News
Article
Dermatology Times
Author(s):
Join Dermatology Times’ quarterly editor in chief Raj Chovatiya, MD, PhD, MSCI, as he reviews key updates in atopic dermatitis.
For nearly the past decade, we’ve heard that the current year is the year for atopic dermatitis (AD) advances. This trend has yet to come to an end, and we find ourselves upping the ante with each subsequent year. The year 2024 was no different, and, yet again, we have more treatment options than ever before. To properly say goodbye to AD innovations in 2024, here are some of the most important clinical updates, trial readouts, stories, and emerging trends to follow for our current, new, and soon-to-be-approved targeted therapeutic options.
Roflumilast
Roflumilast 0.15% cream was approved for the treatment of mild to moderate AD in July for adults and children 6 years and older. New long-term extension data from the pivotal trials showed that proactive, twice-weekly use among individuals who achieved complete disease clearance was able to maintain disease control for most of the year. We also saw the first presentation of efficacy and safety of a 0.05% formulation for children aged 2 to 5 years, which was remarkably consistent with data from older age groups.
Ruxolitinib
Short- and long-term maximum use data for children aged 2 to 11 years with extensive AD showed similar pharmacokinetics to that observed in older age groups, without systemic accumulation or adverse events related to potential bone marrow suppression and impressive clearance of skin lesions. This story of reassuring safety and promising efficacy was echoed in phase 3 extension data in the same younger age group.
Tapinarof
Tapinarof 1% cream is expected to be approved for AD in early 2025 with a Prescription Drug User Fee Act action date set for March. With more to follow, recently presented phase 3 long-term extension data demonstrated that most patients achieved nearly clear or clear skin at least once during the extended, flexible treatment period, with the possibility for multiple off-drug treatment weeks for patients achieving complete skin clearance.
Dupilumab
It was first approved in 2017, but new dupilumab stories abound, with notable data showing catch-up in growth for pediatric AD patients within a few months of initiating treatment. In addition, we saw newer data showing the possibility for some children to be off drug for variable amounts of time after achieving disease control. Label updates continue to roll out, with the addition of data for hand-and-foot AD and indications for eosinophilic esophagitis down to aged 1 year, chronic rhinosinusitis with nasal polyps for adolescents, and chronic obstructive pulmonary disease in adults.
Tralokinumab
Two major themes this year included management of AD in special sites and the power of real-world experience. Combined placebocontrolled and long-term extension data revealed remarkable control of head-and-neck disease (a major real-world challenge) among individuals on continuous therapy, which was re ected in early readouts of noninterventional data from adults receiving standard-of care tralokinumab. An interesting trend to watch in the published literature is accumulating global reports showing disease improvement after tralokinumab treatment in patients refractory to prior targeted systemic treatments—begging for better understanding of overlapping and distinct features of mechanism of action among all AD therapies.
Lebrikizumab
Our newest systemic therapy for AD, lebrikizumab, was approved in September for the treatment of moderate to severe AD in adolescents and adults. Most recently presented data demonstrates consistent safety and efficacy for patients treated for up to 3 years with notable maintenance of response for those initial therapeutic responders who transition from every-2-week to every-4-week dosing. An interesting early readout was presented from a unique study dedicated to understanding lebrikizumab treatment in patients with diverse skin tones. Aside from standard measures of efficacy (which were consistent with the pivotal trials), a major focus of this trial was the design of a clinical score to measure postinflammatory pigmentary alteration, which improved in those who had a positive response to therapy.
Nemolizumab
The FDA accepted the biologics license application for nemolizumab to treat moderate to severe atopic dermatitis in adolescents and adults in February, backed by data showing positive response among individuals treated with nemolizumab every 4 weeks in combination with topicals, with the possibility to transition to every-8-week maintenance dosing after 16 weeks. Slated to be approved before the end of the 2024 (nemolizumab was not formally approved for AD at the time of writing this article), there will surely be more to follow in 2025. The current year was an overall busy one for nemolizumab, as it received its first overall approval for prurigo nodularis in adults in August on the back of data showing highly rapid and significant itch improvement—even after a single dose.
Upadacitinib
This year saw the first readout of a new clinical trial analyzing efficacy and safety of upadacitinib vs dupilumab in adults. With upadacitinib dosing and flexible dose escalation mirroring the approved label, more than double the number of patients treated with upadacitinib achieved a highly stringent and novel composite primary end point for skin clearance and itch improvement compared with dupilumab. Long-term safety with up to 5 years of continuous therapy has yet to identify any new safety risks, with rates of adverse events of special interest continuing to remain at background levels seen in reference epidemiologic cohorts.
Abrocitinib
One common-sense label update made immediately before the start of the year specified the ability for health care providers to dose escalate abrocitinib per their clinical assessment at any time in the treatment course. Publications and presentations have demonstrated patient phenotypes that have an efficacious response to therapy (eg, itch-dominant AD, regional disease), offered insight on predicting longer-term response based on early response after only a few weeks of therapy, and have shown a remarkable breadth of inflammatory and autoimmune conditions where abrocitinib may be an effective off-label treatment option. While it’s been quite a year for AD therapy, I think we’ve learned our lesson when it comes to prognostication. Thank you, 2024, but the best is surely yet to come. Here’s to the new year!
Raj Chovatiya, MD, PhD, MSCI, is a clinical associate professor of medicine at Rosalind Franklin University Chicago Medical School in Illinois and founder and director of the Center for Medical Dermatology and Immunology Research.