CE / CME
Physician Assistants/Physician Associates: 1.00 AAPA Category 1 CME credit
Nurse Practitioners: 1.00 Nursing contact hours, includes 1.00 hour of pharmacotherapy credit
Released: January 15, 2025
Expiration: January 14, 2026
AAD Guideline Algorithm 2024
In 2024, the American Academy of Dermatology (AAD) released updated guidelines for AD management. These comprehensive guidelines reviewed all available treatments at the time of survey and publication. Since their release, several new medications have been approved by the FDA that were not included in these guidelines, but it is encouraging to observe how the focus has shifted in certain areas of management.30
The updated guidelines emphasize the importance of assessing patients for signs and severity of disease, evaluating comorbidities, and considering the extent to which their quality of life is impacted. In addition, it is advised to discuss and identify potential exacerbating factors during each patient visit.30
The guidelines utilize a color-coded recommendation system to communicate treatment guidance:
One area where strong recommendations remain unchanged is the use of moisturizers and emollients. Of interest, the significance of bathing practices has been deemphasized compared to previous years.30
Updates on Topical and Maintenance Treatment for Mild to Severe AD
When discussing topical therapies, there remains a strong recommendation for the use of topical corticosteroids, topical calcineurin inhibitors (TCIs), cristaborole ointment, and ruxolitinib cream. Ruxolitinib cream is a newer option; it is a topical Janus kinase (JAK) inhibitor formulated as a 1.5% cream that is applied twice daily. This medication falls within the category of nonsteroidal therapies, making it suitable for application to sensitive areas of the body. There is a conditional recommendation for the use of wet dressings. It is worth noting that roflumilast was not evaluated in these guidelines.30
Updates on Systemic Therapies for Moderate to Severe AD
Moving to oral systemic therapies for AD, there are several key recommendations. There is a conditional recommendation for phototherapy and a strong recommendation in favor of dupilumab. Dupilumab, the first biologic approved for AD, is an interleukin (IL)-4 and IL-13 inhibitor. It is approved for patients as young as 6 months old and has demonstrated extensive clinical success.30
Tralokinumab, an anti-IL-13 biologic, is approved for moderate to severe AD in patients aged 12 years and older. This medication also received a strong recommendation within the guidelines.30,31
Lebrikizumab, another IL-13 inhibitor, received FDA approval for moderate to severe AD after the release of these guidelines. Although it is similar to tralokinumab and often grouped with it, lebrikizumab is not officially included in the guidelines.30,32
Among JAK inhibitors, upadacitinib received a strong recommendation for use.33 Abrocitinib and baricitinib, additional JAK inhibitors, are classified as immunosuppressants. Despite receiving a strong recommendation from the AAD for patients with moderate to severe AD, these medications carry potential side effects and have received a boxed warning from the FDA.
The far-right category of the guidelines lists more traditional, older, systemic medications: methotrexate, azathioprine, cyclosporin, and mycophenolate mofetil. They all received a conditional recommendation for use. At the bottom of this category, systemic corticosteroids received a strong recommendation against use in patients with AD. This is due to the significant side effects risks, particularly the potential for disease rebound observed in patients following corticosteroids treatment, making them a less favorable option.30
Dupilumab Efficacy by Racial Subgroup: Wk 16
This analysis examines dupilumab’s efficacy across racial subgroup at 16 weeks, based on a subgroup analysis from phase III randomized controlled trials, specifically LIBERTY AD SOLO, SOLO 2 and CHRONOS.34
The investigation stratified participants into 3 distinct racial subgroups:
On the far right of the figure, the dotted line represents the point of no difference. Results to the left of this line indicate that dupilumab was significantly superior to placebo. Across all racial groups, patients treated with dupilumab demonstrated greater efficacy compared to those receiving placebo.34
Of note, patients in the Asian subgroup showed slightly better outcomes, with data points positioned further to the left of the line, suggesting greater efficacy. However, all subgroups—White, Asian, and Black—achieved positive results with dupilumab compared to placebo.34
Dupilumab Safety by Racial Subgroup: Wk 16
When evaluating the safety of dupilumab by racial subgroup at Week 16, the data reveal patterns across different populations. The analysis categorizes participants into 3 subgroups: Asian participants (represented in green), Black participants (represented in dark blue), and White participants (represented in orange).34
When analyzing the occurrence of at least 1 treatment-emergent adverse event, patients with AD in the Asian arm demonstrated approximately 83 events in the dupilumab group compared to 121 events in the control group. The Black arm exhibited fewer events overall, while the White arm showed a comparatively higher frequency of events.34
This trend remained consistent across additional safety outcomes. For treatment-emergent serious adverse events, the Asian subgroup reported low numbers, with very low numbers observed in the Black subgroup and slightly higher numbers in the White subgroup. Similar trends were observed for adverse events leading to treatment discontinuation and the occurrence of conjunctivitis.34
In summary, patients in the minority subgroup, specifically the Asian and Black subgroups, experienced fewer safety concerns with dupilumab compared to patients in the White subgroup.
Lebrikizumab Efficacy by Racial Subgroup: Wk 16
Next, we will look at lebrikizumab, an IL-13 inhibitor that is FDA-approved for patients aged 12 years and older. This subgroup analysis evaluates efficacy at Week 16. This graph illustrates 4 treatment groups:
The overall results are shown in the gray bar, with racial subgroups broken down as follows:
At the lower-dose monthly regimen, lebrikizumab efficacy appeared slightly better among patients in the White subgroup. However, at the higher-dose monthly regimen, efficacy became consistent across all racial subgroups. This consistency was even more apparent with the higher dose administered biweekly, demonstrating that patients in all racial subgroups achieved similar efficacy with lebrikizumab at higher dosing intervals.35
Lebrikizumab Safety by Racial Subgroup: Wk 16
When evaluating the safety of lebrikizumab by racial subgroup at Week 16, the findings are consistent with previous results for dupilumab. Patients in the Black subgroup are shown in the center, and patients in the White subgroup are represented on the right.9,36
The data indicate low numbers of concerning adverse events across both groups. However, patients in the White subgroup reported slightly higher numbers of events compared to patients in the Black subgroup. Of importance, there were no increased safety concerns identified for patients in the Black subgroup in this study.36
Tralokinumab Efficacy by Racial Subgroup: Wk 56
Tralokinumab, another IL-13 inhibitor, is FDA-approved for patients aged 12 years or older with moderate to severe AD. This subgroup analysis evaluates treatment efficacy across different racial groups. The analysis is broken down by several measures:
Patients were separated by racial subgroups: Asian (green), Black (orange), and White (dark blue).
EASI-75 scores were consistent across all racial subgroups. For EASI-90, patients in the Asian subgroup showed slightly lower scores, while patients in the Black and White subgroups demonstrated similar outcomes. The IGA scores showed that patients in the Black subgroup had the best response. Similarly, for EASI ≤7, there was a slightly greater improvement among patients in the Black subgroup.37
Tralokinumab Safety by Racial Subgroup: Wk 56
When evaluating the safety of tralokinumab by racial subgroup at Week 56, the results show that severe or serious adverse events were infrequent across all groups, which is a positive outcome. Of note, the number of adverse events was lower among patients in the Asian or Black subgroup compared to patients in the White subgroup.37
This finding is particularly reassuring, as these racial subgroups have historically been underrepresented in clinical trials. Including these subgroups in this study provides insights and it is encouraging to see that there were no increased safety concerns specific to these populations.37
Abrocitinib Efficacy by Racial Subgroup and Skin Type: Wk 12
In a pooled analysis of phase II and III clinical trials, patients with AD who received abrocitinib, a JAK inhibitor, or placebo were stratified by racial subgroups and Fitzpatrick skin type.
Abrocitinib demonstrated consistent efficacy across racial subgroups and Fitzpatrick skin types in a pooled analysis of phase II and III clinical trials.
Abrocitinib by Racial Subgroup: Wk 12
Abrocitinib was evaluated for safety by racial subgroup at Week 12. The analysis focused on treatment-emergent adverse events, specifically nasopharyngitis, nausea, and headache, which were the most frequent events occurring in greater than 10% in any group.38
Patients in the Asian subgroup had low rates (less than 10%) for most events, except for nausea, which occurred in approximately 15% of patients. Patients in the Black subgroup had even lower rates of these adverse events, while patients in the White subgroup showed slightly higher rates across these categories.38
These safety findings demonstrate consistent safety outcomes across racial subgroups and provide reassurance that patients in monitory groups do not experience increased safety concerns with abrocitinib.38
Upadacitinib: EASI 75 at Wk 16
Upadacitinib, another JAK inhibitor, was evaluated for efficacy in patients with AD using EASI-75 at Week 16. The study examined 2 dosing regimens: 15 mg daily and 30 mg daily, with the higher dose demonstrating superior efficacy. In the analysis, higher response rates indicate greater therapeutic improvement. For patients receiving upadacitinib 30 mg daily, the results were very consistent across racial subgroups.39
In a separate study evaluating upadacitinib, the 15 mg dose also showed consistent efficacy, with approximately 60% response rates across racial subgroups. However, in patients receiving the 30 mg dose in the Black subgroup, there was a slight dip in efficacy. By contrast, patients in the Asian and White subgroups showed similar performance at this dose level.39
These findings highlight the consistent efficacy of Upadacitinib across dosing regimens and racial subgroups, with only a slight variability observed in 1 subgroup at the higher dose.
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