A combination regimen of upadacitinib and topical corticosteroid (TCS) demonstrated sustained safety and efficacy through 52 weeks in adolescents and adults with moderate to severe atopic dermatitis (AD), according to research findings published in the Journal of Allergy and Clinical Immunology.
The study cohort included patients from 12 to 75 years of age with chronic moderate to severe AD, characterized by 10% or greater of body surface area affected, Eczema Area and Severity Index (EASI) 16 or greater, Validated Investigator’s Global Assessment for AD (vIGA-AD) 3 or greater, and Worst Pruritus Numerical Rating Scale (WP-NRS) score 4 or greater.
Participants were randomly assigned to receive either once daily 15 mg upadacitinib plus TCS (n=300), 30 mg upadacitinib plus TCS (n=297), or placebo plus TCS (n= 304). A total of 283 patients in the placebo group were rerandomly assigned at week 16 to either 15 mg upadacitinib plus TCS (n=144) or 30 mg upadacitinib plus TCS (n=139).
Researchers evaluated treatment-related safety and efficacy, as defined by the percentage of patients who experienced 75% or greater improvement in EASI (EASI-75), vIGA-AD of clear/almost clear with improvement 2 grades or more (vIGA-AD 0/1), and WP-NRS improvement 4 or more. These safety and efficacy assessments were performed at each visit and through week 52.
At the 52-week follow-up, the percentages of patients who received 15 mg upadacitinib plus TCS and 30 mg upadacitinib plus TCS who experienced EASI-75 were 50.8% and 69.0%, respectively. In total, 33.5% of patients in the 15 mg upadacitinib group and 45.2% in the 30 mg upadacitinib group experienced vIGA-AD 0/1. In addition, 45.3% of patients treated with 15 mg upadacitinib and 57.5% of patients treated with 30 mg upadacitinib experienced WP-NRS improvement 4 or more.
During the 52-week treatment period, upadacitinib plus TCS was generally well tolerated, and the investigators observed no new safety risks beyond the current label. In addition, there were no reported deaths during the study.
The rate of major adverse cardiovascular events and venous thromboembolic events was approximately 0.2 or lower per 100 patient-years. Similar exposure-adjusted event rates of any treatment-emergent adverse event (AE), serious AE, and AEs that led to treatment discontinuation were similar between the 2 upadacitinib dose groups.
Limitations of this study included the small sample size as well as the assessment of only objective outcomes vs subject outcomes important for patients (eg, quality of life).
Despite these limitations, the investigators concluded that the findings from the “study further support the potential of upadacitinib + TCS as a well-tolerated and effective long-term treatment option with a positive benefit–risk profile in adults and adolescents with moderate-to-severe AD.”
Disclosure: This clinical trial was supported by AbbVie. Several study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Silverberg JI, de Bruin-Weller M, Bieber T, et al. Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. J Allergy Clin Immunol. Published online August 14, 2021. doi:10.1016/j.jaci.2021.07.036