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Oplezura (ruxolitinib) is currently the first and only approved treatment in the UK for non-segmental vitiligo that supports repigmentation.

Oplezura, manufactured by Incyte Corporation, is a topical cream with the active component ruxolitinib used for vitiligo treatment (1). It was approved by the UK’s Medicine and Healthcare Products Regulatory Agency in July 2023 for treatment of non-segmental vitiligo with facial involvement in adults and children over 12 years old to aid repigmentation (2). The treatment is currently available on private prescription to eligible patients, however, as of the latest National Institute for Health and Care Excellence (NICE) update, a decision on the treatment’s availability on the NHS is expected on 31 st July 2024 (3). This article aims to provide you with the overview on how Oplezura (ruxolitinib) works, its effectiveness based on the recent clinical trials, the recommended use of the cream and its side effects.

What is Oplezura (ruxolitinib)?

Oplezura is a prescription-only steroid-free cream applied to the skin (4). It is sold in either 60 g or 100 g tubes. The active substance in the medication is ruxolitinib (ruxolitinib phosphate; 5). It is a 1.5% ruxolitinib cream, meaning that each gram of Oplezura contains 15 mg of the active compound. Besides repigmentation support in vitiligo, the cream is also used for treatment of mild and moderate eczema (6). In the UK, ruxolitinib is also licensed in a tablet form (Jakavi) for treatment of certain blood disorders, such as myelofibrosis or polycythaemia vera (7).

How does ruxolitinib work?

Ruxolitinib is one of the Janus kinase (JAK) inhibitors used to treat chronic inflammatory disorders. JAK1 and 2 are enzymes that play a key role in the immune pathway responsible for melanocyte (pigment cell) destruction in vitiligo. Ruxolitinib blocks those enzymes and reduces the immune system’s ability to destroy melanocytes (8). Specifically, ruxolitinib has three effects on vitiligo, as explained by Incyte (9):

Stops depigmentation Induces repigmentation Prevents relapses

Repigmentation happens by reducing the autoimmune activity in the skin, which then encourages the melanocytes to travel from vitiligo lesion edges and hair follicles into the lesion itself and produce pigment (10).

How effective is Oplezura? A summary of recent trials and what to expect

In 2022, the results of two big Oplezura trials, TRuE-V1 and TRuE-V2, were combined and published as one study (11). The study investigated the effectiveness of Oplezura on patients with vitiligo. It had over 650 participants from North America and Europe, each over 12 years of age with non-segmental vitiligo, with depigmented areas covering 10% or less of total body surface area, including both the face and the rest of the body. The researchers monitored patients for up to 2 years for changes in their vitiligo lesions.

Most participants found marked improvements with ruxolitinib, particularly when it came to vitiligo patches on the face. However, there was some variation in how quickly participants responded to the treatment. Roughly one third of the participants achieved a 75% repigmentation of the patches on their face at 6 months of treatment. Half the patients achieved that in a year. Two thirds of patients saw the same improvement at 2 years (although some participants dropped out of the study). Some participants – 15% – saw as much as 90% repigmentation of the lesions on their face at 6 months.

Oplezura was slightly less effective on non-facial areas of the body with around a quarter of the participants achieving 50% repigmentation of the lesions on their whole-body surface area after 6 months.

For a more detailed, patient-friendly summary of the results of TRuE-V1 and TRuE- V2 please visit Incyte’s Oplezura website.

While the results of the study appear very promising, it is important to remember that repigmentation takes time. The pigment cells, melanocytes, destroyed in vitiligo have to regenerate and migrate from healthy skin to the lesions. This is a slow healing process and will not happen overnight – just like when you scrape your knee, your body may take quite a while to completely heal the injury. Some parts of the body will repigment faster than others and some may not respond to the treatment at all. Areas with completely white hairs are unlikely to repigment. There are many patterns in which a lesion may repigment and your healthcare provider should teach you how to look for signs of this (4, 10). Tracking your progress with photos may help as well. The next section will explain how to make sure you are benefitting the most from the treatment.

How to use Oplezura (5, 4, 6)

Oplezura is a prescription-only cream that can be applied anywhere on the body, including sensitive areas like around the eyes, mouth and genitalia. It is important to make sure the cream does not enter the eyes or mouth as it is intended for skin use only. Apply the cream twice daily with a minimum of 8 hours between the two applications – ideally as part of the morning and evening routines. A thin layer should be spread on the smallest area of the skin necessary. You may apply the cream on up to 10% of the body surface area affected by vitiligo which equals to about the size of ten handprints. Avoid washing treated skin for at least 2 hours after application. You should wash your hands after applying the cream (unless the skin there is being treated). To maximize the effectiveness of Oplezura, make sure to use it as intended – twice a day – otherwise you may not make the most of the treatment. You should use up to one 60 g tube of the cream per week, or up to one 100 g tube over two weeks. Oplezura should be stored at room temperature.

You should track your progress with regular photos. After prescribing Oplezura, the doctor will schedule follow-up appointments to monitor your progress and to examine your skin. If you achieve less than 25% repigmentation after a year of treatment, the doctor may decide that the treatment is not appropriate for you and stop it.

Oplezura is not licensed for use in pregnancy. Patients should not breastfeed during treatment and for about four weeks after the last dose. People of childbearing potential have to use effective contraception during treatment and for four weeks after the treatment is stopped.

Oplezura should not be used in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants (such as azathioprine or cyclosporine). It is unlikely to interact with other drugs, such as medications for high blood pressure or antidepressants, since it is a topical drug. Patients must inform their healthcare provider if they have ever had any type of cancer before receiving the prescription.

Possible side effects of Oplezura (6)

You are very unlikely to experience serious side effects when using Oplezura, as it is a topical cream only. Research has found that the most common side effect of the medication is application site acne, experienced by up to 10% of patients. Another common side effects were itching and redness of the application side, as well as headaches, runny nose and fevers. As ruxolitinib is a JAK inhibitor you may be at increased risk for developing infections, such as urinary tract infections. Studies have found a very small increase in the risk of developing skin cancer, as well as cardiovascular events such as heart attacks or blood clots, particularly if you have
had any of those in the past. It is important to inform your healthcare provider if that happens to be the case. You will see your healthcare provider regularly for skin inspections and other health monitoring to minimise those risks.

What happens now?

NICE had their second committee meeting about ruxolitinib on the 6th of June 2024 (3). Currently, the decision on whether ruxolitinib should be available on the NHS for eligible patients is expected on 31 st July 2024. NICE base their decisions on the effectiveness of a treatment, the balance between the benefits and potential harms, as well as the quality of available evidence (12). The Vitiligo Society will keep you updated regarding any decisions from NICE on the matter. Ruxolitinib is a very promising treatment for vitiligo and making the treatment accessible on the NHS could make a huge difference for those affected by it.

References

Incyte Corporation. What is OPZELURA® (ruxolitinib) for nonsegmental vitiligo [Internet]. Oplezura (Ruxolitinib) Cream 1.5%. 2024 [cited 2024 Jun 6]. Available from: https://www.opzelura.com/vitiligo/what-is-opzelura Tucker R. Ruxolitinib cream gains MHRA approval for non-segmental vitiligo. Hospital Pharmacy Europe [Internet]. 2023 Jul 7; Available from: https://hospitalpharmacyeurope.com/clinical-zones/dermatology/ruxolitinib-cream-gains-mhra-approval-for-non-segmental-vitiligo/ NICE. Project information | Ruxolitinib for treating non-segmental vitiligo in people 12 years and over [ID3998] [Internet]. National Institute for Health and Care Excellence. 2024 [cited 2024 Jun 6]. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10893 Incyte Corporation. Opzelura (ruxolitinib) cream [Internet]. Incyte UK Promotional Website. 2024 [cited 2024 Jun 6]. Available from: https://www.opzelura.co.uk/ EMC. Opzelura 15 mg/g cream – Summary of Product Characteristics [Internet]. Electronic Medicines Compendium. 2023 [cited 2024 Jun 6]. Available from: https://www.medicines.org.uk/emc/product/14903/smpc#gref Incyte Corporation. Prescribing information [Internet]. Oplezura (Ruxolitinib) Cream 1.5%. 2023 Sep [cited 2024 Jun 6]. Available from: https://www.opzelura.com/opzelura-prescribing-information NICE. Ruxolitinib [Specialist drug] [Internet]. BNF. [cited 2024 Jun 6]. Available from: https://bnf.nice.org.uk/drugs/ruxolitinib-specialist-drug/#indications-and-dose EMA. Opzelura [Internet]. European Medicines Agency. 2023 [cited 2024 Jun 6]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura Incyte Corporation. Opzelura (ruxolitinib) cream [Internet]. Incyte UK Promotional Website. 2024 [cited 2024 Jun 6]. Available
from: https://www.opzelura.co.uk/ Birlea SA, Goldstein NB, Norris DA. Repigmentation through Melanocyte Regeneration in Vitiligo. Dermatologic Clinics [Internet]. 2017 Apr 1;35(2):205–18. Available from: https://doi.org/10.1016/j.det.2016.11.015 Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, et al. Two phase 3, randomized, controlled trials of ruxolitinib cream for vitiligo. The
New England Journal of Medicine [Internet]. 2022 Oct 20;387(16):1445–55. Available from: https://doi.org/10.1056/nejmoa2118828 NICE. Making decisions using NICE guidelines [Internet]. National Institute for Health and Care Excellence. Available from: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/:~:text=NHS%20medicines%20information.-,Using%20recommendations,quality%20of%20the%20underpinning%20evidence.

Funding disclosure:
The Vitiligo Society has project work supported by an educational grant from Incyte Biosciences UK Ltd. The Vitiligo Society maintains full control over the all project management and content, ensuring independence and impartiality in its work.

When it comes to any external funding we follow the current guidance and rules as set out by the Charity Commission and the Fundraising Regulator. We report any research collaborations and/or financial contributions received from industry in our annual reports and accounts as well as being transparent about our partnerships on our website.

Let’s get right to it: mental health matters when you live with vitiligo. Why? Although vitiligo is an autoimmune disease with physical symptoms, the social and cultural implications of losing your skin’s pigment can have a significant impact on mental health. It’s not uncommon for those with vitiligo to report experiencing anxiety, depression and lower self-esteem as a result of this condition.

I’ve lived with vitiligo for more than twenty years and know this to be true first-hand. After getting vitiligo at the age of seven, I struggled mentally throughout high school. Despite putting on a smile for everyone else, I was depressed and loathed myself and the way I looked. At one point I thought that I didn’t deserve friends because of the way I looked. “Who would want to be friends with someone who looks like me?” – I would think.

Today, I’ve come a long way mentally and emotionally in my journey with vitiligo. Along the way, I’ve learned that proactively taking care of my mental health is key to living with vitiligo. In fact, managing my mental health has given me the freedom to live happily with this condition. That doesn’t mean that every day is perfect. I still struggle. But investing in things that support my mental health has given me a strong foundation – and a game plan for when things are difficult.

Here’s how I approach mental health care in my own life:

Starting each day with a gratitude journal

Each morning, I start my day with a gratitude journal. A gratitude journal is a record of things for which you are grateful or thankful for. Typically, you keep a gratitude journal by documenting 3-5 things you are thankful for each day. Some of my recent entries include the simply joy of my warm cup of coffee, the opportunity to go for a walk each day and the chance to take some time away from work. The entries can be big or small – but the important part is to make this a daily practice. By consistently starting my day with a focus on the things that I appreciate in my life, I’ve built a habit of looking for the “good” in my day.

Getting 30 minutes of exercise in at least once a day

Most people have a love-hate relationship with exercise – and that includes me. Yet, the difference that 30 minutes of moving my body makes in my day is worth the investment. Exercise is proven to have mood-boosting benefits – and those benefits go a long way to improving my mental health and headspace. While I have a set of workouts I like to move through a few times a week, I most often get exercise by taking a 30-minute walk or bike ride around my neighborhood. Changing my physical space and moving my body not only boosts my mood but reduces my stress levels and helps me approach my day from a place of clarity.

Going to therapy

It’s okay to ask for help. I’ve needed to ask for help more than once in my own life and at these times, I’ve sought out therapy from a licensed professional. The situations that led me to seek out a therapist weren’t about my life with vitiligo. Yet the mental burden I was carrying because of these situations was causing me undue stress around my skin, simply as a side effect. Therapy has been an invaluable way of working through difficult situations and emotions for me. Each session, I would leave feeling a weight lifted from my shoulders. And while life wasn’t perfect after a therapy session, I knew I had a safe space to return to if things felt unmanageable.

Leaning on a vitiligo community

There’s power in knowing that you aren’t alone. The first time I spoke to another woman with vitiligo, I was in my twenties and had been living with vitiligo for more than a decade. I cried tears of relief. I was overwhelmed with the realization that for the first time in my life, I felt like someone understood me. That feeling was transformative and gave me an unexpected amount of confidence in living with vitiligo. Today, I continue to lean on the women with vitiligo in my life that I now call friends. Sharing my story and hearing their own gives me a mental outlet to process this journey in a safe space.