Upadacitinib 15 mg and 30 mg outperformed placebo in Measure Up 2, the second part of a phase 3 study on the monotherapy.
Findings of AbbVie’s Measure Up 2, the second part of a phase 3 study, demonstrate upadacitinib (RINVOQ) monotherapy meets primary and secondary endpoints among individuals with moderate to severe atopic dermatitis.
Endpoints included 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.
Investigators conducted Measure Up 2 to evaluate the safety and efficacy of upadacitinib 15 mg and 30 mg monotherapy versus placebo in both adolescents and adults with atopic dermatitis who were candidates for systemic therapy.
The findings suggested significantly more patients who received either dose of upadacitinib monotherapy showed improvement in skin clearance and reduction in itch compared to placebo at week 16. Further, 60% of patients receiving the 15 mg dose and 73% of those taking 30 mg achieved EASI 75 versus 13% in the placebo group (P <.001). Among those treated with upadacitinib, 39% (15 mg) and 52% (30 mg) achieved vIGA-AD 0/1 compared to 5% of patients receiving placebo (P <.001).
At week 16, 42% of patients in the 15 mg group and 60% of those in the 30 mg group experienced clinically meaningful reductions in itch, defined as improvement in Worst Pruritus Numerical Rating Scale >4. Only 9% of patients receiving placebo achieved such reductions (P <.001). In both dose groups, patients had an early reduction in itch maintained through week 16.
The reduction of itch started after 1 day following the initial dose. Compared to the placebo group, reductions in itch were observed for patients receiving upadacitinib 30 mg 8% versus 1% (P <.001). For those receiving upadacitinib 15 mg, 12% experienced a reduction in itch 2 days following the first dose compared to 3% of patients in the placebo group (P <.001).
“These data support our continued efforts to provide additional options for those living with moderate to severe atopic dermatitis,” Alan Irvine, MD, DSc, lead study investigator of Measure Up 2, said in a statement.
Serious adverse events occurred in 1.8% of patients in the upadacitinib 15 mg group and 2.5% of those in the 30 mg groups compared to 2.9% of the placebo group. The most common adverse events among patients in the upadacitinib groups were acne, headache, and upper respiratory tract infection.
"We are encouraged by these results that reaffirm the data from Measure Up 1 and underscore the potential impact (upadacitinib) could have for individuals struggling to control their atopic dermatitis," said Michael Severino, MD, 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."