Novel jakinib stops the itch in teen AD
The oral Janus kinase (JAK) inhibitor abrocitinib, otherwise called jakinib, does well in patients 12–17 years of age with atopic dermatitis (AD) in the phase III JADE TEEN study, providing instant itch relief.
“Traditionally, we have been treating AD with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control,” said lead author Dr Lawrence Eichenfield, professor of dermatology and paediatrics, University of California and Rady Children’s Hospital, both in San Diego, California, US.
Having AD that does not respond to treatment is especially difficult for teenagers. In the JADE TEEN study, both doses of abrocitinib met the co-primary endpoints and were generally well tolerated.
“Now we know that abrocitinib is safe and effective in this patient group. We now have something new to offer these kids,” Eichenfield told an audience of dermatologists at this year’s AAAAI meeting. [AAAAI 2021, abstract 467]
Efficacy in the 12-17 age bracket demonstrated
Abrocitinib has been studied in the core phase III trials JADE Mono 1 and 2 as a monotherapy. The current study is a spin-off of those studies that looked at abrocitinib in adults.
This time, 285 teens (mean age 14.9 years, 50.9 percent male, 56.1 percent White), with moderate-to-severe AD, were randomly assigned to receive abrocitinib 200 mg daily (n=95), abrocitinib 100 mg daily (n=95), or placebo while on background topical therapy (n=95) for 12 weeks.
The primary endpoints were an Investigator’s Global Assessment (IGA) response of clear or almost clear (scores of 0 and 1, respectively), with at least a 2-point improvement, and a 75 percent or greater improvement in Eczema Area and Severity Index score (EASI-75) at week 12. The Peak Pruritus Numerical Rating Scale (PP-NRS) responses — indicating itch — were also assessed as a secondary endpoint.
At the end of the 12-week period, abrocitinib, in combination with topical therapy, significantly improved AD severity vs placebo – 46.2 percent of those who received abrocitinib 200 mg and 41.6 percent of those who received abrocitinib 100 mg achieved IGA responses vs 24.5 percent of those on placebo.
Additionally, 72 percent of those treated with abrocitinib 200 mg and 68.5 percent of those on abrocitinib 100 mg had a 75 percent or greater improvement on EASI-75 vs 41.5 percent of those on placebo.
Rapid, profound itch relief with abrocitinib higher dose
For the PP-NRS, 55.4 percent of those who received the higher dose of abrocitinib and 52.6 percent of those who received the lower dose had a 4-point or greater improvement in score compared with 29.8 percent of those on placebo.
“The percentage of patients achieving essentially no itch, as captured in the fact that more than half of those on the higher dose of abrocitinib made it to no itch, is a new data point and is important to note,” Eichenfield reported at AAAAI 2021.
This is welcome news, as “a lot of the other medicines don’t really get a significant percentage of the population to an itch score of 0–1,” he added. “Abrocitinib brought about a rapid and profound itch relief.”
JADE TEEN extends the utility of abrocitinib in this younger population, demonstrating that the drug is as effective and safe in patients aged 12-17 years of age.
“We’re very excited about the introduction of oral JAKs to our AD armamentarium,” said Eichenfield. These findings, combined with previous studies, showed that “abrocitinib monotherapy or in combination with topical therapy appears effective and well-tolerated in adolescents with moderate-to-severe AD.”
AD ranges in severity, and there is a great deal of moderate-to-severe AD that has a tremendous negative impact on patients. “Jakinibs not only inhibit the stimulation of the JAK pathway, they also provide anti-inflammatory effects, offering curative potential in more severe disease,” he added.