Upadacitinib exhibits ‘favorable benefit-risk profile’ in atopic dermatitis treatment

Key takeaways:

• Up to 73% and 84% of patients aged 12 to 17 years taking upadacitinib 15 mg and 30 mg, respectively, achieved 75% improvement in atopic dermatitis.
• Upadacitinib was generally well tolerated.

Compared with adults, upadacitinib exhibited similar efficacy and safety results in adolescents aged 12 to 17 years in the treatment of moderate to severe atopic dermatitis, according to a study.

“Onset of AD typically occurs early in life with a lifetime prevalence of 14.8% in adolescents aged 12 to 17 years,” Amy S. Paller, MD, MS, Walter J. Hamlin professor of dermatology and chair of the department of dermatology at Northwestern University Feinberg School of Medicine, and colleagues wrote. “AD in adolescents can be associated with low self-esteem, mood disturbances, antidepressant use, poor sleep quality, school absenteeism and impaired overall health-related quality of life.”

Using data from three phase 3 clinical trials — Measure Up 1, Measure Up 2 and AD Up — this analysis evaluated the efficacy and safety of upadacitinib in adolescents aged 12 to 17 years with moderate to severe AD.

A combined total of 552 patients were randomly assigned to receive oral upadacitinib 15 mg, 30 mg or placebo, alone or with topical corticosteroids, once daily for 16 weeks.

Results showed that of those that received 15 mg, 73% (95% CI, 63%-84%), 69% (95% CI, 57%-81%) and 63% (95% CI, 51%-76%) in Measure Up 1, Measure Up 2 and AD Up, respectively, achieved the primary endpoint of at least 75% improvement in EASI at week 16.

In the 30 mg group, 78% (95% CI, 68%-88%), 73% (95% CI, 62%-85%) and 84% (95% CI, 75%-94%) also achieved the same, respectively.

In contrast, of patients taking placebo, 12% (95% CI, 4%-20%), 13% (95% CI, 5%-22%) and 30% (95% CI, 19%-42%) achieved the primary endpoint in the respective studies.

Across all studies, pediatric patients and adolescents treated with upadacitinib reported improved quality of life scores, with decreases from baseline that ranged from 7.5 to 11.4 points. In contrast, decreases from baseline among those taking pediatric patients and adolescents placebo ranged from 3.6 to 6.3 points.

The authors report that the drug was “generally well tolerated” and resembled a safety profile as seen in adults with the most prevalent adverse event being mild to moderate cases of acne, especially in the 30 mg dosage. Adverse events were equal between upadacitinib and placebo; however, treatment-emergent adverse events were elevated in both the 15 mg and 30 mg upadacitinib dosages (57%-62% and 61%-72%, respectively) compared with placebo (43%-50%) across all studies.

“These results support a favorable benefit-risk profile for upadacitinib treatment in adolescents with moderate to severe AD,” the authors concluded.