RA: New Drug Reduces Symptoms, Increases Functioning

Research led by a Stanford University researcher has shown that a new drug, baricitinib, reduced symptoms and improved physical functioning in rheumatoid arthritis (RA) patients who had exhausted other options. The study, appearing in the March 31, 2016 issue of The New England Journal of Medicine, was a 24-week randomized, double-blind, placebo-controlled trial, which was carried out at 178 centers in 24 countries and involved more than 500 adults.

“This is the first drug to demonstrate meaningful clinical benefit in patients who’ve failed virtually every other commercial drug for rheumatoid arthritis, ” said Mark Genovese, M.D., professor of immunology and rheumatology and the study’s lead author, in the March 30, 2016 news release. The senior author was Josef Smolen, M.D., of the Medical University of Vienna, in Austria.

As indicated in the news release, “baricitinib belongs to a new category of small-molecule drugs, available in pill form, called Janus-kinase inhibitors. They work by interfering with intracellular enzymes whose signaling action is necessary for various inflammatory substances in the body to be effective.”

“Some 55 percent of the patients assigned to the higher dose experienced a reduction of at least 20 percent in the number of affected joints at week 12, the primary endpoint of the study. For patients on the lower dose, 49 percent experienced a similar reduction. In contrast, only 27 percent of the patients receiving a placebo saw this effect. Patients on either dose of baricitinib also had improved physical function and reductions in markers of inflammation, both in absolute terms and in comparison with placebo, the study found.”

“The drug worked well across all patient subgroups, independently of what they’d been taking before or how long they’d had the disease, ” said Dr. Genovese.

Dr. Genovese told OTW, “The hard work done by many immunology labs to better understand this biochemical pathway, and the significant effort that went into the non-clinical, and then Phase I and II clinical trials led up to this pivotal Phase III study. In this trial we studied a population of patients who had failed biologic agents because this is the area of the greatest need. We were pleased to see that baricitinib works well in patients who have active disease that has been refractory to many other agents and that it demonstrated that benefit can be obtained independent of the number or the type of agent previously used. If surgeons have patients with active disease they should refer them back to the rheumatologist for consideration of new treatment options.”