This website is intended for healthcare professionals only.

Hospital Healthcare Europe
Hospital Pharmacy Europe     Newsletter    Login            

Press Releases

Take a look at a selection of our recent media coverage:

Subpopulations of children with atopic dermatitis linked to cognitive impairment

25th March 2024

Children with atopic dermatitis (AD) and attention-deficit/hyperactivity disorder (ADHD) or a learning disability are at increased risk of cognitive impairment and should be prioritised for assessment, research suggests.

Previous studies had suggested AD was associated with cognitive impairment in children, US researchers wrote in the journal JAMA Dermatology, but it was unknown whether certain subpopulations of children with AD were at greater risk.

To answer this question, lead study author Dr Joy Wan, assistant professor of dermatology at the Johns Hopkins University School of Medicine, and colleagues designed a cross-sectional study using data from the 2021 US National Health Interview Survey (NHIS).

Drawing on a weighted sample of 69,732,807 children (13.2% with AD), researchers found when compared to those without the condition, children with the condition were more likely to experience learning difficulties (10.8% vs 5.9%) and memory difficulties (11.1% vs 5.8%).

In multivariable logistic regression models adjusted for sociodemographic factors, asthma, food and seasonal allergies, AD was associated with increased odds for learning difficulties (adjusted odds ratio: 1.77) and memory difficulties (adjusted odds ratio 1.69).

However, further analysis showed the association was primarily limited to children with neurodevelopmental comorbidities, such as ADHD or learning disabilities, pointing to them being the subgroups of children with AD at highest risk of cognitive impairment.

‘The findings of this study suggest that evaluation for cognitive impairment in children with AD should be prioritised among those with comorbid neurodevelopmental disorders,’ Dr Wan and colleagues wrote.

While the mechanism underlying the interaction between AD and neurodevelopmental disorders was unknown, it was possible that AD-related sleep disturbances might be more likely to negatively impact cognitive functions in children with ADHD or learning disability, the authors continued.

‘Our results also suggest that memory and learning difficulties related to AD may vary by developmental condition,’ Dr Wan and colleagues added.

In children with ADHD, for example, AD was associated with nearly three-times greater risk of memory difficulties but was not associated with learning difficulties.

However, in children with learning disabilities, AD was linked with twice the odds of memory difficulties but half the odds of learning difficulties.

It was possible that children with AD and concomitant learning disabilities were more likely to receive appropriate interventions, perhaps due to greater healthcare use or caregiver awareness, leading to relatively lower odds of reported learning difficulties.

‘Another possibility is that AD affects different areas of cognition to varying degrees, with perhaps a greater impact on memory than on learning,’ Dr Wan and colleagues said.

The study included children aged 17 years and younger without intellectual disability or autism, the researchers said, noting that strengths of the research included its population-based nature and the data adjustment for confounders.

Limitations included the cross-sectional study design and reliance on caregiver-reported symptoms.

‘Finally, we were unable to examine factors, such as AD severity, age at AD diagnosis, and sleep, which were not collected in the NHIS data,’ the researchers wrote.

Methotrexate gives more sustained control than ciclosporin in children with severe atopic dermatitis

28th September 2023

Methotrexate (MTX) is an effective treatment for children with severe atopic dermatitis and provides more sustained disease control than ciclosporin (CyA) upon discontinuation, according to the findings of a recent randomised controlled trial.

In the TREAT trial, published in the British Journal of Dermatology, a team led by King’s College London, set out to examine the safety and efficacy of these two main first-line conventional systemic immunosuppressive therapies in children and young people with severe atopic dermatitis.

The parallel group, assessor-blinded randomised trial included 103 participants aged between two and 16 years of age whose atopic dermatitis was unresponsive to potent topical treatment.

The participants were randomised to receive either 4 mg/kg/day of CyA or 0.4 mg/kg per week of MTX for a total of 36 weeks. They were also followed up for 24 weeks.

The co-primary endpoints were the change from baseline to 12 weeks in the Objective Severity Scoring of Atopic Dermatitis (o-SCORAD) and time to a first significant flare (relapse) after treatment cessation.

Among the 52 participants assigned to CyA, there was a greater improvement in disease severity by 12 weeks (mean difference o-SCORAD = -5.69 p = 0.01). In fact, more participants reached o-SCORAD-50 at 12 weeks in the CyA arm compared to the MTX (Odds ratio, OR = 2.60, 95% CI 1.23 – 5.49, p = 0.01).

However, by week 60, MTX was superior (OR = 0.33, 95% CI 0.13 – 0.85, p = 0.02). Furthermore, participant-reported post-treatment flares were higher in the CyA arm (OR = 3.22, 95% CI 0.42 – 6.01, p = 0.025) and both treatments gave rise to a similar level of serious adverse events.

The researchers also highlighted that MTX is significantly cheaper than CyA and concluded that MTX is a useful and safe treatment in paediatric patients with severe atopic dermatitis and a good alternative to CyA, especially in settings where healthcare resources are limited.

Methotrexate is potential gold standard

Until now, there has been no adequately powered randomised clinical trial evidence in relation to the safety and treatment success of methotrexate and ciclosporin for paediatric patients with atopic dermatitis. With new high-cost therapies being introduced, establishing a gold standard for treatment with the conventional systemic therapies like methotrexate and ciclosporin is deemed necessary.

Commenting on these findings study author Professor Carsten Flohr, chair in dermatology and population health sciences at King’s College London and consultant dermatologist at St John’s Institute of Dermatology, part of Guy’s and St Thomas’ NHS Foundation Trust, said: ‘This is the largest paediatric trial using conventional immuno-modulatory treatments in severe atopic dermatitis and was conducted across 13 centres in the UK and Ireland and is likely to change our treatment paradigm around this condition, not just for patients in the UK but also internationally.‘

Monthly eblasakimab dosing effective in moderate to severe atopic dermatitis

18th July 2023

Eblasakimab is the first biologic treatment for moderate to severe atopic dermatitis to show a competitive efficacy profile when given as a once-monthly dose, according to data released by the manufacturer, Aslan pharmaceuticals.

The novel monoclonal antibody targets the interleukin-13 (IL-13) receptor subunit of the Type 2 receptor, that is a key pathway in several allergic inflammatory diseases, including atopic dermatitis.

The findings, while yet to be published, relate to the phase 2b TREK-AD study, which randomised patients to one of five eblasakimab dosing arms for a total of 16 weeks: 300 mg every two weeks, 400 mg every two weeks, 400 mg every four weeks, 600 mg every four weeks or a placebo.

The study’s primary endpoint was the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 16 versus placebo. The study also included a validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) score of 0/1 (i.e. clear or almost clear).

Eblasakimab efficacy

A total of 289 patients were randomised and treated in the intent-to-treat (ITT) population across the five dosing arms. Patients treated with eblasakimab 600mg, 400mg and 300mg, all saw a rapid onset of action in the first few weeks of treatment, with a statistically significant improvement in EASI score by Week 4.

When assessed at Week 16, some 62.7% of eblasakimab patients given 600 mg monthly achieved a reduction of at least 75% from baseline (EASI-75) compared to 30.7% given the placebo (p = 0.0041).

In addition, 34.1% of eblasakimab patients receiving the 600 mg dose, achieved an EASI90, compared to only 10.1% on the placebo (p = 0.0088).

Finally, 31.2% of these patients achieved vIGA-AD score of 0 or 1 compared to 15.1% with the placebo (p = 0.0502).

No new safety signals were seen in the study, and the frequency of adverse events was comparable between the active eblasakimab treatment and placebo arms, with the most frequently observed adverse events being nasopharyngitis (13.4% vs 8.8% for placebo), atopic dermatitis (8.6% vs 7.0% for placebo), headache (6.9% vs 7.0% for placebo) and upper respiratory tract infection (6.5% vs 5.3% for placebo).

Commenting on these findings, Eric L. Simpson, lead investigator in the TREK-AD study and Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University, said: ‘This is the first time we’ve seen a once-a-month treatment option deliver competitive efficacy data, which would be a game-changer for patients with atopic dermatitis.

‘We haven’t seen much in the way of advancement since the launch of dupilumab, and there remains a huge unmet burden of disease experienced by patients. These results support eblasakimab’s potential to be a leading therapy for the treatment of atopic dermatitis, if approved.‘

Ruxolitinib cream significantly improves patient outcomes in atopic dermatitis

26th October 2021

Ruxolitinib, the first topical JAK inhibitor, has received FDA approval for the short-term treatment of mild to moderate atopic dermatitis.

Biopharmaceutical company Incyte has been granted approval by the FDA for Opzelura™ (ruxolitinib) cream, the first, topical janus kinase (JAK) inhibitor used in the treatment of mild to moderate atopic dermatitis (AD). More specifically, Opzelura™ can be used for the short-term and non-continuous, chronic treatment of AD in non-immunocompromised patients, 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. The importance of inhibition of JAK is based on the fact that the janus kinase (JAK)-signal transducer and activator of transcription (STAT), or JAK-STAT pathway, has been shown to play an essential role in the dysregulation of immune responses in AD. Although there are four separate JAK-STAT pathways, ruxolitinib, is a selective inhibitor of only JAK1 and JAK2, effectively suppressing the cytokine signalling involved in AD pathogenesis.

Clinical efficacy

The efficacy of ruxolitinib was examined in a 2020 study among adult patients with mild to moderate AD. Participants were  randomised for 8 weeks to three different strengths of ruxolitinib; 1.5% cream, applied twice daily or once daily, a 0.5% and 0.15% cream, vehicle or triamcinolone cream 0.1% applied twice daily for 4 weeks, then vehicle for 4 weeks.

The results showed that all concentrations of ruxolitinib were more effective after 4 weeks than placebo, the greatest improvement occurred with the  1.5% strength, based on an improvement in the Eczema Area and Severity Index (71.6% vs 15.5%; ruxolitinib vs placebo, p < .0001). Interestingly, the authors of the study reported that use of ruxolitinib 1.5% both once a twice daily produced a numerically greater improvements compared with triamcinolone after 4 weeks but that the difference was not statistically significant.

Based on these early finding, the company conducted two phase 3, randomised, placebo-controlled trials comparing topical ruxolitinib 0.75% and 1.5% in patients 12 years and over with mild to moderate AD. The primary outcome was Investigator’s Global Assessment treatment success at week 8 (i.e., an investigator’s Global Assessment score of 0/1 and ≥2-grade improvement from baseline). The results were published in May 2021 and showed that significantly more patients achieved the primary outcome at week 8 with 0.75% ruxolitinib (50.0% vs 15.1%, ruxolitinib vs placebo) and 1.5% ruxolitinib (53.8% and 7.6%), both with p < 0.001.

The company have now released data on the trial’s secondary outcomes which included the proportion of participants with at least a 4-point improvement in the itch Numerical Rating Scale (NRS), and the proportion of participants with at least a 6-point improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form. The latest data release show that 20.9% and 23.8% of patients using 0.75% and 1.5% topical ruxolitinib achieved a greater than 6-point improvement in sleep scores. Similarly, 41.5% and 51.5% using the 0.75% and 1.5% creams had at least a 4-point improvement in NRS.

Now that ruxolitinib has been approved by the FDA, the company intends to seek EMA approval.

Source. Incyte Press release October 29, 2021