Dr Elaine Agius discusses new TRuE-AD4 analysis exploring the efficacy and safety of ruxolitinib cream across different anatomical regions in adults with atopic dermatitis.
TouchDERMATOLOGY coverage from BAD 2026:
Ruxolitinib cream, a JAK1/JAK2 inhibitor, has demonstrated efficacy and safety in adults with moderate atopic dermatitis who had an inadequate response, intolerance, or contraindication to topical corticosteroids and topical calcineurin inhibitors and who were otherwise eligible for systemic therapy in the Topical Ruxolitinib Evaluation in Atopic Dermatitis 4 (TRuE-AD4) study (NCT06238817).
The treatment is approved in the USA for the short-term and intermittent chronic treatment of mild-to-moderate atopic dermatitis when the disease is not adequately controlled with other topical prescription therapies, or when those therapies are not advisable. However, it is not currently approved for atopic dermatitis in the UK.
At the British Association of Dermatologists Annual Meeting (BAD) 2026, findings from a subsequent TRuE-AD4 analysis evaluating the consistency of response across different anatomical regions were presented.
In this Q&A, we speak with study investigator and presenter, Dr Elaine Agius (Guy’s and St Thomas’ NHS Foundation Trust, London, UK), about the rationale for the analysis, the responses observed across the head and neck, trunk, upper limbs, and lower limbs, and the potential implications of these findings.
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Q. Could you tell us about the TRuE-AD4 study?
TRuE-AD4 was a phase 3b, multicenter, double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of ruxolitinib cream in adults with moderate atopic dermatitis.
The study included patients who had failed topical corticosteroids and topical calcineurin inhibitors. To ensure that the study population had moderate disease, eligible patients had, for example, 10–20% body surface area involvement and a Dermatology Life Quality Index (DLQI) score above 10, indicating a substantial impact on quality of life.
The study had a 24-week treatment period. The first 8 weeks were double-blind and vehicle-controlled, with patients randomized in a 2:1 ratio to ruxolitinib cream 1.5% or vehicle. They applied the treatment twice daily, continuously, for 8 weeks. A total of 241 patients participated in the study. Of these, 160 were randomized to ruxolitinib cream 1.5% and 81 to vehicle.
At Week 8, patients who had achieved at least a 50% improvement in Eczema Area and Severity Index score (EASI-50) continued double-blind treatment for a further 16 weeks. Those who had not achieved EASI-50 were eligible to enter an escape arm.
Q. What were the aims of your analysis?
Our analysis focused on the first 8-week, vehicle-controlled period of the study and evaluated efficacy across all anatomical regions.
The reason for this was that, ideally, an eczema treatment needs to be effective across all areas of the body, including sensitive areas such as the face and neck. We know that involvement of these highly visible areas can have a substantial impact on patients’ quality of life.
In the UK, the topical treatments currently available for these areas include corticosteroids and calcineurin inhibitors, but there are limitations to their use, particularly in sensitive areas. Topical corticosteroids cannot be used continuously over long periods because of the risk of skin atrophy and other side effects, while calcineurin inhibitors can cause application site burning, particularly when applied to the face. There is therefore a real need for a topical treatment that can effectively address eczema in these sensitive areas.
Q. What did your analysis show about the efficacy of ruxolitinib cream across different anatomical regions?
The analysis first looked at overall EASI score, body surface area involvement, and SCORing Atopic Dermatitis (SCORAD) at Week 8. What we saw were significant improvements from Baseline in EASI score as early as Week 2, which were sustained at Weeks 4 and 8. Similar improvements were also observed across the other outcome measures.
When the results were broken down by anatomical region, what we saw was an early treatment response from Week 2, which continued to improve through Week 8. The bottom line was that, regardless of the region treated or the outcome measure assessed, ruxolitinib cream produced a similarly early and sustained response over the 8-week period.
Q. What was observed in terms of the safety and tolerability of ruxolitinib cream?
We found that ruxolitinib 1.5% cream was very well tolerated, consistent with its established safety profile. Application-site reactions were reported in 5.6% of patients and were mainly mild acne. None of these reactions led patients to discontinue the study or stop treatment.
Importantly, we did not see the systemic adverse events highlighted for oral JAK inhibitors. There were no major adverse cardiovascular events, thrombotic events, serious infections, or malignancies. There was one case of herpes zoster, but this did not occur at the application site. Overall, the safety findings were reassuring.
Q. How might these findings be used to further support treatment decisions in AD?
Within the topical treatment landscape, these findings support ruxolitinib 1.5% cream as an alternative option to topical corticosteroids and calcineurin inhibitors, particularly for patients with moderate atopic dermatitis.
At present, when patients with moderate atopic dermatitis in the UK do not respond adequately to topical corticosteroids and calcineurin inhibitors, we would usually consider a systemic treatment, such as methotrexate or ciclosporin, or move on to a biologic or oral JAK inhibitor. The important point from this study is that ruxolitinib cream may offer another topical option that could delay, or potentially avoid, the need for systemic treatment in these patients.
→ Abstract: Agius E, Peris K, Prajapati VH et al. O12 Efficacy of ruxolitinib cream for the treatment of moderate atopic dermatitis across anatomic regions in the phase IIIb TRuE-AD4 study. British Journal of Dermatology, Volume 195, Issue Supplement_1, June 2026.
This content has been developed by Touch Medical Media for touchDERMATOLOGY in collaboration with Dr Agius. It is not affiliated with the British Association of Dermatologists (BAD). Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
Disclosures: Elaine Agius reports serving as an investigator for AbbVie, Almirall, Amgen, Apogee, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Lilly, Novartis, Sanofi and UCB. She received no financial support from any of these organisations.
Cite: TRuE-AD4: Ruxolitinib cream delivers consistent efficacy across all anatomical regions in moderate atopic dermatitis. touchDERMATOLOGY. July 22, 2026.
Editor: Gina Furnival
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