NEW YORK (Reuters Health)—Risankizumab, an inhibitor of interleukin (IL) 23, provides some relief for patients with active psoriatic arthritis (PsA) whose symptoms have responded poorly to standard treatments, according to 24-week results of a phase-3 trial.
“Despite the range of available therapies for psoriatic arthritis, efficacious, well-tolerated therapeutic options are needed to treat the diverse disease manifestations in patients who have not responded adequately to standard treatment,” Dr. Lars Erik Kristensen of the University of Copenhagen and colleagues write in BMJ Annals of the Rheumatic Diseases.1
Current first-line treatments for PsA include non-steroidal anti-inflammatory drugs, local corticosteroid injections for musculoskeletal symptoms and topical therapies for psoriasis. For patients with an inadequate response or poor prognosis, conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), antitumor necrosis factor therapy and other biologics are recommended.
Risankizumab, a humanized IgG1 monoclonal antibody that specifically targets IL-23’s p19 subunit, has been approved by the U.S. Food and Drug Administration as a treatment for moderate to severe plaque psoriasis, but not PsA.
“I really welcome a new mode of action, which we will have to learn how to optimally use in PsA patients,” Dr. Kristensen tells Reuters Health by email. “We have patients with PsA who do not respond or tolerate the drugs we had so far for treating this.”
In the double-blind KEEPsAKE 1, Dr. Kristensen and his colleagues randomly assigned 964 patients with active PsA to receive 150 mg of risankizumab or placebo at zero, four and 16 weeks. The primary endpoint was the proportion of patients whose symptoms improved by 20% or more based on the ACR20 criteria at week 24.
All patients were adults whose PsA symptoms had lasted at least six months, in accordance with the Classification Criteria for Psoriatic Arthritis. They had five or more tender joints; five or more swollen joints; one or more cases of erosion based on a centrally read radiograph (hands, feet or both) or high-sensitivity C-reactive protein (at least 3.0 mg/L); and active plaque psoriasis, defined as at least one psoriatic plaque of 2 cm or more in diameter or nail psoriasis.
The participants had previously had an inadequate response, intolerance, or a likely risk of harm from one or more csDMARDs. Continuation of concomitant therapy with two or fewer csDMARDs was allowed, but patients with prior exposure to biologics were excluded. The percentage of patients undergoing concomitant csDMARD treatment was similar between the risankizumab and placebo groups (76.0% vs. 76.7%, respectively).