After Rinvoq won two new indications in as many months, AbbVie's immunology compatriot Skyrizi is getting in on the approval action.
Skyrizi clinched a second nod, this time to treat adults with active psoriatic arthritis, AbbVie said late last week. The green light positions Skyrizi to treat an inflammatory disease that affects roughly 30% of psoriasis patients, the Illinois-based drugmaker noted. Last year, BMO Capital Markets analyst Gary Nachman forecast $350 million in psoriatic arthritis sales for the drug by 2025.
"Patients often do not suspect a connection between their psoriasis skin symptoms and the joint pain, swelling and stiffness they may be experiencing, potentially leading to a delay in diagnosis and treatment of psoriatic arthritis," Thomas Hudson, M.D., senior vice president of research and development and chief scientific officer at AbbVie, said in a statement.
The FDA gave its thumbs up on data from the pivotal Keepsake-1 and Keepsake-2 studies, in which Skyrizi trumped placebo at reducing a composite symptoms measure, ACR20, after 24 weeks. Specifically, 57.3% of Skyrizi patients in Keepsake-1 and 51.3% of patients on the AbbVie drug in Keepsake-2 saw at least a 20% reduction in their symptoms at the six-month mark. Comparatively, just 33.5% and 26.5% of placebo patients hit the primary endpoint in Keepsake-1 and -2, respectively.
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Skyrizi also helped reduce the swelling of fingers and toes as well as swelling of the enthesis—where a tendon or ligament meets a person’s bone—in patients who already had the conditions, known as dactylitis and enthesitis, AbbVie said.
In patients with coexistent plaque psoriasis, Skyrizi bested placebo at improving skin lesions, too, as measured by the Psoriasis Area Severity Index (PASI 90) at the 6-month mark.
Finally, Skyrizi charted a statistically significant improvement in physical function over placebo as measured by the Health Assessment Questionnaire-Disability Index over that same period of time. The average difference was 0.20 in Keepsake-1 and 0.16 in Keepsake-2.
The trials included patients who responded poorly to or couldn't tolerate biologic therapies plus non-biologic disease-modifying antirheumatic drugs, AbbVie said.
The dosing for the new indication is the same Skyrizi regimen at play in moderate-to-severe plaque psoriasis, AbbVie noted. A patient receives a single 150mg injection below the skin four times a year after two starter doses. Skyrizi can be taken alone or alongside disease-modifying antirheumatic drugs, AbbVie said.
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Skyrizi plus arthritis and atopic dermatitis med Rinvoq are the linchpins in AbbVie’s post-Humira strategy. The company recently reconfirmed its projection that the meds would clinch a combined $15 billion in sales in 2025. Ahead of the 2022 J.P. Morgan Healthcare Conference, the drugmaker reduced Rinvoq’s sales estimate for the middle of the decade by $500 million but boosted Skyrizi’s by the same amount, courtesy of a warning on Rinvoq’s label and Skyrizi’s continued strength in psoriasis, AbbVie said at the time.
Rinvoq, for its part, has been picking up new indications at a rapid clip. The drug in December won approval in psoriatic arthritis. Then, a little less than a week ago, the FDA gave Rinvoq its blessing in moderate-to-severe atopic dermatitis. That nod specifically covers patients who’ve failed on or aren’t suitable for other pills or injections.
In the third quarter of 2021, Skyrizi raked in $796 million in worldwide sales, AbbVie reported in October. Rinvoq's haul, meanwhile, over the same period was $453 million.