Rapid and sustained improvements in itch and quality of life with upadacitinib plus topical corticosteroids in adults and adolescents with atopic dermatitis: 52-week outcomes from the phase 3 AD Up study

Abstract

Purpose: Atopic dermatitis (AD) adversely impacts quality of life (QoL). We evaluated the effect of upadacitinib, an oral selective Janus kinase inhibitor approved for moderate-to-severe AD, plus topical corticosteroids (+TCS) on patient-reported outcomes (PROs) over 52 weeks.

Materials and methods: In the phase 3 AD Up study (NCT03568318), adults and adolescents with moderate-to-severe AD were randomized 1:1:1 to once-daily upadacitinib 15 mg, 30 mg, or placebo + TCS. Itch, skin pain/symptoms, sleep, QoL, daily activities, emotional state, mental health, and patient impressions of disease severity/improvement/treatment satisfaction were assessed.

Results: This analysis included 901 patients. Within 1–2 weeks, PRO improvements were greater with both upadacitinib doses than with placebo (p <.05). Improvements increased through weeks 4–8; rates were generally maintained through week 52. At week 52, the proportion of patients with clinically meaningful improvements in itch (Worst Pruritus Numerical Rating Scale improvement ≥4), skin pain (AD Symptom Scale Skin Pain improvement ≥4), sleep (AD Impact Scale [ADerm-IS] Sleep improvement ≥12), daily activities (ADerm-IS Daily Activities improvement ≥14), and emotional state (ADerm-IS Emotional State improvement ≥11) ranged from 62.1%–77.7% with upadacitinib 15 mg + TCS and 71.3%–83.6% with upadacitinib 30 mg + TCS.

Conclusions: Upadacitinib + TCS results in rapid, sustained improvements in burdensome AD symptoms and QoL.

Keywords:

• Atopic dermatitis
• disease burden
• patient-reported outcome measures
• quality of life
• upadacitinib

Acknowledgments

AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. AbbVie and authors thank all the trial investigators and the patients who participated in this clinical trial.

Medical writing support was provided by Morgan A. Gingerich, PhD, and Akua Adu-Boahene, MD, MPH, of JB Ashtin, and funded by AbbVie.

Authors contributions

All authors have critically reviewed the manuscript and approved the final version for submission. BMC, HT, and XH participated in study concept/design. NM, HT, XH, and RGL participated in data acquisition. XH, YY, YL, and SZ participated in statistical analysis. NM, MCC, MS, BG, BMC, HT, CSS, KA, and RGL participated in data interpretation. All authors agree to be accountable for all aspects of the work.

Disclosure statement

N Magnolo has received honoraria as an advisor, speaker, and/or consultant for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen, La Roche-Posay, LEO Pharma, Lilly, Novartis, Pfizer, Dr. Wolff, and UCB Pharma. MC Cameron has received honoraria as a consultant or speaker for AbbVie, Amgen, Bristol Myers Squibb, Dermavant, Evelo, Incyte, Journey Medical, LEO Pharma, Lilly, Ortho Pharmaceutical, Pfizer, Regeneron, and Verrica. M Shahriari has received honoraria as a consultant for AbbVie, Amgen, Arcutis, BMS, Dermavant, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Novartis, Ortho Dermatologics, Pfizer, Regeneron, and Sanofi-Genzyme; has served as a speaker for AbbVie, Arcutis, BMS, Dermavant, Lilly, Janssen, Pfizer, Sanofi-Genzyme, Regeneron, and UCB; and has served as an investigator for AbbVie, Cara, the Corrona Atopic Dermatitis Registry, Dermavant, Dermira, and Novartis. B Geng has served as an advisor, consultant, speaker and/or researcher for ADMA Biologics Inc., AstraZeneca, BioCryst, Chiesi, Galderma, GlaxoSmithKline, Grifols, Horizon, Koru, Novartis, OptiNose, Pfizer, Regeneron, Sanofi, Takeda, and Teva. BM Calimlim, H Teixeira, X Hu, Y Yang, Y Liu, S Zhang, C Sancho Sanchez, and K Altman are full-time employees of AbbVie and may hold AbbVie stock or stock options. RG Langley has received honoraria as an investigator, speaker, and/or consultant for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, and UCB Pharma, and has served as a speaker for AbbVie, Amgen, Celgene, LEO Pharma, Merck, Novartis, Pfizer, and Union Therapeutics.

Data availability statement

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the United States and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/.html.

Additional information

Funding

This work was supported by AbbVie Inc.