NORTH CHICAGO, Ill.—Plaque psoriasis is an immune disease in which red, scaly patches appear on the skin, most commonly on the scalp, knees, elbows or lower back. According to the National Psoriasis Foundation, the exact cause of the disease is unknown, but “Scientists believe that at least 10 percent of people inherit one or more of the genes that could eventually lead to psoriasis. However, only 2 percent to 3 percent of the population develop psoriasis.” Dr. Anne Bowcock, a professor of genetics at Washington University School of Medicine in St. Louis, “has identified a gene mutation known as CARD14 that, when triggered, leads to plaque psoriasis,” the National Psoriasis Foundation reports.
New to the ranks of therapeutics for this disease is Skyrizi, which recently posted strong data in a head-to-head Phase 3 study against Cosentyx in adults with moderate-to-severe plaque psoriasis. The drug was approved just this past April by the U.S. Food and Drug Administration (FDA) for the aforementioned indication, and is a joint effort between AbbVie and Boehringer Ingelheim.
The trial in question was a randomized, open-label, efficacy assessor-blinded, active-comparator study to determine the safety and efficacy of Skyrizi vs. Cosentyx in adults with plaque psoriasis. Patients were randomized to receive either two 75 mg subcutaneous injections of Skyrizi at baseline, four weeks later and every 12 weeks after that, or two 150 mg subcutaneous injections of Cosentyx at baseline; at weeks one, two, three and four; and then every four weeks after that. Primary endpoints consisted of non-inferiority at week 16 and superiority at week 52, with secondary endpoints consisting of Psoriasis Area and Severity Index (PASI) 100 at week 52, a static Physician Global Assessment score of clear or almost clear (sPGA 0/1) at week 52 and PASI 75 at week 52.
In this study, Skyrizi treatment led to significantly higher rates of skin clearance compared to Cosentyx, meeting the primary endpoint of non-inferiority at 16 weeks, at which point 74 percent of Skyrizi patients achieved PASI 90 (at least 90-percent improvement from baseline) vs. 66 percent of Cosentyx patients. Skyrizi met the second primary endpoint as well, showing superiority via PASI 90 data at week 52. Of the Skyrizi-treated patients, 87 percent achieved PASI 90 at 52 weeks, compared to 57 percent of Cosentyx-treated patients.
Skyrizi also outperformed Cosentyx in all ranked secondary endpoints, including PASI 100, PASI 75 and sPGA 0/1 at week 52.
“In this study, Skyrizi showed superior efficacy compared to Cosentyx in helping patients achieve and maintain high levels of skin clearance at week 52,” Dr. Michael Severino, vice chairman and president of AbbVie, commented in a press release. “Head-to-head data like these are crucial to help patients and their doctors 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 adults living with psoriasis.”
Safety data for this study showed a safety profile for Skyrizi that is consistent with that seen in previous studies, with no new safety signals. In addition, the rate of adverse events between Skyrizi and Cosentyx were comparable, and the rate of serious adverse events was 5.5 percent in the former group and 3.7 percent in the latter. In terms of adverse events leading to discontinuation of the study, Skyrizi had a rate of 1.2 percent while Cosentyx had a rate of 4.9 percent.
Time will tell whether this strong performance will help Skyrizi usurp Cosentyx in the psoriasis market. Cosentyx has a bit of legacy for Skyrizi to overcome, having been approved by the FDA in January 2015 and holding a strong market share since then. Analysts are generally positive on the drug's potential, however.
Motley Fool's Brian Orelli noted that “Skyrizi has been off to a solid launch. The drug was approved by the Food and Drug Administration in April, and by the third quarter—the first full quarter on the market—AbbVie had already sold $76 million worth of the drug in the U.S. In the same quarter, Novartis booked $937 million in global sales of Cosentyx, suggesting AbbVie and Boehringer Ingelheim have plenty of room to run—although to reach that level, the healthcare companies would need to also beat Cosentyx in psoriatic arthritis and ankylosing spondylitis, both of which Cosentyx is also approved to treat.”
Geoffrey C. Porges of SVB Leerink Research commented that “This is another study confirming the superiority of IL-23 inhibition to IL-17 inhibition as a treatment strategy in psoriasis.”
“Skyrizi in particular offers the advantage of long-term three-monthly dosing, compared to monthly dosing with Cosentyx and Taltz. Today’s positive head-to-head trial result increased our conviction that Skyrizi will continue to grow strongly and gain share from its competitors (Cosentyx annual sales ~ $3bn),” he added. “We currently forecast Skyrizi sales reaching $1bn this year, and growing to $2.7bn by 2022, before meaningful contributions from additional indications boost revenue, with total revenue ultimately reaching $6.5bn by 2028. Our Skyrizi forecast is 16-22 percent higher than the latest consensus for the 2020-2025 time frame and is a key element of our positive stance towards AbbVie’s stock.”