator of the ruxolitinib trials, told Healio.

David Rosmarin

The approval was based on data from two phase 3 TRuE-V clinical trials, which included more than 600 people with nonsegmental vitiligo.

At week 24, approximately 30% of patients treated with Opzelura had at least a 75% improvement in facial Vitiligo Area Scoring Index (F-VASI75), compared with approximately 8% and 13% of those in the vehicle arms.

At week 52, approximately 50% of patients achieved F-VASI75 and about 30% achieved F-VASI90.

“It’s important to know that repigmentation takes time. Some patients respond early, some may take a little more time. But the longer you use the medicine, the more benefits the patient will get,” Rosmarin said. “When we look at different subgroups … all the patients seem to have a consistent response.”

The drug’s side effects included mild acne and application site reaction.

“With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” Hervé Hoppenot, Incyte CEO, said in the release. “We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we’re pleased that eligible vitiligo patients now have a choice to address repigmentation.”

Opzelura was previously approved for the short-term, noncontinuous treatment of mild to moderate dermatitis.

Perspective

Back to Top John E. Harris, MD, PhD)

John E Harris, MD, PhD

This is a momentous occasion, one for which we have been waiting for thousands of years — literally. Topical ruxolitinib, or Opzelura, has just been approved for the treatment of vitiligo by the FDA.

I started writing about this drug in 2015, when we were the first to give it to a vitiligo patient orally and it worked. In 2017, Dr. David Rosmarin, of Tufts Medical Center, had ruxolitinib put into a cream and showed it worked topically for patients with vitiligo on their face.

While Opzelura was already approved in September 2021 for atopic dermatitis, most couldn’t get it covered by insurance for vitiligo because it wasn’t approved for it. But now it is! The phase 3 clinical trial enrolled volunteers aged as young as 12 years, and so the approval covers its use for children 12 years and older. Safety data from the trial looked good. The only side effect noted in those using the drug more than placebo, and therefore attributable to the drug, was localized acne bumps in about 10% to 15% of users.

However, please note — Opzelura has a “black box warning” on the label, meaning that the FDA wants you to know that there could be a small risk for serious infections, heart disease, blood clotting, cancer or even death. These were not seen in the clinical trials for the topical drug ruxolitinib but have been reported in small numbers of those taking the oral version of the drug, which results in very large concentrations in the blood. These concentrations were not seen in trials when volunteers used the cream, but this is a “better safe than sorry” approach by the FDA, so that users are made fully aware.I’m really excited about this and expect this is only the tip of the iceberg. There are so many more ideas being tested now, and I anticipate more options will be available for patients soon.

John E Harris, MD, PhD

Professor and Chair, Department of Dermatology

Founding Director, Vitiligo Clinical Research Center

Founding Director, Autoimmune Therapeutics Institute

UMass Chan Medical School

Effects of platinum and palladium nanocolloid on macrophage polarization in relevance to repigmentation of vitiligo

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Abstract

Background

Elevated oxidative stress is accepted to be the initial event in vitiligo leading to the final pathological regulation of immune systems known as autoimmune reaction, which destroys melanin‐forming cells, melanocytes. Recently, we reported an efficient topical use of PAPLAL, nanocolloid of platinum and palladium, having intense catalase‐like activity to vitiligo patients. In addition, we found that PAPLAL has dual effects on the AhR and Nrf‐2 pathways in keratinocytes, and suggested its contribution to the recovery of immune state in vitiligo. The precise mechanism developing autoimmune reaction in vitiligo, however, remains to be clarified. It is important to clarify what kinds of cells play an essential role in the development of vitiligo.

Objective

To further understand the effective mechanisms of PAPLAL on immunity of skin, and to confirm a role of autoimmunity in vitiligo development, we studied the effect of PAPLAL on macrophage polarization and its activities which are recognized to play a pivotal role in immune and inflammatory reactions in many organs.

Methods

Rat and human macrophages were cultured and stimulated in vitro with both LPS and IFN‐γ for M1 polarization and IL‐4 and IL‐13 for M2 polarization with or without PAPLAL. Expression of typical M1 and M2 markers was determined at mRNA and protein levels.

Results

Simultaneous treatment with PAPLAL suppressed remarkably the production of M1 markers, iNOS, and TNF‐α; further, PAPLAL also suppressed M2 markers, mannose receptor (Man R), Chitinase 3‐like 3 (YM‐1), and iron regulatory protein‐1 (IRP‐1), at mRNA and protein levels, but less effectively compared to those of M1. PAPLAL, however, did not suppress phagocytic activity of M0, M1, and M2 cells.

Conclusion

These results indicate that macrophages may be involved in the therapeutic potential of PAPAL by altering immunological environment disturbed in skin, with the delicate shift of the M1‐M2 polarization, but without affecting on phagocytic activity.

Doctors Found A Cure For Vitiligo.

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Vitiligo is a disease that causes the loss of skin color in blotches. The extent and rate of color loss from vitiligo is unpredictable. It can affect the skin on any part of your body. There are various treatments for this conditions, but they’ve all proven to be unpredictable and with not so positive results for everyone, until now. The Havana Center Histotherapy Center in Cuba found an innovative treatment, involving a drug called Melagenina Plus, made from human placenta, with the ability to stimulate the production of melanocytes. This treatment is a very innovative approach which has so far yielded very successful results. According to studies, this treatment has proven effective in 86% of cases in which it was used. Meaning it successfully cured 86% of all participants, which is a very promising rate. The best thing about this remedy is that it has virtually no side-effects and can be used by everyone, children and pregnant women included. Its effectiveness mostly depends on the following factors:

  • Age
  • Race
  • Percent of body affected
  • Time course of the disease
  • The affected body areas
  • Correct application of the treatment
  • Vitiligo
Vitiligo

The treatment for vitiligo is performed in the course of 3 consecutive days:

 

Day 1: Presentation of the innovative treatment for vitiligo at a specialized medical conference, consultation and start of the treatment. If it’s necessary the patient will be advised to consult a psychologist at no additional cost. Day 2 and 3: Explanatory presentations on the use of Melagenina Plus so that the patient can continue using it at home. Patients will receive instructions on the proper method of application, dosage and duration depending on the severity of the condition. The patient isn’t required to go to the hospital to receive the treatment. If the doctors think that it is necessary, they will put you through psychology consultation at no additional cost. The second and the third day you will be learning how to use Melagenina Plus. Also the doctors will show you how to continue with the home treatment. They will also show you how to take proper amount of the remedy, according to the degree and extension of the disease on your body. If you follow the instructions that doctors give you and apply the treatment as you should, the vitiligo will be just an unpleasant memory.  

For vitiligo patient, arthritis drug restores skin color

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Left hand of vitiligo patient before and after treatment with tofacitinib.

A medication for treating rheumatoid arthritis has restored skin color in a patient suffering from vitiligo, according to dermatologists at Yale School of Medicine. The disfiguring condition is best known as the disease that plagued late pop star Michael Jackson.

The finding was published June 24 in JAMA Dermatology.

Vitiligo is a common, psychologically devastating condition that causes skin to lose its pigmentation or color. Current treatments, such as steroid creams and light therapy, are not reliably effective in reversing the disease. Recent advances in vitiligo research led Yale investigators to consider an existing class of FDA-approved medications known as Janus kinase (JAK) inhibitors, as a possible treatment.

Last year, Dr. Brett King, assistant professor of dermatology and principal investigator of the research, broke new ground when he published a paper demonstrating the effectiveness of the JAK inhibitor tofacitinib citrate in treating hair loss caused by alopecia areata. King and co-author Dr. Brittany Craiglow, believed the same medicine might be effective for vitiligo.

After five months of treatment, the patient’s hands show significant repigmentation.

To test the hypothesis, King and Craiglow administered tofacitinib to a 53-year-old patient with prominent white spots covering her face, hands, and body. For more than a year prior to taking tofacitinib, the numbers of these white spots had been increasing.

Within two months of treatment, the patient experienced partial repigmentation on her face, arms, and hands — the areas that concerned her most. After five months, the white spots on her face and hands were nearly gone, with only a few spots remaining on other parts of her body. Notably, tofacitinib caused no adverse side effects during the course of treatment.

The results could represent a breakthrough in vitiligo treatment, say the researchers.

“While it’s one case, we anticipated the successful treatment of this patient based on our current understanding of the disease and how the drug works,” said King.

King said further research would be necessary to confirm the drug’s safety and efficacy and cited work by University of Massachusetts Medical Center dermatologist and scientist John Harris as the inspiration for trying tofacitinib in this patient.

“It’s a first, and it could revolutionize treatment of an awful disease,” said King. “This may be a huge step forward in the treatment of patients with this condition.” King hopes to conduct a clinical trial using tofacitinib, or a similar medicine, ruxolitinib, for the treatment of vitiligo.

Vitiligo: concise evidence based guidelines on diagnosis and management

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Vitiligo is a common disease that causes a great degree of psychological distress. In its classical forms it is easily recognised and diagnosed. This review provides an evidence based outline of the management of vitiligo, particularly with the non-specialist in mind. Treatments for vitiligo are generally unsatisfactory. The initial approach to a patient who is thought to have vitiligo is to make a definite diagnosis, offer psychological support, and suggest supportive treatments such as the use of camouflage cosmetics and sunscreens, or in some cases after discussion the option of no treatment. Active therapies open to the non-specialist, after an explanation of potential side effects, include the topical use of potent or highly potent steroids or calcineurin inhibitors for a defined period of time (usually 2 months), following which an assessment is made to establish whether or not there has been a response. Patients whose condition is difficult to diagnose, unresponsive to straightforward treatments, or is causing psychological distress, are usually referred to a dermatologist. Specialist dermatology units have at their disposal phototherapy, either narrow band ultraviolet B or in some cases photochemotherapy, which is the most effective treatment presently available and can be considered for symmetrical types of vitiligo. Depigmenting treatments and possibly surgical approaches may be appropriate for vitiligo in selected cases. There is no evidence that presently available systemic treatments are helpful and safe in vitiligo. There is a need for further research into the causes of vitiligo, and into discovering better treatments.