Upadacitinib Can Significantly Improve Clinical Outcomes in Patients With Atopic Dermatitis
Findings originate from phase 3 data that was recently presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting.
Upadacitinib allows most patients with moderate to severe atopic dermatitis (AD) to achieve consensus-based minimal disease activity (MDA), said Jonathan Silverberg, MD, PhD, MPH, professor and director of Clinical Research and director of Path Testing at George Washington University School of Medicine and Health Sciences, in an interview with Pharmacy Times.
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MDA is a study outcome target that encompasses clinically reported outcomes (ClinRO) and patient-reported outcomes (PRO), and “achieving these targets may optimize overall disease management in patients with moderate-to-severe AD,” Silverberg told Pharmacy Times.
Silverberg is one of the investigators of the phase 3 Measure Up 1 and Measure Up 2 studies, which evaluated the efficacy of upadacitinib (15 and 30 mg, Rinvoq; AbbVie) monotherapy for MDA (includes clinical and patient reported outcomes) at 16 and 52 weeks in patients with moderate to severe AD.1
Clinician outcomes include Eczema Area and Severity Index [EASI], SCORing AD, Investigators’ Global Assessment (IGA), and body surface area. At 16 weeks, 53.3% of patients who received 15 mg and 65.8% who received 30 mg achieved at least 1 of the ClinRO targets, compared with 10.0% in the placebo arm.
Patient-reported outcomes include Worst Pruritus Numerical Rating Scale (NRS), Pain NRS, Sleep NRS, Patient-Oriented Eczema Measure, Hospital Anxiety and Depression Scale, and Dermatology Life Quality Index. At 16 weeks, a significantly higher number of patients treated with upadacitinib 15 mg or 30 mg achieved at least 1 PRO (56.4% and 69.7%, respectively), as opposed to placebo (16.6%).
Within the upadacitinib arm, 42.5% of patients in the 15 mg arm and 55.9% of patients in the 30 mg arm achieved at 1 ClinRO and 1 PRO target, while only 6.4% of patients on placebo achieved this response.
At 52 weeks of treatment with upadacitinib, 54.2% of the 15 mg arm and 59.4% of the 30 mg arm continued to respond to 1 of the clinical outcomes. Further, 56.0% of the 15 mg arm and 68.6% of the 30 mg arm maintained a PRO, and more than half of patients on the 30 mg arm maintained at least 1 clinical and patient response at 52 weeks (54.5%).
AD (eczema) is a disease characterized by inflammation, redness, and skin irritation. This can cause extreme itching, and scratching can worsen the redness and swelling. AD can also cause rashes that “weep” fluid, or crust and scale over. The environment, genetics, and immune system can all contribute to eczema, which often develops in childhood.2
In 2022, the FDA approved upadacitinib for treatment of moderate to severe AD in adults and children aged 12 years who did not respond to other therapies.3 These new data, presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, show that upadacitinib can lead to achievable and maintainable goals that can improve disease management, Silverberg said in the interview.1
“This is important information that patients and their health care providers should consider when discussing treatment goals for AD,” Silverberg said in the interview.
REFERENCES
1. Treatment With Upadacitinib Increases the Achievement of Minimal Disease Activity Among Patients With Moderate-to-Severe Atopic Dermatitis: Results From Phase 3 Studies (Measure Up 1 and Measure Up 2).
2. Atopic Dermatitis. NIH. News Release. November 2022. Accessed on March 12, 2024. https://www.niams.nih.gov/health-topics/atopic-dermatitis#:~:text=Atopic%20dermatitis%2C%20often%20referred%20to,and%20irritation%20of%20the%20skin.
3. Smith T. Phase 3 Results on Upadacitinib for Atopic Dermatitis with Jonathan Silverberg, MD, PhD. HCP Live. March 8, 2024. Accessed on March 12, 2024. https://www.hcplive.com/view/phase-3-results-on-upadacitinib-for-atopic-dermatitis-with-jonathan-silverberg-md-phd
