David Rosmarin, MD, Vice-Chair of Research and Education, Department of Dermatology at Tufts Medical Center talks about a new treatment for vitiligo patients.
Interview conducted by Ivanhoe Broadcast News in August 2019.
For starters for our viewers who are not that familiar, could you tell me a little bit about vitiligo?
ROSAMIN: Vitiligo is a disease where the immune system is too active in the skin and it attacks the pigment cells known as melanocytes. This leads to white patches, which can occur anywhere. They are often in exposed areas of the skin such as the face and hands but can affect anywhere on the body. Vitiligo affects about 1 percent of the population, so there are about 3 million people in the United States that are estimated to suffer from vitiligo. It affects all ethnicities and nationalities and affects men and women.
Is it hereditary?
ROSAMIN: There is a genetic component. If somebody has a first degree relative with vitiligo, they have six times the likelihood of also developing it themselves. However, there’s also certain other factors that are at play. It’s not completely a genetic disease.
What are some of those other factors?
ROSAMIN: There’s something in the environment and it’s not clear what that predisposes some people to and not others to getting vitiligo.
Is the age of onset different for people?
ROSAMIN: Yes. Some people get it when they’re very, very young and some people get it when they’re older. It can really happen at any time. But it’s very common for the onset of the disease to be in the teenage years or 20’s or 30’s.
What would you do if you had this? What are the standard treatments?
ROSAMIN: Even though so many people suffer from vitiligo, there are currently no FDA approved treatments to re-pigment vitiligo. There are some medicines that we use off label, however not currently approved. One of the most common treatments that’s used is light treatment, or photo therapy. The challenge there is that patients must come in about three times a week. Oftentimes it’s not covered by insurance or there can be high copays, so access is always a challenge for patients. There are some people who it works for and some people who don’t respond. And, re-pigmentation can be a very slow process. We can also try some other topical medicines such as topical tacrolimus, brand name pro topic, or Elidel, Pimecrolimus as well as topical steroids. They work for some people and not others. They also have some downsides in terms of side effects.
Are those long lasting? Is it a permanent change? Or do you find that it works for a while and then stops working?
ROSAMIN: Vitiligo is a chronic disease, so the immune system is fundamentally too active. It can come back at any point in time even after somebody is re-pigmented. People can get new spots.
Are there other health risks and concerns, or side effects from having vitiligo?
ROSAMIN: For most people, it just involves the skin. But for some, they can have their immune system overactive in other organs as well. The most common one is to have an overactive thyroid.
So, we know that Barbara worked outdoors in Parks and Recreation. Are there other concerns when it comes to your skin and protection when you have vitiligo?
ROSMARIN: We usually recommend that patients avoid sunlight if they have vitiligo for two main reasons … one is we don’t want them to get burned without having the protection of the pigment, and second is that exposure to sunlight can enhance the contrast of the vitiligo and make it more obvious.
Talk to me a little bit about the clinical trial research that you’re doing in phase 2. What is it and what does it look to do?
ROSAMIN: Insight is a pharmaceutical company that has a patent for a medication called ruxolitinib cream. They sponsored a study that involved 157 patients, which is the largest vehicle controlled double blind study that’s ever been conducted in vitiligo to see if it would help patients repugnant, particularly on the face. After six months about half the patients who had the two highest doses of ruxolitinib cream re-pigmented quite well on the face. We’re optimistic with continued use, when you hit the year mark and beyond, that there’ll be even more patients who re-pigment significantly. That data will be released at a later time.
Are there any potential concerns or side effects from this?
ROSAMIN: Luckily, this medication was tolerated very well. There is a slight signal for application site reaction in a small few patients, but right now the safety looks quite promising. It’s well-tolerated.
So, by reaction, you mean a rash?
ROSAMIN: A little bit of redness, could be slight burning sensation.
Who would be the best candidate for a treatment like this?
ROSAMIN: The first question that patient needs to ask is do they want to re-pigment or not? It’s important that we respect a patients’ autonomy and that it’s not for everybody. It’s also important to accept patients’ decisions and if people want to remain with some areas of white patches, that we respect them for who they are. However, I believe that patients who are younger, it will be easier to re-pigment them. It doesn’t matter the duration of disease. In this study, there were patients who had vitiligo for over 40 years that re-pigmented quite well. So, hopefully this will have broad application for almost anyone who has vitiligo.
Barbara said a lot of these treatments aren’t covered and the insurance just says it’s cosmetic, so we’re not covering it. What do you say as a physician who works with these patients?
ROSAMIN: In the dermatology community, vitiligo is considered to be a medical condition, not a cosmetic one. We’re hopeful that with advocacy from support groups, such as friends in Boston as well as the American Academy of Dermatology, and the global vitiligo foundation, we can convince insurance companies to cover treatments for vitiligo and recognize that it’s not a cosmetic disease. It’s important for patients to have access.
What are the next steps? You said you’re wrapping up stage 2? How many sites are there?
ROSAMIN: There were over 30 sites across the country. The Phase 3 program, which will be even larger, is set to begin in the winter. We will be recruiting hundreds of patients. Tufts will likely be one of the sites for the Phase 3 program.
Would you consider this a breakthrough treatment after all of these years of nothing FDA approved?
ROSAMIN: I do think this is a breakthrough because it can re-pigment a significant number of patients and has a very good safety profile. It gives hope and promise to patients who want to re-pigment that didn’t have it beforehand. I’m very optimistic that after the Phase 3 program it will become the first medication that’s FDA approved to re-pigment vitiligo.
How many times a day does it have to be applied and over what period of time?
ROSAMIN: The dose is twice a day.
And, this was for six months?
ROSAMIN: The first part of the study is six months, but there’s continued improvement beyond six months. It’s dependent on the particular patient. Some patients may need to use it for one year. Some may need to even use it for longer than that to truly achieve clearance.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Jeremy Lechan, PR Tufts Medical Center
617-636-0104
jlechan@tuftsmedicalcenter.org
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