Controversial vitiligo ‘miracle cream’ may soon be offered on NHS in move that could be the ‘light at end of the tunnel’ for thousands of sufferers
- Ruxolitinib, brand name Opzelura, is a drug used to treat skin condition vitiligo
- Vitiligo is where white patches appear on the skin due to a lack of pigment
A controversial ‘miracle cream’ used to treat vitiligo could soon be offered on the NHS.
Vitiligo is an autoimmune skin condition caused by a lack of melanin and results in white patches on areas such as the face and fingers.
Ruxolitinib has been hailed as a wonder drug by some patients because it can return the skin to its natural colour.
Drug regulators at the MHRA are now weighing up whether it should be approved or not in Britain. One sufferer said the drug could be ‘the light at the end of the tunnel’.
But ruxolitinib, branded as Opzelura, is controversial due to its serious potential side effects, such as cancer and blood clots.
A clinical trial of the drug yielded strong results in some people, pictured here is one woman at day one (left), week 24 (middle) and week 52 of treatment (right)
Ruxolitinib has been hailed a miracle cream by some as it can return the skin to its natural colour and could be ‘the light at the end of the tunnel’ for sufferers
Opzelura, which costs $2,000 (£1,600) for a single tube, was approved in the US last year.
The drug has an FDA black box warning on its packaging, saying that it can also cause serious infections, immune system problems, low blood cell counts, and increases in cholesterol.
Opzelura must be prescribed by doctors, rather than sold over the counter, as the treatment requires monitoring by medics.
The National Institute for Care and Health Excellence (NICE) is planning assess the risks and benefits of the drug to determine whether the cost of it being provided to patients on the NHS can be justified.
European regulators could also be set to recommend it to people aged 12 and over.
Teacher Joti Gata-Aura, who is Indian, has lived with the condition for 20 years.
She told the BBC that due to her vitiligo, her ‘identity was stripped’ and that she was constantly searching for treatments.
‘People are going through what I went through 20 years ago,’ she said.
‘This could be light at the end of the tunnel for many people.’
The cream is to be applied to un-pigmented spots of the skin twice a day. It is not to be used on more than ten percent of the bodies surface area.
It may take around 24 weeks for the drug to show its effectiveness in many patients. For some it could take up to a year to reach its maximum potential.
The drug showed promise in recently completed Phase 3 clinical trials, which included 600 participants.
Those that used the cream showed visible improvement in the colour of their skin, with half reaching the threshold of successful re-pigmentation after a year.
Vitiligo is caused by the person’s own body attacking melanin-producing cells in the skin, mistaking them for foreign invaders.
The condition affects around one in 100 people in the UK and roughly one in 200 in the US.
About 50 per cent develop their first symptoms before the age of 20, though it’s not clear why.
Model Winnie Harlow, who started developing vitiligo when she was around four years old, told Cosmopolitan last year that it was ‘incredibly isolating as a child’
However, ‘stressful’ events, such as childbirth, exposure to certain chemicals or even cuts to the skin, may trigger it, according to the NHS – there is also a genetic risk.
There is no cure, but some treatments can reverse pigment loss if used early enough.
Model Winnie Harlow, who started developing vitiligo when she was around four years old, told Cosmopolitan last year that it was ‘incredibly isolating as a child.’
‘I vividly recall being in third grade and trying to befriend two girls who would run away from me because their mothers didn’t want them to ‘catch’ what I had, as if I were contagious,’ she said.
However she said she credits her loving family for her confidence and feels her skin has been one of her ‘greatest gifts’.
What is Opzelura?
Opzelura is a topical prescription medicine used on the skin used to treat non-segmental vitiligo in patients aged 12 or older.
There are two types of vitiligo – segmental and non-segmental.
Non-segmental vitiligo is the most common type and sees symmetrical white patches appear on both sides of a person’s body, on the backs of their hands, arms, skin around body openings, knees, elbows and feet.
Segmental is less common and just affects one area of the body.
Opzelura has to be prescribed by doctors as the treatment progress needs monitored.
What is it?
Opzelura is regimentation treatment cream for people who have non-segmental vitiligo.
It is to be applied twice-a-day on up to 10 per cent of the body surface area, including around the eyes.
In trials for the cream, about half of people saw a significant return in their natural skin colour. Around one in six had complete regimentation in just three months.
It is not recommended to take Opzelura alongside other JAK inhibitors or immunosuppressants.
What are the common side effects?
- Acne at the application site
- Itching at the application site
- Common cold (nasopharyngitis)
- Urinary tract infection
- Redness at the application site
What are the serious side effects?
- Serious infections, including tuberculosis, have occurred in people taking JAK inhibitors by mouth.
- Increased risk of death in people aged 50 or over who have at least one heart disease and are taking JAK inhibitors by mouth.
- Cancer and immune system problems, such as melanoma.
- Increased risk of cardiovascular events such as heart attack or stroke in people aged 50 or over who have at least one heart disease and are taking JAK inhibitors by mouth.
- Blood clots in the veins of a person’s legs or lungs can happen and may be life-threatening.
- Low platelet counts (thrombocytopenia), low red blood cell counts (anaemia) and low white blood cell counts (neutropenia) can occur.