Key takeaways:
- By week 8, a higher proportion of patients who applied ruxolitinib cream 1.5% vs. vehicle achieved IGA treatment success (50.6% vs. 14%).
- Through 52 weeks of treatment, no serious adverse events were reported.
Ruxolitinib cream 1.5% was safe and well tolerated up for the short- and long-term treatment of atopic dermatitis in adolescents, according to an analysis of two phase 3 studies.
Ruxolitinib cream 1.5% is currently approved in the U.S. for the treatment of patients aged 12 years and older with mild to moderate AD and is also approved in the U.S., United Kingdom and European Union for nonsegmental vitiligo. Ruxolitinib cream, although a topical, is a part of the Janus kinase (JAK) inhibitor class.
“[JAKs] modulate inflammatory cytokines involved in the pathogenesis of AD,” Lawrence F. Eichenfield, MD, FAAD, chief of pediatric and adolescent dermatology at Rady Childrens Hospital-San Diego, professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine and a member of the Healio Dermatology Peer Perspective Board, and colleagues wrote. “Ruxolitinib is a selective inhibitor of JAK1 and JAK2.”
Lawrence F. Eichenfield
The efficacy and safety of ruxolitinib cream 1.5% has been demonstrated in two phase 3 studies, TRuE-AD1 and TRuE-AD2. Using pooled data from these studies, the researchers compared the drug’s performance with vehicle through 8 weeks of treatment for AD in adolescents as well as test the drug’s ability to control AD long-term through 52 weeks.
In the study, 137 patients aged 12 to 17 years were randomly assigned to vehicle (n = 45) or ruxolitinib cream (n = 92).
By week 8, a higher proportion of patients who applied 1.5% ruxolitinib cream vs. vehicle achieved IGA treatment success (50.6% vs. 14%), EASI-75 (60.9% vs. 34.9%) and a greater than 4-point change in itch numerical rating score (52.1% vs. 17.4%; P = .009). Additionally, by day 2, patients applying ruxolitinib cream reported a higher mean reduction in itch scores vs. vehicle, as measured by a numerical rating scale (–0.9 vs. –0.2; P = .03).
Of the 137 patients in the 8-week trial, 104 moved to the extension trial (ruxolitinib, n = 82; vehicle, n = 22) and a total of 83 completed all 52 weeks. Participants applied ruxolitinib cream 1.5% on an “as-needed” basis. Researchers reported IGA scores of 0/1 were sustained or increased among those using the study drug during the extension trial.
At the end of the study, adverse event reports showed that, at any given time, at least 1.8% of patients were experiencing an adverse event during ruxolitinib treatment. However, none were serious and they did not include warnings listed for JAK inhibitors such as serious infections, malignancies, major adverse cardiovascular events or thromboembolic events.
“In adolescents with AD, 1.5% ruxolitinib cream demonstrated anti-inflammatory and antipruritic effects that were comparable with those in the overall study population,” Eichenfield and colleagues concluded. “Ruxolitinib cream was well tolerated.”
Sources/Disclosures
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Disclosures:
Eichenfield reports serving as a consultant, speaker, advisory board member or investigator for AbbVie, Amgen, Arcutis, Aslan, Bristol-Myers Squibb, Castle Biosciences, Dermavant, Eli Lilly, Forte, Galderma, Incyte, Janssen, Johnson & Johnson, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi–Genzyme, Target RWE and UCB. Please see the study for all other authors’ relevant financial disclosures.