AbbVie has announced positive topline results from a head-to-head study of its selective JAK inhibitor, Rinvoq (upadacitinib), in adults and adolescents with moderate-to-severe atopic dermatitis.
The phase 3b/4 LEVEL UP trial has been evaluating Rinvoq against Regeneron/Sanofi’s Dupixent (dupilumab) in patients aged 12 years and older who had an inadequate response to, or were not advised, systemic therapy.
An estimated 10% of adults and 24.6% of adolescents are affected by atopic dermatitis, a chronic inflammatory condition characterised by itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, face and neck.
AbbVie’s Rinvoq showed superior efficacy to Dupixent in the study’s primary endpoint, with a significantly higher proportion of Rinvoq-treated patients simultaneously achieving near-complete skin clearance and little-to-no itch at week 16.
Results also showed that Rinvoq was superior to Dupixent for all ranked secondary endpoints, including the rapid onset of achieving near-complete skin clearance and little-to-no itch.
Roopal Thakkar, senior vice president, chief medical officer, global therapeutics, AbbVie, said: “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.
“Results from this study show that patients with moderate-to-severe atopic dermatitis can strive for both little-to-no itch and clearer skin.”
Rinvoq already holds approvals to treat certain patients aged 12 years and older with moderate-to-severe atopic dermatitis, as well as adults with rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis and non-radiographic axial spondyloarthritis.
“Too many patients are still not achieving optimal disease control in atopic dermatitis despite taking steps to manage their condition,” said Jonathan Silverberg, the George Washington University School of Medicine and Health Sciences. “Results from the LEVEL UP study highlight how treatment options such as [Rinvoq] can achieve high treatment goals in atopic dermatitis…”
The latest readout comes just days after AbbVie shared positive topline results from a late-stage study of a Rinvoq combination in adults with giant cell arteritis, an autoimmune disease of medium and large arteries.