Topical ruxolitinib is an FDA-approved option for patients >12 years old for AD treatment. Last month, Incyte announced the positive topline results from its phase 3 TRuE-AD3 (NCT04921969) trial evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in pediatric patients aged 2 to 12 years with atopic dermatitis. The randomized, vehicle-controlled, pivotal phase 3 trial met its primary endpoint of the proportion of patients achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at week 8. Incyte's positive phase 3 data provides hope for a non-steroidal topical treatment option for pediatric patients.6
Other emerging topicals Paller mentioned included roflumilast, therapeutic aryl hydrocarbon modulating agents, and topical commensal Staphylococcus hominis. All of these options are still in early trial phases for both adults and pediatric patients.
Janus kinase (JAK) Inhibitors
Paller also gave a brief update on JAK inhibitors and where they stand in the treatment of pediatric patients. Safety is a concern for JAK inhibitors and typically serves as a deciding factor for parents.1
Paller's Pearls On JAK Inhibitors
- Abrocitinib and upadacitinib approved in US for >12 year olds and at higher doses, may be more efficacious than dupilumab
- Rapid and strong effect on itch (IL-31 effect)
- Advantage of oral agent taken once daily and rapid clearance
- Easy stop and start (seasonal; intermittent for flares)
- May be advantageous for patients with concurrent alopecia areata/vitiligo
- Class has Black Box warning based on tofacitinib data in adults with RA
- No signal for malignancy, thromboembolism, high risk infections in AD trials
Patient Adherence
Treatment adherence in pediatric patients with AD is key to seeing clearer skin in most cases. Steve Feldman, MD, PhD, professor at Wake Forest University School of Medicine in Winston-Salem, North Carolina, presented strategies to keep patients and their parents on the right track. He compared the importance of consistency to his own children taking piano lessons growing up.
“If you look at studies of treatments for pediatric AD, they bring patients back weeks 1, 2, 4, 6, and 8. Well, that’s the standard approach to teaching people piano. Those visits create accountability,” Feldman said. “The normal things we try to do to get people to take their medicines just aren't going to work. If a piano teacher doesn't have weekly lessons, that recital is going to sound terrible.”
Feldman emphasized the importance of clear, written instructions to ensure the patient, their parent, and the clinician are on the same page on how the treatment will work and best communication practices to ensure the progression of treatment. He shared that he will occasionally give his cell phone number for photo updates if a family is concerned about missing school or paying another copay for a follow up visit. In an interview with Dermatology Times, Feldman expressed how a change in routine—such as going back to school or a holiday break—can affect adherence too.
He said, “Recently, colleagues and I took some patients and gave them topicals to use with computer chips in the cap from since all health I've been working with them. They will record when people open and close the container. These caps will record how much medicine the patient uses. And we did this before the Christmas holidays, over the Christmas holidays, and after to see if people use their medicines well and then if a change in their life, causes them to break habits and lose efficacy over time, which we appear to have found not surprisingly so. I would think during school people's lives are regimented and it's easier for them to establish a habit but to change from one period to another period, like from summer to school, I would think would throw everything off.”
Feldman has co-authored a book with co-authored by Daniel Lewis, MD,about adherence strategies titled Practical Ways to Improve Patient Adherence, which is available on Amazon. Both Feldman and Lewis showcase their experiences that equipped them with knowledge to share with colleagues.
Conclusion
A hot topic during the panel’s Q&A was about patient and parent skepticism of new treatment options as they are heavily advertised on television. Feldman, Lio, and Paller have seen both extremes: families who do not want to use anything unnatural and those seeking a quick fix with the latest advancements for AD management. All 3 panelists addressed the importance of assessing each individual and situation to ensure good education, the right diagnosis, and treatment history leading to this point.
“We’re always trying to find that equanimity to balance it correctly. And that is the art, I think, of medicine,” said Lio.
References
1. Feldman S, Lio P, Paller A. Atopic dermatitis panel. Presented at: Society for Pediatric Dermatology 48th Annual Meeting; July 13-16, 2023; Asheville, NC.
2. Jensen P. Use of alternative medicine by patients with atopic dermatitis and psoriasis. Acta Derm Venereol. 1990;70(5):421-424.
3. Callaway J, Schwab U, Harvima I, et al. Efficacy of dietary hempseed oil in patients with atopic dermatitis. J Dermatolog Treat. 2005;16(2):87-94. doi:10.1080/09546630510035832
4. Witte M, Krause L, Zillikens D, Shimanovich I. Black tea dressings – a rapidly effective treatment for facial dermatitis. Journal of Dermatological Treatment. 2019;30(8):785-789.
5. Lin YK, Leu YL, Yang SH, Chen HW, et al. Anti-psoriatic effects of indigo naturalis on the proliferation and differentiation of keratinocytes with indirubin as the active component. J Dermatol Sci. 2009;54(3):168-174. doi:10.1016/j.jdermsci.2009.02.007
6. Incyte announces positive topline results from phase 3 trial evaluating ruxolitinib cream (Opzelura) in children with atopic dermatitis. Incyte. July 11, 2023. Accessed July 11, 2023. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-topline-results-phase-3-trial