New Phase 3 Data Shows Long-Term Efficacy of Upadacitinib in Atopic Dermatitis

New data dives deeper into ongoingPhase 3 study Measure Results from Up1 (NCT03569293), a study evaluating the efficacy and safety of the oral Janus kinase 1 (JAK1) inhibitor upadacitinib for the treatment of moderate to severe atopic dermatitis (AD) over 140 weeks. The primary objective of this study was to evaluate the sustained efficacy of upadatinibin long-term treatment. This included assessment of the proportion of patients with a 75% or more reduction from baseline in the Eczema Area and Severity Index (EASI 75) and the proportion of patients with a vIGA-AD score of clear (0) or almost clear (1) and a reduction of 2 or more grades from baseline (vIGA-AD 0/1) at week 16.

Patients aged 12 to 75 years with moderate to severe atopic dermatitis were randomly divided into three groups: Upatinib 15 mg, Upatinib 30 mg, or placebo (PBO) once daily. At week 16, PBO-treated patients were rerandomized to receive upadacitinib 15 mg (PBO/UPA15) or upadacitinib 30 mg (PBO/UPA30) once daily. The study used an observed case (OC) approach for all efficacy endpoints, with no missing data imputation.

Efficacy results demonstrate sustainability over an extended140-week period. The proportion of patients achieving EASI 75 at week 140 was consistently high, with 88.8% (upatinib 15 mg), 90.3% (upatinib 30 mg), 83.5% (PBO/upatinib 15 mg) and 89.4% (PBO/upatinib 30 mg) showing significant improvement. Similarly, the proportions of patients achieving vIGA-AD 0/1 were 63.4% (upatinib 15 mg), 65.5% (upatinib 30 mg), 60.4% (PBO/upatinib 15 mg), and 75.5% (PBO/upatinib 30 mg).

Additionally, a significant number of patients experienced a reduction of 4 points or more on the Worst Itch Numerical Rating Scale (WP-NRS ≥ 4) at Week 140, indicating meaningful improvement in itch. The incidence of adverse events, including serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs), was monitored and assessed as an exposure-adjusted rate (PY) per 100 patient-years (PY). Upatinib 15 mg and upapatinib 30 mg demonstrated a favorable safety profile consistent with previous reports.

This interim analysis provides compelling evidence that upapatinib Sustained efficacy and safety in the treatment of moderate to severe atopic dermatitis for 140 weeks. These findings are very promising for clinicians seeking long-term solutions for adolescent and adult patients with atopic dermatitis. As data from additional pivotal studies become available, this study may further solidify upadacitinib as a vital treatment option in clinicians' armamentarium.