The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
SKYRIZI is the new option for psoriatic arthritis. (© AbbVie Inc. All rights reserved.)
The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
The regulator’s decision is based on positive results from two Phase III trials: KEEPsAKE-1 and KEEPsAKE-2, which assessed the safety and efficacy of SKYRIZI in adults who have the disease, including those who had a low response or responded negatively to biologic treatments and/or disease-modifying antirheumatic drugs (DMARDs).
What is Psoriatic Arthritis?
PsA is a systemic inflammatory illness that affects around 30% of patients diagnosed with psoriasis, causing skin lesions linked with pain, fatigue, and joint stiffness. In the two studies, the drug successfully met the primary endpoint of ACR20 response on the 24th week (33.5%) compared to those who were given a placebo (26.5%).
Significant improvements were also reported across symptoms, including those involving tender, painful and swollen joints. In addition, participants who had coexistent plaque psoriasis saw an improvement in the appearance of lesions, as measured using the Psoriasis Area Severity Index, and in patients’ overall physical function.
“In the pivotal KEEPsAKE trials, SKYRIZI demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis. 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,” noted Alan J. Kivitz, M.D., CPI, the founder and medical director of the Altoona Center for Clinical Research and clinical trial investigator for KEEPsAKE, in a statement.
SKYRIZI is an interleukin-23 (IL-23) inhibitor that works by binding to IL-23’s p19 subunit in order to block it. IL-23 is present in many inflammatory processes and is often linked to psoriasis. It is currently approved in the U.S. for plaque psoriasis in adult patients eligible to undergo phototherapy or systemic therapy.
Its dosing regimen for PsA is the same as what is given to patients with moderate to severe plaque psoriasis. It is given as a 150 mg injection subcutaneously four times a year and can be given either by itself or in combination with DMARDs.
The studies are ongoing, and patients who are part of the long-term KEEPsAKE extension trial remain blinded to the original randomization for the entire trial duration. The goal is to assess the drug’s long-term safety, efficacy, and tolerability in those who have already completed the placebo-controlled phase.
“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. 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,” noted Thomas Hudson, M.D., the senior vice president for research and development at AbbVie, in the same press release.
Aside from PsA, Phase III trials for the drug in Crohn’s disease, psoriatic arthritis, and ulcerative colitis are ongoing.
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