The trial (A2302E1) was an extension of two Phase 3 studies (ERASURE, NCT01365455, and FIXTURE, NCT01358578) covering 120 patients with psoriasis. Novartis presented the results at the 13th Annual Maui Derm for Dermatologists in Maui, Hawaii.
After a year of Cosentyx, patients with at least a 75 percent improvement in symptoms were randomized to receive either 300 mg a day of Cosentyx or a placebo. If the placebo patients relapsed, they were put back on Cosentyx. Researchers used a Psoriasis Area Severity Index (PASI) 75 response to determine which patients had achieved a 75 percent improvement in symptoms.
Patients with continuous treatment maintained a high level of response. Twenty-one percent of the 120 patients who discontinued treatment maintained clear skin for up to a year without treatment. Ten percent maintained clear skin after two years without treatment.
The PASI score for the group that stopped treatment after a year was 2.9, versus 20.5 before treatment began. The score for the group that stopped treatment after two years was 1.7, versus 19.2 before treatment.
Patients who had psoriasis longer were more likely to relapse. Researchers concluded that early treatment with Cosentyx increased the likelihood of no relapse.
Previous studies had shown that Cosentyx delivers clear or almost clear skin in up to 80 percent of patients for as long as four years. The PASI scores those patients achieved were 90 to 100.
“These results suggest that Cosentyx may go beyond simply treating symptoms and could actually modify the course of psoriasis, and highlights the need for further investigation into early intervention,” Vas Narasimhan, Novartis’ global head of drug development and chief medical officer, said in a press release. “Being able to change the course of disease is the ultimate goal of treatment, which is why we are investing in the STEPIn trial to further understand the disease modifying ability of Cosentyx in psoriasis.”
The STEPIn (NCT03020199) trial will look at the benefits of early use of 300 mg of Cosentyx in patients with new cases of moderate to severe plaque psoriasis. It will assess whether the therapy can lead to prolonged symptom-free periods by preventing new lesions or the reactivation of old ones.
Cosentyx is a human monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine, inhibiting its interaction with the IL-17 receptor. It is the first IL-17A inhibitor to demonstrate the potential of modifying the course of psoriasis. The U.S. Food and Drug Administration has approved Cosentyx to treat plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.