Novartis’ investigational psoriasis drug secukinumab (AIN457) bested Amgen’s Enbrel in a Phase III study presented at the 22nd Congress of the European Association of Dermatology and Venereology in Istanbul, Turkey.
Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes IL-17A.
The FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) study found that secukinumab showed improved efficacy ompared to Enbrel in patients suffering from moderate-to-severe plaque psoriasis.
Secukinumab was more effective in clearing skin faster with a long-lasting effect than Enbrel, the head-to-head trial showed.
Data from an additional phase III study, SCULPTURE (Study Comparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed regimens vs reTreatment Upon start of RElapse), showed efficacy of secukinumab dosed at monthly intervals. Novartis plans to file for approval in the EU and the US later in 2013.
Secukinumab is also being evaluated for psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis, among others. Additionally, secukinumab is in phase II studies for the treatment of multiple sclerosis.
Mark Lebwohl, MD, professor and chairman of the Department of Dermatology at Mount Sinai School of Medicine in New York City, spoke with Plastic Surgery Practice about these findings and the current thinking on how to best treat psoriasis and prevent its downstream consequences.
“Secukinumab is a suberb drug. It works and works really fast and has a durable effect,” he says. While the use of biologics such as tumor necrosis factor alpha (TNFa)-blockers have revolutionized the treatment of psoriasis, many people don’t respond to TNF blockers, and some stop responding over time.
A growing body of evidence suggests that psoriasis is more than skin deep, and it can increase risk for diabetes, metabolic syndrome, and heart disease. As such, there is a huge movement to treat the condition more aggressively and hopefully stave off these consequences.
Available biologics do seem to lower these risks for these comorbidities. “Will the same thing happen with Il-17 blockers? We hope so,” he says.
“There are a lot of patients out there who are suffer badly from psoriasis and joint disease and cardiovascular disease and all of the associated complications of psoriasis,” he says. “We should be paying more attention and we do have drugs, but we are not taking advantage of them.”
The main reason is expense. Concerns about side effects—namely, infection and cancer—also exist, but “the risk for non-skin cancers is small and skin cancer risk is one that we are pretty good at handling,” he says. Patients are tested for signs of infection before beginning treatment with these biologic drugs.