AbbVie’s SKYRIZI Demonstrates Superior Complete Skin Clearance Over Novartis’ Cosentyx in Head-to-Head Phase IIIb Trial for Moderate-to-Severe Plaque Psoriasis

June 13, 2020 News /BioValleyBIOON/ -- AbbVie recently at the American Academy of Dermatology (AAD) onlineMeetingNew data from the head-to-head Phase IIIb IMMerge study (NCT03478787) in psoriasis were published. The study was conducted in adult patients with moderate-to-severe plaque psoriasis, comparing the IL-23 inhibitor Skyrizi (risankizumab) withNovartisA comparison was conducted with the IL-17A inhibitor Cosentyx (Chinese brand name: Kesenting; generic name: secukinumab, commonly known as “Su Jin Dan Kang”). The results showed that at Week 52 of treatment, Skyrizi was superior to Cosentyx in terms of skin lesion clearance rates. Specifically, at Week 52, 66% of patients in the Skyrizi group achieved complete skin lesion clearance—defined as a 100% reduction in the Psoriasis Area and Severity Index (PASI 100)—compared to 40% in the Cosentyx group, with a statistically significant difference (p < 0.001).

IMMerge was a multicenter, randomized, open-label, blinded-endpoint, active-controlled study comparing the safety and efficacy of Skyrizi versus Cosentyx in adult patients with moderate-to-severe plaque psoriasis who were candidates for systemic therapy. In the study, patients were randomized in a 1:1 ratio to receive either: (1) Skyrizi (n=164) at a dose of 150 mg (administered as two 75-mg subcutaneous injections) at baseline, week 4, and every 12 weeks thereafter; or (2) Cosentyx (n=163) at a dose of 300 mg (administered as two 150-mg subcutaneous injections) at baseline, weeks 1, 2, 3, and 4, and every 4 weeks thereafter. The study had two primary endpoints (non-inferiority at week 16 and superiority at week 52 in achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index [PASI 90]) and three secondary endpoints (PASI 100 at week 52, static Physician’s Global Assessment [sPGA] score of 0/1 at week 52, and PASI 75 at week 52). Safety was assessed in all patients.

In January this year, AbbVie announced the top-line results of the study, showing that Skyrizi met the primary endpoints of non-inferiority at Week 16 and superiority at Week 52 in terms of PASI90 compared to Cosentyx. Additionally, Skyrizi demonstrated superiority over Cosentyx across all secondary endpoints (including PASI100, PASI75, and sPGA 0/1 at Week 52) (p < 0.001).

Primary endpoint results demonstrated higher skin clearance rates with Skyrizi compared to Cosentyx: (1) At Week 16, the proportion of patients achieving PASI 90 was 74% in the Skyrizi group versus 66% in the Cosentyx group. (2) At Week 52, the proportion of patients achieving PASI 90 was 87% in the Skyrizi group versus 57% in the Cosentyx group (p < 0.001). Secondary endpoint results showed that at Week 52, the proportion of patients achieving a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin (sPGA 0/1) was significantly higher in the Skyrizi group than in the Cosentyx group (88% vs. 58%, p < 0.001).

Existing safety data indicate that the safety profile of Skyrizi is consistent with previously reported findings, with no new safety signals observed over 52 weeks. The incidence of adverse events (AEs) was comparable between Skyrizi and Cosentyx. The most common AEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, and diarrhea. The incidence of serious adverse events was 5.5% in the Skyrizi group and 3.7% in the Cosentyx group. The incidence of AEs leading to discontinuation of the study drug was 1.2% in the Skyrizi group and 4.9% in the Cosentyx group. No patient deaths occurred in either treatment group.

AbbVie Vice Chairman and President Michael Severino, M.D., previously stated, “In this study, Skyrizi demonstrated superior efficacy compared to Cosentyx in helping patients achieve and maintain high levels of skin clearance at Week 52. Head-to-head study data such as these are critical in helping patients and their physicians make informed treatment decisions. We are pleased to add these results to the growing body of evidence supporting Skyrizi as a differentiated treatment option for patients with psoriasis.”

Dr. Richard B. Warren, Professor and Honorary Consultant Dermatologist at the Dermatology Centre of Salford Royal NHS Foundation Trust, University of Manchester, and Chief Investigator of the IMMerge study, stated: “I have witnessed firsthand the incredibly positive impact that achieving and maintaining complete skin clearance can have on the lives of patients with psoriasis. These new data are critical as they underscore that complete skin clearance is a realistic treatment goal for patients with psoriasis.”

The active pharmaceutical ingredient of Skyrizi is risankizumab, a monoclonal antibody 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 believed to play a key role in many chronic immune-mediated diseases. Risankizumab was initially developed by the German pharmaceutical company Boehringer Ingelheim (BI). In February 2016, AbbVie acquired the global commercialization rights to risankizumab through an upfront payment 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 ulcerative colitis and other inflammatory conditions.ImmunologyDisease.

Skyrizi is entering a highly crowded market, where it will compete with multiple drugs, including:NovartisCosentyx and Ilaris,Eli Lillysuch as Eli Lilly’s Taltz, Valeant’s Siliq, Johnson & Johnson’s Tremfya, and Sun Pharma’s Ilumya. Among these drugs, Tremfya and Ilumya are also biologic therapies that selectively target IL-23. Nevertheless, despite all this competition, the industry remains highly optimistic about Skyrizi’s commercial prospects. The pharmaceutical market research firm EvaluatePharma previously predicted that the drug’s annual sales would reach $2.2 billion in 2024.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A). It can selectively block the activity of circulating IL-17A, reduce immune system activity, and improve disease symptoms. Studies have revealed that IL-17A plays a role in driving the body's response in variousAutoimmunityplays a crucial role in the immune response of inflammatory diseases, including psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx was approved for market launch in January 2015 and has currently been approved for four indications (PsO, PsA, AS, and nr-axSpA). For the top three indications, Cosentyx boasts up to five years of continuous efficacy and safety data, with more than 300,000 patients worldwide having received treatment with this drug.

In China, Cosentyx® (Secukinumab) received approval from the National Medical Products Administration (NMPA) in late April this year for the treatment of adult patients with ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. This marks the second indication approved for Cosentyx® in China, following its initial approval in March 2019 for the treatment of moderate-to-severe plaque psoriasis (PsO). It is currently the first and only interleukin inhibitor approved in China for the treatment of ankylosing spondylitis (AS).

In 2019, global sales of Cosentyx reached $3.551 billion, representing a 28% increase from 2018. Pharmaceutical market research firm EvaluatePharma predicts that Cosentyx will become the driving force behindNovartisAs one of the key products for future growth, with a steady expansion of indications, Cosentyx’s sales are expected to continue their steady climb in the coming years. (Bioon.com)

Original Source:AbbVie Presents New Late-Breaking Data Showing SKYRIZI® (risankizumab-rzaa) Achieves Superior Rates of Complete Skin Clearance Versus COSENTYX® (secukinumab) at 52 Weeks