Rinvoq Found Superior to Dupixent in Key Endpoints of Open-Label Trial Treating Atopic Dermatitis

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Findings from the Phase IIIb/IV LEVEL UP (NCT05601882) trial demonstrated the superiority of AbbVie’s Rinvoq (upadacitinib) over Dupixent (dupilumab) in the treatment of individuals 12 years of age and older with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or in whom use of systemic therapy is not advisable.¹

Rinvoq is a Janus kinase (JAK) inhibitor that modulates the signaling pathway at the point of JAKs to inhibit the phosphorylation and activation of signal transducers and activators of transcription.² The drug is currently approved to treat moderate to severe rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis; active non-radiographic axial spondyloarthritis; moderate to severe ulcerative colitis; and moderate to severe Crohn disease.

“Even while receiving conventional treatments, many patients with atopic dermatitis still continue to live with significant itch and inflammatory skin symptoms that can profoundly impact their everyday lives," Roopal Thakkar, MD, senior vice president, chief medical officer, global therapeutics, AbbVie, said in a press release. "Results from this study show that patients with moderate-to-severe atopic dermatitis can strive for both little to no itch and clearer skin.”¹

The multi-center, randomized, open-label, efficacy assessor-blinded trial evaluated the efficacy and safety of Rinvoq compared with Dupixent in patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe AD. The trial was comprised of a 35-day screening period, followed by the 16-week treatment period one and the 16-week treatment period two. As part of period one, patients were randomly assigned to receive Rinvoq at 15 mg QD or Dupixent as per its label, whereas for period two, patients were administered Rinvoq as per protocol-defined criteria.

The trial’s primary endpoint was simultaneously achieving a 90% or greater decrease in Eczema Area and Severity Index (EASI 90) score and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at week 16. Key ranked secondary endpoints included achieving EASI 90 and a WP-NRS of 0/1 at week 16 in patients with a baseline WP-NRS >1. The mean body surface area of individuals enrolled in the trial was 38%, with 42% of those enrolled having severe disease (vIGA-AD = 4) at baseline.

For the trial’s primary endpoint, investigators found that Rinvoq produced superior efficacy over Dupixent, with a significantly greater proportion of participants achieving both a 90% or greater decrease in EASI 90 and a WP-NRS of 0 or 1 at week 16, at 19.9% for Rinvoq compared with 8.9% for Dupixent. For the trial’s key secondary endpoints, 40.8% of patients administered Rinvoq achieved EASI 90 at week 16 compared with 22.5% of patients administered Dupixent, and 30.2% of patients administered Rinvoq achieved a WP-NRS of 0/1 at week 16 compared with 15.5% of patients administered Dupixent.

"Too many patients are still not achieving optimal disease control in atopic dermatitis despite taking steps to manage their condition," said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Sciences, said in the release. "Results from the LEVEL UP study highlight how treatment options such as [Rinvoq] can achieve high treatment goals in atopic dermatitis with combined measures of EASI 90 and NRS 0/1, not just itch resolution or just skin clearance."¹

References

1. New Data Show RINVOQ® (upadacitinib) Demonstrated Superiority Versus DUPIXENT® (dupilumab) Across Primary and All Secondary Endpoints in an Open-Label Head-to-Head Atopic Dermatitis Study. News release. AbbVie. April 25, 2024. Accessed April 25, 2024. https://news.abbvie.com/2024-04-25-New-Data-Show-RINVOQ-R-upadacitinib-Demonstrated-Superiority-Versus-DUPIXENT-R-dupilumab-Across-Primary-and-All-Secondary-Endpoints-in-an-Open-Label-Head-to-Head-Atopic-Dermatitis-Study

2. Rinvoq prescribing information. North Chicago, IL: AbbVie Inc; 2019. www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf. Updated August 2019. Accessed April 25, 2024.