Delgocitinib ointment safely reduces symptoms in paediatric atopic dermatitis
Treatment with delgocitinib ointment, a topical Janus kinase (JAK) inhibitor, for paediatric atopic dermatitis (AD) is effective and well tolerated when applied for up to 56 weeks, according to a phase III trial and a subsequent open-label, long-term study in Japan.
“The study results indicate that delgocitinib ointment is a promising therapeutic option for AD in children as well as in adults,” the researchers said.
The first part of the study was a 4-week double-blind period in which Japanese patients aged 2–15 years were randomly assigned in a 1:1 ratio to receive either delgocitinib 0.25% ointment or vehicle, while the second part was a 52-week extension period. Eligible patients joined part 2 to receive either 0.25% or 0.5% delgocitinib ointment.
Nearly half of the patients presented with moderate AD at the start of the study. By the end of treatment in part 1, the least-squares mean percent change from baseline in modified Eczema Area and Severity Index score (mEASI), the primary endpoint, was significantly larger for delgocitinib ointment than for vehicle (–39.3 percent vs 10.9 percent; p<0.001). [J Am Acad Dermatol 2021;85:854-862]
Improvements in AD were also noted through week 56 in the second part of the study. Notably, treatment was well tolerated, and adverse events were mostly mild and not related to delgocitinib across the study periods.
“In part 2, the 0.5% ointment could be used according to the patient's disease condition (eg, mEASI score ≥10 or inadequate response to the 0.25% ointment),” the researchers said. “The 0.5% ointment, which is the same strength for AD in adults, is expected to be used for AD in children in clinical practice, if deemed necessary.”
Safety results in the present study were comparable to those in the long-term study involving adult patients with AD. There were no new safety concerns with delgocitinib ointment in children with AD. [J Am Acad Dermatol 2020;82:823-831; J Dermatol 2020;47:114-120]
Paediatric patients with AD usually suffer from pruritus, leading to impairment of quality of life, such as sleep disturbance. In the present study, delgocitinib ointment induced a rapid reduction in pruritus score, which was consistent with previous clinical studies. [J Am Acad Dermatol 2020;82:823-831; Br J Dermatol 2018;178:424-432; J Allergy Clin Immunol 2019;144:1575-1583]
This result also supported a recent report which suggested that JAK inhibitors potentially have a direct antipruritic effect. Given such evidence, the antipruritic effect of delgocitinib ointment can help alleviate distress in children with AD. [Cell 2017;171:217-228.e13; J Dermatol Sci 2020;97:161-164]
Of note, the present study was limited by the inclusion of only Japanese patients and, in part 2, the absence of a control group. In addition, rescue therapy was allowed.
“Because only Japanese patients were included, it is unclear whether the study results are applicable to non-Japanese patients who have different clinical phenotypes of AD,” the researchers said. “Delgocitinib ointment, which targets multiple cytokine axes, is potentially effective in those populations.” [J Allergy Clin Immunol 2019;143:1-11; Int Immunol 2018;30:419-428]