U.S. FDA Approves SKYRIZI® (risankizumab) for Active Psoriatic Arthritis, Demonstrating Significant Improvement in Skin and Joint Symptoms

News on January 22, 2022 /BioValleyBIOON/ -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for the novel anti-inflammatory drug IL-23 inhibitor Skyrizi (risankizumab, 150mg): for the treatment of adult patients with active psoriatic arthritis (PsA).Clinical TrialIn China,Skyrizi treatment significantly improved skin and joint symptoms, while also significantly enhancing physical function and quality of life.

This approval marks the second indication for Skyrizi. In the European Union, Skyrizi was approved in November 2021 for the treatment of adult patients with active PsA who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). In 2019, Skyrizi received approval in the United States and the European Union for the treatment of adult patients with moderate to severe plaque psoriasis.

In terms of dosing, the regimen for Skyrizi in treating PsA patients is consistent with the existing dosing regimen for treating patients with moderate to severe plaque psoriasis:Four times a year, 150mg per subcutaneous injection(At Week 0 and Week 4, initially two doses are given, then once every three months), andCan be administered alone or in combination with DMARD.

PsA is a systemic inflammatory disease that affects the skin and joints, impacting approximately 30% of patients with psoriasis. The approval and launch of Skyrizi will provide a valuable new treatment option for patients with PsA, helping to improve the symptoms and signs of the disease. In pivotal phase 3 studies, patients receiving Skyrizi were treated with two initial doses, followed by four maintenance doses per year. Compared with placebo, Skyrizi significantly improved skin and joint symptoms, physical function, and a higher proportion of patients achieved minimal disease activity.

Thomas Hudson, M.D., Chief Scientific Officer and Senior Vice President of Research and Development at AbbVie, said: "Patients with psoriatic arthritis (PsA) often do not recognize a connection between their psoriasis skin symptoms and the joint pain, swelling, and stiffness they may experience, which can lead to PsA beingDiagnosis"And treatment delays. We are proud to expand the use of Skyrizi to PsA patients."

The new indication approval for Skyrizi in treating PsA is based on data from two pivotal Phase 3 clinical studies (KEEPsAKE-1 and KEEPsAKE-2). These two studies were conducted in adult patients with active PsA, including those who had an inadequate response or intolerance to biologic and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).

The results showed that, compared with the placebo group, the Skyrizi (150mg) treatment groupA significantly higher proportion of patients reached the primary endpoint of ACR20 response at Week 24.In two studies, at week 24 of treatment, 57% and 51% of patients in the Skyrizi treatment groups achieved an ACR20 response, compared to 34% and 27% in the placebo groups (p<0.001).

Secondary endpoints: At week 24 of treatment, compared with the placebo group, the Skyrizi treatment groupSignificant improvements in skin clearance (measured by at least a 90% improvement in the Psoriasis Area and Severity Index [PASI90]), physical function (measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]), and minimal disease activity (MDA).。

In the KEEPsAKE-1 study, the Skyrizi group and the placebo group showed PsA Sharp/van der Heijde scores (PsA mTSS) of 0.23 and 0.32, respectively, at Week 24, a secondary endpoint (p=0.496 [Note: Lower scores indicate slower radiographic progression]). In these two studies, the safety profile of Skyrizi was generally consistent with its safety profile observed in treating plaque psoriasis, with no new safety risks identified.

KEEPsAKE-1 and KEEPsAKE-2 Clinical Data

The active pharmaceutical ingredient of Skyrizi is risankizumab, a monoclonal antibody drug that selectively blocks interleukin-23 (IL-23), an immune-inflammatory mediator in the body, by specifically targeting the IL-23p19 subunit. IL-23 is a cytokine considered to play a key role in many chronic immune-mediated diseases. Risankizumab was initially developed by German pharmaceutical company Boehringer Ingelheim (BI), and AbbVie acquired global commercialization rights to risankizumab in February 2016 by paying an upfront fee of $600 million.

In 2019, Skyrizi was approved in the United States and the European Union for the treatment of adult patients with moderate to severe plaque psoriasis. Currently, Skyrizi is in Phase III clinical trials for the treatment of Crohn's disease and psoriatic arthritis. In addition, AbbVie is also evaluating Skyrizi for the treatment of other inflammatory conditions such as ulcerative colitis.ImmunologyDisease.

Skyrizi is entering a very crowded market and will compete with several drugs, including:NovartisCosentyx and Ilaris,Eli LillyTaltz from AbbVie, Siliq from Valeant, Tremfya from Johnson & Johnson, Ilumya from Sun Pharmaceutical, etc. Among these drugs, Tremfya and Ilumya are also biologic therapies that selectively target IL-23.

However, despite all these competitors, Skyrizi's sales performance has been very strong, with global sales reaching $1.59 billion in 2020, an increase of more than 100% over the previous year. With a series of Phase 3Clinical TrialThe success of AbbVie has led to an optimistic forecast,Skyrizi and another oral anti-inflammatory drug, the JAK inhibitor Rinvoq, will reach $150 billion in sales by 2025., which will be able to offset the impact on the flagship product Humira (adalimumab) in the U.S. market starting from 2023.BiosimilarSales loss due to competition. (Bioon.com)

Source of Original Text:U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis