Michael Wilcock and Ersa Tsoutsoura present further analyses of high-cost drug prescribing for atopic dermatitis at a UK hospital, expanding on their 2023 evaluation of dupilumab use. This report examines adherence to guidelines for initiating and reviewing biologic and Janus kinase inhibitor therapies, offering valuable insights into real-world prescribing patterns and clinical decision-making in a secondary care dermatology setting.
Atopic dermatitis (AD), a common chronic inflammatory skin disease, has key features that include an eczematous eruption accompanied by intense itch, which can have a profoundly negative effect on all aspects of patients’ quality of life, especially in those with moderate-to-severe disease.1 It is typically an episodic disease, and there are no curative treatments for AD. Treatment is based on reducing symptom burden.
In the UK, the burden of eczema management falls on primary care, while those with more severe disease are more likely to be referred for specialist care.2 For most patients, emollients, topical corticosteroids and topical calcineurin inhibitors are sufficient to achieve disease control.
Those with more severe, widespread or refractory AD may consider the use of phototherapy or immunosuppressants such as cyclosporin or methotrexate. Other therapies include biologics that target interleukin (IL)-4 and IL-13 cytokine signalling pathways such as dupilumab; IL-13 signalling alone, such as tralokinumab or lebrikizumab; or those such as abrocitinib that inhibit Janus kinase (JAK) pathways.
There are various national guidelines for managing AD,3,4 while across England and Wales, high-cost drugs excluded from the NHS Payment by Results tariff, commissioned by integrated care systems (ICS), have been approved by the National Institute for Health and Care Excellence (NICE) for moderate to severe AD.5–9
Since our previous report specifically on the use of dupilumab in AD,10 the dermatology department at Royal Cornwall Hospitals NHS Trust has developed a simple pathway for moderate-to-severe AD that describes the use of standard therapy before treating with biologics or JAK inhibitors. As before, the hospital, in conjunction with the local ICS, utilised the Blueteq high-cost drug management system.
Objectives and audit methodology
This retrospective, single-site follow-on study aimed to audit adherence to NICE guidelines for the initiation and 16-week follow-up of patients prescribed any of the NICE-approved therapies for AD.
The audit criteria included confirming that patients had moderate-to-severe disease, that all patients had either responded to at least one systemic immunosuppressant or were deemed unsuitable for such treatment, and that therapy was discontinued at 16 weeks if the disease had not responded adequately.
Disease response was defined as achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI 50) and a minimum four-point reduction in the Dermatology Life Quality Index (DLQI) from baseline. Moderate and severe/very severe AD were defined by baseline EASI scores of 7.1–21.0 and 21.1–72.0, respectively.11
An extract was downloaded from the Blueteq system in early 2025 to identify patients who had been approved to start treatment for AD. Relevant data such as patient demographics and treatment details were imported into Microsoft Excel. Hospital correspondence was examined to identify AD severity scores at baseline and during the review period, as well as other relevant information.
Health Research Authority criteria for research and service evaluation were considered. This was a retrospective assessment involving no changes to the service delivered to patients. We used the NHS Health Research Authority tool, which helped confirm that no ethical approval was required for this project. Patient data were used in accordance with local NHS hospital policy.
Treatment choices for AD and early response outcomes
The sample consisted of 50 patients with a mean age at the start of therapy of 49 years (8–80 years; 30 males) who had undergone the 16-week review. At the time of analysis, the sample comprised 37 patients receiving dupilumab, seven patients receiving tralokinumab, four patients receiving upadacitinib and two patients receiving abrocitinib. In line with safety warnings, the JAK inhibitors were only used in patients under 65 years of age.
Five of the 50 patients – four on dupilumab and one on tralokinumab – had not tried an immunosuppressant but had received only phototherapy. Of those, one patient had been commenced on therapy at a tertiary centre, one had a contraindication to methotrexate, and one patient did not want to try methotrexate or azathioprine. It was unclear why the remaining two patients had not attempted immunosuppression.
Baseline EASI scores ranged from 2 to 47.6, with three patients not falling within the moderate-to-severe category (scores of 2, 3.6 and 5.6). Baseline DLQI scores ranged from 1 to 30. One paediatric patient stopped treatment due to severe needle phobia.
At the approximately 16-week review, the mean EASI score decreased from 23.2 to 4.9 for all 50 patients overall, and the mean DLQI score decreased from 17 to 6.
A total of 11 patients (22%) did not meet the NICE-defined treatment response at the review point, failing to achieve the required reduction in EASI and/or DLQI scores, but remained on treatment. This represents a notably higher proportion compared to just 3% (one out of 29 patients) in our previous audit of a smaller cohort.
Of these 11 patients, three did not meet the necessary EASI reduction target of 50%, five did not meet DLQI thresholds, and three met neither. At a later follow-up, six of the 11 subsequently achieved the NICE recommended reductions.
This audit highlights a need to improve adherence to NICE guidelines, particularly around immunosuppressant use and ongoing assessment of treatment efficacy.
AD prescribing patterns and patient realities
Clinical decision making is known to be complex, involving a combination of evidence-based guidelines, clinical judgement, patient preferences and other factors.12 Further work has shed light on the diverse factors influencing prescriber decision-making in medical practice.13 However, how NICE guidelines and any accompanying criteria then shape this complexity of decision-making is not well understood.
These decisions are shaped by far more than clinical guidelines alone. While NICE guidelines provide a framework for eligibility, they do not account for the complete clinical, psychological and social context in which decisions are made.
Interestingly, the baseline EASI scores were somewhat lower, with a mean of 23.2 in the current study compared with our previous work in which the mean was 29.7.10 This variability seen between our current audit of 50 patients and the earlier, smaller sample can be explained by principles of statistical variation. It is expected that smaller studies show wide fluctuations due to random chance, whereas larger samples yield more stable and representative results.
There were three patients at the commencement of treatment with EASI scores indicating that their AD was not moderate-to-severe, and a further patient with a baseline DLQI score of 1, who was therefore unable to achieve the NICE 16-week review response of a four-point reduction. These patients raise questions about the decision-making process for initiating treatment.
In our current study, six of the 50 (12%) patients did not meet the required EASI-50 reduction. Phase 3 trials of dupilumab and tralokinumab have reported that approximately 15% and 20% of patients, respectively, did not achieve the reduction at 16 weeks.14,15 Likewise, a network meta-analysis demonstrates that the numerical efficacy in EASI-50 response, over 12 to 16 weeks for various systemic therapies, was at its best 84% for monotherapy and 87% in combination with topical therapy.16
A heterogeneous longitudinal course with varying severity, flares and persistence characterises AD.17 It is possible that some patients may have had flares of their AD at the 16-week review, influencing their response scores. For example, a patient may achieve clear skin between weeks 2 and 14 but then flare by week 16 and be officially considered a treatment non-responder.
Furthermore, the NICE technology appraisal for nemolizumab notes that a patient expert explained that symptoms can vary significantly from day to day, and, therefore, the EASI score at an appointment may not accurately reflect the full extent of symptoms experienced at other times.9 One long-term follow-up study reported that treatment with dupilumab does not exclude the risk of a relapse, which can be estimated at around 50% within a timespan of three years.18
Three of the patients on dupilumab were aged under 12 years and hence did not strictly fall within the NICE technology appraisal remit of moderate-to-severe AD in adults. However, the licensed indication for dupilumab does cover severe AD in children aged six months to 11 years of age who are candidates for systemic therapy, and these patients would be covered by commissioning conditions under an appropriate NHS England policy. These three patients did have EASI scores at baseline indicative of severe disease.
Unsurprisingly, most of this patient sample were receiving dupilumab, as this was the first novel systemic agent to enter routine clinical practice. Nine (18%) of the 50 patients had commenced on dupilumab when it was the only NICE-approved choice available, and they continued it.
A further 20 patients commenced dupilumab from 2023 onwards when NICE guidance had approved three other options, including tralokinumab, which is suitable for those aged over 65 years. However, our analysis did not ascertain if these 20 patients received dupilumab because of a history of smoking or a history of risk of cardiovascular disease or cancer, which are cautions for JAK inhibitors.
Recognising study limitations
We acknowledge several limitations inherent in this retrospective study. The findings are based on secondary data and our interpretation of that data, which may be affected by the completeness and quality of the underlying medical records.
Our analysis focused solely on the disease severity measures specified in NICE guidance, without considering other indicators of disease burden.19 Additionally, we did not assess the use of concomitant topical therapies or the documentation of treatment-related adverse effects, such as conjunctivitis.
There are multiple factors to consider and discuss with the patient in a shared decision-making process regarding the choice of any systemic therapy, including mode and onset of action, short-term and long-term efficacy, safety, risk factors, comorbidities and other patient-specific factors.20
At the review stage, objective assessment tools such as EASI and DLQI offer a standardised way to document disease progression and justify escalated care.21 However, these measures primarily reflect objective severity rather than patients’ satisfaction with their disease control.20
Patient-reported outcomes and qualitative feedback often reveal nuances in treatment experience, including symptom relief, emotional wellbeing and functional status that standardised scales may overlook. Consequently, incorporating both objective measures and patient-reported experiences is essential for a holistic evaluation of treatment effectiveness and to guide ongoing management decisions tailored to the individual’s needs.
Strengthening governance through multidisciplinary review
Actions put in place by the dermatology department since the most recent audit include ensuring a more robust initiation process and multidisciplinary team discussion for those not meeting the NICE 16-week response recommendations. The results have been presented to the dermatology team and the importance of a comprehensive pre-treatment assessment to ensure patients meet established clinical criteria before starting therapy has been highlighted.
A formalised multidisciplinary team, comprising pharmacists, dermatologists, specialist nurses and, where appropriate, other relevant specialists such as rheumatologists, has been established to provide independent clinical review for patients who do not achieve the expected clinical response within the NICE-recommended 16-week assessment period. For these individuals, joint discussions allow for careful consideration of alternative therapeutic strategies, potential adjustments in treatment, or additional supportive interventions.
By embedding these steps into routine practice, the dermatology department ensures that treatment decisions are evidence-based, patient-centred and aligned with national guidelines, ultimately improving clinical outcomes and resource utilisation.
AD prescribing insights and lessons learned
Prescribers must consider whether to start, continue, or withdraw biologic treatment based on a nuanced balance of the following factors:
- Clinical severity and trajectory: A patient may meet the minimum criteria for biologics, but the clinician may judge their disease to be stable or likely to improve with alternative therapies. Conversely, a patient with borderline eligibility but significant quality-of-life impairment may prompt earlier intervention
- Patient circumstances and preferences: Patients with demanding jobs, caregiving responsibilities, or mental health challenges may require more rapid symptom control. This can influence decisions to initiate treatment earlier, or to continue despite suboptimal clinical response, to preserve overall wellbeing
- Perceived risk of deterioration: For some patients, delaying biologic therapy may increase the risk of hard-to-control flares. This potential future harm may, for some clinicians, influence the decision to initiate treatment even when the NICE markers are not reached
- Monitoring and uncertainty: Flares of inflammatory skin diseases are often unpredictable and can be significantly distressing for patients. In some cases, patients are reviewed remotely or with delays, resulting in uncertainty regarding the true current severity of their condition. This uncertainty can prompt clinicians to adopt a cautious approach, opting to continue biologic therapy rather than discontinue it prematurely, even when formal criteria for continuation may not be fully met
- Systemic pressures and administrative barriers: The administrative burden associated with stopping and potentially restarting biologic treatment, such as navigating multiple approval forms and processes, can create anxiety among clinicians. As a result, clinicians may prefer to maintain ongoing therapy, deferring formal treatment reviews in the hope of reassessing response at a later, more convenient time.
Conclusion
When applied to biologic prescribing patterns, this recent audit provides a more robust and representative view of clinical practice, whereas individual clinician decisions or atypical patient scenarios may have had a more significant influence on the earlier, smaller audit.
This audit has provided a meaningful review of current prescribing practices for biologics and JAK inhibitors in AD within a secondary care setting. While most patients met the expected response thresholds set out by NICE, a notable proportion either lacked full documentation of eligibility criteria or failed to reach the required treatment response at 16 weeks. These findings underscore the importance of conducting rigorous baseline assessments and maintaining systematic documentation to ensure that treatments are initiated appropriately and monitored consistently.
Furthermore, although NICE and other guidelines aim to standardise care, the real-world application involves complex decision-making that cannot always be codified. Understanding this discretion and its impact on initiation thresholds and the continuation of therapy is crucial when interpreting audit results or addressing apparent inconsistencies in prescribing practice.
For hospital pharmacy teams, this audit underscores their vital role in overseeing the governance of high-cost medicines, supporting clinicians through the Blueteq system, and ensuring that prescribing decisions align with national guidelines and local commissioning frameworks.
Enhanced collaboration between pharmacy and clinical teams, including timely multidisciplinary reviews for patients with suboptimal responses, remains essential to uphold clinical standards and promote the equitable and cost-effective use of biologic therapies.
Authors
Michael Wilcock MPhil Pharmacy Department
Ersa Tsoutsoura MPharm Dermatology Department
Both of Royal Cornwall Hospitals NHS Trust, Truro, UK
References
1 Guttman-Yassky E, Renert-Yuval Y, Brunner PM. Atopic dermatitis. Lancet 2025;405:583–96.
2 de Lusignan S et al. Patterns and trends in eczema management in UK primary care (2009–2018): A population-based cohort study. Clin Exp Allergy 2021;51(3):483–94.
3 AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel; Chu DK et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE- and Institute of Medicine-based recommendations. Ann Allergy Asthma Immunol 2024;132(3):274–312.
4 Wollenberg A et al. European Guideline (EuroGuiDerm) on atopic eczema: Living update. Eur Acad Dermatol Venereol 2025 May 2:doi: 10.1111/jdv.20639.
5 National Institute for Health and Care Excellence (NICE). Dupilumab for treating moderate to severe atopic dermatitis. NICE Technology appraisal guidance (TA534). [Accessed August 2025].
6 NICE. Baricitinib for treating moderate to severe atopic dermatitis. NICE Technology appraisal guidance (TA681). [Accessed August 2025].
7 NICE. Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis. NICE Technology appraisal guidance (TA814). [Accessed August 2025].
8 NICE. Lebrikizumab for treating moderate to severe atopic dermatitis in people 12 years and over. NICE Technology appraisal guidance (TA986). [Accessed August 2025].
9 NICE. Nemolizumab for treating moderate to severe atopic dermatitis in people 12 years and over. NICE Technology appraisal guidance (TA1077). [Accessed August 2025].
10 Wilcock M, Roberson L, McInnes A. Adherence to NICE criteria for initiation and continuation of treatment with a biologic in atopic dermatitis. Hospital Pharmacy Europe 2023.
11 Leshem YA et al. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol 2015;172(5):1353–7.
12 Montori VM, Brito JP, Murad MH. The optimal practice of evidence-based medicine: incorporating patient preferences in practice guidelines. JAMA 2013;310(23):2503–4.
13 Hartjes MG et al. Understanding factors that influence the drug choice of prescribers: A Q-methodology study. Br J Clin Pharmacol 2025 Feb 24:doi: 10.1002/bcp.70009.
14 de Bruin-Weller M et al. Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo controlled, randomized phase III clinical trial (LIBERTY AD CAFÉ). Br J Dermatol 2018;178:1083–101.
15 Wollenberg TA et al. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol 2021;184(3):437–49.
16 Silverberg JI et al. Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. J Eur Acad Dermatol Venereol 2021;35(9):1797–1810.
17 Chovatiya R, Silverberg JI. Evaluating the Longitudinal Course of Atopic Dermatitis: Implications for Clinical Practice. Am J Clin Dermatol 2022;23(4):459–68.
18 Trave I et al. Frequency and clinical features of disease flares in patients with atopic dermatitis treated with dupilumab. J Dermatolog Treat 2025;36(1):2495831.
19 Kleyn CE et al. Burden of Moderate to Severe Atopic Dermatitis in Adults from France, Italy, and the UK: Patient-Reported Outcomes and Treatment Patterns. Dermatol Ther (Heidelb) 2022;12(8):1947–65.
20 Müller S, Maintz L, Bieber T. Treatment of atopic dermatitis: Recently approved drugs and advanced clinical development programs. Allergy 2024;79(6):1501–15.
21 Buttar BA et al. Evaluating the necessity of formal atopic dermatitis severity measurement tools in clinical practice. J Dermatolog Treat 2025;36(1):2469646.
This article was originally published by our sister publication Hospital Pharmacy Europe.
