J&J’s Skin Drug Beats Humira in Final-Stage Psoriasis StudyBy
Drugmaker positioning itself to expand immune treatments
Guselkumab targets protein involved in skin immune response
Johnson & Johnson’s experimental drug for psoriasis hit its main goals and outperformed a rival in a final-stage study, positioning the company to expand its arsenal of immune-disease treatments.
The drug, called guselkumab, cleared or nearly cleared the skin of 81 percent of patients after 48 weeks of treatment, the company said Saturday in a summary of research findings. That compared with a 55 percent rate among those on AbbVie Inc.’s Humira, New Brunswick, New Jersey-based J&J said.
The company’s second-best-selling medication last year, Stelara, is already approved for psoriasis, a cause of itchy, scaly skin. Its top-selling therapy, Remicade, competes with Humira for treatment of a number of conditions, including psoriasis. As cheaper copycats of Remicade called biosimilars approach the market, J&J is looking for new drugs to treat immune disorders.
Both Humira and Remicade work by tamping down the activity of a protein called tumor necrosis factor that drives inflammation, an immune process that overreacts in psoriasis and other diseases. Both drugs are used to treat a range of autoimmune conditions, including rheumatoid arthritis and Crohn’s disease. Guselkumab targets a protein called interleukin-23, which is more specifically involved with the skin’s immune responses, according to Andrew Blauvelt, president of the Oregon Medical Research Center and lead investigator of the J&J-sponsored study.
“We’re targeting the disease better,” with guselkumab than with Humira, Blauvelt said by phone. “What we get, in my view, is higher efficacy.”
In the study, which looked at 837 patients, 4.9 percent of those on guselkumab had a serious side effect compared with 4.5 percent of those on Humira after 48 weeks. The study met its main goals, as 85 percent of patients taking guselkumab had clear or nearly clear skin after 16 weeks, compared with 6.9 percent of patients receiving a placebo, and 73 percent had nearly all their skin cleared, compared with 2.9 percent of patients on placebo.
One patient in each of the two groups suffered a heart attack, and two patients on guselkumab developed cancer -- one prostate cancer and the other breast cancer -- compared with none among patients taking Humira. Blauvelt said he didn’t think the cancers, which are relatively common, were drug-related, and that longer-term safety studies are required.
The data were presented Saturday at the European Academy of Dermatology and Venereology Congress in Vienna.