AbbVie's Rinvoq again tops Dupixent in head-to-head atopic dermatitis trial

2024-04-25

临床结果上市批准临床3期

Sanofi and Regeneron Pharmaceuticals' dual IL-3 and IL-14 blocker Dupixent (dupilumab) is firmly entrenched as an initial-line treatment option for moderate-to-severe atopic dermatitis, but for the second time, AbbVie's JAK inhibitor JAK inhibitor Rinvoq (upadacitinib) has outperformed its rival in a head-to-head match-up.

On Thursday, AbbVie toplined results from the Phase IIIb/IV LEVEL UP trial showing that its drug outperformed Dupixent in adult and adolescent patients who had inadequate response or were considered unsuitable for systemic therapies.

Both drugs are already approved for atopic dermatitis; Dupixent got a head start with a US green light back in 2017. The drug's sales reached €2.8 billion in the first three months of this year, according to financial results reported by Sanofi on Thursday.

Meanwhile, Rinvoq finally scored an approval for the indication in 2022 after safety concerns with JAKs as a class held back its application at the FDA.

Better skin clearance, itch relief

The 16-week LEVEL UP study is designed to randomise up to 880 patients to receive either once-daily oral Rinvoq or Dupixent injections given every other week following an initial dose.

For the study's primary endpoint, 19.9% of patients on Rinvoq simultaneously achieved ≥90% reduction on the Eczema Area and Severity Index (EASI 90) along with no or minimal itch based on the Worst Pruritus Numerical Rating Scale 0/1 at week 16. That compares with just 8.9% for the Dupixent arm.

Rinvoq also demonstrated superiority across all ranked secondary endpoints, including 40.8% of patients achieving EASI 90 at week 16 versus 22.5% of those on Dupixent. For itch resolution over the same period, the rates were 30.2% and 15.5% for the two drugs, respectively.

Safety-wise, AbbVie said Rinvoq's profile in LEVEL UP was consistent with prior atopic dermatitis studies, with rates of serious adverse events at less than 1% for both groups. In a recent interview with FirstWord, key opinion leader Gilberto Alvarez del Manzano indicated that he was "not too concerned about safety with JAK inhibitors JAK inhibitors in the right population."

Rinvoq prevails again

The LEVEL UP data adds to previous head-to-head results from the Phase IIIb HEADS UP study, unveiled in late 2020, where Rinvoq also showed superiority over Dupixent across the primary and secondary endpoints in atopic dermatitis.

While Dupixent maintains its stronghold, the landscape is shifting as new oral and injectable competitors with more convenient dosing regimens angle for a share of the dermatitis pie.

At the recent American Academy of Dermatology (AAD) meeting, less-frequent dosing emerged as a major theme. Sanofi reported data supporting potential every-12-week dosing for its anti-OX40L antibody amlitelimab, while Galderma is considering every-eight-week dosing for its anti-IL-31 nemolizumab.

Alvarez del Manzano noted that reducing injection frequency from every-other-week "would matter a lot" in driving uptake, adding that "many patients would rather inject than take a pill every day."

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