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

RCT finds tralokinumab effective in adolescents with atopic eczema

25th April 2023

Tralokinumab targets IL-13 and appears to be both effective and tolerable in those aged 12 – 17 with moderate to severe atopic eczema

Adolescent atopic eczema (AE) gives rise to a negative impact on patient’s quality of life. There is already good evidence to suggest that interleukin-13 (IL-13) creates inflammation in AE. Tralokinumab (TK) specifically neutralises IL-13 and therefore reduces inflammation. Previous work has demonstrated efficacy for the drug adults with moderate to severe AE. However, it remains uncertain whether TK is effective for adolescents with moderate to severe disease.

The current randomised, double-blinded, placebo-controlled enrolled adolescents (12 – 17 years) with moderate to severe AE. Individuals received monotherapy with TK either 150 or 300mg or matching placebo every two weeks for 16 weeks. The primary endpoint was an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear/almost clear) at week 16. An alternative was a 75% or higher improvement in EASI (i.e., an EASI 75). Those meeting the primary outcome at week 16 continued in a maintenance phase until week 52.

Tralokinumab and atopic eczema outcomes

There were 289 participants with a median age of 15 years (51.6% male) and of whom, 97 and 98 had 150 and 300 mg of TK respectively.

At week 16, significantly more patients receiving TK had an IGA of 0 or 1 than placebo: 21.4% (150 mg) and 17.5% (300 mg) vs 4.3% for placebo (p < 0.01 and p = 0.002 respectively). In addition, 28.6% of TK 150 mg patients had an EASI75, 27.8% of the TK 300 mg group but only 6.4% of those in the placebo arm. Larger improvements were seen for both doses of the drug compared to placebo for itch and quality of life scores.

At week 52, 62.9% of all tralokinumab participants maintained their IGA score of 0 or 1 with doses administered either every 2 or 4 weeks. The drug was tolerable with a similar proportion of adverse events in all three arms.

Tralokinumab therefore appears effective for adolescents with moderate to severe AE.

Paller AS et al. Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial. JAMA Dermatol 2023

Enhanced vs reactive treatment of atopic eczema reduces hen egg allergy

11th April 2023

Enhanced treatment of infants diagnosed with atopic eczema appears to reduce hen’s egg allergy compared to a conventional treatment approach

UK and Japanese researchers have shown that among infants with atopic eczema, enhanced treatment, i.e., to both clinically affected and unaffected skin, is more effective at preventing hen’s egg allergy than conventional or reactive treatment, applied only to clinically affected areas.

There appears to be an increase in the prevalence of food allergy in some areas of the world, thus highlighting the need for better strategies for prevention, diagnosis and therapy. For example, one study of Japanese children found a caregiver-reported immediate food allergy prevalence of 7.6% in children aged 1, with hen egg allergy being the most common at 5.4%. The presence of atopic eczema is associated with the development of food allergies, with a suggestion that infants with early eczema onset (within the first 1 – 4 months after birth) have an increased risk of developing food allergy at 3 years of age. Given the relationship between atopic eczema and food allergies, researchers wondered if early treatment of the disease could reduce the subsequent development of allergies. One retrospective analysis showed that early aggressive use of topical corticosteroids to shorten the duration of atopic eczema in infants, was associated with decreased development of food allergy by 24 months of age.

Based on the findings of this retrospective analysis, in the current study, researchers conducted a randomised controlled trial. Infants aged 7-13 weeks with atopic eczema were treated with topical steroids and randomised 1:1 to enhanced early skin treatment or conventional reactive treatment, i.e., applying topical corticosteroids only to areas of clinically affected skin. The team set the primary outcome as the proportion of immediate hen’s egg allergy confirmed by oral food challenge at 28 weeks of age.

Enhanced early treatment and the development of hen’s egg allergy

A total of 640 children were included, 318 of whom were assigned to enhanced early treatment. Two-thirds (66%) of children in the enhanced group were aged 7 to 10 weeks at enrolment.

Enhanced treatment significantly reduced hen’s egg allergy compared with the conventional treatment (31.4% vs. 41.9%, p = 0.0028). However, a higher proportion of infants in the enhanced group experienced serious adverse events (5.3% vs 1.9%). In addition, the intervention reduced mean body weight and height when assessed at week 28.

The authors concluded that while enhanced control of atopic eczema appeared to reduce hen’s egg allergy, the treatment protocol of this trial should be modified in order to avoid the adverse effects of topical corticosteroids.

Yamamoto-Hanada K et al. Enhanced early skin treatment for atopic dermatitis in infants reduces food allergy. J Allergy Clin Immunol 2023

Lebrikizumab monotherapy effective in moderate to severe atopic eczema

28th March 2023

Lebrikizumab monotherapy given every two weeks without the use of topical steroids is effective for moderate to severe atopic eczema

Two identical randomised, double-blind, placebo-controlled trials have shown that treatment with lebrikizumab alone in patients 12 years of age and older with moderate to severe atopic eczema led to a significant improvement in disease severity.

Although atopic eczema affects approximately 20% of children, the condition persists in around 7% of adults. Moreover, atopic eczema has a huge negative impact on the quality of life of sufferers and can even increase the risk of suicide ideation. While it has been recognised in recent years that elevated levels of both interleukin-4 and interleukin-13 (IL-13) are implicated in the pathophysiology of the disease, it has been recently demonstrated that IL-13 is the primary up-regulated cytokine in skin biopsy samples from patients with atopic eczema. The monoclonal antibody, lebrikizumab exerts selective antagonism of IL-13 and which is sufficient to control atopic eczema and improve patient’s quality of life. In fact, a recent, randomised, phase 3 trial demonstrated the benefit of lebrikizumab when combined with topical steroids in adolescents and adults with moderate to severe atopic eczema. However, whether lebrikizumab is effective alone is currently unclear and was the objective of the current study.

The current publication includes the findings from two identical phase 3 trials, ADvocate1 and ADvocate2, in which patients with moderate-to-severe atopic eczema, aged 12 years and older, were randomised 2:1 to either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks. The primary outcome was based on an Investigator’s Global Assessment (IGA) score of 0 or 1 (indicating clear (0) or almost clear (1)), with a reduction of at least 2 points from baseline and was assessed after 16 weeks. The main secondary outcome was a 75% improvement in the Eczema Area and Severity Index score (EASI-75 response), whereas other measures included assessments of itch and of itch interference with sleep.

Lebrikizumab and atopic eczema disease severity

In the first trial, 424 patients with a mean age of 35.5 years (51.8% female) were randomised to lebrikizumab (283) or placebo with similar demographics in the second trial.

In the first trial, the primary outcome occurred in 43.1% of those assigned to lebrikizumab group and in 12.7% placebo patients and this difference was statistically significant (p < 0.001). In addition, a significant difference was seen in the EASI-75 response (58.8% vs 16.2%, p < 0.001). Similar and significant findings were observed in the second trial.

In both trials, a significantly higher proportion of patients given lebrikizumab group also achieved reductions in pruritus and improvements in sleep loss scores.

The authors concluded that 16 weeks of treatment with lebrikizumab was effective in adolescents and adults with moderate-to-severe atopic eczema.

Silverberg JI et al. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Eng J Med 2023

Dupixent approved for severe atopic dermatitis in children from 6 months

30th January 2023

Dupixent has had a license extension in the EU so that it can now be used to treat severe atopic dermatitis in children from 6 months of age

In a press release from Regeneron, the company described how data from a study in the Lancet, showed that Dupixent treatment plus topical corticosteroids (hydrocortisone 1%) was effective in children under 6 years of age. The Lancet trial enrolled and randomised 162 children aged 6 months to 6 years, to the drug or placebo. In the trial, participants were included if they had an Investigator’s Global Assessment (IGA) score of 3 – 4, which represents moderate to severe disease. The drug was given at a dose based on the bodyweight. For instance, if > 5 kg but < 15 mg, a dose of 200 mg was given once every 4 weeks and for children weighing > 15 kg but < 30 kg, a dose of 300 mg was given. The primary endpoint was set as the proportion of participants with an IGA score of 0 or 1 (i.e., clear or almost clear) skin after 16 weeks. At week 16, there was a 24% difference in IGA scores between Dupixent and placebo and which was statistically significant (p < 0.0001). The study also observed that the drug’s safety profile was generally in line with what might be expected.

The press release describes how in practice, 85 to 90% of children will develop atopic eczema before the age of 5 years and in Europe alone, it is estimated that up to 80,000 children aged between 6 months and 5 years have uncontrolled severe atopic dermatitis and might therefore benefit from a trial of systemic therapy. According to the EMA, Dupixent will now be indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years and who are candidates for systemic therapy.

The drug was approved for the same paediatric population by the FDA in June 2022.

Lebrikizumab and topical steroids effective in moderate to severe atopic eczema

19th January 2023

Lebrikizumab targets interleukin (IL)-13 and in combination with topical steroids appears effective in moderate to severe atopic eczema

Lebrikizumab in combination with low to mid-potency topical corticosteroids is an effective therapeutic approach for adults with moderate to severe atopic eczema according to the results of a randomised, placebo-controlled trial by an international research group.

Atopic eczema (AE) is a chronic, relapsing and remitting skin disease which, according to one UK-based study, affects up to 16.5% of children aged 2 years and 2.8% of adults aged 30-39. Moderate to severe disease symptoms include intense itch, sleep disturbance together with skin pain, affecting sleep, daily activities and occurs in 28.9% and 11% of adults, respectively. Both emollients and topical corticosteroids (topical steroids) are used to manage mild to moderate disease whereas systemic therapy and or phototherapy is recommended for those with more severe disease. In recent years, biologic therapies such as dupilumab have emerged for the treatment of individuals with moderate to severe disease.

Another recently introduced biologic is the monoclonal antibody lebrikizumab, which targets interleukin (IL)-13, a pro-inflammatory Th2 cytokine central to AE pathogenesis and which is an important driver of the clinical manifestations of AE. Although lebrikizumab has been shown to provide a rapid and dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate to severe AE, no studies have examined the value of the drug in combination with topical steroids, which is reflective of real-life practice.

Consequently, in the current study, researchers randomised eligible patients, i.e., with a diagnosis of moderate-to-severe AE, 2:1 to lebrikizumab and topical steroids or placebo and topical steroids. An initial lebrikizumab loading dose of 500 mg was administered subcutaneously, at baseline and week 2, followed by 250 mg once every two weeks. The primary efficacy endpoint was the percentage of patients with an investigator’s Global Assessment scale (IGA) score of 0 or 1 (i.e., clear or almost clear) and a 2 or more point improvement from baseline at week 16. A key secondary objective was the percentage of patients achieving 75% improvement in EASI (EASI-75) at week 16.

Lebrikizumab and atopic eczema outcomes

A total of 211 patients with mean age of 37.2 years (48.8% female) were randomised to lebrikizumab and topical steroids (145) or placebo and steroids.

After 16 weeks of treatment, an IGA score of 0 or 1 with a 2-point or more reduction from baseline was achieved by 41.2% of those receiving lebrikizumab compared to 22.1% on placebo (p = 0.01), although a statistically significant difference was observed as early as week 8.

There was also a significantly higher proportion of lebrikizumab patients achieving an EASI75 (69.5% vs 42.2%, p < 0.01) and this time, a statistically significant difference was achieved and maintained from as early as week 4 and maintained through week 16.

The authors concluded on how lebrikizumab in combination with topical steroids was superior to topical steroids alone, adding how safety data was consistent with previously reported AE trials.

Simpson EL et al. Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic DermatitisA Randomized Clinical Trial (ADhere). JAMA Dermatol 2023

Early emollient use among high-risk infants prevents atopic eczema

12th January 2023

An analysis suggests that early emollient use prevents the development of atopic eczema in high-risk infants especially if an emulsion is used

Early prophylactic emollient use (EU) among high-risk infants, prevents the development of atopic eczema (AE) and emollient emulsions are likely to be the most effective, according to the findings of a network meta-analysis by Chinese researchers.

Atopic eczema is a chronic, inflammatory disorder of the skin and which affects between 0.9% and 22.5% of children aged 6 to 7. It is characterised by a persistent skin dryness, erythema and pruritus, leading to an impaired in quality of life. While the precise cause remains to be determined, a feature of the disease is a defective epidermal barrier that enables greater water loss through the skin leading to dryness.

However, this can be remedied to a large extent through EU, which alleviates the clinical symptoms and reduces the need for anti-inflammatory agents such as topical corticosteroids. In recent years, it has been suggested that early emollient use to high-risk infants, i.e., those with a family history of the disease or other atopic conditions such as asthma or hay fever, might prevent the subsequent development of AE.

The evidence to support this is equivocal, with one meta-analysis finding that use of emollients made no difference, whereas another concluded that prophylactic emollient use, initiated in early infancy may prevent AE, especially in high-risk populations and when used continuously. A further consideration and which might account for the observed discrepancies in the meta-analyses, is the type of emollient used. In fact, there is some data to show that different emollient creams have different effects on the skin and only certain types have the ability to improve the skin’s barrier and protect against irritants that trigger eczema.

With some uncertainty over whether early EU could prevent the development of AE, in the present study, the Chinese researchers undertook a network meta-analysis to address both whether the early application of emollients in infancy could prevent the later development of AE and which types of emollients were most effective. They used the surface under the cumulative ranking area curve (SUCRA) which to rank the different types of emollients, which could be either emulsions, creams or mixed formulations (e.g., creams, gels) and where a higher SUCRA value indicated a greater preventive efficacy. 

Early emollient use and the development of atopic eczema

A total of 11 trials with 3,483 subjects were included in the network meta-analysis. Overall, the results showed that the development of AE was significantly lower after early emollient application (Risk Ratio, RR = 0.75, 95% CI 0.57 – 0.99, p = 0.001). In addition, this risk was also significantly lower, when the analysis was restricted to high-risk infants (RR = 0.64, 95% CI 0.47 – 0.88).

When examining the different types of emollients, the SUCRA values were highest for emollient emulsions, with values of 82.6% for all populations and 78.0% for high-risk populations.

The authors concluded that the early application of emollients is an effective strategy for preventing AE development in high-risk infants and that an emollient emulsion may be the optimal type of formulation.

Liang J et al. Systematic review and network meta-analysis of different types of emollient for the prevention of atopic dermatitis in infants. J Eur Acad Dermatol Venereol 2022

RCT finds dupilumab effective for children under six with atopic eczema

26th September 2022

An RCT has found that dupilumab improves the signs and symptoms of atopic eczema in children aged 6 years and under

Although dupilumab is licensed for moderate to severe atopic eczema from 6 years of age, the drug also appears to be effective in children under 6 years of age according to the findings of a randomised, double-blind, placebo-controlled trial by US researchers.

Atopic eczema is a common childhood condition with a global real-world prevalence study in the paediatric population finding that the 12-month prevalence ranged from 2.7% to 20.1% across countries but that severe disease was generally less than 15%. Dupilumab is a human monoclonal antibody against the interleukin-4 receptor alpha, inhibiting the signalling of interleukin-4 and interleukin-13. The drug has been shown to be effective for adults with moderate to severe disease.

For example, in two identical randomised, placebo-controlled trials, where the primary outcome was the proportion of achieving a score of 0 or 1 (clear or almost clear) on the Investigator’s Global Assessment and a reduction of 2 points or more in their score from baseline at week 16, this occurred in 36% of those who received dupilumab every other week and in 36% who received dupilumab weekly.

As mentioned earlier, whilst licensed from age 6, to date, there is limited data on the effectiveness in children under 6 years of age apart from one phase 2, open-label study, which found that a single-dose dupilumab was generally well tolerated and substantially reduced clinical signs/symptoms of eczema.

The present study was the first, large scale, randomised, placebo-controlled trial of dupilumab in children as young as 6 months old. The US team recruited children aged 6 months to under 6 years with moderate to severe atopic eczema (investigator’s Global assessment, IGA score of 3 – 4) with an inadequate response to topical corticosteroids. These children were then randomised 1:1 to either subcutaneous placebo or dupilumab 200 mg (body weight > 5 kg to < 15 kg) or 300 mg (> 15 kg but less than 30 kg) every 4 weeks in addition to a low-potency topical corticosteroid (hydrocortisone acetate 1%) for a total of 16 weeks.

The primary endpoint at week 16 was the proportion of patients who achieved an IGA score of 0 or 1 (indicating that their skin was either clear or almost clear). For the secondary endpoint, the team assessed the proportion achieving an EASI75, i.e., a 75% improvement in their eczema area and severity index also at week 16.

Dupilumab and improvement in disease severity

A total of 162 children with a mean age of 4 years (61% male) were randomised to dupilumab (83) or placebo. Among those assigned to dupilumab, 76% had an IGA score of 4 and both groups received hydrocortisone.

At week 16, a significantly higher proportion of patients taking dupilumab achieved the primary outcome (28% vs 4%, p < 0.0001) and this also occurred for the secondary endpoint of an EASI75 (53% vs 11%, p < 0.0001).

A similar proportion of patients had at > 1 treatment-emergent adverse event (64% vs 74%, dupilumab vs placebo).

The authors concluded that dupilumab with concomitant low potency topical steroids significantly improved disease severity compared to placebo in children under 6 years of age and that the drug was well tolerated.

Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial Lancet 2022

Older adults with atopic eczema at greater risk of developing Alzheimer’s disease

2nd May 2022

Having atopic eczema in adulthood appears to be associated with a significant increased risk of developing Alzheimer’s disease and dementia

Having atopic eczema in older life increases the risk for developing Alzheimer’s disease, according to a study by researchers from UC Berkeley School of Public Health, Berkeley, California, USA.

Alzheimer’s disease (AD) is a neurodegenerative disorder which is progressive and characterised clinically by cognitive decline and physiologically by the presence of two core pathologies; amyloid β plaques (Aβ) and neurofibrillary tangles (NFTs). AD is the most common form of dementia which, according to the World Health Organization (WHO), affected some 55 million people in 2021 with AD accounting for 60-70% of all dementia cases.

Among those with AD, there is a sustained inflammatory response in the brain which is thought to represent a persistent immune response and a factor exacerbating both Aβ and NFTs. Moreover, there is emerging evidence that peripheral inflammation is an early event in the pathogenesis of AD. Atopy, which manifests as either allergic rhinitis, atopic eczema or asthma, represents a set of peripheral inflammatory diseases that have been found to be associated with a modestly increased risk of AD and dementia. To date, only one study has suggested that atopic eczema may be an independent risk factor for new-onset dementia and in particular, AD.

For the present analysis, the team set out to determine whether active atopic eczema among older adults was associated with incident AD and wondered if the strength of this association was dependent upon atopic eczema disease severity. They performed a longitudinal cohort study of patient data collected from the Health Improvement Network, which provides information on a representative sample of patients from UK general practitioners.

The researchers included patients aged 60 to 100 years of age without a prior diagnosis of AD or dementia and for whom the primary exposure was the presence of active atopic eczema and for which at least two prescriptions for treatment of the condition had been issued. The severity of atopic eczema during follow-up was categorised as either mild moderate or severe and the primary outcome was a new diagnosis of dementia during the period of follow-up.

The researchers also examined the reported disease codes for dementia and excluded those where the condition was drug- or alcohol-related or due to trauma or a rarer form (e.g. Huntington’s). The analysis was adjusted for potential confounders including gender, smoking, alcohol status, etc.

Atopic eczema and risk of Alzheimer’s disease

In a total of 1,767,667 individuals aged 60 to 100 years of age at baseline, 57,263 were diagnosed with dementia over mean of 6.8 years of follow-up. The median age of patients with a dementia diagnosis was 82 years, of whom, two-thirds (65%) were female.

Atopic eczema was diagnosed in 12% of the whole cohort and using mild disease severity as the default, 44% had moderate and 5% disease severity over the follow-up period.

Considering AD, the analysis showed that after adjustment for confounders, mild atopic eczema was associated with a 22% higher risk of AD (HR = 1.22) and this risk was higher still for those with moderate (HR = 1.37) and severe (HR = 1.52) disease.

With AD being the most common form of dementia, the researchers also examined the link between atopic eczema and the risk of developing dementia. The incidence of dementia was 57/10,000 person-years among those with atopic eczema compared to 44/10,000 person-years among those without the condition. Overall, patients with atopic eczema had a 27% higher risk for dementia after adjustment for potential confounders (hazard ratio, HR = 1.27, 95% CI 1.23 – 1.30). Further adjustment for co-morbidities slighted attenuated this risk but it remained significant (HR = 1.19, 95% CI 1.16 – 1.22).

The authors concluded that given the increased risk of AD among adults with atopic eczema, clinicians consider the impact of screening those with eczema for signs of cognitive impairment.

Magyari A et al. Adult atopic eczema and the risk of dementia: A population-based cohort study J Am Acad Dermatol 2022

Cochrane systematic review answers only some questions on topical steroids use in eczema

4th April 2022

Use of topical steroids in atopic eczema was examined in Cochrane review but only answered some relevant clinical usage questions

A Cochrane review on the use of topical steroids, has offered some, but not all, of the answers to help clinicians and patients to use these drugs optimally in the treatment of adults and children with atopic eczema, despite the fact that these agents have been used in practice for many decades.

Atopic eczema (atopic dermatitis) is defined as a chronic, itchy, inflammatory skin condition that affects people of all ages, although it presents most frequently in childhood. According to NICE guidance, which, although focusing on children, is applicable to adults, emollients should form the mainstay of atopic eczema management and should always be used, even when the condition has cleared. Where the disease flares, NICE advocates a stepped approach to management involving the use of emollients and topical steroids. The first use of topical steroids, in the form of cortisone acetate ointment (referred to as compound F) was reported in 1952 and topical steroids are categorised in terms of their potency which ranges from mild, moderate, potent and very potent with more potent agents inducing a greater degree of skin blanching (i.e., vasoconstriction). They are also available in different strengths and formulations, e.g., creams, ointments and foams, with designed to be used only once daily.

Nevertheless, despite the widespread availability of the drugs, there is surprising lack of clarity on how to best use topical steroids in clinical practice. The purpose of the current Cochrane review was therefore to try and answer several relevant questions to support clinicians and patients. In trying to answer these questions, the review included only randomised controlled trials in adults and children with eczema and which compared at least two strategies of topical corticosteroid use.

Optimal use of topical steroids

A total of 104 trials with 8443 participants were included in the analysis although 55 trials had a high risk of bias in at least one domain, mostly due to lack of blinding or missing outcome data.

The use of moderate compared to mild potency topical steroids resulted in more participants achieving treatment success, which was defined as cleared or marked improvement in eczema, based on an investigator global assessment scale (odds ratio, OR = 2.07, 95% CI 1.41 – 3.04).

In trials assessing adults and children with moderate or severe eczema, the use of potent topical steroids once compared to twice daily, did not reduce the number of patients achieving treatment success (OR = 0.97, 95% CI 0.68 – 1.38).

One strategy advocated by the NHS is weekend treatment, where a person whose eczema is under control, uses the topical corticosteroid every weekend on the trouble sites to prevent a disease relapse. flare. The review found supportive evidence for this approach and concluded that this resulted in a large decrease in likelihood of a relapse from 58% to 25% (risk ratio, RR = 0.43, 95% CI 0.32 – 0.57).

Another area explored included whether to use a cream or ointment formulation but there was no evidence to support use of either formulation. Advice from the NHS is that if a topical corticosteroid is prescribed, patients should wait about 15–30 mins after applying an emollient before using topical steroids. However, the review found no evidence to support this recommendation.

Although the Cochrane review provided some answers to support clinicians in their use of topical steroids, as the authors noted, there was a lack of evidence on adverse effects since studies were small and did not always use the most reliable methods. Therefore, the review offers some, but not all, of the answers to support the optimal use of topical steroids.

Lax SJ et al. Strategies for using topical corticosteroids in children and adults with eczema. Cochrane Database Sys Rev; March 2022

Dupilumab reduces COVID-19 symptom burden in patients with atopic eczema

9th December 2021

Use of dupilumab in patients with moderate-to-severe atopic dermatitis led to a reduction in COVID-19 symptom burden suggesting a protective effect of the drug

Patients with moderate-to-severe atopic eczema prescribed the monoclonal antibody dupilumab experienced less severe COVID-19 symptoms according to the results of a prospective study by researchers from the Department of Dermatology, and Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, US.

Atopic eczema is a chronic skin disease and is characterised by T helper 2 (Th2)-driven inflammation due to a Th1/Th2 imbalance. Moreover, cytokines released by Th2 cells including IL-4, IL-5 and IL-13 elevate production of IgE and increased inflammation in the skin and aggravate the skin barrier defect seen in atopic eczema. Interestingly, research suggests that infection with COVID-19 leads to an increased level of various interleukins, including IL-13. Since the mode of action for dupilumab involves blockage of the two interleukins, IL-4 and IL-13, it might be possible that the drug impacts on the severity of symptoms in those with COVID-19.

For the present study, the US researchers examined a disease registry within the department of dermatology at their hospital which included medication prescribed for patients with moderate-to-severe atopic eczema. They enrolled patients 9 years of age and older either at the time of a clinic visit or invited them to participate over the telephone. They included patients prescribed dupilumab, other systemic agents and either limited or no current treatment. Individuals were asked about the presence and duration of COVID-19 symptoms and based on their responses, categorised on a 1 – 5 scale ranging from mild disease (1), severe (3) through to 5 (fatal). The primary outcome was the presence of moderate-to-severe COVID-19 symptoms.


A total of 1237 patients were included, of which 632 with a mean age of 41.2 years (47% male), were prescribed dupilumab, 107 other systemic agents including oral JAK inhibitors, prednisolone, methotrexate and mycophenolate. The remaining 498 patients were on limited treatment or no treatment, with the majority (71%) prescribed only topical agents. In terms of COVID-19 severity, the majority (77%) of all individuals scored 0 on the 1 – 5 scale.

Among non-dupilumab treated patients, there was a nearly four-fold increased risk of experiencing moderate-to-severe COVID-19 symptoms (odds ratio, OR = 3.89, p = 0.01) compared to those prescribed dupilumab. Similarly, this risk was elevated for those with either limited or no treatment (OR = 1.95, p = 0.04).

In addition, when examining the relationship among those with a PCR confirmed COVID-19 diagnosis, non-dupilumab treated patients again had a significantly increased risk of moderate-to-severe COVID-19 symptoms compared to those prescribed dupilumab (OR = 13.79, p = 0.002), as did those with limited or no treatment (OR = 2.44, p = 0.05).

Commenting on their findings, the authors speculated that given the over-expression of Th2 cells in atopic eczema, patients were unable to mount a sufficient Th1 response to viral infections. With the use of dupilumab, which attenuated the Th2 response, the Th1/Th2 imbalance could be redressed allowing individuals to mount a greater Th1 response against the virus.

They concluded by suggesting that future studies should seek to understand the implications of their findings for other specific viral infections.


Ungar B et al. COVID-19 Symptoms Are Attenuated in Moderate-to-Severe Atopic Dermatitis Patients Treated with Dupilumab. J Allergy Clin Immunol Pract 2021