AbbVie announced that its Rinvoq (upadacitinib) as a monotherapy hit both primary and all secondary endpoints in the second Phase III trial, Measure Up 2, in patients with moderate to severe atopic dermatitis.
AbbVie announced that its Rinvoq (upadacitinib) as a monotherapy hit both primary and all secondary endpoints in the second Phase III trial, Measure Up 2, in patients with moderate to severe atopic dermatitis.
The co-primary endpoints were at least a 75% improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1, clear or almost clear, at week 16. The study evaluated the efficacy and safety of two doses, 15 mg and 30 mg, once a day, compared to placebo in adolescents and adults with moderate to severe atopic dermatitis who are eligible for systemic therapy.
“We are encouraged by these results that reaffirm the data from Measure Up 1 and underscore the potential impact Rinvoq could have for individuals struggling to control their atopic dermatitis,” said Michael Severino, vice chairman and president of AbbVie. “We are committed to delivering on the needs of people living with atopic dermatitis, many of whom continue to endure relentless itch and skin symptoms that can interfere with daily activities.”
At the 16th week, 42% of the 15-mg-dose and 60% of the 30-mg-dose patients showed clinically meaningful decreases in itch, which was defined as improvement in Worst Pruritus Numerical Rating Scale (NRS) greater than or equal to 4, compared to 9% of patients who received placebo. At both doses, patients had early decrease in itching, which continued through the 16th week. After a single day after the first dose, itch reduction compared to placebo was observed in the 30 mg-dose group. For patients on the lower dose, 12% showed a reduction in itch after only two days after the first dose compared to 3% in the placebo group.
“Atopic dermatitis is more than a rash or itchy skin,” said Alan Irvine, professor of dermatology, Trinity College Dublin, Ireland, and lead study investigator of Measure Up 2. “These data support our continued efforts to provide options for those living with moderate to severe atopic dermatitis.”
Atopic dermatitis is a chronic, relapsing inflammatory skin conditioned marked by intense itching and scratching that leads to cracked, scaly, oozing skin. It affects about 25% of adolescents and 10% of adults at some point in their lives. In adults, about 20 to 46% have moderate to severe disease.
Rinvoq originated out of AbbVie. It is an oral, once-daily, selective and reversible JAK inhibitor. It is approved for adults with moderately to severely active rheumatoid arthritis who have not responded to or are intolerant to methotrexate. Phase III trials are ongoing with the drug in atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, Axial spondyloarthritis, Crohn’s disease, ulcerative colitis and giant cell arteritis.
On July 9, the FDA approved the company’s supplemental Biologics License Application for use of Botox for treatment of spasticity in pediatric patients two years of age and older, including patients with lower limb spasticity caused by cerebral palsy. AbbVie picked up Botox when it acquired Allergan. Botox was first approved in June 2019 for pediatric patients with upper limb spasticity and in October 2019 for pediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy. The drug has not demonstrated effectiveness in improving upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture.
