"This drug has had, in this trial, the highest efficacy we have ever seen with any biologic in psoriasis before," says study researcher Kristian Reich, MD. Biologics are genetically engineered proteins derived from human genes.
Reich, a partner at Dermatologikum Hamburg and professor of dermatology, venerology, and allergology at Georg-August-University in Gottingen, Germany, says that after a year of therapy, roughly 60% of the 154 patients in the briakinumab group had near or complete clearance of their skin lesions. Those same results were achieved by about 10% to 20% of 163 patients in the methotrexate group.
"This is unheard of," Reich tells WebMD. "We in dermatology have never spoken about remission before. But with this drug, the word 'remission' is on the table."
But as successful as the drug appears to be for some patients, it may come with a significant risk. Patients taking briakinumab had more serious infections and more cancers than those taking methotrexate.
"We had amazing responses," Reich says. "Obviously, the price that this comes with is the increased rate of serious infections and cancers."
Abbott, the company that makes briakinumab, announced in January that it was withdrawing its bid to get the drug approved in the U.S. and Europe after regulators asked to see more robust proof that the medication was safe.
At that time, the company said it wanted to evaluate the "next steps" for briakinumab and might try for approval again at a later date.
"This is the single most effective drug we've had in psoriasis, ever," says Kenneth B. Gordon, MD, a dermatologist and clinical associate professor at the University of Chicago's Pritzker School of Medicine. "Many of us were disappointed it was withdrawn because there would be a subset of patients who wouldn't respond to anything else and it would have been nice to have for them."
Gordon was not involved in the current study, but he has been involved in research of the drug and has been a paid consultant and investigator for Abbott.