On July 21, AbbVie announced that the second Phase III Measure Up 2 study of upadacitinib, a JAK1 inhibitor, administered once daily at doses of 15 mg and 30 mg as monotherapy in patients with moderate-to-severe atopic dermatitis, successfully met its primary and all secondary endpoints.
Measure Up 2 employed a multicenter, randomized, double-blind, parallel-group, placebo-controlled design to evaluate the efficacy and safety of upadacitinib in patients aged 12 to 18 years with moderate-to-severe atopic dermatitis who met the indications for systemic therapy. Patients were randomized to receive upadacitinib 15 mg, 30 mg, or placebo. Patients in the placebo group switched to upadacitinib treatment at Week 16. The primary endpoints were the proportions of patients achieving EASI 75 (≥75% improvement in the Eczema Area and Severity Index) and vIGA-AD 0/1 (Validated Investigator’s Global Assessment for Atopic Dermatitis score of 0 or 1) after 16 weeks of treatment. Secondary endpoints included the proportion of patients with an Itch Numerical Rating Scale (NRS) score ≥4 at Week 16, the proportion of patients achieving EASI 90, the change from baseline in Itch NRS, the change from baseline in EASI, the proportion of patients in the 30 mg group with an Itch NRS score ≥4 on Day 2 (after the first dose), and the proportion of patients in the 15 mg group with an Itch NRS score ≥4 on Day 3 (after two doses), among others. The Measure Up 2 study is currently ongoing, and safety, tolerability, and efficacy data from the long-term extension phase following the placebo-controlled period have not yet been disclosed.
The results showed that the proportions of patients achieving EASI 75 at Week 16 in the upadacitinib 15 mg, 30 mg, and placebo groups were 60%, 73%, and 13%, respectively, and the proportions achieving vIGA-AD 0/1 were 39%, 52%, and 5%, respectively.
At Week 16, the proportions of patients achieving an improvement in pruritus symptoms with a Numerical Rating Scale (NRS) score ≥4 were 42%, 60%, and 9% in the upadacitinib 15 mg, 30 mg, and placebo groups, respectively. Furthermore, both upadacitinib treatment groups achieved earlier improvement in pruritus symptoms, which was sustained for up to 16 weeks. On Day 2 (after the first dose), the proportion of patients with an NRS score ≥4 for pruritus was significantly higher in the 30 mg group compared to the placebo group (8% vs. 1%). On Day 3 (after two doses), the proportion of patients with an NRS score ≥4 for pruritus was significantly higher in the 15 mg group compared to the placebo group (12% vs. 3%).
In terms of safety, no adverse events different from those observed with upadacitinib in the treatment of rheumatoid arthritis and psoriatic arthritis were observed. The incidence rates of serious adverse events within 16 weeks were 1.8%, 2.5%, and 2.9% in the upadacitinib 15 mg, 30 mg, and placebo groups, respectively. The most common adverse events across the three groups included acne (12.7% vs. 14.5% vs. 2.2%), headache, and upper respiratory tract infections.
Atopic dermatitis is the most common form of eczema, a chronic inflammatory disease that typically manifests as a rash. Patients with moderate-to-severe atopic dermatitis are characterized by rashes that may cover large areas of the body, often accompanied by intense, persistent pruritus, skin lesions, and dryness, cracking, erythema or hyperpigmentation, crusting, and exudation. Pruritus is one of the most burdensome symptoms for patients and can be debilitating. Atopic dermatitis affects 25% of adolescents and 10% of adults.