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11th August 2025
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.
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.
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.
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.
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.
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.
Prescribers must consider whether to start, continue, or withdraw biologic treatment based on a nuanced balance of the following factors:
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.
Michael Wilcock MPhil Pharmacy Department
Ersa Tsoutsoura MPharm Dermatology Department
Both of Royal Cornwall Hospitals NHS Trust, Truro, UK
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.
Real-world analysis of the first season of vaccination against respiratory syncytial virus (RSV) has shown a dramatic impact on hospitalisation in both older people and newborns.
An analysis done by the UK Health Security Agency (UKHSA) found RSV vaccination was 82% effective against hospitalisation in older people last winter.
It also showed it was ‘highly effective’ in preventing hospitalisation for older people with a chronic respiratory condition and those who are immunosuppressed.
The study of patients across 14 NHS hospitals in England from October to March assessed more than 1,000 75-79-year-olds admitted for acute respiratory infection.
Overall vaccination was found to be 87% effective against admission for severe disease, including needing oxygen supplementation.
A second study also looking at real-world implementation of the maternal RSV vaccine programme found it was 72% effective in preventing hospitalisation for newborns whose mothers are vaccinated more than 14 days before delivery.
Reporting these findings in The Lancet Child and Adolescent Health, researchers said vaccine effectiveness was 58% when including mothers who were vaccinated at any point up to their child being born.
Both maternal and older people vaccination were introduced in September.
Latest figures show that 54.7% of pregnant women giving birth in March had received the RSV vaccine, while uptake among elderly people has been steadily rising with 62.9% of 75-to-79-year-olds now vaccinated, UKHSA said.
Earlier this summer, the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the catch-up RSV vaccination programme in older adults should be expanded to include those over the age of 80 years.
The JCVI had previously said this age group would be reassessed once there was more certainty on the effectiveness of the RSV jab among those over 80 years old and the ‘real-world’ impact of the vaccine.
In February, research found a major drop in RSV-related hospitalisations following vaccination among eligible older age groups in Scotland.
Commenting on the latest RSV-related hospitalisation figures, Dr Conall Watson, UKHSA immunisation consultant said: ‘RSV can be a particularly serious infection for older people, so this new evidence will also give much reassurance that having the RSV jab will greatly reduce their chances of ending up in hospital.’
He added: ‘As a parent and health professional I can’t stress enough the importance of getting the RSV vaccine during every pregnancy.’
Dr Watson encouraged all pregnant women in week 28 of pregnancy or soon after to contact their maternity service or GP practice to arrange a vaccination, adding that women later on in pregnancy who haven’t received the vaccination should also receive one.
Greta Hayward, consultant midwife at the UKHSA, said: ‘The RSV season usually starts in October and while there is no risk-free birth month, babies born in late summer or the autumn are most likely to be admitted to hospital.
‘Hundreds of babies attend emergency departments each day for bronchiolitis through most of November and December. That is why it is so important that over the summer pregnant women reaching 28 weeks of pregnancy, ensure they are vaccinated as soon as possible.’
Last month, NHS England announced that vulnerable premature babies who need extra protection against RSV will receive a long-lasting single injection of nirsevimab as part of a new immunisation programme.
A version of this article was originally published by our sister publication Pulse.
6th August 2025
Better integration and coordination between primary and secondary care, including undertaking medicines reconciliation, will improve medication support during and after hospital discharge for people with chronic obstructive pulmonary disease (COPD), new research suggests.
COPD patients frequently encounter challenges with their medications, such as non-adherence to medicines and incorrect use of inhalers, which can lead to readmission and poor outcomes.
Understanding the context of these challenges and addressing barriers to optimal care delivery can be beneficial before any new interventions are implemented. As such, an research team aimed to identify areas in which medicines support could be improved during and after hospital discharge.
The researchers interviewed hospital pulmonary ward staff at a university hospital in Norway between December 2023 and February 2024, conducting focus groups with nurses and nursing assistants working on the pulmonary inpatient ward and semi-structured interviews with doctors working on the inpatient or outpatient pulmonary ward.
Through systematic text condensation, the researchers identified six key themes and categorised them as organisational-level and practitioner-level issues.
At an organisational level, staff found transferring patients from secondary to primary care challenging, especially when there was no clear overview of services available for discharged patients in different areas.
Staff reported that medicine lists were not always updated by hospital physicians; medicine reconciliation was not always completed in primary care, sometimes leading to avoidable medication errors; and the interoperability of electronic health record (EHR) systems across different care settings did not function effectively.
The responsibility of post-discharge follow-up and patient education on medicine use was often not clearly delegated to pulmonary rehabilitation, general practice or pharmacy. In outpatient clinics, staff experienced time pressures that meant individualised education and training on medicines was not always possible.
Additionally, disparities in financial resources among primary care providers contributed to organisational-level issues, leading to inconsistent access to rehabilitation services and a lack of understanding from hospital staff about ‘what awaits the patient when they are discharged’.
At the practitioner level, the three themes that emerged included competence around COPD resources for rehabilitation, clarification of professional roles and task distribution, and the need for practitioners to educate and support patients.
Staff reported a significant knowledge gap regarding inhalers and medical devices within non-specialised healthcare settings, including general hospital wards and intermediate care units, as well as home care services, which could lead to longer hospital stays. A proposed solution was for hospital staff or pharmacists to provide training for home care staff to mitigate this risk.
In primary care, general practitioners were found to be reluctant to modify hospital-initiated medicines, but hospital staff noted that pharmacists could detect errors in prescribing and undertake medicines reconciliation.
Additionally, staff agreed that more time needs to be spent educating patients on the proper use of inhalers, with structured discharge consultations being one suggestion for achieving this. Hospital pharmacy was also highlighted as a suitable place for inhaler training away from busy wards.
The researchers concluded that improving medicines support for patients with COPD requires better coordination and integration across all care levels, with increased support and education for healthcare workers in both primary and secondary care. They added that medicine reconciliation should be undertaken to ensure that updated medicine lists are used across care levels.
Future research should include more than one hospital and the views of community pharmacists, general practitioners and nursing staff, the researchers noted.
Reference Nygård T et al. Providing medicines-related support for people with COPD before and after hospital discharge—a qualitative study of hospital staff perspectives. BMC Health Serv Res 2025;25(1):899.
With insights from ESCMID Global 2025, Gerry Hughes explores how artificial intelligence is supporting the management of infectious diseases, as well as the associated risks and future directions.
Artificial intelligence (AI) is reshaping infectious disease care, from the diagnostic laboratory to antimicrobial stewardship at the bedside. At ESCMID Global 2025, there was widespread agreement that AI’s greatest value lies in its ability to support, not supplant, expert clinical judgment.
Researchers and healthcare professionals showcased practical applications where AI can help to address early diagnosis, outbreak detection, antimicrobial prescribing and information dissemination.
AI is driving tangible improvements in diagnostic and documentation workflows, potentially enhancing speed, accuracy and scalability in both laboratory and clinical settings.
Presenting work from Monash University in Melbourne, Australia, at ESCMID Global, Dr Nenad Macesic and colleagues explored how AI could extract more value from matrix-assisted laser desorption/ionisation time-of-flight (MALDI-TOF) mass spectrometry. Although widely used for bacterial species identification, this technology has previously not been reliable for strain typing.
The Monash team trained a neural network using nearly 2,000 clinical bacterial isolates using MALDI-TOF and whole genome sequencing, which is the gold standard analysis tool.
For common pathogens like E. coli, S. aureus, and E. faecium, the AI model achieved strong accuracy, particularly when paired with high-resolution genomic data. While further work is required, the findings demonstrated the potential application of AI-augmented MALDI-TOF analysis of clinical bacterial strains in practice.
Complementing this, a European collaborative led by researchers at the University of Oldenburg in Germany, presented CarbaDetector – a free web-based research tool that uses machine learning to predict carbapenemase-producing Enterobacterales from basic disk-diffusion results.
In external testing, it showed 97.8% sensitivity, with higher specificity (56.6%) than the reference antibiogram. The researchers suggested that CarbaDetector may help reduce unnecessary confirmatory testing in clinical labs.
A third project presented by Justin Xu, a PhD candidate in machine learning at the University of Oxford’s Big Data Institute, UK, demonstrated how AI can support the interpretation of chest X-ray reports. His team used GPT-4 to convert unstructured radiology text into structured formats, enabling further classification by a mathematical model.
Using large publicly available datasets, the model achieved high performance in identifying infectious disease-related findings. Future work on this approach is set to apply similar AI methods to infectious disease consultation notes, aiming to improve diagnosis and documentation while reducing the costs of manual data annotation.
Professor Shruti Gohil, associate medical director, hospital epidemiology at the University of California, Irvine in the US, discussed results from the INSPIRE antimicrobial stewardship trials. These studies evaluated how context-aware clinical prompts integrated into electronic healthcare systems could improve empiric antibiotic choices.
Unlike traditional alerts, the prompts were iteratively developed over a one-year period to ensure user acceptability and to reduce known challenges such as alert fatigue. They used local microbiological data and patient-specific risks to tailor advice. Importantly, they did not require clinicians to respond with a simple ‘yes’ or ‘no’ but provided actionable recommendations and tracked prescriber actions arising from the alerts.
Publications arising from these studies, for pneumonia and skin and soft tissue infections, reported optimised extended-spectrum antibiotic selection without an increase in adverse events. Professor Gohil noted the importance of accompanying the prompt rollout with an educational campaign to support adoption.
Generative AI represents a transformative force in medicine, comparable in impact to the introduction of electricity or the internet, Professor José Ramón Paño-Pardo, attending physician at the University Clinical Hospital of Zaragoza in Spain said during his ESCMID Global session.
While not a substitute for clinical judgment, he continued, large language models (LLMs) like ChatGPT can enhance diagnostic reasoning and accelerate knowledge dissemination. He brought attention to the results of a recent randomised trial demonstrating the impact of LLMs on diagnostic decision-making.
In that study, 50 physicians in family, internal and emergency medicine found that access to a LLM did not significantly improve diagnostic reasoning compared with conventional resources alone.
Physicians using the LLM performed similarly to those relying solely on standard tools. Interestingly, the LLM outperformed physician groups when assessed independently, suggesting that while the technology shows promise, further development is needed to effectively support AI-mediated clinical reasoning in practice
Professor Paño-Pardo cautioned that generative AI tools, while capable of synthesising information and streamlining documentation, must be subject to rigorous clinical oversight. Their outputs are not inherently reliable and should support rather than supplant the judgement of infectious disease specialists, he said.
Recent European guidance on the responsible use of generative AI urges the research community to apply such tools with transparency and caution – particularly in writing and manuscript development. The guidance advises against using AI in sensitive tasks such as peer review, and calls for robust oversight, training and a clear commitment to research integrity.
Professor Erlangga Yusuf, a consultant in medical microbiology at the Erasmus Medical Centre in Rotterdam, Netherlands, echoed these recommendations in using generative AI to support scientific writing.
During his ESCMID Global session, he highlighted that while these tools struggle with technical tasks like data visualisation or systematic literature reviews, they excel at improving grammar, clarity and flow.
He reported successfully using ChatGPT to rephrase manuscript sections, align writing with journal guidelines and refine logical progression of concepts and ideas. However, he cautioned researchers to stay actively involved in the writing process, ensuring outputs remain accurate and meaningful.
Key limitations of partnering with LLMs in academic writing include hallucinated references, a lack of true comprehension and potential data privacy risks, he warned. Professor Yusuf encouraged researchers to treat LLMs as collaborators rather than authors and maintain rigorous oversight of AI-generated content.
This year’s ESCMID Global stimulated a deeper appreciation of how AI can be responsibly integrated into infection services. Whether in the form of predictive modelling, structured prompts or support with documentation, the technology is here – and the likelihood is that its role in research and healthcare will only expand.
However, one particular message was abundantly clear: AI is not a shortcut. It demands validation, oversight and transparency. When implemented with rigour and accompanied by education and governance, AI can enhance clinical excellence.
For infection specialists, now is the time to engage with these tools, shape their evolution and ensure they serve the needs of both patients and professionals alike.
4th August 2025
President of the Royal College of Pathologists, Dr Bernie Croal, speaks to Kathy Oxtoby about the evolving landscape of pathology in the UK, the challenges and opportunities facing this vast specialty, and where he sees the field going next.
Pathology is the glue that holds much of healthcare together and is a prime example of multidisciplinary working at its best. Supporting diagnostic processes, guiding doctors on the right way to treat common diseases, using cutting-edge genetic technologies to treat patients with life-threatening conditions and much more besides, pathologists are the crucial backbone of research, advancing medicine and devising new treatments.
And this is something that Royal College of Pathologists president Bernie Croal has spent his career championing. ‘We talk about pathology involving patients from before you’re born all the way through to after you’re dead – that’s the pathology journey we will all dip into at some point,’ he says.
In fact, he points out that a staggering 95% of healthcare interactions involve pathology in one form or another to optimise patient care. ‘It’s not just about diagnosis, it’s about screening, prevention, treatment – and across the 17 disciplines [of pathology] we’re involved with all of that,’ he says.
The pathology landscape continues to evolve, and there are some exciting developments within the specialty – some of which have already reached patients.
One of the most recent and well known is the emergence of self-injectable glucagon-like peptide-1 (GLP-1) agonists for the treatment of obesity. Chemical pathologists have played an instrumental role in the research and clinical trials and are now one of the groups delivering and monitoring this therapy across the NHS and the private sector.
‘That’s quite a dramatic development and we’re beginning to see potential impacts on large numbers of the population,’ says Dr Croal.
The capacity for GLP-1s to treat a previously underserved patient population echoes another substantial advancement in pathology: genomic medicine.
Dr Croal notes that being able to use the pathology and genomic data together has had ‘a huge influence on practice in the last 10 years’ and is paving the way for more personalised medicine that can support better outcomes for patients, especially in cancer.
‘Knowledge about genomic testing and the use of that genomic information to select treatments for cancer, for example, is clearly a significant step forward in how we manage those patients’, he says. ‘We’re now beginning to see treatments become a lot more successful and patient centred.’
He also predicts that further combination of pathology and genomics will lead to many more new cancer treatments, which will ‘significantly alter the outcomes and the survival rates for cancer’.
Technology in a range of forms is playing an increasingly important role in progressing the field. For example, Dr Croal says pathologists are beginning to see a lot more automation in their labs. This has ‘already happened in the blood science labs, but we’re also beginning to see it in the histopathology labs’, he says, which is ‘bringing more efficiency to the whole process’.
In addition, one of the few positive outcomes of the Covid-19 pandemic is the widespread use of online meetings. This has allowed for a new, efficient and collaborative way of working that Dr Croal says is invaluable.
‘Being able to speak to other pathologists around the country – around the world even – has been a big advantage,’ Dr Croal says.
‘All pathologists work not just with other pathologists in other disciplines within pathology, but with a huge variety of other healthcare professions across the whole of healthcare,’ he adds. ‘[Covid] advanced the ability to sit in a virtual room and discuss patients and issues with doctors in, say, surgery, cancer wards and general practice, and do it all remotely.’
An innovation taking this pursuit of efficiency to the next level is artificial intelligence (AI), which Dr Croal says could ‘revolutionise different parts of the pathology journey’.
Research has already shown how AI can be used to drive efficiencies in cancer diagnosis, predict future health risks using AI-enabled ECG and analyse digital images for stroke care – and that’s just scratching the surface of the possibilities. AI has the potential to help make myriad processes quicker, more efficient, and result in better outcomes for patients.
For Dr Croal, AI is currently ‘a real buzzword’, but he says the vision needs to be turned into reality.
He says: ‘Everyone’s talking about it, but the reality is it’s not really happening at the moment.’ It seems that the research is promising but the transition of AI into everyday practice is a little way off.
And the reason is simple. ‘Across pathology we need to improve the IT systems and further implement digital pathology in order for us then to think about how we can use AI to make systems better, more efficient, and ensure that AI can be better for patients,’ Dr Croal explains. ‘There’s a long way to go, but we desperately need investment into pathology services to enable us to take advantage of it. AI is very expensive and at the moment the NHS simply can’t afford to implement it.’
That said, the future looks somewhat brighter as genomic data and technology have been announced as fundamental to the new 10 Year Health Plan for England. This shift to digital is set to drive a new way of delivering healthcare, but Dr Croal notes that this will need a significant investment in pathology at a level beyond the current reality. In short, he says the Government needs to step up with the necessary investment and the strategies must be workable amidst current NHS pressures.
According to Dr Croal, the biggest challenges facing pathology in the UK are the same ones facing all of healthcare and in many countries around the world: ‘a workforce crisis and a funding crisis’.
‘Clearly, healthcare in the UK is not doing well at the moment. We don’t have enough money, our infrastructure is crumbling, we don’t have enough staff in the right place, and we’ve got huge waiting lists where people are suffering and dying unnecessarily,’ he says. ‘We’re also seeing some pathology services beginning to fail across the UK.’
In fact, paediatric and perinatal pathology now has a consultant vacancy rate of almost 40%. In major areas like Birmingham, Leicester, Bristol and the whole of Northern Ireland, there are now no paediatric and perinatal pathologists, which means ‘those services have gone’ for those local populations and alternative plans have to be put in place.
It’s not just paediatric and perinatal pathology that’s being affected, as ‘we’re beginning to see shortages across all of pathology’. This is exacerbated by the number of pathologists choosing to work in the private sector, Dr Croal says. This adds pressure on the NHS because these individuals tend not to be involved in the training of new pathologists.
‘We need to support NHS pathology to ensure we have those training centres, and the presence of pathologists within NHS hospitals,’ he adds.
But that’s easier said than done. Underpinning these issues is a reduction by the Government in the number of pathology training posts available in recent years. Dr Croal estimates that in five to 10 years’ time, there may be a 40% shortage of consultant pathologists across the board.
As RCPath president, this is something Dr Croal is tackling head on. Earlier this year, the College published a new workforce strategy, ‘which is aiming not only at trying to improve the training part of the equation, but also focusing on retention of the pathologists that we already have’, he says.
This includes plans for how automation, digital, AI and other innovations can be used to manage increasing pathology workloads and generate intelligent solutions to support the imbalance between workforce and workload. But it emphasises that ‘AI will help us do the work, not replace us’.
The overall aim of the strategy is to safeguard future service delivery and eliminate the workforce crisis that threatens the delivery of care to patients.
While there may be workforce challenges, pathology ‘is more popular than it ever has been’, according to Dr Croal, and part of the appeal is ‘being able to combine science and medicine’.
Younger members of the profession are also increasingly seeing pathology as a specialism offering optimal work-life balance. ‘It enables many of us to mostly work during the day, and it is better for flexible and part-time working,’ he explains.
For the first time ever, the majority of pathology consultants being trained now are female. ‘It’s been a big shift, since even 10 years ago, and it’s a shift we all very much welcome,’ Dr Croal says. ‘It means we’ve got a better balance of males and females across our disciplines.’
Dr Croal anticipates that ‘there will be huge competition for pathologists’ in the future, and ‘because a lot of the pathologist activity can be done virtually, that will enable pathologists to work anywhere’.
It is hoped that this flexibility, connectivity and efficiency will form part of the solution to the workforce crisis in the UK and across Europe, which, in turn, will better support patient care and outcomes.
Halfway through his three-year presidency, Dr Croal is looking at developing a new pathology plan to take the specialism towards a more technological future. ‘We want to explicitly document what we think pathology needs and what direction it needs to go in, covering important areas around IT, digital and AI, but also around workforce and how we can make that work better,’ he explains.
With the recent publication of the new 10 Year Health Plan for England, Dr Croal is now ‘looking to see how pathology fits into that, and how we can develop our own plan that demonstrates the importance of pathology and what pathology can do’.
‘The plan doesn’t come with much in the way of new funding or a clear implementation strategy,’ he says. ‘It will be up to the NHS and pathology to work differently and demonstrate importance and value – the latter hopefully shifting healthcare budgets towards pathology.’
With the specialisms being so instrumental across the healthcare spectrum, Dr Croal is adamant that more investment will go a long way.
‘If we invest in pathology, if we improve pathology, then the rest of healthcare benefits,’ he says. ‘It’s the best way of investing in healthcare and improving services for patients.’
A new study highlights the risks of atopic dermatitis flare-ups after discontinuing the use of dupilumab. Nearly half of patients who stopped taking the systemic biologic treatment, for reasons other than limited clinical effectiveness, required restarting dupilumab within a year. When clinicians resumed treatment, symptoms were found to improve again within 16 weeks.
The researchers noted limited data on how discontinuing the use of dupilumab affects patients with atopic dermatitis, which is especially important for patients who may pause or stop treatment because of pregnancy, clinical remission or through personal choice.
They therefore conducted a multi-centre, retrospective study of data from 208 people with severe atopic dermatitis who discontinued dupilumab for reasons unrelated to inefficacy. Using the Eczema Area and Severity Index (EASI), the Pruritus Numerical Rating Scale (P-NRS), the Atopic Dermatitis Control Tool (ADCT), and the Dermatology Life Quality Index (DLQI), they assessed disease activity after discontinuation of treatment.
The study employed Kaplan-Meier analysis to evaluate the necessity of restarting systemic treatment and to determine the time to retreatment after stopping dupilumab.
The primary outcome was the time and likelihood of disease worsening and the need to restart systemic treatment after discontinuing systemic therapy. Worsening of the condition was defined as EASI >7.0, EASI increase ≥6.6, P-NRS ≥4, P-NRS increase ≥4, ADCT ≥7, ADCT increase ≥5, or DLQI increase ≥4, as well as the need to restart systemic treatment.
The main reasons for discontinuing dupilumab were clinical remission (43.3%), pregnancy or wanting to become pregnant (20.7%), and patient choice (11.1%).
Patients with a family history of atopic dermatitis or non-classical forms of the disease were more likely to see their symptoms worsen after discontinuing the therapy.
A significant portion (42.8%) of patients resumed systemic treatment, around 47 weeks after discontinuing dupilumab, with a baseline median EASI score of 10.0 and a median P-NRS of 6.0. The chances of resuming systemic therapy were 25% at 31 weeks and 50% at 94 weeks. Once patients restarted medication, atopic dermatitis symptoms improved within 16 weeks.
The researchers stated that restarting dupilumab was effective after treatment interruption and led to significant clinical improvements. This supports the long-term use of dupilumab to manage atopic dermatitis, particularly in those at higher risk of recurrence, they added.
Reference
Barei F et al. Clinical Course of Atopic Dermatitis after Dupilumab Discontinuation: A Multicenter Real-World Study. Clin Exp Dermatol. 2025 Jun 20:llaf275.
31st July 2025
New research finds adalimumab biosimilars are effective and safe in treating paediatric psoriasis across both treatment-naive patients and those who switch from the originator adalimumab.
Many adalimumab biosimilars are approved to treat the same conditions as their originator (brand name Humira), and they have been used safely and effectively in patients with psoriasis. However, the performance of adalimumab biosimilars in children with psoriasis is unknown.
A new study addresses this knowledge gap by evaluating outcomes in children who initiated biosimilar therapy directly, as well as those who switched from the originator adalimumab.
The 52-week study is an observational, retrospective study, involving patients enrolled across 10 clinical sites in Italy, Portugal and France. All patients started biosimilars after January 2022, and the activity of their psoriasis was measured using the Psoriasis Area Severity Index (PASI), as well as safety data, at Weeks 16, 24 and 52 following adalimumab biosimilar initiation. Absolute PASI scores were measured, as well as PASI 75 and PASI 90, which indicate the improvement in psoriasis of 75% and 90%, respectively.
A total of 102 paediatric patients with psoriasis participated in the study, with 72 being biosimilar-naive and 30 switching from the originator adalimumab.
In both paediatric patient cohorts, the median absolute PASI remained low at Weeks 16, 24, and 52. In the naive group, the absolute PASI decreased over time, from 5.4 at Week 16 to 2.8 by Week 52. PASI 75 was achieved by 77.8% of patients, and PASI 90 by 46.3% of patients at Week 52.
Patients in the switch group showed lower PASI scores throughout, starting at 2.6 at Week 16 and decreasing to 1.4 by Week 52. Those who switched to adalimumab biosimilars achieved higher PASI 75 and PASI 90 response rates of 92.6% and 55.6%, respectively, at Week 52.
The researchers concluded that adalimumab biosimilars are a safe and effective treatment option for children with psoriasis, and the study supports the use of biosimilars as viable alternatives to originator adalimumab in paediatric psoriasis.
Switching from the originator adalimumab did not result in a loss of efficacy or an increased safety risk for most patients. In fact, adverse events were infrequent, and no treatment-emergent serious adverse effects were reported.
This approach makes treatment available to more people and provides an affordable option for healthcare systems, the researchers said.
Larger and longer studies are needed, and future research should examine the individual differences between biosimilars and explore a cost analysis of potential changes, they added.
Reference Bertoli C et al. Effectiveness and Safety of Adalimumab Biosimilars in Pediatric Psoriasis: A Multi-Center International Experience. Psoriasis: Targets and Therapy 2025;15:233-241. This article was originally published by our sister publication Hospital Pharmacy Europe.
24th July 2025
Dr Sizheng Steven Zhao, lead author of the 2025 British Society for Rheumatology guideline on managing axial spondyloarthritis, presents its practical recommendations on targeted therapies, multidisciplinary care and extra-musculoskeletal manifestations, discussed within a holistic treatment framework that emphasises shared decision-making and the ongoing role of non-pharmacological strategies.
Axial spondyloarthritis (axSpA) is a chronic, immune-mediated disease that primarily targets the spine and sacroiliac joints. It may also involve peripheral joints, entheses and extra-musculoskeletal manifestations, such as acute anterior uveitis, psoriasis and inflammatory bowel disease (IBD).1
Symptoms of axSpA typically start in early adulthood but diagnosis can take several years.2 Chronic inflammatory pain and stiffness are well recognised to have adverse effects on quality of life, social participation and mental health.3–5 The comorbidity burden is also higher than that of age-matched people without axSpA,6 which can influence treatment choice.
Since the publication of the 2017 British Society for Rheumatology axSpA guideline,7 pharmacological management has expanded from tumour necrosis factor inhibitors (TNFi) to include other biologic disease-modifying antirheumatic drugs (bDMARDs), targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) and treatment strategies such as drug tapering.
Therapeutic options for treating extra-musculoskeletal manifestations as index conditions have similarly evolved. This increasingly complex therapeutic landscape forms the scope and context in which we updated the guideline in 2025.8
The guideline was developed by a multidisciplinary working group representing a broad range of perspectives, including individuals with lived experience of axSpA, as well as specialists in rheumatology, ophthalmology, dermatology, gastroenterology, epidemiology, nursing, physiotherapy and pharmacy, alongside the National Axial Spondyloarthritis Society.
Unlike European and US guidelines, we focused on targeted therapies, particularly pragmatic recommendations for their use in the presence of extra-musculoskeletal manifestations.
Although the guideline focuses on pharmacological therapies, non-pharmacological modalities such as physiotherapy, hydrotherapy, lifestyle interventions and patient education form the cornerstone of axSpA management. Pharmacological treatments should facilitate and enable physical activity, not replace it.
Recent research has highlighted the challenges of diagnosing axSpA. For example, roughly one-third of the general population can have inflammatory and/or structural changes on their MRI report,9 and around a third of axSpA cases may not be axSpA when centrally adjudicated.10 This means that we must be open to re-evaluating the diagnosis, particularly when patients do not respond to multiple lines of therapy.
The guideline recommends the use of the AxSpA Disease Activity Score (ASDAS) for monitoring disease. Unlike the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), ASDAS is shown to correlate with radiographic progression.11,12 Definitions of high disease activity using ASDAS ≥ 2.1 or the BASDAI ≥ 4 usually coincide, but when discordant, the ASDAS definition better predicts treatment response.13,14
Adopting ASDAS should be straightforward for those already familiar with using the Disease Activity Score-28, which incorporates C-reactive protein levels and patient global assessment of health.
There are only three classes of drugs for this condition, which may need many decades of treatment. Therefore, any treatment decisions should consider the overall number of available therapeutic options, adverse prognostic factors for disease progression and treatment response, as well as the extent of inflammatory disease activity.
The presence of extra-musculoskeletal manifestations should not trigger a reflex treatment decision. A more considered approach involving discussion with ophthalmologists, dermatologists and gastroenterologists is required where possible.
Monoclonal TNFi are preferred for uveitis, but a history of inactive uveitis is not a contraindication for other classes of drug. Monoclonal TNFi and Janus kinase inhibitors are preferred for IBD, but, again, a history of inactive IBD is not an absolute contraindication for other drugs.
Treating to a numerical target may lead to rapid cycling through available treatment options, while the leading treat-to-target TICOSPA trial did not achieve its primary outcome or the majority of secondary outcomes.15 Therapeutic targets should therefore be agreed upon with the person with axSpA, rather than being based solely on disease indices.
In sustained remission, increasing the dosing interval via therapeutic tapering can be considered. However, withdrawing therapy is invariably followed by a disease flare that cannot always be re-controlled.
The axSpA multidisciplinary guideline working group proposed a range of research recommendations to address key evidence and identified the top 10 priorities.8
These include exploring non-pharmacological management options and conducting head-to-head clinical trials to compare the effectiveness of targeted therapies. Further research is needed into strategies for managing fatigue in axSpA, as well as the evidence supporting the sequential use of targeted therapies. The group also emphasised the importance of identifying criteria for initiating and predicting success in therapeutic tapering.
Additional priorities include improving the management of difficult-to-treat axSpA and clarifying the role of imaging in assessing treatment response. The effective use of patient-initiated follow-up was also identified as an area requiring further investigation.
Finally, the group emphasised the need for more evidence on the comparative safety of targeted therapies in axSpA populations and the safety and efficacy of combining targeted therapies in individuals with axSpA and extra-musculoskeletal manifestations.
The primary objective of treatment is to support patients with axSpA in leading healthy, fulfilling and productive lives. This is achieved by optimising health-related quality of life through the comprehensive management of all disease manifestations, preventing structural damage and preserving physical function. Also important are the goals of maintaining work productivity and promoting social participation.
Effective management should be a collaborative process, developed in partnership with the person living with axSpA. Treatment decisions must reflect an individual’s needs, goals and preferences, while also considering the resources available within the healthcare setting.
Finally, a multidisciplinary approach is essential, coordinated by a rheumatologist and supported by a team that can deliver holistic care. This includes both pharmacological and non-pharmacological interventions tailored to the individual’s overall health and disease profile.
Sizheng Steven Zhao MBChB PhD
Clinical senior lecturer (associate professor) and consultant rheumatologist, University of Manchester
Vulnerable premature babies who need extra protection against respiratory syncytial virus (RSV) are set to receive a long-lasting single injection of nirsevimab, NHS England has said as it announces a new immunisation programme.
Administered during ongoing care by a specialist neonatal team, nirsevimab will replace the monthly injections of palivizumab previously offered to some babies.
Available in England from September, the single injection can provide effective protection for the six-month duration of a typical RSV season, NHS England said.
Nirsevimab is a long-acting monoclonal antibody and supplies antibodies against RSV, rather than encouraging the body’s own immune system to produce them, as is the case with the existing vaccination programme. It works by binding long-term to the RSV fusion (F) protein.
Clinical trial data suggests nirsevimab offers more than 80% protection against the virus, compared to 55% protection for palivizumab.
The injection will be offered seasonally to eligible high-risk infants and young children with complex heart, lung or weakened immune system conditions.
Dr Conall Watson, consultant epidemiologist at the UK Health Security Agency said: ‘This new NHS nirsevimab immunisation programme will offer really important protection for very premature babies born before they can be protected by mum’s antenatal vaccination.
‘UKHSA has been working closely with [the Joint Committee on Vaccination and Immunisation] and the NHS to provide evidence in support of this programme and we are delighted to see this launch ahead of winter 2025.’
The nirsevimab rollout is based on the results of the phase 2/3, randomised, double-blind, palivizumab-controlled MEDLEY trial.
A total of 918 preterm infants and infants with congenital heart disease and/or chronic lung disease of prematurity who were entering their first RSV season and were eligible to receive palivizumab were included.
They were randomised to receive a single 50mg (in infants weighing less than 5kg) or 100mg (in infants weighing 5kg or more) intramuscular injection of nirsevimab or palivizumab.
Safety was assessed by monitoring the occurrence of treatment emergent adverse events and treatment emergent serious adverse events for 360 days post-dose. The incidence of adverse events was similar across treatment groups and cohorts and the safety profile of nirsevimab was similar to that of palivizumab.
At day 151, serum levels of nirsevimab were similar to those reported in the MELODY trial, which assessed nirsevimab in healthy late-preterm and term infants.
The results illustrated that nirsevimab helps protect infants against RSV during their their first season with a single dose.
Babies born prematurely have a high risk of contracting RSV in their first winter, when their own immunity is low, with NHS England citing that premature babies are three times more likely to need hospital admission due to RSV, and 10 times more likely to need intensive care, compared to full-term babies.
NHS England also noted that 30,000 children under the age of five are hospitalised with RSV, and it causes around 30 infant deaths each year. It estimates that if 95% of eligible infants receive nirsevimab, there could be nearly 350 fewer hospital admissions, including in paediatric intensive care units, this year.
It is expected that health systems in Scotland, Wales and Northern Ireland will also offer nirsevimab from this autumn, meaning that around 9,000 babies and infants in the UK could benefit annually.
In 2024, the UK became the first country in the world to have a national RSV vaccination programme to protect both newborns – via maternal vaccination during pregnancy – and older adults against the virus.
Earlier this year, England’s RSV vaccination programme was found to have achieved a ‘significant’ reduction in hospital admissions among older people.
This month, updated advice from the Medicines and Healthcare products Regulatory Agency urged healthcare professionals to be alert to a small increased risk of Guillain-Barré syndrome following RSV vaccination in adults aged 60 years and older. It stressed that there is currently no evidence of an increased risk of Guillain-Barré syndrome in pregnant women following RSV vaccination.
21st July 2025
A nasal spray formulation of adrenaline, offering a needle-free alternative in the emergency treatment of anaphylaxis, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
The adrenaline (epinephrine) nasal spray (brand name EURneffy), already available in Europe, is indicated for use in adults and children who weigh 30 kg (4 stone and 10 pounds, or around 66 pounds) or more.
It is a ready-to-use single dose nasal spray that delivers its entire contents (2mg) upon activation, with the MHRA noting that the plunger should be pressed once the product has been inserted into the nostril. It is suitable for use when the nose is congested due to a cold or allergy.
Healthcare professionals are being encouraged to make sure that patients using the new product are fully familiar with the different procedure for its use, and that patients are also fully aware of the use of other adrenaline auto-injectors.
Patients will be advised to carry two nasal sprays with them in case a second dose is needed and make sure that friends, family and colleagues know they have them in case of an emergency.
The new nasal spray will be continually monitored for safety and effectiveness, and the MHRA is encouraging anyone who suspects they are having a side effect from this medicine to talk to their doctor, pharmacist or nurse as well as reporting it to the Yellow Card scheme.
Commenting on the approval, Julian Beach, MHRA interim executive director of healthcare quality and access, said: ‘Patient safety is our top priority, which is why we’re pleased to approve the first needle-free nasal spray formulation of adrenaline for the emergency treatment of anaphylaxis in the UK. Until now, adrenaline for self-administration has only been available via auto-injectors.
‘While this represents an important new option, adrenaline auto-injectors remain a vital and potentially life-saving treatment, giving people experiencing anaphylaxis valuable time before emergency help arrives.
‘We continue to encourage everyone at risk of severe allergic reactions, and those around them, to familiarise themselves with how to respond in an emergency. Resources and guidance are available on the MHRA website to help people be prepared.’
Manufacturing problems for the injectable EpiPen have resulted in widespread shortages since 2017, plus knock-on shortages of other brands of adrenaline auto-injectors.
This month, the charity Anaphylaxis UK shared an update on Anaphylm – a postage-stamp sized film designed to be placed under the tongue to deliver adrenaline during an emergency allergic reaction. An application for the device is now being considered by the US Food and Drug Administration following strong clinical trial results in both children and adults.
Earlier this year, Allergy UK welcomed positive results of the first clinical trial to assess whether immunotherapy can desensitise adults allergic to peanuts. The Grown-Up Peanut Immunology study (GUPI) saw adults with peanut allergy receive repeated supervised doses of the equivalent of 0.5-1% of a whole peanut over several weeks, before increasing the dose and switching to eating peanuts or peanut containing foods, observed by a clinician.
Last year, research from King’s College London found that exposing children to peanuts from infancy to age five reduced the rate of peanut allergy in adolescence by 71%.
And in December, a report on child deaths related to asthma and allergies published by the National Child Mortality Database outlined recommendations and key improvements needed in professional practice to prevent future deaths.
A version of this article was originally published by our sister publication Nursing in Practice.
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