Can Opzelura be used on children? Here's everything we know.

Last updated: 16 January 2024

Can Opzelura be used on children? Here's everything we know.

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Opzelura (ruxolitinib) has been approved in the USA, the EU and the UK since mid-2023 1,2. It's used to treat atopic dermatitis and non-segmental vitiligo.

Currently, Opzelura is indicated for patients aged 12 and up. However, as many as 25% of vitiligo cases start before the age of 10 3. Atopic dermatitis is also common at an early age, with about 20% of children affected 4. Considering that both conditions can affect the patient's quality of life, you may be wondering if Opzelura can be used on children.

Here's everything you need to know about Opzelura and children. Including the latest research and ways to access the medicine for pediatric use, if your doctor recommends it.

Can Opzelura be used on children: The latest clinical trial results

 

Opzelura(ruxolitinib) in children with atopic dermatitis (eczema)

Earlier in 2023, the TRuE-AD3 clinical trial focused on children aged 2 to 12 with atopic dermatitis 5. The most important reported results of this study were:

  • 56% of children treated with Opzelura cream (0.75% and 1.5%) achieved clear or almost clear skin after 8 weeks of treatment. In comparison, this outcome was reported by only 10.8% of those using a non-medicated cream;

  • 67% of patients treated with Opzelura achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75) after 8 weeks of treatment. The result for the control group was 15%;

  • Patients treated with Opzelura experienced a significant improvement in itch relief. More than half of them achieved at least a 4-point reduction in their itch Numerical Rating Scale (NRS) score;

  • Opzelura was well-tolerated. There were no reports of serious infections, major adverse cardiovascular effects, malignancies or thromboses at week 8 of the treatment 5.

The results of the TRuE-AD3 trial are encouraging for the potential use of Opzelura in children with atopic dermatitis.

Opzelura(ruxolitinib) in children with non-segmental vitiligo

No clinical trial data are available yet on Opzelura's safety and efficacy for children with non-segmental vitiligo. We also couldn't find information on any ongoing clinical trials involving Opzelura and pediatric vitiligo patients.

Unfortunately, this makes it impossible to say if Opzelura can be safely used for babies and young children.

When will Opzelura be approved for children?

It's impossible to say, as no official application has been submitted for the approval of Opzelura for pediatric use.

Can your doctor prescribe Opzelura for children?

Opzelura (ruxolitinib) has not been approved anywhere for use in children under the age of 12. However, your doctor has the authority to prescribe Opzelura for the treatment of babies and young children anyway. They can do so based on the available clinical trial results, and the specifics of the patient's case.

A treating doctor may prescribe Opzelura to a pediatric patient with atopic dermatitis. However, they're unlikely to prescribe it to children with vitiligo until more data is available.

Has your child's doctor made the decision and prescribed Opzelura for pediatric use? Depending on where you are based, it may be complicated to fill that prescription. One reason is that Opzelura is not widely available in Europe and the UK yet. Another reason is that it's not approved for pediatric use anywhere.

If you have an Opzelura prescription you're struggling to fill, Everyone.org can help. We specialize in sourcing and delivery of prescribed medicines that are unavailable to a patient. Contact us, so we can help you.

 

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References:

  1. Opzelura | European Medicines Agency. European Medicines Agency, Accessed 12 December 2023.
  2. MHRA Products. MHRA, Accessed 12 December 2023.
  3. Vitiligo in Children: A Distinct Subset, Accessed 12 December 2023.
  4. Trends in eczema prevalence in children and adolescents: A Global Asthma Network Phase I Study. Clinical & Experimental Allergy, March 2023.
  5. Incyte Announces New Data for Ruxolitinib Cream (Opzelura®) in Children with Atopic Dermatitis | Incyte. Investors, 13 October 2023.