A breakthrough medication in vitiligo treatment that has been available in the U.S. for more than two years has finally been approved in Canada.
Ruxolitinib, known by its brand name Opzelura, is a topical cream that received the green light from Health Canada on Oct. 16. It is the first and only medication approved by the federal regulator for the treatment of nonsegmental vitiligo — an autoimmune condition that causes loss of pigment in the skin.
“I know people who’ve been waiting for a long, long time for this medication to be approved in Canada,” says Omar Sharife, president of Vitiligo Voices Canada – a support group for people with vitiligo. “The fact that it is the only ever approved medication for vitiligo in Canada, despite the fact that there’s been treatments for years and years and years, that really says something to the technology, the investment the pharma companies that are working on these kind of things are making. It brings a lot of hope to people.”
Sharife knows the struggle of other treatments all too well. He was around 18 years old when he first noticed a heart shaped patch of skin on his forehead that was lighter than the rest of his body.
“At that time, treatment was steroid creams and a sort of light treatment. And the light treatment essentially burnt my skin in the hopes of sort of re-pigmenting it. So I would often go do light treatment, come back with blisters and hope that after the blisters went away, the colour would come back for me. Back then the colour did come back on my forehead,” he says.
But as the condition spread to his fingertips and up his arms, Sharife began to feel like it was a losing battle.
“Over the years I realized that there was no cure for it. The treatments that I was utilizing were not helpful as it was progressing,” he says.
Vitiligo is not just skin deep
Sharife says while the cosmetic impacts of the painless condition are obvious, it’s the internal, mental battle that can be more hurtful and scarring.
“Mentally my journey was really, really tough. At that time, 20 years ago, people weren’t talking about mental health, people weren’t talking about vitiligo. Back then Michael Jackson was interviewed by Oprah, and even Oprah kind of made fun of the fact that he was lightening his skin,” he recalls. “So it was really tough trying to manage the vitiligo, manage the effects of my identity essentially changing. It was a constant rollercoaster of emotions for me.”
Dr. Sam Hanna, medical director at Dermatology on Bloor says the mental health impacts of vitiligo should not be underestimated.
“One of the associations that we know that is quite common is the psychiatric or psychological impact of the disease. And we know this isn’t just sort of sadness … people have a really high rate of depression, anxiety. We even see suicidality associated with it. So this is a really important condition that we have not had great therapies for,” he says.
For Sharife, daily living became increasingly stressful. He began dreading going to work and other social interactions. The most anxiety-inducing activity was going to a restaurant.
“A simple task of going to a restaurant, sitting in one space, trying to make yourself feel like nobody’s looking at you when you know that you’re being looked at because you look different — that was a huge, huge thing for me,” he says. “I really stopped going to restaurants because the anxiety would show itself in me breaking out into an uncontrollable sweat, literally just wiping the sweat off of my forehead. And that just compounded the anxiety because one, I’m already feeling anxious, and two, I’m like, ‘are they looking at me?’ And three, I’m like, ‘I’m sweating like a pig, so of course they’re looking at me!’ So it was just this continuous battle.”
As more of his skin lost pigment, Sharife says he started losing his confidence as well.
“On a yearly basis, I would notice there would be more and more spots and I would have to create rules that would make me feel comfortable. I said to myself at one point, ‘I’m never wearing a short sleeve shirt shirt again because I didn’t want to show my elbows’ … and it was a constant thing on a yearly basis of creating a rule that made this year that much easier,” he says. “When it started on my face again, that was a real challenge and it was really, really difficult because I can’t hide what people can see and essentially your biggest insecurity is on display.”
Actor and model Omar Sharife says the mental health impacts of vitiligo can be devastating. HANDOUT/Omar Sharife
It took years of counselling before Sharife was able to learn how to cope with the often crippling anxiety that grew worse as his vitiligo became more pronounced.
“Even the counseling was challenging because I don’t think a lot of counselors understand the impact and how to help somebody with a visual difference. So it took me a lot of trial and error to find the right person to actually get me to the point that I’m at today,” he says.
Sharife is now a working actor and model, raising awareness and hoping to destigmatize and demystify the condition via his social media posts and through Vitiligo Voices Canada. When Opzelura was first approved in the U.S., he was one of the faces in their marketing campaign.
“For me personally, to have my condition and be on TV made it easier for me to walk down the street. But the amount of people that I’ve had come up to me and say, ‘oh my God, to finally see somebody with vitiligo on TV, that was huge for me.’ So it continues to drive me … and it is exactly why I do what I do on my social media as well as continuing the acting and modeling.”
How the new medication works
“[The medication is] topical ruxolitinib cream applied twice a day to the affected areas. It’s approved for adolescent and adults — so greater than 12,” says Hanna. It is also approved for atopic dermatitis or eczema.
He explains that the body has a natural system called the JAK-STAT pathway that comes into play in inflammatory and immune diseases. When the molecules that are part of this normal inflammatory pathway are revved up more than they should be, it can cause increased inflammation. With vitiligo, that inflammation is abnormally directed against the skin’s pigment cells.
“Part of that inflammatory cascade is that some of our own cells … that are not supposed to attack our own tissues in this case are attacking our own pigment cells. They don’t die. They’re just distracted by this inflammatory cascade. And so if we can turn that off, turn that down, then the pigment cells can start to do their work again and make pigment,” he says. “So that’s what topical ruxolitinib does — in a selective way it kind of turns down the volume on the specific parts of the JAK-STAT inflammatory pathway that are abnormally expressed in vitiligo.”
Hanna says different autoimmune conditions involve different tissues. Since the skin is the “battle site” in vitiligo, there isn’t necessarily any other circulating abnormality, so a topical treatment makes sense.
“When we apply that medication locally, that certainly can have that impact. Obviously with a cream the amount of surface area that it’s reasonable to treat varies. So hopefully we’ll have additional options coming down the road for patients with more extensive disease,” he says. “For somewhat limited vitiligo, maybe less than 15 or 20 per cent body surface area, this is a nice option and the first thing that I’ve ever had approved for my patients with vitiligo. So I’m very excited to have it in my hands.”
The side effects of the cream are minimal and local, like skin irritation.
“We’re not seeing concerns about systemic effects … this medicine has been fairly well tolerated with very limited irritant side effects,” says Hanna.
In terms of timelines, Hanna says re-pigmentation will not occur overnight.
“When we look at clinical trials, they’re designed to have official endpoints. What we see if we look out to six months or even 12 months, is that vitiligo when it responds, is very, very deliberate and slow. We know that even though we are seeing effectiveness, that full effectiveness we’re going to get in an individual may take even longer than that,” he says. “I don’t think we’ve really fully seen what the duration of treatment is going to be. It depends on how severe it is when you start and how extensive it is. These treatments can be quite prolonged, which is another reason why it’s nice that this is a cream.”
Sharife says he’s excited for the vitiligo community to have access to the medication in the near future.
“Having something that’s much more reliable, maybe even less invasive than the light treatment that tends to burn and blister people’s skin is super, super important,” he says. “I think for myself personally, I’ve gone through my journey. I like who I am and I couldn’t see myself without vitiligo. So personally for me, it’s not a choice, but I am so excited for everybody else that needs it or that wants it to have that opportunity.”
Hanna estimates the cream should be available to patients by the end of the year.
