AbbVie reported that its Skyrizi met both primary and all ranked secondary endpoints in its Phase III trial that went head-to-head with Novartis’ Cosentyx in plaque psoriasis.
The Phase III, multicenter, randomized, open-label, efficacy assessor-blinded, active-comparator trial studied the safety and efficacy of Skyrizi compared to Cosentyx in adults with moderate to severe plaque psoriasis. Patients were divided evenly to receive Skyrizi as two 75 mg subcutaneous injections at baseline, four weeks later and every 12 weeks afterwards, or 300 mg Cosentyx as two 150 mg subcutaneous injections at baseline, weeks 1, 2, 3 and 4, then every 4 weeks after.
The two primary endpoints were non-inferiority at week 16 and superiority at week 52, both determined by Psoriasis Area and Severity Index (PASI 90). Skyrizi met both primary endpoints.
There were three ranked secondary endpoints, PASI 100 at week 52, sPGA 0/1 at week 52 and PASI 75 at week 52.
Skyrizi demonstrated significantly higher rates of skin clearance compared to Cosnetyx, with at least a 90% improvement from baseline in PASI 90 at week 52. Of the patients receiving Skyrizi, 87% hit PASI 90 compared to 57% of the patients receiving Cosentyx. At week 16, Skyrizi also hit the other primary endpoint of non-inferiority to Cosentyx with 74% of patients hitting PASI 90 compared to 66% of the patients receiving Cosentyx.
The safety data in the trial was consistent to what had been observed in other studies, with no new safety signals. The adverse event rates between the two drugs were comparable. The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, joint pain and diarrhea. Adverse events so severe that they led to discontinuing the drug were 1.2% in the Skyrizi group and 4.9% in the Cosentyx group.
“In this study, Skyrizi showed superior efficacy compared to Cosentyx in helping patients achieve and maintain high levels of skin clearance at week 52,” said Michael Severino, vice chairman and president of AbbVie. “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.”
Skyrizi has been approved for moderate to severe plaque psoriasis in adults by the U.S. Food and Drug Administration in April 2019. It has also been approved for that indication in Europe.
AbbVie is on something of a roll this year and analysts expect it to be a great buy for investors. It will close on its acquisition of Allergan early this year, and in December, the FDA approved its Ubrelvy for migraines. Ubrelvy has a few advantages over other migraine therapies on the market, including that it can be taken orally. It can also be taken after the headache stars, rather than ahead of time. The FDA itself noted at the time, “Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication.”
The drug is expected to hit the market in the first quarter of this year, which will likely give the company revenues a boost, which has been consistent with about 8% growth over the last two years. Ubrelvy will be facing some competition, including Eli Lilly’s Reyvow, which was approved in October 2019, and Amgen and Novartis’ Aimovig.
Once the Allergan deal is complete, AbbVie plans to let Allergan Aesthetics operate as an individual business unit, while integrating the rest of the business into its operations.
