Among its dozen FDA approvals for a variety of autoimmune disorders, AbbVie’s Humira has plenty of competition in most of its indications. In the debilitating skin condition hidradenitis suppurativa however, Humira is a solo act—a status it has enjoyed since its FDA nod in 2015.
But AbbVie may soon have some competition as Novartis has reported that its blockbuster Cosentyx provided rapid and sustained relief to HS patients in two phase 3 trials.
The placebo-controlled Sunshine and Sunrise studies, which included more than 1000 patients in 33 countries, differed in their dosing regimens—and their results.
In the Sunrise trial, in which a 300mg dose of Cosentyx was given every two and four weeks, investigators saw a statistically significant number of patients achieve a hidradenitis suppurativa clinical response (HiSCR), which is defined as a greater than 50% reduction in inflammatory lesions and no increase in abscesses or draining fistulas. While 42% of those on Cosentyx every two weeks and 46% of those on Cosentyx every four weeks reached HiSCR, 31% did the same on placebo.
In the Sunshine trial, patients receiving Cosentyx every two weeks achieved a statistically significant HiSCR response compared to placebo. For those receiving Cosentyx every four weeks, the drug outdid placebo in HiSCR but did not reach the clinical significance threshold. While 45% of patients receiving Cosentyx every two weeks and 42% of those on Cosentyx every four weeks reached HiSCR, 34% did the same on placebo.
In addition, a secondary endpoint was skin pain. In data pooled from the two studies, Cosentyx proved statistically superior to placebo in reducing skin pain.
The data were presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress. Novartis said it has submitted the data to regulators in Europe and plans to do so before the end of the year in the United States.
“We hope to offer Cosentyx as a potential new treatment option as soon as possible to support this underserved patient community as part of our ambition to expand Cosentyx to 10 indications,” said Todd Fox, Novartis’ global head of medical affairs immunology, said in a release.
Cosentyx, which has been approved to treat five diseases, generated sales of $4.7 billion last year, which was an 18% increase from 2020.