Rinvoq(upadacitinib)

Rinvoq (upadacitinib) received sNDA approval for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis. Efficacy was demonstrated by statistical superiority versus placebo for co-primary endpoints at Week 16: the proportion of subjects achieving a vIGA-AD score of 0 (“clear”) or 1 (“almost clear”) with at least a 2-grade reduction from baseline, and the proportion of subjects achieving at least a 75% reduction from baseline in EASI score (EASI-75). In pediatric patients, ACR 70, 90, and 100 response rates were 88.9%, 75.0%, and 58.3% respectively.

Serious infections reported with Rinvoq include pneumonia and cellulitis. Opportunistic infections observed include tuberculosis, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis, with a higher risk of herpes zoster. Discontinuation rates in upadacitinib 15 mg groups ranged from 3% to 4%, compared to 12% in placebo groups. A pediatric study for patients aged 6 months to 11 years has been deferred, with a postmarketing study (PMR 4212-1) planned for this age group, targeting at least 300 subjects with an exposure duration of at least 52 weeks, with a final report submission by June 2026.