Company behind Humira and Skyrizi asks regulators to green-light Rinvoq for psoriatic arthritis

AbbVie, the North Chicago company behind the longtime blockbuster biologic Humira (adalimumab) and the new biologic Skyrizi (risankizumab-rzaa), has asked the U.S. Food and Drug Administration (FDA) and its European counterpart to approve its rheumatoid arthritis (RA) drug Rinvoq (upadacitinib) for psoriatic arthritis. Rinvoq is a JAK inhibitor administered as a once-daily pill; it was approved for RA in 2019.

In a Phase Three clinical trial of Rinvoq in adults with active psoriatic arthritis who had been unsuccessfully treated with at least one biologic, the drug significantly beat placebo (a pill with no active ingredient) in the percentage of patients who achieved at least a 20% improvement in joint arthritis (ACR20), and in the percentage who achieved at least a 75% improvement in skin psoriasis. Rinvoq also demonstrated comparable success to its sibling Humira in achieving ACR20 after 12 weeks. Despite some concerns about potential safety issues with JAK inhibitors at higher doses, they are winning market share as an alternative to biologics and with daily pill dosing.

JAK inhibitors fight psoriatic arthritis differently than the biologics, offering patients an additional treatment option. It is not yet clear, though, if JAK inhibitors will be able to clear psoriasis as effectively as biologics. Xeljanz, a JAK inhibitor from Pfizer that is FDA approved for psoriatic arthritis, has shown effectiveness in skin psoriasis but is not currently FDA-approved for that.

AbbVie’s Skyrizi, meanwhile, is FDA-approved for psoriasis, and in Phase Three trials for psoriatic arthritis, where it is performing well. Skyrizi actually bested Humira in clearing psoriasis it its own clinical trial head-to-head sponsored by AbbVie. With biosimilar versions of Humira being sold in Europe and coming to the U.S. in 2023, AbbVie seems well-positioned to survive generic competition for Humira with its arsenal of new treatments to combat psoriatic disease.

[Last updated 6-2-2020]