AbbVie eyes Humira matching move into psoriatic arthritis for immunology follow-up Skyrizi
Pharma borg AbbVie hasn’t had many roadblocks on its path to dominance with megablockbuster Humira regularly topping pharma’s bestseller list. But Humira’s days on top are numbered, and AbbVie is making the case for newer immunology meds like IL-23 Skyrizi to help take the sting out of a costly 2023 patent cliff.
Helping that cause, Skyrizi bested placebo in terms of reducing psoriatic arthritis patients’ symptoms from baseline after six months of treatment, according to data from two Phase III trials unveiled Tuesday.
Skyrizi nailed the primary endpoints in the Keepsake-1 and -2 trials, with 57% and 51% of patients, respectively, on 150-mg doses of the drug showing a 20% reduction in symptoms from baseline compared with 34% and 27% dosed with placebo. Gender and racial demographics for both patient populations weren’t immediately available.
On targeted secondary endpoints, Skyrizi also beat out placebo, showing significantly higher rates of patients who achieved skin clearance on the PASI 90 index, physical function and minimal disease activity. Keepsake-1 dosed psoriatic arthritis patients who had previously tried and failed to respond to at least one disease modifying anti-rheumatic drug, while the second study tested patients who tried and did not respond to at least one DMARD or a biologic.
Both studies are ongoing with a 184-week follow-up period remaining blinded, AbbVie said, to determine long-term safety and efficacy. AbbVie plans to present the data at an upcoming conference.
Skyrizi’s strong showing will warm AbbVie’s heart as the pharma giant approaches the 2023 arrival of US biosimilars for megablockbuster immunology med Humira, long the bestselling drug in pharma and the linchpin of AbbVie’s growth.
But paired with JAK inhibitor Rinvoq — which launched just months after Skyrizi’s market arrival in April 2019 — AbbVie is hoping to soak up as much of Humira’s expected sales loss as possible. CEO Rick Gonzalez threw down the gauntlet at last year’s JP Morgan Healthcare Conference, saying the pair of drugs could hit a combined $20 billion in annual sales — matching Humira’s peak — if it could pick up that drug’s indications and more, like atopic dermatitis.
Meanwhile Rinvoq is doing work on its own. Last month, AbbVie unveiled data from its Phase III U-Achieve study showing the drug topped placebo in helping ulcerative colitis patients achieve clinical remission at the eight-week mark and significantly reduced key symptomatic biomarkers, including gastrointestinal inflammation.
Twenty-six percent of patients administered a once-daily, 45-mg dose of Rinvoq hit clinical remission after two months compared with just 5% on placebo, AbbVie said. Rinvoq also induced gastrointestinal improvement in 36% of patients; meanwhile, just 7% patients on placebo hit that mark.
Rinvoq also aced its other secondary endpoints over placebo, including achieving clinical response in patients and reducing swelling of the mucosal lining. U-Achieve is one of two inductive studies AbbVie has planned for Rinvoq in UC along with three pivotal trials for a possible regulatory submission.
Rinvoq’s UC quest is part of a wide-ranging clinical program for the drug that includes ongoing late-stage trials for unapproved indications in atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis and Takayasu’s arteritis.