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19th January 2023
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
4th April 2022
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