FDA approves Skyrizi for adults with active psoriatic arthritis
The FDA has approved AbbVie’s risankizumab-rzaa for the treatment of adults with active psoriatic arthritis, expanding its initial indication from plaque psoriasis only.
Risankizumab (Skyrizi; AbbVie, Boehringer Ingelheim), an interleukin-23 inhibitor, made its U.S. debut in 2019 for moderate-to-severe plaque psoriasis among adults who are candidates for systemic therapy or phototherapy. The new approval for PsA follows results from the KEEPsAKE 1 and KEEPsAKE 2 trials, both of which resulted in statistically greater improvements in signs and symptoms, relative to placebo, among patients who received the drug.
“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, MD, senior vice president of research and development and chief scientific officer at AbbVie, said in a company press release. “We’re proud to expand the use of Skyrizi to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms.”
KEEPsAKE 1 and KEEPsAKE 2 together enrolled 1,407 adults with active PsA, active plaque psoriasis or nail psoriasis, with at least 5 swollen and tender joints, including those with inadequate response, or an intolerance to, biologic therapy and/or non-biologic disease-modifying antirheumatic drugs.
Across the two phase 3 studies, risankizumab met the primary endpoint of ACR20 response at week 24, compared with placebo, and demonstrated significant improvements across several other PsA manifestations, including swollen, tender and painful joints.
“In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis,” Alan J. Kivitz, MD, CPI, KEEPsAKE researcher and founder/medical director of the Altoona Center for Clinical Research, as well as the Altoona Arthritis and Osteoporosis Center, in Duncansville, Pennsylvania, said in the release. “This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis, alongside a quarterly dosing schedule that may fit their patients' lifestyle.”
According to AbbVie, risankizumab maintains a dosing regimen for PsA that is consistent with its existing regimen for plaque psoriasis — a single 150 mg subcutaneous injection four times a year, after two starter doses at weeks 0 and 4. It can be administered alone or in combination with DMARDs.
The drug is part of a collaboration between AbbVie and Boehringer Ingelheim, with the former leading its global development and commercialization.