AbbVie’s IL-23 Inhibitor Skyrizi Receives Second Indication in the EU for Active Psoriatic Arthritis
AbbVie
Innovative Drug Developer
FDA
U.S. Food and Drug Administration
European Union
The European Union (German: Europäische Union; French: Union européenne), abbreviated as the EU, is headquartered in Brussels, the capital of Belgium. It evolved from the European Communities and originally had six founding member states: Germany, France, Italy, the Netherlands, Belgium, and Luxembourg. The Union currently has 28 member states and 24 official languages.In December 1991, the European Council meeting in Maastricht adopted the Treaty on European Union, commonly known as the Maastricht Treaty. On November 1, 1993, the Maastricht Treaty officially entered into force, marking the formal establishment of the European Union. In 2012, the EU was awarded the Nobel Peace Prize.Donald Tusk serves as President of the European Council, and Antonio Tajani is President of the European Parliament. Jean-Claude Juncker, former Prime Minister of Luxembourg, is President of the European Commission.The EU’s treaties have been amended multiple times, and its operations are governed by the Treaty of Lisbon. Politically, all member states are democracies (according to The Economist’s 2008 Democracy Index). Economically, it constitutes the world’s second-largest economic entity (with Germany, France, and Italy being members of the G8). Militarily, the vast majority of EU member states are also members of the North Atlantic Treaty Organization (NATO).
On November 17, 2021, AbbVie announced that the European Commission (EC) had approved the second indication for Skyrizi (risankizumab), an interleukin-23 (IL-23) inhibitor, as monotherapy or in combination with methotrexate (MTX), for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response to or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Psoriatic Arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple systems, including the joints and skin. Inflammation produced by the immune system can lead to joint pain, fatigue, stiffness, and cause red, scaly rashes.
Skyrizi selectively blocks IL-23 by binding to the p19 subunit of IL-23. IL-23 is a cytokine involved in inflammatory processes and is considered to be associated with many chronic immune-mediated diseases, including psoriasis. Skyrizi has been approved by the U.S. FDA and the European Union for the treatment of psoriasis. It is also in Phase 3 clinical trials for the treatment of inflammatory diseases such as Crohn's disease and ulcerative colitis.
This approval is based on positive data from two randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trials. Both trials met their primary endpoints, with 57.3% and 51.3% of patients receiving Skyrizi achieving an ACR20 response (indicating at least a 20% reduction in disease severity compared to baseline) at week 24 of treatment, compared to 33.5% and 26.5% in the placebo groups (p<0.001). Additionally, the trials also achieved sequential secondary endpoints, showing significant improvements in skin clearance (measured by PASI 90), physical function (assessed using the HAQ-DI index), and minimal disease activity (MDA). For specific data, please see the figure below.
▲Performance of Skyrizi in Primary and Secondary Endpoints in Two Phase 3 Clinical Trials (Image Source: Reference [2])
References:
[1] AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of Skyrizi® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis. Retrieved November 17, 2021, from https://www.prnewswire.com/news-releases/abbvie-expands-immunology-portfolio-in-the-european-union-with-the-european-commission-approval-of-skyrizi-risankizumab-for-the-treatment-of-adults-with-active-psoriatic-arthritis-301426412.html
[2] Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients. Retrieved January 5, 2021, from https://www.prnewswire.com/news-releases/risankizumab-skyrizi-phase-3-results-demonstrate-improvements-in-disease-activity-across-joint-and-skin-symptoms-among-psoriatic-arthritis-patients-301201081.html
(Original text has been abridged)
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